Cancer never stops: SARS-CoV-2 pandemic and the effect on research within GOG partners

Abstract

<h3>Objectives:</h3> The SARS-CoV-2 pandemic forced a shift in conducting clinical research. Ensuring the safety of all stakeholders (patients, research personnel, family members), maintaining financial viability, and overcoming operational restrictions (limited access to sites, workforce restrictions, reduced data collection) are barriers to continuing clnical research. GOG Partners, the GOG Foundation industry-sponsored clinical trials group, has been proactive to implement the following: 1) immediate compliance with CDC, FDA, and NIH guidelines with regard to clinical trial management; 2) systems that allowed for remote monitoring and other remote activities (telemedicine patient visits, remote data collection, shipping of drug to patients, virtual study start-up); 3) enhance enrollment opportunites away from university-based sites towards community-based practices; 4) increased frequency of our operations meetings with industry. The objective of this report is to describe how the pandemic affected accrual to GOG Partners' trials. <h3>Methods:</h3> Accrual data for GOG Partners trials over the past 4 years (2017- July 2020) were collected. ‘Pandemic' months were considered March thru July 2020. Information collected included accrual numbers, institution type (university versus non-university), and region of country. Descriptive statistics were analyzed. <h3>Results:</h3> Over the past 4 years, the median monthly accrual to GOG Partners trials was 43 patients (range: 14-95). Between March and July 2020, the median accrual was 59 patients (range: 43-72). For the same 5-month period over the past 3 years (March to July 2017, 2018, 2019) the median accrual was 36 (14-95). Accrual in March 2020 was 69 patients. Accrual decreased to 43 patients in April 2020 and 47 patients in May 2020 with respective z-scores of -0.25 and -0.01. June and July 2020 showed increased accrual with 59 and 72 patients respectively. The median number of participating sites per month over the past 4 years was 32 (9-66). There was an immediate decline in the number of sites participating from April to May 2020 of 36%. The number of sites participating in June and July were 38 and 52, respectively. During the pandemic, the accrual in the New England, Mid-Atlantic, Pacific and South Atlantic regions varied from their baselines. These variations followed the trends in COVID-19 spread. Non-university institutions accrued at a near-average rate throughout the months of April and May. During that same period, universities observed a decline in accrual of 48%. <h3>Conclusions:</h3> Accrual to GOG Partners' trials increased 37% over the median monthly accrual since the pandemic began. During the pandemic, total monthly accrual fell below or reached the median during only 1 month. Regional diversity of sites participating in GOG Partners' studies helped in preventing a more dramatic drop in participation. While overall accrual has historically shown to be relatively balanced between institution types, non-university institutions were less negatively impacted.