An open source approach to clinical trials

 It lets patients help decide what they actually need...

A new drug development company, Transparency LifeSciences, is planning to offer an alternative to the normal clinical trial process—trying to make it more transparent, faster, cheaper, more effective, more inclusive, and more easily available to patients.

Dr. Tomasz Sablinski, founder of Transparency Life Sciences, has been frustrated by the “secrecy” in the clinical trials process. “The price you pay when you hide what you’re doing is you only get feedback from a precious few people.” He believes, “You have to add patients to the mix, because they’re really the reason you’re doing drug development.”

Dr. Sablinski is recruiting patients, physicians, and scientists—online—to share information, offer suggestions, and help create and launch this new, open type of clinical trial. Information and results will be available to everyone—whether the results are negative or positive.

Successful trial drugs would be sent on for FDA approval. The entire process would take less time and money than most current clinical trials. Some currently underfunded studies could potentially move ahead using this less expensive approach.

Patients are already sharing information with each other and with researchers online about their treatment history, reactions to drugs, and suggestions about improving the clinical trial experience. Patients will have input into the type of trial they would prefer.

Telemedicine (using technologies to provide health care at a distance) is expanding. Most of the actual clinical trials sponsored by Transparency Life Sciences will be conducted largely online and by phone so patients need not make numerous trips to a trial center or even live near a center.

This “open source” or “crowdsourcing” approach relies on sharing and transparency—nearly the opposite of most current drug development programs. Dr. Sablinski hopes to begin several trials soon with safe, repurposed drugs (generic medications originally developed for other purposes) and quickly move on to FDA approval if they work.  For now, his company is not focusing on cancer, but that may change.  Innovation to accelerate research, make it less expensive, and engage participants more directly is just as important in cancer research as in other areas of medicine.

This approach has many possibilities, but is still in its infancy. Stay tuned for results.

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(c) 2012 Tom Beer and Larry Axmaker