Steps to Reduce Missed Deadlines and Unnecessary Costs in Research Studies and Trials


Event Details

  • Date:
  • Categories:

High cost along with patient recruitment and retention pose major obstacles to conducting clinical trials in the U.S. According to the Tufts Center for the Study of Drug Development (CSDD), it now costs up to $2.6 billion to bring a new drug to market, and according to a study by the Center for Information and Study on Clinical Research Participation (CISCRP), 80% of clinical studies recruiting patients in the U.S. are delayed due to recruitment problems.  Unfortunately, those delays mean it can take longer for innovative medicines to be studied and approved, leaving patients to wait years for new treatment options.  What solutions do researchers have to help alleviate these burdens, while also still completing their research?

In this webinar, we will discuss:

  • Best ways on how to determine the optimal recruitment timeline
  • Benefits of in-home collection, processing and procedures
  • How to overcome the challenges of longitudinal studies

Speakers:

Gerald Lee, Chief Product Officer, Sanguine Biosciences
Amanda Effres, ACRP-CP, Head of Feasibility & Study Design, Sanguine Biosciences

Transcript

Allison Proffitt

On behalf of Clinical Research News and our sponsor for today’s event, Sanguine, welcome everyone. Today we’ll be discussing the twin challenges traditionally facing clinical trials in the US, high cost, and patient recruitment and retention problem. And when you add those to the unique roadblocks raised in our current climate researchers are often at a loss for how to optimize patient recruitment, collect data and deliver results. We’re going to explore some solutions to these problems today. I’m Allison Proffitt, Editor of Clinical Research News and I’m the moderator for today’s event. Now, I’d like to introduce our presenters.

Allison Proffitt

Gerald Lee is the Chief Product officer and co-founder at Sanguine. Gerald helped establish the laboratory infrastructure and now he facilitates patient recruitment and developing software to enable mobile clinical trials. Amanda Effres is the head of feasibility and study design at Sanguine, where she reviews all the researcher requests for sampling studies and other Sanguine services. Determining how Sanguine’s approach can adapt to suit the needs of the requesting researchers while also optimizing study timelines. So, welcome to you both. Gerald, will you start us off?

Gerald Lee

Yeah. Thank you, Allison. And thank you everyone, for your time today. I really appreciate your joining us. And so today my colleague, Amanda and I will be talking about the title right here, steps to reduce missed deadlines and unnecessary costs in research studies and trials. So let’s dive in. So starting with the problems, I think many of those on the call are aware of these issues in terms of the study delays. And much of it has to do with patient recruitment and retention issues. And depending on where you look, the stats can be as high as 50% of trials not meeting their enrollment deadlines. A lot of trials are either failing or not enrolling or decides not enrolling enough patients. And a lot of this has to do with the research process trials being inconvenient unengaging, many patients end up dropping out of the trials up to 30%, for some. And a vast majority do not sign up or drop out because of many different factors, whether it’s inconvenience, lack of transportation, increased travel burden, other constraints, conflicts and fear and anxiety.

Gerald Lee

So there are many reasons for this. And we know that these are all sorts of problems that may affect the ability to finish these trials on time and on budget. And so I don’t think we could be in a webinar without mentioning COVID-19, which hit the US in February, March, earlier in other parts of the world. And so the impacts of COVID-19, I mean, we saw our side ourselves early in March and April, in the beginning of the pandemic in the US. Patients were even initially reluctant to do visits at-home and to participate in at-home research, that’s waned a little bit. But there is still a reluctance on the patient side to visit sites for fear of contamination. As we know there are travel restrictions, whether at the local or state level, and also facility closures and restrictions. And so this made a big impact on trials in terms of increasing those timelines, delaying studies and metadata releases, periodically, COVID-19 reporting did a survey of many sites seeing the top five actions taken to mitigate these risks.

