Key phrase: unconventional clinical trial designs
Author: Rebecca Schlossberg
The COVID19 pandemic has been the catalyst for widespread change in the clinical trial space. In order to ensure the continuity of trials a hybrid decentralized research approach has been adopted, and seems to have become the standard as we move into 2022. What started out as a need for trials to be uninterrupted has now become the preferred method because virtual trials improve the patient and physician experience. Pharma, biotechs and contract research organizations are always seeking to make clinical trials faster and more efficient.
Trial decentralization has thus emerged as the best way to do so. This involves bringing a big part of the trials activities directly to the patient as opposed to the standard which required that the patient be in the clinical trial facilities during the course of treatment. The traditional paradigm made it very difficult for patients to enroll in clinical trials, as they needed to uproot their entire lives to do so. When coronavirus emerged clinical trial managers needed to evaluate how they would continue their work while still ensuring that safety measures were being met. Travel and resources were extremely limited during the pandemic, thus, access to trial sites was reduced by 80%.
As expected, the number of trial enrollments significantly dropped and trials began to stall. From January until April in 2020 the number of trials conducted dropped by 50% (Xue et al., 2020). They began to make small but significant changes to the process by allowing the treatments to be administered in the patient’s home and conducting the monitoring from a local nearby facility. Additionally, trials began to adopt new protocols that allowed for remote consent, virtual patient monitoring, video conference assessments, and siteless phlebotomy (Agrawal, 2020).
These new practices for COVID19 have proven to be beneficial in the long run as well, and the consensus is that they will become permanent fixtures in the clinical trial space. Decentralized clinical trials improve participant retention, engagement and satisfaction. One survey showed that 98% of patients reported increased satisfaction with telemedicine (Agrawal, 2021).
Decentralization has not only improved the experience, increased efficiency, and lowered the bar of entry but also allowed for more inclusivity, specifically for racial minorities who were previously unable to participate. These trends can set the stage for a reduction in ethnic and socio-economic prejudice in the space.
It is important to note that decentralized clinical trials are not always going to be the appropriate model and may need to be adjusted. Often, a hybrid approach will be necessary. This is specifically relevant when trials span multiple jurisdictions and countries, where regulations, laws, technological uptakes and cultural norms will vary. As such, moving past the pandemic, clinical trials will most likely consist of a hybrid approach where some parts of the trial will be remote while other aspects will take place in person.
While hybrid decentralization seems to be the panacea to the clinical trial challenges, it is not a cure for all of the barriers and will inevitably bring issues of its own. Some challenges posed by this new paradigm include identity verification, insurance coverage concerns and new telemedicine laws. For example, while many digital health solutions will require adherence to electronic record and signature requirements, the FDA has reiterated that telecommunications platforms themselves are not subject to 21 CFR part 11. Clinical trial awareness among providers and patients alike is still the most difficult challenge in the arena. Regardless of where the trial is being conducted, if patients and physicians aren’t aware of the trial, enrollment and participation will continue to be low. As such, sites like the Clinical Trial Guide will become more pertinent in the coming years.
The global clinical research industry is expected to increase exponentially in the coming years. With this in mind it is crucial that significant changes be made to the design of clinical trials to accommodate this growth. Hybrid decentralized clinical trials may become a preferred paradigm as we move forward into the future.
Xue, J. Z., Smietana, P. P., Webster, K., Yang, G., & Agrawal, G. (2020). Clinical trial recovery from COVID-19 disruption. Nature Reviews Drug Discovery, 19(10), 662+. https://link.gale.com/apps/doc/A636843725/AONE?u=anon~dbe9a253&sid=bookmark-AONE&xid=8d1426e1.
Clinical Trial Transformation Initiative, CTTI Recommendations: Decentralized Clinical Trials 2 (2018), available at https://www.ctti-clinicaltrials.org/sites/www.ctti-clinicaltrials.org/files/dct_recommendations_final.pdf.
Agrawal, G. (2021, June 10). Stepping up the decentralization of clinical trials | McKinsey. Www.mckinsey.com. https://www.mckinsey.com/industries/life-sciences/our-insights/no-place-like-home-stepping-up-the-decentralization-of-clinical-trials
John Z. Xue et al., “Clinical trial recovery from COVID-19 disruption,” Nature Reviews Drug Discovery, September 2020, Volume 19, pp. 662–3, nature.com.
“COVID-19 and clinical trials: The Medidata perspective,” Medidata Solutions, May 4, 2020, medidata.com
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