Patient-centered trials: Can they boost participation AND empower patients?

April 18th, 2013
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The traditional clinical trial (which, by the way, has been a “tradition” for only about 30 years) involves recruiting a number of people who are required to come to a site on a regular basis to participate. After the trial is over, the trial participant receives payment (sometimes) and not much else. Rarely, if ever, are results or data shared with participants.
This model is starting to show some cracks (particularly for U.S.-based trials), however, as recruitment becomes more challenging, and regulatory and liability issues require larger and more complex trial structures. But our era of the Internet, greater consumer power and a trajectory towards tailored, “precision” medicine could provide an answer: more personalized, patient-centered clinical trials. And the trials are more than just a lure for volunteers; they can change how medical research is conducted, all the way down to the results.
Clinical trial planners and coordinators might take a cue from Google. Instead of developing a solution or product and then marketing it to potential customers (Google Health notwithstanding), the company develops products based on what customers are searching for. Likewise, clinical trials should instead seek to address the question; “What do patients want?”
The Dutch Burns Foundation took this approach recently. First it surveyed burn physicians and found that practitioners wanted to see better ways to treat burned skin, or new techniques in cosmetic surgery. Then it surveyed the patients, and found a different answer. The patients wanted solutions to wound itching. Similarly, in cancer studies, survival rates are the most common endpoint, but many patients are most concerned about side effects. In this case, addressing the side effect problem might increase patients’ willingness to continue with chemotherapy treatments, a common problem in cancer therapy.
Online reporting and record-keeping will also help create more patient-centric trials. Mytrus Inc., helped Pfizer create its first “virtual” clinical trial, which included online check-ins and reporting, and electronic informed consent. Mytrus estimates that 30% of studies could be done virtually, directly with each patient, reducing the number of trial sites needed by 80%, slashing study time and costs, and easing recruitment woes.
Data sharing will probably be a large part of tomorrow’s clinical trials, too. The group Genetic Alliance launched a site Reg4All (Registries for All Diseases), which gives clinical trial participants access to their trial data. Trial coordinators can use the registry’s online platform to share data, while preserving privacy.
The computer is not a miracle worker, however. In randomized, double-blind trials, sharing data can be a problem. And it’s still important to make sure volunteers understand why they’re there, and that they won’t necessarily receive a treatment for their disease (and even if they do, it might not work). But these more tailored approaches certainly make it more possible for the patient to have a greater investment in the study.
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About the Author:

I have 20 years experience in clinical research, including leading diagnostic and pharmaceutical clinical studies in disease areas ranging from cancer to infectious disease to cardiology, diabetes, and autoimmune disorders. Send me an email.