Gerald Lee

And as you can see here on the right, many of those ultimately will lead to increased costs, more study delays. Whether it’s pausing patient enrollment, delaying the trials, extending the windows and so forth. So ultimately the impact, it was interesting because, I guess back in May, and from the Senate Health Committee, Dr. Francis Collins, the Director of NIH, expressed concerns about potential $10 billion losses in NIH funded research due to COVID restrictions. And even before COVID, there have been studies up to 85% of trials will experience delays. And this would account for 600,000 to $8 million in loss each day from these study delays. So the question is, we can’t solve everything, it’s a big problem. But the question really is how can we improve? And so for us it’s taking a direct to patient approach, and we look at it as an integrated approach. In our definition this includes elements of patient engagement, mixed with an at-home visit. And so, you’ve probably seen a lot of individual companies do one or the other. We do both.

Gerald Lee

We engage patients directly via high tech and support model to increase convenience and reach. And it’s an integrated solution that provides touch points for the patients and streamlines their experience. And it works well with both earlier stage research studies that require biospecimen data. And also in trials in terms of working with the site as an extension working side by side with both the site and the patient. And so with this direct-to-patient approach, we feel like it helps really optimize for the study timelines. And we’ve been doing this since 2011, and have taken this approach for the past eight, nine years. And as a result of this approach we’ve been able to build up a nice patient community from various therapeutic areas, mainly in chronic diseases, rare diseases. And we survey our patients, consistently scoring over a nine out of 10 on our satisfaction scores. And I have worked with multiple of patient advocacy groups taking this integrated patient recruitment and outreach approach.

Gerald Lee

And interestingly, and since the COVID-19 pandemic hit we’ve seen a significant increase in requests for these types of services and at-home trial visits. So in terms of the direct-to-patient approach, we’re going to first talk about elements of patient engagement and how we approach that. And my colleague, Amanda will get into more details about that and even present a few case studies. Ultimately, we take approach towards patient recruitment and outreach, integrating that with the high-touch study support staff for to provide the patients with support, help answer questions, and I guess, resulting in high satisfaction. And also we do too have capabilities to do remote screening and e-consents, and pre screening for trials. And so we take this integrated approach with our patient recruitment. And I’m actually going to hand off now to Amanda so that she can dive into the patient engagement portion.

Amanda Effres

Thanks, Gerald. As we see here, an integrated recruitment approach is one that’s active and direct to patient. The elements include patient advocacy. So partnering directly with patient advocacy groups and organizations focused in your disease areas of interest to utilize their communication platforms to spread the word on your research. Sanguine currently holds over 50 partnerships with such organizations, some of their logos are there as you see on the right. And that’s helped us to really work directly and target patients of the specific condition of interest to ensure that they will be interested and willing to participate by going to them directly through that organization and group. In social media and digital advertising, we’re leveraging online platforms to reach patients and effectively target them, say through geographic areas. So working on a trial, you’re able to geo target advertisements in the area surrounding sites. Sanguine does this regularly.

Amanda Effres

And on a monthly basis, we reach over 20,000 patients across these platforms and networks to sign up and enroll into the various studies we’re working on. The third approach as part of this recruitment strategy that’s direct to patient is of course, reaching out and engaging with your own established patient community. Sanguine’s own patient community, as Gerald said, has grown over the years to over 30,000 patients. And these patients have opted in to learn more about research opportunities from Sanguine thus making them more highly engaged and ready to participate. Whether we identify patients through these patient advocacy group partnerships, through online engagement, or directly through our in house study coordinators. The process is the same from when they speak to our in house study coordinator evaluating their eligibility to participate and taking them through the process through the participation process based on your specific protocol requirements.

Amanda Effres

So as Gerald mentioned earlier, it’s a very high touch partnership that we have directly with patients to ensure that they understand the participation requirements from end to end through screening through the end of their participation in your particular study. So looking at these specifically, starting with the benefits of patient advocacy group partnerships, we wanted to highlight four of those. The first being again, these patients are highly engaged. They’re members of these Patient Advocacy Groups interested not only in support but accessing information about their condition. And that includes research opportunities. In our experience, we’ve made information available on these groups websites. They’ve also incorporated recruitment campaigns with an email blast to their members. Sanguine has even participated in events to be present there and offer information about potential projects and trials that were involved in that patients might be interested in.

