How the Direct-to-Patient Approach Can Streamline your Research Study and Trials


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The research process can be an inconvenience and a burden for the patient test subject; currently over 40% of test subjects drop out mid-way through the trial. In traditional research models, study participants travel to a medical facility/study-site for screening, baseline, monitoring, and follow-up visits – depending on the study design. However, this model increases the burden on study participants and their caregivers, such as work-time loss, study site visits outside typical physician visits, transportation issues, use of paid-time-off hours, overcoming mobility/disability limitations, inconvenient study-visit timing, and inability to commit to repeat visits.

In-home patient visits for biospecimen collection are an alternative to combat these existing barriers. As a biopharma community, we need to look for ways not to delay research and clinical trials, but continue to make strides for treatments and cures.  Home visits are an alternative to keep studies and trials moving forward.

In this Sanguine S3 Webinar, we will discuss:

  • Benefits of in-home collection, processing and procedures
  • How to avoid study delays due to lack of samples
  • How to get better access to patients
  • Case studies demonstrating successes with same day collection

Speakers:

Gerald Lee, Chief Product Officer, Sanguine Biosciences

Amanda Effres, ACRP-CP, Head of Feasibility & Study Design, Sanguine Biosciences

Transcript:

John Fremer:

We’d like to welcome you to our Sanguine Speaker Series webinar. Today’s topic is How the Direct-to-Patient Approach Can Streamline Your Research, Study & Trials. Our speakers are Gerald Lee, Sanguine’s chief product officer and Amanda Effres, Sanguine’s head of feasibility and study design. And I’ll hand it over now to the presenters. 

Gerald Lee:

Thank you, John. And like to give a thanks to our listeners today for joining us in this webinar with myself and my colleague Amanda, and today, we’re happy to talk with you all about how the direct-to-patient approach can streamline your study in trials. So let’s dive in. 

Gerald Lee:

The overview on the agenda for today is, first, we’re going to start with some of the problems and of course, how we’re dealing with these in the COVID centered world and how it’s impacted research and sharing some of the things that we’ve seen here at Sanguine. 

Gerald Lee:

And then we’re going to talk about Sanguine’s direct-to-patient approach and what it is. And, of course, the benefits of this direct-to-patient approach. And lastly, diving into some case studies with my colleague, Amanda [inaudible 00:01:03]. So some of the problems that we face, I think most of us are aware of these as, we focus on recruitment and retention.

Gerald Lee:

And especially when talking about rare disease conditions or diseases of low prevalence or stringent IE criteria. It’s also really becoming tougher to identifying patients into studies and trials and this remains a challenge. Many trials fail to meet enrollment timelines, many do fail.

Gerald Lee:

And there is a problem with limited access to rare disease populations, and populations of small sizes. Ultimately, this affects timelines, budgets, and the ultimate success of many of this studies. And then of course, on the patient side, the retention piece is an issue for various reasons, many patients will drop out of trials, and are not able to continue for various reasons from inconvenience to lack of resources and transportation, lack of engagements, any sort of limitations, financial constraints, fear, anxiety, scheduling conflicts, and ultimately, it’s just hard for many folks to have that type of commitment and time, energy and resources to put into these initiatives. 

Gerald Lee:

Now talking about the impact of COVID-19 on research. And especially in the beginning of the pandemic in the US, in March, April, you saw a lot of preventative measures that were in place, for good reasons in terms of public health. But still, of course, has presented numerous challenges to the research community. 

Gerald Lee:

And these measures, included [inaudible 00:02:50] travel restrictions, facility closures and limited access and unwillingness and reluctance to visit sites, because of the fear of especially high risk areas of infection and spread. And this is especially important for more vulnerable populations, there’s elderly or populations with autoimmune conditions [inaudible 00:03:16]. And these measures impacted research in a way that disrupted trial continuity, to increase study delays.

Gerald Lee:

And there is a report and survey taken from sites that show the top mitigation strategies that sites have taken to combat the effects of COVID-19. And these strategies included positive enrollments, extending visit windows, and ultimately delaying a lot of these trials moving to increase costs and these delays. I believe the NIH estimates that about $10 billion in NIH funded research will be affected from the effects of the pandemic.

Gerald Lee:

And this is not to mention the increased direct and indirect costs incurred by the industry due to lost time. So all this ultimately impacts these studies, increase in cost and these delays. And we want to show how this has affected us at Sanguine, since March. And so as you can see from the chart on the left, COVID has become a dominant force for obvious reasons.

