Open call for innovation gives everyone a voice in clinical study design

Transparency Life Sciences, LLC (TLS), a new drug development company, has launched a thoroughly innovative platform for clinical studies, with an objective of reducing the cost of safety testing by 60 to 80 percent. The ambitious claims of TLS have captured the attention of biotech and pharma researchers who recognize the need for innovation in their respective fields. By cross-referencing crowdsourcing methods, online media, and other communication technologies, the stage is set for an upside-down, flip-over-backwards, mix-it-up renovation for the world of regulatory studies.

There is an undeniable need to update the processes we rely on to evaluate food and drug safety. The Food and Drug Administration (FDA) and Environmental Protection Agency (EPA) are largely responsible for setting the requirements drug manufacturers must satisfy before their products can be marketed for human use. These requirements are updated on a regular basis to reflect new data and knowledge about drug interactions, unexpected side effects, etc. But, the requirements often create a bottleneck effect that prevents new drugs from ever getting to the market, leaving drug companies with no means of recovering their investments.

Unfortunately, the reason for the bottleneck is not directly related the safety of the drug; rather, the additional testing requires additional funding which is in short supply. As a result, a large number of drugs cease to be developed due to the cost of further research. TLS aims to reduce the costs in a completely different way than any other research organization has attempted with an interactive, web-based environment for designing protocols and contributing data for clinical studies. They invite doctors, researchers, patients, patient family members, and pretty much anyone who wants to contribute to get involved.

The company prides itself on being transparent throughout the entire process of conducting clinical trials. There are three projects currently in the works. One project is testing lisinopril which has indication for multiple sclerosis (MS) patients. The second is for sulodexide which has applications for peripheral vascular disease, and the third is a naltrexone-based drug for Crohn’s disease. Basically, you create a profile and begin contributing your “expertise” from a researcher or patient standpoint. The user guidelines are quite vague, pretty standard, and really don’t prevent any non-experts from contributing to the patient surveys, etc.; however, the process lacks validation and authentication of its contributors.

The fate of the program depends heavily on website visitors getting involved. The company’s site says there may be financial incentives for contributors on some projects.

With all due respect, I cannot image a drug ever being approved as safe on the basis of crowdsourcing, online media and “telemedicine.” Historically, a major component of regulatory research is based on standards, consistency, controlled environments, and quality assurance. Although the company’s strategy to enhance the drug development process by implementing trials with lower costs and higher data value seems smart, I doubt this approach will ever replace costly clinical trials. Plain and simple, there is no replacement for safety.