Amanda Effres

Second, this is a targeted approach to recruitment. By going directly to these groups, you’re accessing and effectively targeting patients based on your research interest. That said, these groups also offer are great resource for feasibility assistance. I can speak from my experience having been on numerous calls with various organizations, they’re able to provide feedback on the study design and allow for a more patient centric approach as you’re developing your criteria for your trial for your early stage research. And these feasibility discussions are very important as they lead to a better trial design that’s going to enroll patients from the real world. And finally, the fourth, of course, accelerated timelines. That’s what we’re here to discuss today by targeting highly engaged patients, by targeting your recruitment approach to these groups, specifically, designing them such that they’re more feasible criteria wise and with the associated participation requirements, that’s going to accelerate your timelines.

Amanda Effres

A specific example here, we partnered with the NPN Research Foundation for myelofibrosis. And within the first month of our recruitment campaigns with that organization we received 53 signups, and that allowed us to finish that project two months early. Through social media and digital advertising. We really just wanted to show that there’s various forms that this can take. On this slide some screenshots of the various materials that we’ve developed and launched online. So a digital flyer for sjogren’s disease study, in the middle Facebook ad for coronavirus, as well as on the right a lupus ad on Twitter. So giving you a specific example of how we’ve applied an integrated engagement approach to accelerate trial enrollment specifically, Sanguine worked on a trial in Hepatitis B vaccines, and was called to assist when trial enrollment was falling behind. The recruitment targets weren’t being met.

Amanda Effres

Most of the sites at this point had hit their limits on available resources, available targeting within their clinics to increase enrollment, not to mention the stringency of the criteria also compounded those efforts. Sanguine took action to provide assistance, online geo targeting the areas around the sites to connect with patients that way who would sign up online, but we also have a fairly robust population in our community. I’m going to go through that later. But we leveraged that community in addition to the signups we received online to speak with these patients. And what was unique about this service offering was we were able to directly connect these interested patients once we utilize the pre screener. And if it was determined that it looked like they were going to potentially qualify and they were interested in being handed off directly to the site.

Amanda Effres

While we were on the phone with these patients, we were able to directly connect them. The site picks up the phone and speaks to the patient right then and there. That was working so well for us that we also decided to launch a referral program. So of the patients that we were speaking to, we asked them to refer any family, friends colleagues, just to supplement what our outreach and engagement was online and with our existing community. The result as you see here, 90 subjects were randomized from the 16 weeks of Sanguine’s referrals allowing us to beat out the 15 brick and mortar sites that were really restricted and limited in their capacity to recruit. Ultimately leading to Sanguine as the number one recruiting site for the trial within a three month period. This is our Sanguine Community, since we started the company back in 2011. So you see it’s diverse and by having a diverse patient database a diverse patient community, you’re well positioned to easily accommodate and fulfill requests for recruitment for early stage, biosamples, studies and for a trial enrollment.

Amanda Effres

So by having these patients already identified as I mentioned earlier, how we communicate with these patients when they sign up when they enter into our community. They accept our privacy policy and are opting in to learn more about research opportunities from Sanguine. so as Sanguine receives research opportunities from our client base, we make those available to our patients based on the conditions of interest. I’ll walk through this in a specific example for COVID-19. So just earlier this year, back in March, when everything really started here in the US. We realized that there was really a need for research in COVID-19. And we wanted to assist and be part of that solution. So first step for us was to build up a patient community, a patient pool of COVID-19 patients. So we did that through online advertisements and recruited nearly 800 patients over the first two months period of our recruitment.