Gerald Lee:

And so many of the new studies and projects that we’ve been working on have been in COVID-19. And we’ve seen a very high demand for location participants with active or recovered COVID, especially for blood and blood derived samples, whether it’s being used for vaccine or antibody research, and especially collecting plasma serum from PCR positive patients, and we ultimately help recruit, screen, gather the documentation, including confirmatory test results, administered surveys and scheduled and collected the samples from the home.

Gerald Lee:

As a result of this, we’ve had to also implement additional safety protocols, including in cancer screening requirements, special safety training for our mobile staff, and also an additional investment in PPE. And during this pandemic, we’ve actually seen about a two to three x increase in requests and demand for at-home trial services. And so we see the industry and the community seeing a need, and a fit when it comes to their trials and their research.

Gerald Lee:

And so we want to know what our researchers and industry folks were saying. And so we ran a survey looking at various factors. And I think one of the questions we asked were most important study design elements, and all these related to populations of lower prevalence, stringent IE criteria and the need for better access. 

Gerald Lee:

We also surveyed a lot of research scientists and industry and they talked about more reliable, longitudinal sampling and visits. And this also relates to many of the common challenges that we heard about in terms of patient access, specifically or presumably for rare disease populations, population for lower prevalence, or strict IE criteria. And then also the theme of retention, of course, for longitudinal studies across. 

Gerald Lee:

All these aspects we saw relate to one another and we think that hopefully that our approach can help a lot, resolve some of these challenges, or help resolve some of these challenges. And ultimately 50% of those survey say, they did not hit their enrollment targets. 

Gerald Lee:

What is Sanguine’s direct-to-patient approach? I don’t think this is the new term. But ultimately, it’s an approach that centers around the patient from building direct relationships and engagement with our patients to perform many procedures such as sample collection, from the comfort of the patient’s home. And what’s most important is that it results in more added convenience, higher patient satisfaction, which ultimately leads to better retention, better outcomes and in a COVID world, this is more important than ever.

Gerald Lee:

One of the other problems in the space has been the increase in complexity, and the indirect line to patients. Whether you’re a researcher or sponsor, dealing with the health system or other stakeholders, vendors, an indirect line makes it much less efficient, more contracting, more management, more complexity, less consistency, and potentially worse outcomes. And here at Sanguine, on the bottom we have direct relationships with our patients, offer a variety of services. And we’re able to streamline and do many of the things that multiple vendors do, that enables better retention.

Gerald Lee:

And ultimately, we feel that increases the probability of success, and potentially better study outcomes. This diagram shows our direct-to-patient model, in terms of it being an integrative approach. And we have on the bottom left our patient engagements, which includes various marketing and recruitment and outreach methods of channels. It also includes elements of a high touch study support staff.

Gerald Lee:

And of course, remote and screening, and you can send capabilities. In terms of, if you’re working on a trial, we can do the prescreening aspects and work directly with those sites, and perform some of the onboarding, or if we’re working on a specimen collection study with research scientists in the space, we have the ability to handle the recruitment, the onboarding, the consent process, all the way through, all the way to the specimen and data collection.

Gerald Lee:

And, of course, what’s important is the need for high quality and reliable data when it comes to running your research and your trials. And so, this model allows us to safely collect self reported surveys, questionnaires, going directly to the patient, ability to perform patient reported outcome studies. And we’re also able to either retrieve retrospective lab results or even run lab analysis test ourselves, in addition to being able to retrieve medical records for those patients, from diagnosis or to collect other pieces of data that’s needed for your study. 

Gerald Lee:

And then lastly, on the bottom right, what brings everything together is this vertically integrated approach of providing the important at-home visits. And so we ultimately bring the convenience of that research to the patient, which allows for better access for our researchers. And some of the features include, we have trained and certified mobile health staff. We can do visits outside of the clinical setting. And we have elements of logistics and shipping support, including elements of kitting, which includes blood draw supplies, blood tubes etc.

Gerald Lee:

And so what are some of the benefits. Ultimately, you increase engagement and convenience for the patient. And what this leads to is multiple aspects. So potentially accelerating your study timelines, enabling trial continuity with our at-home visit model. It presents an element of broader patient reach, which increases your recruitment, flexibility and geographical reach with our decentralized model, leading to accelerated recruitment.

Gerald Lee:

And with this model, we improves patient retention, we have high satisfaction scores here at Sanguine from a patient side and providing less travel burden provides more convenience, which leads to of course better retention. And for a lot of the scientist benched researchers that we work with in the industry, this method enables reliable longitudinal sample collection, so far longitudinal studies, which may span six months or even multiple years. We have an average retention rate of over 90%. 

