Clinical research plays a vital role in today’s medicine; without it medical scientists would not be able to treat and prevent diseases that is life threatening. The unlocking of the human DNA sequence has unleashed unlimited potential to discover and develop treatments for genetic diseases. However clinical research has several roadblocks which make it a slow process.
Academic health researchers find it difficult and challenging to get participants for clinical trials. Managed care providers are reluctant to refer patients to clinical trials as they are trying to cut down their overall costs. The process of gathering the right number of participants is lengthy, expensive and leads to delays in executing a clinical trial. On the other hand, participants are not always willing to share their health data due to privacy concerns and the level of trust they can have in the researcher. There is also an information gap between participants and researchers; willing participants don’t know the path to reach the right researchers.
Reg4All is a participant centric, cross disease registry platform where participants can choose to share their health data with privacy settings at a granular level. The data is stored in a HIPAA compliant database and the privacy consent layer is powered by Genetic Alliance’s industry partner, Private Access. Researchers can get access to the data based on the privacy settings chosen by the participant and can verify if there is a population available to build a cohort for their study. Researchers can get the data based on user privacy settings. The tool also consists of a gamified survey where researchers can create survey questions that are relevant to their specific disease interest area. This helps the researcher in getting preliminary answers to the disease specific data elements. As the participants have answered the disease specific questions themselves, the registry data is of better quality and less erroneous. In the future Reg4All may also have the ability to import patient data from Electronic Health Record systems. As participants have willingly provided their health data with an informed consent, chances of participants opting out midway from the study is much lower.
Reg4All can be accessed by researchers through a search engine called RecruitSource. Researchers need to have an Institutional review Board (IRB) approval before they can apply for access to the Reg4All registry database. Researcher and the associated study area will be verified throughhttp://www.clinicaltrials.gov. Researchers can create notification alerts which can track if there are participants meeting researcher’s search criteria. Researcher can send notification request if the participant has shared identifiable health data. Participant can choose to give consent to researcher’s notification request for participating in clinical trial.
Searching participants through RecruitSource is currently available to researchers at no cost. Until we establish standardized pricing, we are working with research teams to develop pricing appropriate to their projects.
Reg4All is a secure platform that can link the right participant with the right researchers and improve the efficiency and effectiveness of clinical trials in translational research.