Amanda Effres

So with those patients we were able to, of course, offer prospective collection of specimens for many researchers. But notice that there was need for immediate access to samples. So some researchers couldn’t wait for prospective collections. And that sparked the idea for us to build out a bio repository of samples. So from those patients, that patient base that we built, again, through the online ads that we pushed. We generated a biobank of serum vials from patients who recovered of COVID-19, creating that diverse sample set in addition to the various associated data points that our in house team of study coordinators collected. This resulted in providing researchers with direct access to COVID-19 samples as well as associated health information. Some of the key features of these requests included PCR confirmed positive infections, researchers were interested in asymptomatic versus symptomatic cases. Patients who are hospitalized due to COVID-19 and under our existing protocol, we were obtaining 180 milliliters of whole blood every six weeks and, of course, through our at-home visit model.

Amanda Effres

So we were visiting these patients in their homes to obtain these samples, which meant that Sanguine needed to step up our COVID precautions and ensure that by visiting these patients we’re doing so safely. Takeaway here, again, outreach to an existing patient community accelerates your study progress. We identified these hundreds of patients that allowed us to fulfill these requests in a very short amount of time for these researchers over this period from March through August. We were awarded over 40 studies which at this point are ongoing or have since been completed.

Amanda Effres

Because we build these relationships directly with our patients through our team of study coordinators, it’s very easy for us to retain them. We’re going to go into the specific reasons later on why patients enjoy participating with Sanguine specifically, but we can retain them at a high rate, as you see here 95% retention rate. It’s also very easy for us to survey our patients and they’re willing to complete those surveys as you see a 94% survey response rate. So again, very important to establish your own patient community from which you can perform outreach and enroll into various research types. I’ll hand it back to Gerald to talk about the at-home visit component of our direct-to-patient approach.

Gerald Lee

Thanks, Amanda. So Amanda, thank you for those examples. And going over the patient engagement section. So now we’re going to go into the second part, the at-home visit component. And for this component, I guess, high level, we use trained and certified mobile health staff. And these are typically visits done outside the clinical setting, of course. Typically at the convenience of someone’s home. And in addition to this we do provide the kit management and all logistic shipping support component as well that will be present in some case studies. So some of the benefits about home visits, I think they’re listed on the left here. It helps enable trial continuity, increase your ability to hit your study timelines. Ultimately, what’s really important is increased patient convenience and satisfaction, which leads to the increase in patient retention. And having an at-home model provide you with a decentralized opportunity to have a broader patient reach, and to essentially accelerate patient recruitment.

Gerald Lee

And on the right there it shows an image of our coverage throughout the US and 50 plus metropolitan areas. And although this model is very beneficial for any type of therapeutic area study type and for patients, it’s especially ideal for studies that involve elderly pediatric populations. High risk populations, especially because of the COVID-19 pandemic. And patients with more debilitating disease states who are more mobile and have a difficult time traveling. And, of course, rare disease studies which require a broader reach of patients nationwide. So in terms of the at-home visits, it provides more flexibility, helps improve patient retention. Again, we use certified and trained and mobile health professionals, and we onboard them ourselves. And they have the ability to do many different things at the home. A common is a blood collection. But as you can see, on the left we have the ability to collect other types of biospecimen at the home.

Gerald Lee

And then in terms of capabilities, longitudinal sampling can be done either for trials or for early stage translational research studies. We do have the ability to do, of course, in-home processing, centrifugation. So many of our staff have mobile centrifuges that they can take to the home and process the blood samples immediately and spin them. And also the ability to do vital sign and other in-home measurements and questionnaires, and also some aspects of IP accountability. And just to add, in terms of trials, we we’ve done both scheduled visits and unscheduled visits as well. So in terms of trial continuity, this is very high level of how we typically work within a clinical trial setting. And we work directly with the sites and have a process from study startup to execution and completion. So during the course of this study … during the course of the trial in the beginning, we do meet with each of the sites, we train them on how to request visits.

