FDA's top regulator: "The clinical trial system is broken"

Janet Woodcock suggests a move towards platform trials with master protocols

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Janet Woodcock, Director for the Center for Drug Evaluation and Research at the FDA, has criticized the current clinical trial climate, claiming the system is broken. She has called for more collaborative efforts to effectively serve the needs of patients.


The solution? Platform trials with master protocols

At the National Academies of Sciences, Engineering and Medicine, Woodcock pitched platform trials with master protocols as the solution to the broken system. She believes this could allow pharmaceutical companies to more efficiently answer clinical questions.

Master protocols offer overarching frameworks which can evaluate multiple treatments and diseases in the same trial.  A platform study focuses multiple drugs on a single disease and utilizes a decision algorithm to allow therapies to enter and exit the platform.

This solution would require competitors to work together, however she believes there is support for this on the ground. Currently, industry and advocacy groups have approached her about kick starting such studies, but there has been some skepticism in the industry.

To some, this is simply not how clinical trials have been run historically therefore they are wary of introducing this new approach. Others are concerned about the collaboration needed. Platform trials are often most useful in highly competitive research areas, where comparative data and combination results will be particularly valuable.

In response, Woodcock said there will be a ‘tipping point’ where “people will realize the strength of [the approach], then there will be opportunities to go into the community and enlist the community practitioners, which will then result in a tremendous increase in ability to enroll patients and answer more questions”.


Start-ups set to disrupt the clinical trial system

A recent Contemporary Clinical Trials journal study found that enrolment remains a chief obstacle for many drug developers. They found that 86% of clinical trials don’t reach their recruitment targets within their specific timeframe. Often times, drug companies are competing to recruit similar patients, some patients are simply not aware that there are trials open to them, the trials may not be geographically convenient or they may have a treatment plan in place so are not seeking an experimental treatment.

Drug developers are now looking to startups to disrupt the current system and increase efficiencies in the process. According to Dow Jones’ Venture Source, venture capitalists have funded at least a dozen software start-ups this year.

There are a variety of start ups and solutions in this field, each aiming to assist with the key challenges faced by developers.

eClinical GPS, from Greenphire, helps sponsors automate and streamline global site payments. This increases overall site satisfaction, easing the burden of managing the finances across multiple sites.

Icertis allows organizations to streamline and systemize the different contracts and related documentation required for a clinical trial.

Verified Clinical Trials developed a worldwide database designed to prevent dual enrolment. This is to safeguard the integrity of the clinical trial data and protect patients help by not allowing for overlap or for patients to skip the 30-day “washout” period.

VitalTrax seeks to increase patient engagments with its mobile app. It allows possible participants to search, review eligibility, apply and stay involved during the course of a clinical trial. It also manages visit reminders and has the functionality for direct messages and alerts.

ObvioHealth has developed an app to enable studies to be run using mobile devices. Their platform also allowed for data to be collected from integrated smart devices.

Elligo provides practices with technology, personnel and services needed to serve as study sites for their patients. This includes pre-qualifying people for studies and scheduling treatment appointments for trial patients.

ePatientFinder created their Clinical Trial Exchange platform to help physicians identify, thoroughly screen and refer patients to clinical trials in their community.