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.
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.
Over 30 years after the emergence of HIV-1, there is no effective vaccine, and AIDS remains an important threat to global public health. Following infection by HIV-1, the host immune response is unable to clear the virus due to a variety of factors, including rapid viral mutation and the establishment of latent reservoirs.