A systematic review published late last week assesses the impact of the COVID-19 pandemic on on-going and new clinical trials and research on a range of diseases . The COVID-19 pandemic has resulted in a series of public health policies, including lock down, that have crippled the healthcare systems of many countries. These measures hugely impact on study participants, care providers, researchers, trial sponsors, and research organizations conducting clinical trials. This pandemic has a substantial impact on the trial sites as they experience difficulty in the continuation of trial activities which eventually hampers the progress of the trial and delays study timelines. Most sites are struggling due to delayed subject enrolment, shortfalls in monitoring, and risks of compromised data integrity, and this situation also has a negative impact on the start of future. Researchers are also concerned regarding the delay or cancellations of trials in the pandemic, which will have financial consequences for research organizations/human resources.
According to one survey, about two-thirds of the respondents have stopped or will soon halt subject enrolment in ongoing clinical trials, one-third halted randomization, and fifty percent of respondents are delaying or planning to delay the studies. Adopting new approaches and understanding the key risk indicators will help managers support trial sites with flexibility and ingenuity. For instance, switching patient site visits to new-trial virtualization, and telemedicine to interact with patients will help manage current clinical trials also beneficial for the post-pandemic era.
- Sathian B, Asim M, Banerjee I, Pizarro AB, Roy B, van Teijlingen ER, Borges do Nascimento IJ, Alhamad HK. Impact of COVID-19 on clinical trials and clinical research: A systematic review. Nepal J Epidemiol. 2020;10(3); 878-887