An Investigational New Drug (IND) application just approved by the US Food and Drug Admininstration is the first ever for a clinical trial protocol developed with the aid of crowdsourcing, its sponsor says.
The US application to assess lisinopril in a Phase II trial as an adjunctive therapy for multiple sclerosis (MS) also represents one of the first protocols to make intensive use of telemonitoring and other remote methods for patient-data collection, notes Transparency Life Sciences (TLS).
The US-based biopharmaceutical concern, which marked its official launch earlier this year as “the world’s first drug development company based on open innovation”, aims to demonstrate the value of its online Protocol Builder platform using repurposed off-patent compounds with extensive safety records.
The idea is to design clinical-trial protocols more in tune with the needs of patients, physicians, researchers and other stakeholders, enhancing the productivity of clinical development and the regulatory viability of resulting compounds while reducing timelines and costs.
A widely used antihypertensive that has shown potential efficacy against MS in animal studies, lisinopril was the first repurposed compound for which TLS opened up a clinical-trial protocol to collaborative input on its crowdsourced web platform.
According to Dr Tomasz Sablinski, founder and chief executive officer of TLS, the company has spent “much of this year” refining the Protocol Builder tool. The responses obtained from patients and healthcare experts were used to strengthen the lisinopril Phase II protocol.
These contributions included “valuable insights on primary and secondary endpoints, inclusion/exclusion criteria and remote monitoring strategies”, Sablinski commented, adding: “Going forward, we expect even more of the content of our protocols will be derived from curated crowd input”.
Another strand of the TLS strategy is to cut significantly the cost and inconvenience to patients of implementing clinical trials by replacing site visits with telemonitoring and other measurements taken in patients’ own homes.
To achieve its goal of a 50% or more reduction in the cost of clinical trials, TLS has partnered with Advanced Monitored Caregiving (AMC Health), a telehealth provider that offers a range of user-friendly in-home telemonitoring solutions.
In the proposed twelve-month lisinopril study, patients will visit clinical-trial staff in person only at the start and end of the protocol. All other study data will be collected at home.
TLS has posted the FDA-approved lisinopril protocol on its website and welcomes further input from patients, clinicians and researchers on details of the design, especially with respect to telemonitoring and statistical analysis.