Gerald Lee

And we coordinate with the patients directly to help ease that site burden, and to have a better handoff process and a reliable process for that. And we’re ultimately trained on the protocol with our staff and our mobile health staff. And we’ll make sure to complete that in-home visit in compliance with the study protocol and within the visit windows. We can complete any sort of documentation according to the protocol specifications, requirements, the lab manual and provide the needed sort of information back to the site and investigators. And we worked with different central laboratories where we ultimately will ship or deliver that sample. And we have ways of managing and transferring that data to the needed parties and notifications can be provided as well. And so that’s a very high level of how this works. I think I’m going to quickly hand it back off to Amanda, where she’ll go into more specific use cases and other case studies that we’ve been a part of. So Amanda, take it away.

Amanda Effres

Talking about at-home visits, increasing patients convenience and retention. We’ve really seen in our experience three main visit types, event based home visits. So these are visits to perform collections and assessments around patient reported outcomes or events. Pre-screening home visits to visit patients to collect samples to assist in the screening process prior to enrolling them in a trial or an early phase study. And then site requested home visits through that process that Gerald just described, working and partnering with the sites and operating as an extension of their staff to ensure that patients can continue to participate from home safely. Understanding the specific requirements of your protocol and the set of events. The schedule of activities is important in determining how and if the schedule can be adapted to include in-home elements and remote elements.

Amanda Effres

So I’m going to go through each of these types of visits to provide specific examples of what we’ve worked on so you can get a sense of how these studies have been designed. The key advantages here again, increasing patient retention by increasing the convenience in the study participation process, the time savings in screening efforts, specifically those pre-screening home visits that can be incorporated into your trial. And then increasing the patient engagement throughout the process. Again, we have in-house team members dedicated and assigned to these studies who are building relationships with these patients maintaining them throughout their entire study participation process. We also do our best to assign the same mobile phlebotomist, mobile nurses so that they’re the same individuals that these patients that these caregivers are working with.

Amanda Effres

And that’s really important in making patients feel comfortable with the process and continuing to participate. So looking first, at event-based home visits, I wanted to highlight three specific examples. But again, you can really adapt this visit type based on what sort of information you’re interested in, what sort of event that you’re interested in. So for these examples the first is a a phase 0 Observational Study, following 40 sickle cell anemia patients. They were followed for a longitudinal period of six months to monitor their activity via wearables, and the frequency and duration of their Vaso-Occlusive Crisis or pain crises. So on a daily basis, they were completing a pain diary scale that was in an ePRO device.

Amanda Effres

So there were baseline visits, visits collecting samples, while patients were not experiencing a crisis. And then very specific time points around their reporting the crisis and resolution of that crisis. In celiac disease, while patients were experiencing a symptomatic episode due to exposure to gluten, we were assigned to sample them in their homes within a five to seven day window of their experiencing a symptomatic episode. And third here in lupus, obtaining blood samples from patients while they were reporting experiencing a flare, and then while they were no longer in flare. Again, these are very specific events related to patient’s symptoms, but you can also adapt this visit type around other events prior to patients taking an infusion. As well as while they’re responding or not responding to treatments. It’s very adaptable. And it’s just really based on what sort of information is important for your research and designing a study so that you’re going to receive samples that are valuable, and can accelerate that.

Amanda Effres

So in these cases, the primary benefit accelerated biomarker research by increasing the access to the samples and information for these researchers. The second type, pre-screening home visits. These examples that I’ve laid out are actually translational or preclinical studies requiring that patients met very specific lab values. But if we think about clinical trials, this can be an option in trials as well if there are components of the criteria related to various specific lab results that need to be met by patients. You can assign a mobile phlebotomist or use a vendor for mobile phlebotomy services to obtain samples in the home, process them if needed and deliver them to the central lab for your trial at the appropriate temperature requirements. So each of these tests as you see listed here, each of them has their own specimen requirements, temperature requirements, and Sanguine is able to accommodate those requirements in the home through mobile centrifugation, alloy coating and then shipping them refrigerated ambient on dry ice.