Gerald Lee:

Many of our participants participate multiple times. And when we’re talking about studies related to those with patients with chronic conditions, we’re able to do the blood-based sample collection, whether you’re talking about flares. For lupus patients the price depends, for our sickle cell patients we have the ability to select sample and data based on a event-driven model.

Gerald Lee:

Ultimately, this approach has enabled us to build relationships and expertise, or experience in various therapeutic areas. Some barriers are here that you see here. I believe it’s also on our website. And if you have specific questions, we’ll, of course, give you some more information and you can reach out to us. But for now, I’m going to hand off to my colleague, Amanda, who will go into more details about our direct-to-patient approach, and also into some case study examples. So Amanda, you can take it away from here.

Amanda Effres:

Thanks, Gerald. Taking a look at these three facets, each in turn starting with patient recruitment and engagement. I thought we’d start off with a review of considerations when determining a recruitment timeline and optimizing that. This shines a light on our own feasibility assessment process, evaluating these five specific features when determining what your overall study timeline will look like.

Amanda Effres:

So what’s the prevalence on the online reach for patient targeting of your condition of interest? How many patients are available in your existing patient database and community that you can perform outreach to, to start before even meeting to launch ads online or work with other partners for recruitment? Three here, how does the stringency of your criteria impact the patient pool that’s available? 

Amanda Effres:

So based on comorbidity restrictions, treatment, medication restrictions, how does that limit the available population for participation in your study? Next, what screening efforts are you intending to utilize that might impact your timeline overall? Are you reviewing medical records? Are there in-home assessments that might be needed as part of your screen like for lab testing? Are there questionnaires that you need to administer that require time and efforts there to determine if patients will ultimately qualify and be enrolled in your study? 

Amanda Effres:

And finally, what’s the impact to your timeline based on what recruitment strategies you end up needing to employ? So considering these features in determining your timeline, we wanted to describe to you folks what Sanguine’s integrated recruitment approach looks like so it involves patient advocacy, social media and digital advertising, as well as outreach to our patient community which has been built by a byproduct of those activities in advocacy outreach and online targeting. 

Amanda Effres:

So looking first at patient advocacy, Sanguine has over 50 partnerships with groups that we’ve partnered with in cases or rare disease of oncology, some of the groups they’re listed on the right. But what works really well in partnering with these patient advocacy groups to target patient populations is we’re leveraging what their existing communication platforms are to reach their members for sign up. 

Amanda Effres:

They’re part of these groups for support, but also interested in learning about research that they might be involved in to help them, to help others like them. It’s a great approach in reaching the patients based on your condition of interest directly. To supplement that outreach, and what’s successful generally across the board, but taking into consideration prevalence and online reach, our social media and digital advertising tools. 

Amanda Effres:

On a monthly basis, Sanguine reaches over 20,000 patients through this method, so across different platforms online, it’s a great way to also target via geography. So think about for trials, you can target for a certain radius around specific locations. That’s an effective approach in targeting patients there, and patient community outreach. 

Amanda Effres:

So your existing database of patients, whether they’re through patient advocacy, outreach, social media, online advertising, our community signs up online and opts in to learn more about research opportunities from us, thus they’re highly engaged, ready to participate. We have over 30,000 patients and spanning those various therapeutic areas Gerald had shown in the previous slides. So by building up that patient community, you’re well positioned to fulfill certain studies based on the recruitment and the criteria constraints.

Amanda Effres:

Taking a look at the specific benefits and kind of elaborating on those a bit more, partnering with patient advocacy groups offers four key benefits that we’ve identified here, that patients are highly engaged to this approach. They’re interested in support and accessing information, but also research. So targeting them through here is an effective way to get them enrolled into your study. So number two, it’s targeted, you’re effectively reaching out to the patients with the diagnosis of interest. 

Amanda Effres:

Three here, partnerships with patient advocacy groups offer feasibility assistance, I can speak to the numerous conversations I’ve had with organizations that have been very productive and helpful to enable patient centric designs, reviewing their specific criteria against the types of patients that are members of their community. That’s certainly assisted my communication with researchers to kind of develop more feasible study designs. 

Amanda Effres:

So if with that approach, that’s definitely going to optimize your recruitment timeline, if you’re mimicking the profiles of patients that are available in the real world, I should say. And forth very important, through this targeted approach, the patients are highly engaged, the design is sound and set up for the right patient. 

