With the COVID-19 pandemic far from being conquered across much of the globe but becoming somewhat more manageably endemic in areas, many clinical trials programs once entirely shuttered or retooled for coronavirus vaccine or treatment studies are reverting to more or less normal operations. Among other topics, the forthcoming June issue of Clinical Researcher, ACRP’s peer-reviewed journal, offers insights from three very different research enterprise perspectives on valuable lessons learned from the crisis.
In “Finding Perspective and Identifying Research Best Practices Amid the Ongoing COVID-19 Pandemic,” Deanna M. Golden-Kreutz, PhD, Angela O. Sow, MACPR, Michelle R. Bright, MA, and Brad H. Rovin, MD, all with the Center for Clinical Research Management at The Ohio State University, focus on “the wide-ranging impact of COVID-19 on research processes and associated best practices that have emerged to manage these impacts on the research environment at” the university’s medical center.
Four overarching key strategies are highlighted: 1) leveraging existing research management infrastructure; 2) establishing a COVID-19 research policy; 3) developing multidisciplinary research working groups; and 4) strengthening connections among institutional research stakeholders. “These strategies demonstrated success in the initial response to the pandemic and have remained critical for research management throughout the ongoing pandemic,” the authors write.
Another article, “Navigating Through an Academic Capstone Project in the Time of COVID-19,” by Nadina Jose, MD, Doreen Lechner, PhD, Barbara Tafuto, MLS, PhD, and Lisa Palladino Kim, MS, delivers a different kind of view from a higher education setting, this time from Rutgers University. The authors track the journey of two Clinical Research Management graduate program students who were faced with the burden of having to readjust their capstone project activities while in lockdown at the height of the COVID-19 pandemic, and highlight the tools they used to cope with the rigors of meeting the project deliverables.
“The capstone project deliberately targets principles of leadership and professionalism encompassing communications and teamwork skills necessary to successfully conduct clinical trials as outlined in Domains 7 (Leadership and Professionalism) and 8 (Communication and Teamwork) of the Joint Task Force Clinical Research Professional Competency Framework,” the authors note. “The COVID-19 pandemic resulted in a considerable barrier for students’ ability to implement their capstone projects under normal processes.” One of the student’s projects involved creating a mapping tool for a specific company’s real-world evidence database, while the other student’s project included assessing the impact of COVID-19 on the Medical Affairs unit’s activities of insight generation, stakeholder engagement, and scientific exchange at another company.
Last but not least, in his opinion piece on “More Sites, Sponsors, and CROs Should Leverage eSource as a Study Manager in Remote Monitoring Situations,” Takoda H. Roland, CCRA, CCRP, CNA, a clinical project manager and owner of Philadelphia Pharmaceutical Research, shares thoughts from his experiences running a global pivotal investigational new drug Phase III study during the pandemic.
“COVID-19 forced contract research organizations (CROs) to rethink their monitoring paradigm,” Roland writes. “Drawing from both my own and my team’s experience with a leading provider of eSource services, our study was able to successfully implement a remote monitoring process to mitigate the issues of running the trial during the pandemic. Even as someone who had long advocated for remote monitoring using eSource, I found myself astounded at the success our team achieved.”
The June 2022 issue of Clinical Researcher, with these articles and other content touching on decentralized clinical trials, patient diversity, digitization of trials, and data analysis for trials, will go online on or around June 21 on the ACRP website.
Edited by Gary Cramer
COVID-19 and the Clinical Research Profession
Read the first and only retrospective shining the spotlight on you and your amazing response to the COVID-19 pandemic. This new white paper, published in April 2022, spotlights the impact of COVID-19 on clinical research professionals at both an organizational and human level, examining their challenges, their insights, their successes, and the personal price many had to pay in the interest of their vocation.