Amanda Effres

They can be equipped with the appropriate materials in the home to safely do provide these services just as they would at the site. The key difference being the patients are able to participate from home, it’s convenient for them during a pre-screening visit, visit one. Instead of needing to review medical records, confirming results historically. These results can offer confirmation that the samples are suitable for for research purposes and fit your specific criteria. So that’s how these pre-screening visits can be adapted into a protocol. And third site-requested home visits. So working directly with sites partnering with sites who’ve opted into allow patients to participate from home. Of course, this needs to be written into the protocol. So in our experience when we are speaking with sponsors interested in adopting their protocol for remote elements or at-home visits that needs to be handled in the protocol and amended so that this service can be offered.

Amanda Effres

So in each of these trials, it was actually written into the protocol that there would be a visiting mobile nurse or phlebotomist at specific visits, or unscheduled visits. So taking a look at each of these in turn, the first Pediatric Phase 4 Atopic Dermatitis study the patients were infants as you see and for a certain population a certain cohort within the trial, they needed to visit the site for a seven day consecutive period to have the IP applied topically. So they’ll help to alleviate the burden of travel having to go back and forth to the site twice a day for a seven day consecutive period. Sanguine offered assistance here for families interested in participating from home, so the nurses visited these patients and performed the services as laid out in the protocol safely in the home environment. In Natural History study in COVID-19, involved recruiting a 400 subjects diagnosed with PCR-confirmed COVID-19 infection.

Amanda Effres

So these are individuals visiting clinics getting tested for COVID-19. If they end up positive, and want to enroll in the study, instead of having them come back to the site to have their blood drawn at days 14 and 35. They’re able to participate from home, self quarantine from home and take those precautions. And again, Sanguine understands the risks associated with COVID-19 and has stepped up our precautions and safety measures in place to protect our phlebotomist, our mobile nurses but also the participating patients. The Phase 1B-DMD trial. The third example here, a rare disease population pediatric subjects diagnosed with Duchenne Muscular Dystrophy, our services involve performing 12 scheduled visits over a very long timeframe. Week three through year four of the subjects participation in the trial, and also performing what we call unscheduled visits. So in the event that the patient’s lab results indicated a value out of range that might end their participation in the study, required retesting.

Amanda Effres

And so the turnaround times for those are fairly quick, just a matter of days needing to assign a mobile phlebotomist, a mobile nurse to go to these patients. Not to mention for this trial, in particular, it’s rare disease. And these patients often resided hundreds of miles from the site. So by offering this service, Sanguine was able to allow these families to continue to participate and make it convenient for them instead of having to travel long distances and maybe even take a flight. And right now, that’s not a safe thing to do. Yet, so these PAD families can stay home and participate from home. It puts them at ease in this process. So the primary benefit again, across trials supporting trial continuity by increasing the retention and convenience for patients in their participation process.

Amanda Effres

We survey our patients quite often, as I mentioned earlier, so we wanted to highlight really here patients like the convenience of at-home being at-home visits and what their top three motivations for participating have been. So they’ve reported, of course, advancing research for their condition, the desire to help other people like them. And because of how easy and convenient it is to participate. Overall, the best part of participating with Sanguine has been the convenience aspect of the at-home participation and making an impact in medical research. And these quotes are actually from the survey so direct patient testimonials. So what are the benefits of direct-to-patient approaches patient engagement and at-home visits, what do they offer? So in summary, we’re saying this approach allows for accelerated study timelines, enabling trial continuity. So having an integrated solution includes outreach and at-home visits will accelerate your study timelines and avoid delays that could be caused if you don’t have these types of approaches in your trial and model.

Amanda Effres

Broader patient reach. We described our geographic regions within which we operate, it’s very easy for us to expand into other areas with determined feasibility there. But when we’re on boarded to work on to trials, we’re increasing the resources that we have in the area surrounding the sites, getting them trained, getting them ready and available to be assigned to these visits as they’re requested by the sites. Improvement in patient retention. So by increasing the patient satisfaction, there’s less of a burden on the patient, it’s more convenient, they’re going to be more willing to participate and stay on in this study. We talked about at-home visits and the ability to collect samples longitudinally, that’s very easy to do if patients are able to participate from home, they’re more likely to want to continue on in longer studies, year plus studies.