Amanda Effres:

So you’re going to have accelerated timelines, we experienced that working with the MPN Research Foundation for myelofibrosis in the first month, outreached through that partnership, we recruited 53 signups which allowed us to finish our project two months ahead of schedule, so saving time and costs for that researcher. 

Amanda Effres:

Taking a look at our direct-to-patient approach and during COVID-19 we wanted to highlight a case here where we didn’t have COVID-19 patients before the pandemic. So beginning in March, understanding a need to accelerate research in this area, decided to build up a patient community through online advertising, social media advertising, so within a two-month period, we recruited nearly 800 patients diagnosed with COVID-19.

Amanda Effres:

During that time, we began receiving many requests from researchers to access these patients for research for sampling. To speed up the process of they’re accessing these samples directly and essentially immediately, we built up a bio repository of samples over 1000 serum vials from patients recovered of COVID-19, while also performing prospective collections for other sample types, whole blood, other blood portions, resulting in researchers gaining direct access to these patients in addition to the associated health data. 

Amanda Effres:

Throughout this process, our in-house study coordinators are screening these patients, consenting these patients and signing them up for these in-home visits. So we wanted to highlight some key features of the requests that we’ve received and accommodated. These patients, PCR confirmed positive infection. We’re reviewing their medical records to determine whether or not they qualify, asymptomatic versus symptomatic cases, whether or not they had been hospitalized due to their infection. 

Amanda Effres:

And that under our protocol we were obtaining up to 180 milliliters of whole blood drawn from these patients in their homes within a six-week period. So really a strategic manner of outreach can accelerate your study progress, and we’ve completed over 40 studies since March through August of this year, because of this direct approach and engaging with these patients.

Amanda Effres:

Taking a look next at in-home visits, what are the benefits, there’s three key benefits that we wanted to highlight here. Of course, by visiting patients in-home, you’re reducing the burden of travel, increasing their satisfaction in the participation process, which leads to improved patient retention overall. 

Amanda Effres:

This approach of direct-to-patient engagement, recruitment broadens your reach, as you see on the map. That’s where our mobile phlebotomy, mobile nursing resources are located throughout the US. So if we’re planning to recruit in certain areas, we can take a look at the feasibility of onboarding appropriate mobile medical resources in those areas. 

Amanda Effres:

So if we can expand our reach and aren’t limited necessarily to restrictive geographies, we can accelerate the patient recruitment timeline that way and I’m going to get into some case studies on that in a little bit. This benefit of at-home visits of course benefits all study participants, but it’s really ideal for specific populations that elderly, pediatric participants, rare disease populations, patients with limited mobility, making it easier for them to participate from home by assessing the types of conditions they may have to help support them in the trial process or research process. 

Amanda Effres:

In-home visits can be flexible, and it’s a matter of understanding what specific requirements are needed as part of your trial. Your early phase research, taking a look at the schedule of activities under the trial protocol to see what can be adapted to the home. In the home there’s a restriction to collecting samples via minimally invasive methods.

Amanda Effres:

We’ve listed these here and at Sanguine this approach offers longitudinal sampling, our phlebotomist and nurses can perform in-home centrifugation, processing, aliquoting, accommodating various temperature of requirements based on the lab manual needs, so Ambien, refrigerated, frozen, administering questionnaires, performing vitals, measurements, potentially physical exams and other assessments, and all compliant with good clinical practice guidelines 21 CFR 11 requirements for e-consenting, keeping that in mind as that’s important. 

Amanda Effres:

The three main at-home visits that we’ve really seen are highlighted here, event-based home visits which Gerald alluded to earlier, collecting samples during patients reporting specific events. Really, it’s a matter of understanding what specific events are important to you based on the patient population you’re interested in. 

Amanda Effres:

We’ve done flare events for sickle cell anemia patients, flare events for autoimmune patients, as well as visiting patients before they take their first dose of medication for the day or around certain dosing schedules for a standard of care therapies. For prescreening home visits, that can be added on to trials that might have a pretty heavy element of lab testing, lab testing requirements as part of the screen. 

Amanda Effres:

So working with a provider that can offer these pre screening services to speak to patients directly. They answer questions based on that, then schedule them for an at-home visit to collect some samples, and perform testing on those samples. And then based on those results, refer them to the appropriate site for the full blown screening visit. 

Amanda Effres:

That’s effective, it saves time, alleviates some of the site’s burden to screen these patients and then kind of whittles down the patient population, the sites are needing to see. So they’re verified from these pre screening visits that they at least meet those aspects of the criteria. So it’s going to save time for the sites.

