Decentralized clinical trials

New developments in the pharmaceutical industry

Tue, 2021 / 07 / 20
Between December 2019 and January 2021, at least 2043 of the ongoing clinical trials listed on had to be suspended or terminated, due to the COVID-19 pandemic. Recruitment difficulties for these types of trials or the long distances patients must accept for treatment in hospitals and trial centers also give reason to think about alternatives to traditional clinical trials. Not least for this, the BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte) discussed the use of so-called decentralized clinical trials in its dialogue of May 26, 2021.

The first approaches for decentralized clinical trials (DCT) are already available in the pharmaceutical industry. On the one hand, decentralized approaches can be used in the traditional treatment or testing center. Here, however, only a few partial aspects are caried out "remotely" with the patients; among other things, eConsent can be used as digital patient education, while most of the measures remain in the treatment center. On the other hand, hybrid studies can be conducted. By using virtual study elements such as wearables or mobile devices, patients' data and results can be recorded directly and transmitted to the person responsible for the study. In this way, a reduction in the number and/or duration of visits for patients to treatment centers can be achieved. Decentralized clinical trials move the study completely to the patient's home, eliminating visits to the trial center. In this case, the investigators would monitor and advise the patients via telemedicine. A first European-wide pilot study is already looking at the generation of scientific evidence through three different study arms (conventional, hybrid and decentralized) and how these study designs affect data quality and patient safety.

However, to guarantee the rights, safety, and well-being of the subjects on the one side, but also to ensure the quality of the study, the data collected, and the robustness of the results, the right conditions for conducting these types of studies must first be established. Some issues that need to be discussed in this context concern the altered doctor/patient relationship during telemedicine studies or the investigator's commitment to this type of clinical study. Questions about technical aspects, for example: "How well does telemedicine work technically? How often are there failures? How user-friendly is it designed? Is it age-appropriate and barrier-free?" must definitely be answered in the course of accompanying research for decentralized clinical studies.

The BfArM has so far concluded that a purely decentralized clinical trial is only an exceptional possibility. However, hybrid models may be a viable alternative in the future if all conditions for are met and there is a justification for the choice of a decentralized study. A far-reaching change in the way clinical trials have been conducted to date could take place in the near future. Therefore, SKC continues to pursue with excitement the further discussions and possible actions around the topic of decentralized clinical trials.

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