Amanda Effres

So having a high patient retention rate, and on average our patients are participating in studies three plus more times. Well positions us to offer highly engaged patients and a unique approach to keeping them in trials and in research. Event-based sample collection, again also offers unique information, accelerating the research process, especially in early phase research studying novel biomarkers, or other indicators in samples around certain patient reported outcomes. So the key takeaways overall to the direct-to-patient approach. We’ve described this, it can be applied to clinical trials to early stage translational research. And that’s been our experience so far in the types of research, it’s worked well in single or longitudinal time point collections for biomarker research, early phase research, as well as adopting clinical trial protocols where we can to offer at-home visits, remote visits, et cetera.

Amanda Effres

It’s a site extension model for trials, enabling trial continuity. So we’re partnering directly with these sites offering our services as needed to ensure that patients remain in these studies offering them convenience in the participation process. This also enables research studies that require biospecimens and de identified patient data. Our team again, in houses managing this process start to finish from identifying the patients through coordinating the visits, obtaining the specific data that you’re interested in and providing that to you in a safe HIPAA compliant manner. So all of these things combined, again, to assist in reducing missed deadlines and unnecessary costs related to delays. So the key features really are, again, are engaging with patients, making sure they’re highly engaged and offering them this convenient option of at-home participation where you can. I want to thank everybody again, for being a part of this webinar. If you’re interested in more information, please feel free to visit our website at sanguinebio.com. Or you can email us directly at study@sanguinebio.com. But thank you so much.

Allison Proffitt

Amanda, thank you so much. And Gerald, thank you as well. So we’ve got some time for questions. Again, if you want to submit a question, please do so in the chat box on the lower right of your screen. I’ve got some that we’ll start with and then you can keep sending them as we go on. So, what is the time commitment involved in incorporating enhanced specimen collections into the process? And that could be for either of you.

Gerald Lee

Yeah, I’ll take that one. Typically, our startup time is four to six weeks. It’s pretty standard it involves training, onboarding and other startup activities. But I’d say four to six weeks is the typical startup time.

Allison Proffitt

Okay. And I know one of you gave sort of an overview of how you can collect skin samples, blood samples, but what and what all can you collect when people are thinking about planning trials, what should they be limiting their thoughts to or not limiting to?

Gerald Lee

Amanda, did you want to add to that?

Amanda Effres

Yeah, sure. So, of course, minimally invasive collection methods for specimen collection in the home. But as we described, there are other assessments that can be done in the home environment, depending on the IP and the route of administration taking a look at that. So really, what’s important there is understanding the specific requirements of your protocol, the schedule of activities and taking a look at which visits can be adapted to the home. We do understand not all of them, of course, can be done in the home environment. But taking a look to see how you can adjust the schedule of events to include an in-home element.

Allison Proffitt

So where were talking earlier about trial launch to life, how does enhanced specimen collection really help with that? Help mitigate that rather?

Gerald Lee

Yeah. So, we think that, I think one of the summer trials that we’ve been a part of, we’ve been able to limit the number of site visits. And also have come into rescue some trials in terms of providing additional services and that would essentially, otherwise delay those trials. And so, I think, especially for COVID-19, if there are visits required at the site that can be done at the home. Let’s say if they needed some sort of test on, clinical test on other procedures are done. Those can be transferred to at-home model, to ensure trial continuity and to not have to lengthen those visit windows. So it could be a way of reducing those study delays, lengthening those visit windows and helping reduce those unnecessary costs related to those study delays. So I think that it’s a mix of both providing that trial continuity and also limiting the delays that may be caused, for example, from this COVID-19 pandemic.

Allison Proffitt

Right. Amanda, do you have anything else?

Amanda Effres

No, I’ll just add the pre-screening home visits as we’ve highlighted can assist and also minimizing the time needed at the site, if some of that burden can be placed on in-home testing. So that’s a great way to help save time as well, utilizing that pre-screening home visit.

