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New recommendations offer guidance on overcoming legal, regulatory, and practical hurdles.
Traditional clinical trials are often expensive, inefficient, include highly selective populations, and can create significant participant burden via travel and other logistical demands. Remote or decentralized clinical trials (DCTs)-those executed through telemedicine, mobile/local healthcare providers (HCPs) and/or mobile technologies that are not bound by geographic limitations-are gaining traction, but adoption has been slow and variable.
With this in mind, the Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by Duke University and the U.S. Food and Drug Administration (FDA), launched a multi-stakeholder DCT project1 to help identify perceived and actual legal, regulatory, and practical barriers to conducting DCTs and identify opportunities to clarify and inform policies that affect the implementation of DCTs.
A decentralized approach allows trial participants to take part in clinical research from anywhere, potentially resulting in accelerated enrollment and more diverse participants’ representative of the target population. In addition, measurements can be more frequent or even continuous because they are not restricted by scheduled clinic visits. DCT approaches may lessen participant burden (e.g., travel costs and time loss), which may enhance retention and facilitate certain research that may otherwise be unduly burdensome under traditional clinical trial constructs. Sites may be asked to fulfill novel roles as technology partners for patients.
In September 2018, CTTI unveiled evidence-based and practical recommendations2 to speed the use of DCTs and potentially improve the efficiency and affordability of clinical trials broadly. These recommendations address barriers that could be hindering the widespread use of DCTs. Use of these recommendations could offer sponsors, CROs, and others many advantages, including improved recruitment and retention, greater participant diversity, and a more comfortable and convenient research experience for participants.
As part of the research for the DCT project, CTTI interviewed representatives from early adopter pharmaceutical or biotechnology companies that were currently implementing or planning DCTs. Some of the challenges identified included ensuring that protocol-defined activities are carried out in a consistent manner, remotely replicating the interactive part of the informed consent process and verifying trial participants’ identities and ensuring their privacy and confidentiality when research is completely remote. Inconsistent state telemedicine laws also make planning and implementation of clinical research with telemedicine components difficult.
To address these challenges, the interviewees suggested starting trial planning early and ensuring the patient perspective is captured in the trial design and conduct. Other suggested solutions included: review and understand individual state laws, develop systems for tracking receipt and drug accountability in remote trials, and enhance current systems to include training and assessments for mobile HCPs.
Informed by evidence, the CTTI recommendations also provide guidance on effective DCT protocol design, investigator delegation and oversight, use of mobile health care providers, and safety monitoring. When sites, sponsors, CROs, and others implement these new recommendations, they can help advance the use of mobile technologies in DCTs, move toward better and more inclusive clinical trials, and possibly address the escalating expense of conducting trials.
A key concept within the recommendations is that DCTs do not have to be an all-or-nothing decentralized trial, but can be a hybrid, incorporating various procedures and activities that are common in traditional studies. There is a broad continuum of hybrid approaches that provide sponsors and CROs with varying opportunities to implement decentralized trials, even if it is their first time doing so.
The potential benefits apply to trials in all disease areas, but could offer particular advantages in rare diseases, where patients are generally limited in number and are highly geographically dispersed.
CTTI’s DCT work is part of a broader set of Mobile Clinical Trials (MCT) solutions, created by more than 250 individuals representing more than 100 organizations across the clinical trials ecosystem. From developing a novel endpoint to selecting mobile technologies to preparing a site, the MCT hub offers free resources to stakeholders who are planning or running a digital trial.
Pamela Tenaerts, MD, MBA, is the Executive Director at the Clinical Trials Transformation Initiative (CTTI). Penny Randall, MD, MBA, is Vice President and Head of the CNS Center of Excellence at IQVIA.