|Year : 2021 | Volume
| Issue : 3 | Page : 175-176
A survey to assess the impact of the COVID-19 pandemic and the resultant lockdown measures on the ongoing clinical trials in India
Jayanti Gupta1, Rakesh N Dadhania2
1 Department of Biostatistics, NishKash Consulting, Bengaluru, Karnataka, India
2 Department of Clinical Research, Quinary Clinical Research, Bengaluru, Karnataka, India
|Date of Submission||09-Dec-2020|
|Date of Decision||11-Dec-2020|
|Date of Acceptance||16-Dec-2020|
|Date of Web Publication||07-Jul-2021|
Dr, Jayanti Gupta
NishKash Consulting, A-1601 Safal Twins, Sion-Trombay Road, Deonar, Mumbai - 400 088, Maharashtra
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Gupta J, Dadhania RN. A survey to assess the impact of the COVID-19 pandemic and the resultant lockdown measures on the ongoing clinical trials in India. Perspect Clin Res 2021;12:175-6
|How to cite this URL:|
Gupta J, Dadhania RN. A survey to assess the impact of the COVID-19 pandemic and the resultant lockdown measures on the ongoing clinical trials in India. Perspect Clin Res [serial online] 2021 [cited 2022 Dec 3];12:175-6. Available from: http://www.picronline.org/text.asp?2021/12/3/175/320814
| Introduction|| |
With the spread of the COVID-19 pandemic all over the world, and the resultant lockdown measures that were adopted, there has been a major disruption to studies that were ongoing before the pandemic started. We conducted an online survey of clinical trial sites across India to explore the impact on their research activities and assess key measures that have been implemented in response.
| Survey Design|| |
This was an observational study conducted between August 27 and September 30, 2020. Two questionnaires, one for investigators/site staff and another for ethics committee (EC) members, were sent to about 1000 sites and 100 ECs across the country. This study was registered at the Clinical Trials Registry-India (CTRI) (registration no. CTRI/2020/08/027420) and approved by an independent ethics committee (ACE-IEC), prior to initiation.
| Results|| |
We received a total of 101 responses to the surveys, 72 from investigators/site staff and 29 from EC members.
Of the 72 responses received from sites, 42% were principal investigators, 39% were study coordinators, and the rest were other clinical research staff. The respondents were from academic hospitals (15%), government hospitals (13%), multispecialty hospitals (40%), specialist hospitals (18%), and trust hospitals (14%). These clinical trial sites are located in 33 towns and cities across the country, distributed as 21% (north), 46% (south), 28% (west), and 6% (east). A total of 347 trials were ongoing across these sites when the lockdown was announced. Oncology (15%), cardiology (14%), endocrinology (11%), and nephrology (10%) were the most common therapeutic areas of these trials.
All sites that responded to the survey were open to patient enrollment before the lockdown. Only 18% could continue with the planned enrollment and follow-up visits, whereas 60% suspended new patient enrollment and 22% of the sites reported a complete suspension of all enrollment and follow-up. Retention of patients in the trials was a major fallout of the lockdown. At the time of the survey, only 20% of the trials had been able to retain most of the participants, whereas 11% of the trials reported losing >50% of their participants.
There were no geographical differences in how sites were affected. The initial months of the nationwide lockdown caused severe disruption to public transportation throughout the country. Transportation within cities was strictly restricted to essential services, and inter-city travel was completely prohibited. This made it impossible for most sites to enroll new patients, plan follow-up visits, and retain the existing participants in the trials. Trials in all therapeutic areas were affected to some extent, with neurology, pulmonology, gastroenterology, and urology being the worst affected and ophthalmology and rheumatology being the least affected.
The trial sponsors played a key role in managing the disruption caused by the pandemic. The majority (76%) of them communicated proactively with the sites and resolved queries on trial management. Conducting follow-up patient visits by phone (77%), remote monitoring by sponsors (65%), and shipping drugs directly to patients (39%) were the commonly adopted strategies to maintain continuity of the trials. However, about 8% of the trials reported receiving little or no support from their sponsors during the lockdown. The management of patient safety and trial integrity have been reported to be severely compromised in these trials.
A key aspect of managing the ongoing clinical trials during the pandemic is communicating with the existing trial participants about their future course on the trials. Almost 50% of the sites in the survey were able to communicate with majority (>80%) of their patients. The remaining sites could contact fewer patients, with 21% of the sites contacting less than half of the enrolled patients. Undoubtedly, this has put many patients at risk with no oversight from investigators or sponsors to manage their disease or address any adverse outcome arising from their participation in the trial.
Of the 29 EC members that participated in the survey, 41% were from institutional ECs and the rest from independent ECs. Nearly 55% of the participants reported facing challenges during the pandemic, primarily, with conduct of routine EC meetings (41%), documentation (24%), and review of ongoing studies (17%). Around 90% of the respondents chose virtual meetings to be a viable alternative to face-to-face meetings and 72% were satisfied with the guidelines received from the regulatory agency during this period.
Despite all the disruptions caused by the pandemic and lockdown, 89% of the respondents expressed their willingness to participate in new clinical trials during COVID-19.
| Discussion|| |
The focus of our survey was to understand the impact of the COVID-19 pandemic on the clinical research landscape in India. Although the number of respondents is limited, it gives us useful insights into the spectrum of issues being faced at the study sites and ECs. Some of the solutions adopted by the survey respondents include more use of technology in monitoring and assessment, virtual consultation, and telemedicine. Wherever possible, these suggestions should be implemented at sites across the country to mitigate the immediate- and long-term risks.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.