Amanda Effres:

And the third here, site requested home visits, working as an extension to the sites, offering in-home visits where we can again based on the specific scheduled events, what can be adapted to the home. Sanguine, has performed scheduled and unscheduled ad hoc by the site’s request for visits that include sample collection, there’s other services, I mentioned on the previous slide, safety lab retesting.

Amanda Effres:

It’s really adaptable. And again, dependent on what the specific needs of your study are and endpoints of your research. We wanted to showcase here just the response from our own patients that we’ve surveyed. They appreciate how convenient home visits are. So these are just some quotes directly from their survey responses that we wanted to highlight, summarizing kind of what their motivations for participating are. The top three. Advancing research for their condition, wanting to help other people like them and because it’s easy and convenient to participate from home.

Amanda Effres:

The best part, kind of reflecting those motivations, convenience of participation and making an impact in medical research. Looking at the third feature of this integrated direct to patient approach, we wanted to review data collection and Sanguine’s capabilities here, starting first with our direct-to-patient approach and study coordinator process. 

Amanda Effres:

So we have a team of study coordinators in-house that are dedicated to various projects and have direct lines of communication with our patients. So four projects, they will be reaching out to patients in our community, in our database that have opted in to learn about research, responding to those patients that are signing up online, but they’re speaking to them by phone, and are available to answer questions they have and work with them through this process.

Amanda Effres:

So based on the patient’s response, they walk them through the process, the participation requirements of the study, e-consenting them and also screening them to ensure that they’re eligible. Our typical screening process includes retrieval and review of patient’s medical records. So evaluating that, clinician impressions, and anything else that might be available in the subjects records.

Amanda Effres:

We’re administering questionnaires that patients are responding to, self reporting to so combining that with medical records and perhaps even performing sample testing, to confirm that they qualify. These are just the different levels of screening that we utilize to ensure patients are eligible before we qualify them, schedule them for in-home visits or refer them to sites for trial enrollment. If it’s visits that we’re assigning them to after that point we’re assigning appropriate medical health professionals. 

Amanda Effres:

In summary, the advantages being this direct approach optimizes study enrollment timelines, we’re going directly to patients, recruiting them directly, speaking with them directly versus waiting for a physician to refer them to us, or a more passive approach that can be taken. This is an active direct approach to reach patients. 

Amanda Effres:

It’s effective in obtaining their patient reported outcomes, other self reported measures directly, you’re speaking with them, you’re not getting this information from a third party. It’s coming straight from these patients themselves.

Amanda Effres:

It offers a dedicated resource for patients, answering questions they have regarding participation requirements, this is very important. We all know studies, participation, varies between studies, trials, single time point, longitudinal time point, so it’s important to have a resource for patients to get them comfortable with the participation requirements, what’s going to happen in their home. Our study coordinators do that on a daily basis with the various patients that they encounter and speak to. 

Amanda Effres:

This process makes it easier for patients to enroll. It’s remote, they can review the consent form remotely, electronically, sign it electronically. And ultimately increasing efficiency in the recruitment and screening process here. 

Amanda Effres:

Taking a look at a couple of our communities and case studies associated, we wanted to highlight for sickle cell disease, you see a heat map of where these patients reside throughout the US. The types of lab result’s that we’ve obtained. This has been based on researchers request to date. And then some of the self reported data that we obtain that’s made available to our researchers, of course, any information collected is deidentified. 

Amanda Effres:

So protecting the patient’s privacy as well, over 60 studies we’ve completed, over 470 patients and conducted hundreds of visits in-home. A lot of our sickle cell patients donate pretty regularly, many of our projects are longitudinally designed, so the patients are donating quite often and continue to do so because it’s convenient for them. 

Amanda Effres:

If we take a look at a specific case study in sickle cell anemia, where we were obtaining data remotely and following patients on a longitudinal basis to perform event-based sampling, in this phase zero study, there were several challenges. The researchers required blood sampling during and after a pain crisis. So think about it, patients experiencing this relaxing event pain crisis, it’s going to be difficult for them unless they’re seeking medical attention to go into a site to have their blood drawn when this happens. 

Amanda Effres:

And the clinical sites because of this had a tough time recruiting and retaining patients. Participation for a six-month period require that they complete an ePRO pain diary on a daily basis as well as wear a wearable watch to track their activity throughout the study duration. 

Amanda Effres:

Sanguine’s actions on this project included a time investment to help educate patients on the study value, the commitment, so that was through our dedicated study coordinators assigned to this. They also monitored the compliance and use of these devices, the ePRO device, the wearable watch, on gathering feedback for the sponsor throughout the study. 

