With the COVID-19 pandemic recently passing one year in duration, clinical research continues to be significantly affected. Sponsors have had to modify trial designs to prevent the suspension, termination, or withdrawal of planned and ongoing clinical trials. The adaptation and usage of decentralized trials and virtual technologies have been strongly accelerated in order to mitigate the issues presented by the pandemic, says GlobalData, a leading data and analytics company.
Gastrointestinal studies currently have the highest proportion of disrupted clinical trials due to COVID-19. GlobalData found that 2.04% of gastrointestinal clinical trials were disrupted due to COVID-19, followed by hematological disorders at 2%.
Mohamed Abukar, MSc, Clinical Trials Analyst at GlobalData, explains: “Gastrointestinal studies and hematological disorders trials generally require more frequent sample collection to assess the efficacy of a therapy through biomarker concentration analysis. The increased use of decentralized and virtual trials may be less suitable for therapy areas that require frequent non-point-of-care data collection and analysis.”
Infectious disease clinical trials have the lowest proportion of disrupted trials, with just 0.91% of trials disrupted and the lowest proportion of Phase I and Phase II disruptions among the top ten therapy areas.
Abukar continues: “Trial coordinators conducting non-COVID-19 related infectious disease trials may have the necessary experience to circumvent the greatest barriers caused by the pathogenesis of COVID-19 and are thus best placed to adapt processes to ensure trials can initiate and continue running.”
While oncology studies have the highest number of disrupted trials among the top ten therapeutic areas, these studies also have the second lowest proportion of trial disruptions due to COVID-19 (1.18%). Teams conducting oncology studies have demonstrated capability in preventing disturbances to late-phase studies and hold the lowest proportion of Phase III (0.33%) and Phase IV (0.09%) disruptions.
Abukar adds: “The relatively low proportion of disrupted trials may be attributed to the urgency of these studies where outcomes are concerned; in some cases, discontinuation of experimental therapies may result in substantial harm to participating patients. Furthermore, as oncology has almost double the number of trials as the second-place central nervous system disorders, a larger amount of funding may be spent in implementing new practices and overcoming barriers.”