Medable and partners have launched a toolkit designed to help ethical reviewers to assess decentralized trials more effectively.
The California tech firm worked with the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center) to develop a toolkit for Institutional Review Boards (IRBs)/Ethics Committees (ECs).
The aim is to create a roadmap for the ethical conduct of decentralized clinical trials (DCTs) according to the taskforce, which argues that standardization will simplify, streamline, and speed the IRB/EC process – a key step towards more efficient, patient-centered research execution.
Medable chief scientific officer, Pamela Tenaerts, set out the rationale for the collaboration, explaining the aim is to make it easier to initiate decentralized trials.
“Decentralized trials hold tremendous promise but to realize their full potential, we must systematically review every step of the start-up process to ensure we are uniformly implementing a DCT start-up framework.
"Together, we are working to remove potential hurdles to DCT adoption by harmonizing the ethical review, approval, and conduct of DCTs.”
This view is shared by Robert Romanchuk, who represents Advarra on the task force, who said “the rapid evolution of DCTs have led to ethics review challenges, including lack of familiarity with the varied and evolving technologies, DCT risks, benefits, and ethical issues.”
“IRB/ECs have different requirements and logistics for submission, review processes, and approval criteria which often leads to variability. It is heartening that other stakeholders have now joined with IRBs to understand their unique concerns with DCTs and have provided guidance and best practices for IRBs, sponsors, and researchers as we move forward in better harmony together.”
Several NIH studies have concluded that reducing IRB turnaround time is “essential” for drug development as delays prevent treatments from getting to patients and slow the improvement of public health outcomes.
The research also suggested that because DCTs offer potentially faster clinical study execution, disjointed and inconsistent ethics reviews could unintentionally slow the process.
To address this, the toolkit is intended to provide a roadmap for the ethical conduct of DCTs. They say that standardization will simplify, streamline, and speed the IRB/EC process – a key step towards more efficient, patient-centered research execution.
The toolkit comprises 13 guides that address common element of a decentralized trial ranging from electronic consent, electronic clinical/patient-reported outcomes assessment, wearable devices as well as remote telehealth visits.
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