Among the many fallouts of the COVID-19 pandemic is a disruption of clinical research. Laboratories are closed, conferences have been cancelled, travel is restricted, supply chains for equipment have been interrupted, and resources have been lost. In particular smaller biotechs have or will incur losses as they have to considerably stretch their financial resources and can’t meet milestones.
The biggest effect has been on planned and already ongoing clinical trials of new drug candidates. Thousands of trials have been stopped or called off altogether (an unprecedented event with long-lasting effects on medicine). According to Michael Lauer, Deputy Director for Extramural Research at the US National Institutes of Health, about 80% of non-COVID trials in the U.S. have been interrupted or stopped. A recent world-wide research report by Informa Pharma Intelligence and Oracle Health Sciences revealed that the COVID-19 pandemic has led to longer enrolment timelines (49%), amended protocols (45%), and paused protocols (41%). Also, clinical trials have become more decentralised, i.e. the investigational medical product was shipped directly to the trial participant. 46% of respondents are planning or implementing such decentralised trials, 44% are considering new vendors, and 36% are considering new geographies for trial locations. However, this move is facing challenges such as patient monitoring and engagement, ensuring data reliability, quality, and data collection.
Most people are not aware how many participants and sites are involved in a clinical trial. Apart from the researchers and clinical doctors overseeing the trial and the patients, it’s caregivers and nurses, postgraduate researchers, postdocs, data scientists and people involved in funding and paperwork. Particular problems have been caused by the stress put on hospitals by the admission of so many critically ill patients and the necessity to avoid an infection of trial participants (or vice versa, as well as the staff at the trial sites).
Decentralising clinical trials
Regulators have been quick to react by changing their guidance so that physical distancing has been possible without compromising the safety of patients in testing and treatment. As an example, if possible, trial participants were provided with the test medication for a longer period of time, or the drug was distributed to their homes by a distributor so that they don’t need to visit the trial site – something that is called decentralisation of trials.
Decentralised trials, however, create problems in terms of compliance, medical control and data assessment. Solutions such as telemedicine have been known for a long time, but have not yet been implemented in clinical trials due to administrative and bureaucratic hurdles, cost and reimbursement.
Nevertheless, at least U.S. regulators have accepted patient evaluation and data sampling via remote solutions, either via email, phone calls or videoconferences or by tele-medical monitoring. The same approach has been applied to many COVID-related trials. Even completely decentralised trials have been conducted – from recruiting via social media to medication distribution to data collection. However, researchers have warned that several of these clinical trials lack control groups, have poorly defined endpoints, lack generalisability to those of a lower socioeconomic status or were designed too early in the pathophysiological course of the disease to result in substantive recommendations.
Creating a roadmap for the future of clinical research
The developments described above raise a lot of questions:
- Are design and data of trials conducted during the pandemic solid?
- Can self-reported outcome be equalled to an independent assessment by a specialist?
- Do online recruiting and telemedical assessment increase or decrease patient heterogeneity?
- What impact do concomitant COVID infections and stress caused by social distancing have on side effects and outcome?
- Can telemedicine be implemented in the clinical trial routine in the post-pandemic era to save costs?
- What else can be copied for the future?
At the same time, it is clear to researchers in academia as well as in industry that the way clinical trials are conducted is outdated in many aspects and overly burdened by red tape. Conducting trials can and should be improved and modernised to benefit patients, clinicians, and researchers. Therefore, the pandemic may act as a catalyst for positive changes in terms of recruitment, monitoring and innovation to create a more efficient, integrated research platform for the future.
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