The Clinical Trials Guru

The clinical trials industry is headed more and more towards a patient-centered model. “Hasn’t it always been this way?” you may be asking yourselves. Yes, if you are looking at the end result, which is hopefully to develop new treatments for your condition. But that’s not what I’m talking about here. Currently, the clinical trials industry revolves around the Investigative Site collecting data from you, the study participant, and then submitting this data to the pharmaceutical company sponsoring the study, who then turns around and gives this data to the FDA. This data is everything from side effects of the study drug to your reported satisfaction with the study drug, and any other info that you can think of that can be collected while you are in a study.

What I mean by a patient-centered model is eventually transferring the responsibility of this data collection from the research site to the patient himself and having the participating patients report their results to the pharmaceutical company directly. While this model is still theoretical at this point, one can certainly see the possibility of this becoming a reality for at least certain therapeutic indications. This does not mean that clinical trials for ALL diseases and disorders will follow this model, but certainly SOME will.

What does this all mean for you? Well, for starters, those of you that would like a more active role in your health care can begin by collecting your personal health records and updating them as necessary. Websites such as patientslikeme.org, curetogether.com and iguard.org let you store your personal health info as well as collaborate with other individuals who may be taking the same medications as you or share similar symptoms, illnesses, etc. From a non-clinical trial perspective, the benefits of keeping records of your personal medical history are obvious. You can now inform your physician of your current condition and keep him updated in almost real time on your progress. An excellent blog I recently discovered that covers this topic, and is written by a guy who started keeping a history of his own medical records is http://epatientdave.com.

As far as clinical trials are concerned, I know from my personal experience as a Research Site Director, that those individuals who have copies of their medical history are given the first opportunity to join a clinical trial, as these medical records are very important for a Research Clinic to have access to. We often do not want to enroll participants unless they are an actual patient of the study doctor’s private practice, or they have their own medical records available when requested. This allows us to collect the best quality data for the pharmaceutical companies that contract with us to conduct their clinical trials. So the take home message is: If you want to get into an extremely desirable clinical trial, you will have a MUCH greater chance of doing so if you have a copy of your medical records on hand. Much more on the topic of patient engagement in the future.