Amanda Effres:

And just this direct connection helped to develop trust, enabling this in-home sample collections throughout this process, and ultimately resulting in our obtaining these valuable biomarker data points for the study sponsor that allowed them to move to the next phase in their research for sickle cell anemia. 

Amanda Effres:

The next community we wanted to take a look at, our SLE community. So nearly 3000 patients, over 12,000 visits have been completed in the home across over 64 or 64 studies. These are some common lab results that we’ve conducted for these patients. So if available in the medical record, we can identify that for the researcher.

Amanda Effres:

But through our lab partnerships, we can also perform these tests for current lab values if the researchers are interested so that can be incorporated in the study designed to offer more data and information to support their research, self reporting symptoms, comorbidities, the treatment duration response, non response, you’ll see them on this heat map. Most of the patients are kind of concentrated on the coasts. And that’s really because that’s where our researchers are located. 

Amanda Effres:

And Sanguine offers same day delivered samples in cases where we can based on your criteria. This next example, this case study I have will highlight that same day delivery service and longitudinal sampling. So for one of our researchers in the South San Francisco area, they’re interested in following 24 lupus patients over a two-year period to track their disease course and flare frequency, excluding certain treatments and of course, needing the samples fresh same day so that meant that we needed to restrict geography to the Bay Area there around their facility.

Amanda Effres:

Sanguine already has an existing community of lupus patients in that area but to supplement the outreach to our existing database, we launched ads online geo targeted to San Francisco, performed screening via medical records and self reported questionnaires to confirm their diagnosis and medications they were taking to ensure that they met the criteria and perform sampling from these patients, in their homes, given the visit schedule, so every two months for the first year, and months 18 and 24 of the second year of participation. 

Amanda Effres:

Really what we wanted to highlight here was the higher retention rate, 96% right now for this study, and we were able to enroll in 24 patients within the first six months of study conduct for this. So accelerated timeline there.

Amanda Effres:

And to close up just a couple other case studies, I wanted to review larger scale studies and trials. The first highlighting again, our approach direct-to-patient recruitment, and how we can have a broad reach to patients to kind of solve certain challenges around geography for studies. In this case, a longitudinal observational study in healthy first degree relatives of Crohn’s disease patients, it was a global study, wanting to enroll 5000, healthy FDRs of Crohn’s disease patients to study the role biomarkers played, disease development. 

Amanda Effres:

So would these healthy individuals eventually be diagnosed with Crohn’s disease, so wanting to follow that path for them and gather valuable biomarker data through biosamples, through patient reported outcomes that they were completing, the limitation really for the study sites was their geography, they have access to their own Crohn’s disease patients, but the FDRs of these CD patients may not reside in the same area as the CD patients. If they’re in another state, not close enough to the site, they’re not going to enroll those patients.

Amanda Effres:

The solution here, that Sanguine offered was operating as a virtual site. Meaning throughout the US, we were unrestricted by geography, the patients didn’t need to come into our site to be evaluated, to be screened, they could do so remotely through the screening process that we have set up. So to start we reached out to our existing Crohn’s disease database, supplemented that with online ads for additional patients to sign up, and our team in-house began screening these Crohn’s disease patients, reviewing their medical records, assessing and evaluating their eligibility to participate based on the criteria. 

Amanda Effres:

And through maintaining these direct and strong relationships to the CD patients, we were able to increase our referral rates to healthy first degree relatives, and as a result, outperform the brick and mortar sites in enrollment speed. And really, because of our expanded access through this remote approach.

Amanda Effres:

And finally, an example of accelerating trial enrollment, this was hepatitis B vaccine trial in healthy participants. There were some challenges here, faced by the sponsor, by the site’s, enrollment rates were falling behind for recruitment. And most of the sites were hitting the limits on the patient’s accessible to be screened.

Amanda Effres:

Not to mention the stringency of the criteria, really focused age range for this. Sanguine, was able to support these sites, launching geo targeted ads in areas near the sites connecting with hundreds of patients already within our community to see if they would be interested in participating based on the regions where the sites were located, and operating as a call center. 

Amanda Effres:

These site, excuse me, these patients were signing up, or responding to our outreach. And so our team of city coordinators would speak to them directly on the phone, evaluate their eligibility based on a prescreener. And if they were interested in taking the next step to be screened at a site, we took a look at where they resided. What we could do is hand them off directly to the site while we were on the line, connect them to the site directly, who would then handle the next steps of getting the patient to the site. 

