Clinical trial industry has experienced a major disruption due to COVID-19 across the globe across all the stakeholders. The interruption affected mainly the clinical trial project administration that included site management, ensuring compliance to regulatory/ethics guidelines, ensuring participant safety, and client satisfaction. The impact has also been felt in the drug development process of novel therapies. A survey of 4599 clinical trials revealed a delay in the project timelines due to hindrance in the patient recruitment (decreased between 40% and 80%) in various subspecialty areas. We carried out the present study to identify the factors impacting the clinical trials during the era of COVID-19 and strategies for mitigating the impact.
Senior clinical research professionals having minimum 4 years of experience across clinical research industry were approached following approval from the Institutional Ethics Committee (IEC) and implied consent. A structured online questionnaire containing two parts: part A consisted of evaluating the critical areas of clinical trials project impacted due to COVID-19 pandemic, and part B consisting of risk mitigation strategies for optimizing the timely completion of clinical trials, were administered. Descriptive statistics were used for analyzing the data.
One-hundred and thirty were approached, of which 49 were included in the final analysis. The mean years of experience of clinical research professionals was 8.2 years with a large majority having between 7 and 11 years. Thirty-four (69%) respondents were belonging to either clinical trial sponsors/clinical trial conducting sites. Forty-two (85%) respondents admitted that the pandemic had negatively impacted the ongoing clinical trials. Among this group, two respondents confirmed that they observed a temporary hold on patients’ recruitment, 11 had to amend the study protocol, and three each confirmed that the studies were either terminated or postponed. Only six respondents stated that the ongoing clinical trials were continuing as planned. Seventeen respondents mentioned that the recruitment reduced by nearly half compared to the prepandemic estimates. Nearly 50% of the respondents stated that patient safety was compromised due to the disruption of clinical trials due to COVID-19, while 38% disagreed on that. The main reasons for the same were listed as follows: restriction for onsite visit by the study participants (69%) and omitting the clinical and lab assessments (22%) that were part of approved clinical trial protocols. Regarding the impact on the regulatory framework, 30% stated delays in regulatory approval, 23% were uncertain on the procedures for protocol amendment, and 18% stated ambiguities in reporting the protocol deviations. Similarly, delays in the review and approval of clinical trials by IEC were reported by 71% of respondents. Regarding the risk mitigation strategies, 69% of respondents suggested clinical trial team personnel visits to the study participants’ home for monitoring the clinical parameters and for collecting samples for laboratory analyses, and 86% stated using the electronic diary for recording trial-related parameters as possible solutions.
We identified various issues and mitigation plans for COVID-19 impact on clinical trials from mid-senior level clinical research professionals. Timely management of clinical trial operations is critical considering the cost involved (US$20–50 million per trial). As iterated by the respondents, we recommend conducting siteless clinical trials (also termed decentralized or virtual clinical trials). Recently, web-based virtual trial has been successfully carried out that has a great potential for reaching out to larger populations rapidly. A hybrid approach (online and at site) is recommended for carrying out the IEC proceedings. Electronic clinical trial management systems and electronic trial master files have also been shown to be efficient in such situations.[5,6]
This is the first study evaluating the impact of pandemic on clinical trial operations. However, the study is also limited by the sample size, not having respondents from regulatory, IEC, and clinical trial participant categories.
To conclude, we have identified the impact of the ongoing COVID-19 pandemic on clinical trial operations and the risk mitigation strategies in the Indian subcontinent. However, validation of the findings in a larger cohort is recommended.
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Conflicts of interest
There are no conflicts of interest.
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2. Sathian B, Asim M, Banerjee I, Pizarro AB, Roy B, van Teijlingen ER, et al. Impact of COVID-19 on clinical trials and clinical research:A systematic review. Nepal J Epidemiol 2020;10:878-87
4. Orri M, Lipset CH, Jacobs BP, Costello AJ, Cummings SR. Web-based trial to evaluate the efficacy and safety of tolterodine ER 4 mg in participants with overactive bladder:REMOTE trial. Contemp Clin Trials 2014;38:190-7