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– May 18, 2020– 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.
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 Science, 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, design and other parts of the trial that could benefit from patient input,” said Harry Glorikian, chief executive officer of Transparency Life Sciences. “By using a tool like TPC, The pharma and biotech companies gain capabilities to help speed up the process while satisfying key guidelines and reducing the overall trial cost.”
Transparency Life Sciences recently received two grants from AWS – the first as part of the Activate Founders and the other from the Jumpstart program. Both programs offer TLS the opportunity to accelerate its broader development activities of bringing unique digital tools to the world of clinical trials. To find out more about Transparency Life Sciences and how the company is blending technology and service to support the changing needs of effective clinical trials, visit www.transparencyls.com.
About Transparency Life Sciences
Transparency Life Sciences (TLS) is a leader in digital drug development services offering virtual and hybrid clinical trials. Rapid advances in digital technology and strong regulatory support create a historic opportunity for TLS to catalyze a fundamental transformation in clinical trial design and execution, significantly improving the quality of clinical trials while reducing their overall cost. TLS’s approach combines crowdsourcing and mobile health technology to advance drug candidates through clinical trials with unprecedented efficiency and patient and regulatory relevance. The use of digital technology allows TLS to reduce or eliminate reliance on physical study sites that are expensive, complex and inconvenient for patients, while limiting the geographic scope of enrollment. For more information, visit transparencyls.com/.
 Therapeutic Innovation & Regulatory Science 2018, Vol. 52(2) 220-229