Allison Proffitt

So with COVID, specifically, I think you’re alluding to that you have done some enhanced sample collection. How did that go? Did you encounter hesitation with patients that maybe didn’t want you to come into the home? How did those interactions work?

Gerald Lee

Yeah, so I would say initially, especially in the beginning of the pandemic there was hesitation. Because I think a lot of individuals went to quarantine. But what we’ve done is we implemented additional safety procedures. And our staff have undergone additional COVID quality trainings. And we’ve also provided additional PPE for all the visits. So, we’ve always provided things like gloves and of course alcohol wipes. But we’ve, in addition to that we’ve required in each of our kids to have gowns, face masks for high risk visits. And we also do further screening on our staff and also ask additional questions to the patients to also minimize the risk to our health staff as well. So we’ve had to take additional precautions. And there was some hesitancy, especially in the beginning. But I think patients, have definitely started coming back being more open to participating, especially from the home. And we’ve taken these additional safety precautions to make sure that’s done safely and of high quality.

Allison Proffitt

Yeah, so in your relationships that you have with patient advocacy groups, did those advocacy groups weigh in on some of the sort of specific COVID concerns to their disease of interest? I mean, were you able to get some feedback from them on what might be most risky for one type of patient versus another?

Amanda Effres

Yeah, I can answer that. That’s been a part of the feasibility assessment on these requests, especially in rare disease and populations with a higher risk of contracting COVID-19. So in partnering with these groups who we also discuss timeline wise, if it makes sense to work on the project right now. If the assessment is these patients are going to be less willing in the middle of a pandemic even with specific precautions in place, they may not want to take the risk just given their specific disease. So having those types of discussions with these groups, letting them weigh in and working with researchers to see how we can adjust their needs and timelines that they’re interested in. It’s really important to incorporate the voice of the patient advocacy group organizations in that.

Allison Proffitt

Absolutely. And this is a related question. Does the advocacy group help you recruit patients not necessarily for COVID but across the board?

Amanda Effres

Yes, they do. So, and how we partner with them directly is understanding what sort of engagement, methods of engagement they utilize with their members. This could be on a monthly basis newsletters, they might hold events, they might just be interested in listing the information up on their website. So we really talk through what their strategies are communication platforms that they use, and then determine what the best approach would be with Sanguine assisting to develop those materials, getting them IRB approved before they’re utilized by these groups. So they’ve actually, right now we’re working on several projects with some rare disease populations that are continuing through this pandemic, through the assistance of these partnerships we have with the advocacy groups.

Allison Proffitt

Right. So how do you prevent sort of engagement fatigue in these communities? How do you ensure that these are connections that are going to last down the road?

Gerald Lee

Yeah, I think ultimately, we have the highest engagement when we do have available studies and trials that patients can be a part of. What we’ve tried to do is other strategies in terms of engagement, we do provide content we do launch our own, we are serving a webinar series as well. And then also thinking of ideas in terms of engaging outside of trials, we may be piloting a support group, online support group in the near future as well. So, obviously, not all patients want to be part of a trial at this moment. Some a lot of patients they may have medications for them, that are working just fine. And so for us, I think we provide both on the level of studies, we provide the trial element.

Gerald Lee

But also we provide an opportunity for patients to participate in research studies that are frankly easier to be a part of. We also just sample blood draw studies that they can just participate from the home. It’s a one visit type of study. And so, yeah, it’s a combination of both providing those opportunities and being very proactive, sending out those email communications about any new projects or new opportunities to participate. And also thinking of other ways to engage outside of that research setting, whether it’s through content and developing potential high touch support groups, as well. So that’s something we have in the works right now.

Allison Proffitt

Awesome. Okay, we are out of time, Amanda and Gerald, thank you both so much. Thank you for sharing this a fascinating look at how this can work even under some really trying circumstances. So, and I also wanted to thank all of our audience. On behalf of Clinical Research News global web symposia, thank you for joining us.

Gerald Lee

Thank you, everyone.

Amanda Effres

Thank you.