Amanda Effres:

Instead of giving the patient the site’s contact details so that they could contact the site or giving the site the patient’s information to contact them. We just connected with them directly after patients opted into sharing their information with the site and speaking with them directly. That was working well so we also launched a participant power referral program. 

Amanda Effres:

So of the patients that we spoke to, did they have friends, colleagues, family members that might be interested so that all supported an increase in the number of referrals you were able to make so our referrals resulted in 90 participants randomized in a 16-week period, which meant we were outperforming the 15 brick and mortar sites and became the number one recruiting site within three months. 

Amanda Effres:

Some final takeaways on our direct-to-patient approach, they can be applied as I was saying to clinical trials, early stage translational research, it’s a matter of understanding what specific needs are for your trial and how we can adapt them to incorporate remote elements, at-home visits, patient convenience where we can, the site extension model offers trial continuity, so patients can continue to participate from home instead of needing to travel back and forth to the site. Again, where this is feasible to do so. 

Amanda Effres:

But especially in a pandemic, it’s important to consider this in existing trials where we can to help support patient participation and retention. A direct approach offers broader access, especially in cases where populations may be rare, or with lower prevalence, it offers greater reach and access to patients. 

Amanda Effres:

And finally, it’s patient centered approach. So it increases the participant’s satisfaction, understanding of the study, and ultimately retains them in your research projects, avoiding the stock deadlines, study delays and unnecessary costs. 

Amanda Effres:

So with that, we want to thank everybody for joining us. Thank you for your time. For more information, please feel free to visit our website at sanguinebio.com or you can email us at study@sanguinebio.com. But thank you so much.

Gerald Lee:

Thanks, Amanda. And I think we have a handful of questions that we can dive into. I think the first question is, what are the qualifications of your mobile healthcare staff? Are they nurses? Are they phlebotomist? I guess I could take that one. 

Gerald Lee:

So depends on the role, of course, our phlebotomist require certified phlebotomy licenses, active licenses. Also other sorts of documentation, including driver’s license, proof of insurance. And they go through background checks. And then in addition, they do go through special I guess, training and onboarding. 

Gerald Lee:

And then if we’re talking about a clinical trial, they go through specific protocol training as well. Much of our staff are phlebotomist throughout the US. But we have done a study where we utilize nurses. It’s actually the case study that Amanda presented with the sickle cell patients. And we tend to contract nurses directly for specific projects, if that’s even. I’m not sure if Amanda, you want to add anything to that?

Amanda Effres:

No, not to that question. 

Gerald Lee:

And I think someone was asking about real world evidence, real world data. So for us, I think, going back to the same example, we did a prospective observational study with Pfizer on sickle cell. This is well published, and we also have a video on this on our website, actually. I think our strength is really having the ability to run these prospective observational studies. That includes a home component, but also the direct-to-patient component where we can collect self reported or a patient-generated data, which includes surveys, more or even at-home data collection. 

Gerald Lee:

And so we have the ability from, I guess, a real world evidence, real world data perspective to run these prospective observational studies, which also includes the ability to collect your own perspective lab results as well. And so all this can be a very powerful combination in regards to real world evidence, and we actually have a few studies right now, prospective observational studies in which we are collecting medical record information, patient generated data assists surveys on a periodic basis and also doing longitudinal time point visits and selecting different biospecimens.

Gerald Lee:

I think we also have a pretty robust database when it comes to various conditions such as lupus and RA. So there is a lot of potential in that respect to run studies related to the rule that [inaudible 00:45:14].

Gerald Lee:

I think, another question, Amanda maybe you could take this one is, do the mobile health home visits by phlebotomist work for collection of plasma PK samples that require temperature monitoring and processing, such as centrifugation and pipetting, aliquoting into separate one to two milliliter sample tubes prior to PK samples being frozen for shipment to the lab for PK analysis? Is this approach feasible for PK sample collection for clinical research studies and have we done it? 

Amanda Effres:

Yeah, that’s a great question. Our mobile phlebotomist, mobile nurses have definitely handled in-home processing centrifugation, aliquoting, utilization of temperature monitors and thus equipped with dry ice to make these shipments possible. Dependent on the scheduling of these PK visits, whether it’s around certain dosing or after they take the IP etc. Taking a look at the feasibility of visiting patients at the various time points needed typically for PK sampling, it’s multi time points. 

Amanda Effres:

So evaluating whether it’ll be feasible to have a phlebotomist visiting at the frequency needed for the protocol. That’s part of the feasibility assessment that we would review. But again, whether or not it’s possible for the phlebotomist to perform in-home sampling with centrifugation, pipetting, temperature monitors, yes, that’s feasible for us. And we have done that.

