Planning key for successful decentralized studies, says FDA report

Oversight is still the biggest challenge in decentralized and hybrid studies according to research, which says training and up front risk assessment are vital for CROs and sponsors running site-free and hybrid drug trials.

The study – published in Therapeutic Innovation and Regulatory Science – looked at trends in drug research and found that although decentralized studies can help increase participation – by, for example, reducing the travel burden on participants – oversight can be difficult.

The authors, from the US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Medical Policy, write “Despite the benefits of decentralized trials, there are challenges. For example, coordination of trial activities with individuals and facilities in multiple locations that are not traditional trial sites” will often be required.

“Also, sponsors and investigators must ensure supervision of those delegated to perform trial-related activities, such as local health care professionals (HCPs) performing physical exams or providing drug infusion services.”

Decentralization plans

To address such issues, the authors write, sponsors and contract research organization (CRO) usually develop specific plans to facilitate decentralization, which detail patients visit schedules, distribution of trial supplies and how local facilities and labs should be used in the study.

However, even with such plans, sponsors and CROs need to be certain that the decentralized is appropriate for the specific study.

“Whether trial decentralization is appropriate must be considered when initiating trial design. This decision should most importantly be based upon the assurance of the safety of trial participants and should take the nature of the IP into account.”

For example, the authors suggest that while fully decentralized trials may be appropriate for drugs that are simple to administer and have well-characterized safety profiles, hybrid studies may be better suited to more complex products.

“Hybrid decentralized trials may be more appropriate in cases where the administration of an investigational drug or a complex medical assessment needs to be performed at a clinical trial site and some follow-up assessments could be performed remotely as appropriate.”

The authors go on to say that, ultimately, the success of any decentralized study relies on planning and caution that sponsors and CROs should carefully consider whether the approach is suited to the specific project.

While the benefits of decentralized clinical trials (DCTs), including improved convenience for participants, are apparent, sponsors should be aware of the potential challenges of conducting a DCT as well as understand which trials are appropriate to be conducted in a decentralized fashion.

“Appropriate training, oversight, and up-front risk assessment and management will be key to implementing a DCT successfully,” they write.

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