Clinical Trial Protocol Design Gets Patient Input Boost from Transparency Life Sciences

New crowdsourced protocol builder leverages patient and clinician engagement to design more efficient clinical trials

BOSTON–(BUSINESS WIRE)–Transparency Life Sciences (TLS) today announced the debut of a novel patient-centric protocol builder for clinical trials called Transparency Protocol Crowdsourcing© (TPC). A combination of technology and service, TPC engages patients, physicians, and researchers to contribute to the setup and design of trials using a proprietary online survey tool. The results are then analyzed using AI-enabled natural language processing and TLS’ proprietary advanced analytic tools to help sponsors draft protocols more relevant to patient needs and clinical practice. The technology, once implemented, can also help understand patient behavior utilizing historical data thereby enhancing engagement.

“It’s only appropriate that clinical trial sponsors work to incorporate a diversity of patient voices and rethink their approach to protocols, design and other parts of the trial that could benefit from patient input.”

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Protocol amendments, which sometimes occur due to limited enrollment or a higher than expected dropout rate, can be costly both in finances and timeline delays. According to a study in Therapeutic Innovation & Regulatory Science1, incorporating a diverse and broad patient voice early on in trial design can result in an increase in net present value over $60 million while expediting time to market by up to 2 ½ years. TPC starts with qualified crowdsourcing with participants responding to key issues of clinical trial design, helping the trial sponsor discover key considerations that can inform and enhance the protocol writing process to encourage greater engagement with the trial and meet these ends.

“People are becoming more involved with their health care choices and have always been motivated to enroll in clinical trials to help find new treatment options that will benefit everyone, so it’s only appropriate that trial sponsors incorporate a diversity of patient voices and rethink their approach to protocols,

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