Gerald Lee:

And another question was, do we find that in-home visits help patients to be better informed about the trial? And are they more likely to ask questions and seek understanding in that type of environment rather than in a clinic? I guess what can say, in regards to this topic is the touch point for the patients with us internally, I’d say when is with our well trained coordinators, they’re always there to answer any questions that patients may have about the study. And it provides ultimately a line of support that many patients really utilize.

Gerald Lee:

And we also, of course, give reminders for upcoming at-home visits. And we think that there is a sense of comfort, as we have folks ready to run through any fine details if needed. I think the feedback that we’ve gotten from patients who have participated with us is, we have a satisfaction score of over 9.3, 9.4 out of 10, consistently. And so I think having that extra line of supports available is just an additional resource that can only help with the process. 

Gerald Lee:

And we think that being able to talk with a coordinator on the phone who you’re familiar with, who knows all the details, who’s trained and can answer any questions or concerns is only a value add. That’s been our experience in terms of how that’s really helped, I guess to provide some of that comfort and what we’ve been talking about is increasing that retention aspect for a lot of these trials in these settings. I don’t know, Amanda, if you wanted to add anything to that. 

Amanda Effres:

No you covered that one.

Gerald Lee:

And then another question is in regards to time commitment. So what is the time commitment involved in incorporating income specimen collections into our processes? Amanda, I think you’d be well versed to answer this question. So I’ll hand this all off to you.

Amanda Effres:

Taking a look at again, trial requirements, the specific needs of your protocol and our experience. Sanguine has been involved in protocols before they’re initiated or after they’ve started and a decision has been made by the sponsor that they’re interested in incorporating this remote element for in-home sampling. For our purposes, as long as the protocol is updated, the consents are updated at the sites to include this in-home remote visit. We would need about four to six weeks to ensure that our staff are appropriately trained on the protocol and the specific needs of your study to begin assigning them. 

Amanda Effres:

So digging in a little bit more into what that process has looked like for us, when we’re on boarded to begin at-home visits for a trial. What happens is after of course, the IRB approvals occur, there’s an introduction to the sites of Sanguine so they’re introduced to us, we present to them what our visit request process looks like. And it’s a streamlined online web form that they’re completing as needed for patients that are enrolled. 

Amanda Effres:

And so we receive that notification on our end, to our teams who will reach out based on when these visits need to occur to ensure that they’re conducted in compliance with the visit windows established by the protocol. 

Gerald Lee:

Thanks Amanda. Next question is, do we work with the IRB for approval? So Amanda I’ll let you take this one as well.

Amanda Effres:

Yeah, we have. And generally, there’s a central IRB for the study. And so if Sanguine is developing any patient facing materials, we’ve assisted with recruitment, as I talked about during the webinar. So those materials are developed by our patient marketing teams, and provided to the sponsor for submission with any other materials. So have you worked with IRBs directly? Yes, in managing our own protocols for early stage translational research projects. 

Amanda Effres:

And so we’re communicating with the IRBs, and submitting those documents ourselves, those packages ourselves, but typically, when we’re working under trials for sponsors, with the CRO’s, generally, that’s not managed, the actual submission of those documents, the package of information isn’t managed by Sanguine for trials or provided to the CRO, to the sponsor, who then would submit that on our behalf with any other materials for the study.

Gerald Lee:

Thank you, Amanda. And I think last question, are your mobile care workers, are they bilingual for minority areas? Yes, we do have some of our mobile care, I think your common secondary language is Spanish. And so we do have mobile care workers who are bilingual, if there is a need for a particular project or trial, we will look to staff with the appropriate resources. And if there is a need for bilingual, mobile health workers, then we’d have the ability to onboard those folks. 

Gerald Lee:

And I think that’s it for questions. And we’re close to coming up on time. And I think on behalf of Amanda and I, and the rest of Sanguine, we’d like to thank everyone again for their time. And of course, if you’d like to learn more, please reach out to us, you can visit our website, which is on the screen at sanguinebio.com. Our contact information is there, you can fill out a form there, or you could email us directly at study@sanguine. 

Gerald Lee:

And we wish you all a great rest of the week, and we hope that you learned something new today. And again, thank you for your time and I’ll now hand it over to John. 

John Fremer:

Thank you for joining Sanguine for our S3 webinar, discussing How the Direct-to-Patient Approach Can Streamline Your Research Study & Trials. As Gerald said for a list of upcoming webinars or to request patient samples, visit sanguinebio.com. Thank you again and enjoy the rest of your day.