Experience, Perceptions, and Recommendations Concerning COVID-19–Related Clinical Research Adjustments

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  • 1 Department of Internal Medicine, Division of Hematology-Oncology,
  • | 2 Harold C. Simmons Comprehensive Cancer Center, and
  • | 3 Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, Texas.
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Background: During the COVID-19 public health emergency, the FDA and NIH altered clinical trial requirements to protect participants and manage study conduct. Given their detailed knowledge of research protocols and regular contact with patients, clinicians, and sponsors, clinical research professionals offer important perspectives on these changes. Methods: We developed and distributed an anonymous survey assessing COVID-19–related clinical trial adjustment experiences, perceptions, and recommendations to Clinical Research Office personnel at the Harold C. Simmons Comprehensive Cancer Center. Responses were compared using the Fisher exact test. Results: A total of 94 of 109 contacted research personnel (87%) responded. Among these individuals, 58% had >5 years’ professional experience in clinical research, and 56% had personal experience with a COVID-19–related change. Respondents perceived that these changes had a positive impact on patient safety; treatment efficacy; patient and staff experience; and communication with patients, investigators, and sponsors. More than 90% felt that positive changes should be continued after COVID-19. For remote consent, telehealth, therapy shipment, off-site diagnostics, and remote monitoring, individuals with personal experience with the specific change and individuals with >5 years’ professional experience were numerically more likely to recommend continuing the adjustment, and these differences were significant for telehealth (P=.04) and therapy shipment (P=.02). Conclusions: Clinical research professionals perceive that COVID-19–related clinical trial adjustments positively impact multiple aspects of study conduct. Those with greatest experience—both specific to COVID-19–related changes and more generally—are more likely to recommend that these adjustments continue in the future.

Submitted July 1, 2020; accepted for publication August 19, 2020. Published online October 7, 2020.

Author contributions: Study design: Gerber, Beg, Williams. Data collection: Williams, Clark. Data analysis: All authors. Manuscript preparation: Gerber, Sheffield, Craddock Lee. Critical revision: All authors.

Disclosures: The authors have disclosed that they have not received any financial consideration from any person or organization to support the preparation, analysis, results, or discussion of this article.

Funding: This work was supported in part by an NCI Midcareer Investigator Award in Patient-Oriented Research (K24CA201543-01, to Dr. Gerber), the Biostatistics Shared Resource of the Harold C. Simmons Comprehensive Cancer Center (5P30 CA142543), and UT Southwestern Academic Information Systems (CTSA NIH grant UL1TR001105).

Correspondence: David E. Gerber, MD, Division of Hematology-Oncology, Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, 5323 Harry Hines Boulevard, Mail Code 8852, Dallas, TX 75390-8852. Email: david.gerber@utsouthwestern.edu

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