In the pandemic era of COVID-19, both the site and sponsors have faced many challenges in conducting clinical trials. The most important tasks in resolving the issues are preventing the pandemic spread and communicating with sites and sponsors. While the site investigators favored indirect contact using telephone and email, the sponsors desired to introduce various tools of DCTs.
The investigators at the site strongly believed that the difficulties could be overcome by themselves despite the pandemic environment. In addition, half of the personnel at the site not only were unfamiliar with the terminologies of novel methods on clinical trials but also had skeptical insights into them. It advocated for a cautious approach to the changes in clinical trial methods. With sposnors’ support, the site investigators must take action against the changes . Our study showed a gap between site investigators and sponsors. Sponsors are more prepared to use DCT elements than site investigators. As site investigators does not recognize the benefits of DCT in terms of patients perspectives, both parties must communicate more efficiently with one another . As the sponsors are required to train clinical research associates (CRAs), CRAs need to play more roles to communicate with site personnel . Each site needs to prepare a new standard operating procedure according to the government’s guidelines and to train the affiliated personnel.
As known well, the COVID-19 pandemic disrupted many clinical trials that were potentially bringing new therapeutics to market . As a result of this crisis, the US Food and Drug Administration, alongside its international counterparts, has developed guidance to protect both research participants and trials by advocating for remote data collection supplemented by telemedicine . The regulatory authorities must set the direction for resolving the issues by developing guidelines. According to global data 2021, digitalization of preclinical and clinical trials was viewed positively by 39% of healthcare and pharmaceutical professionals in North America, 39% in Europe, and 28% in the Asia-Pacific region . In our study, clinical trial sponsors believed that DCT items, such as digitalization, were required for successful clinical trials even after the pandemic era. However, some DCT items cannot be used in some countries including South Korea due to regulatory hurdles [14, 15]. Hence, regulatory authorities need to find hurdles with sponsors and sites and to solve those hurdles. In addition, trial sites also need to support remote monitoring performed by sponsors.
This study has several limitations. First, contrary to the sponsors, only one trial site was considered for the survey. Although overestimation of our result is cautious, it is advisable to see a viewpoint of the personnel working at the site. Second, one of the surveys for the sponsors was conducted the previous year; due to the interval between the surveys, the pandemic status, policy response, and social attitude may be different from the two points. However, even in this advanced year, it is interesting to note that many site investigators remain unaware of new approaches to conducting clinical trials. Third, the subjects who participated in clinical trials were not surveyed on. Changes in trial methods have a direct impact on the subjects. The changes must be geared toward the subjects’ benefit and convenience.