Clinical trial visits in the age of COVID-19: implementation of research participant safety measures

Authors

  • Kathryn J. Krueger School of Nursing, University of Kansas Medical Center, Kansas City, Kansas, United States of America
  • Faith Rahman School of Nursing, University of Kansas Medical Center, Kansas City, Kansas, United States of America http://orcid.org/0000-0002-9598-3972
  • Qiuhua Shen School of Nursing, University of Kansas Medical Center, Kansas City, Kansas, United States of America
  • John B. Hiebert School of Nursing, University of Kansas Medical Center, Kansas City, Kansas, United States of America
  • Janet D. Pierce School of Nursing, University of Kansas Medical Center, Kansas City, Kansas, United States of America

DOI:

https://doi.org/10.18203/2349-3259.ijct20211466

Keywords:

COVID-19, Clinical trials, Patient safety recommendations

Abstract

The COVID-19 pandemic is having a major impact on how current clinical trials are being conducted in the United States. Researchers have experienced the effects of COVID-19 through the halting and delaying of clinical trials, the lack of personal protection equipment (PPE), the closing of clinical sites, and a decrease in participant recruitment. Many clinical trials will have more missing data because of a participant’s inability to attend in-person visits, discontinuation of trial activities, or interruption of time-sensitive study collection data due to COVID-19. All of these events affect the data quality of trials. Government agencies such as the Food and Drug Administration (FDA), centers for disease control and prevention (CDC), and National Institutes Of Health (NIH) have issued recommendations for investigators conducting clinical trials to combat the spread of COVID-19 and to maintain data integrity. Institutions sponsoring clinical trials have also provided guidelines to continue, modify, or pause research studies that are essential to ensure participant and research team safety. Key recommendations include implementing telehealth appointments, wearing a protective mask and face shield, quarantining for 14 days if exposed to COVID-19 or having travelled, and, if possible, maintaining a 6-foot distance. It is also recommended that investigators implement COVID-19 screening questionnaires prior to and during on-site visits. This includes participants and research personnel completing a temperature check and questionnaire screen before in-person data collection. This article will discuss the challenges encountered by researchers conducting clinical trials and provide resources and examples to assist investigators during the COVID-19 pandemic.

Metrics

Metrics Loading ...

References

Jin Y, Yang H, Ji W, Wu W, Chen S, Zhang W, Duan G. Virology, Epidemiology, Pathogenesis, and Control of COVID-19. Viruses. 2020;12.

Malik YA. Properties of Coronavirus and SARS-CoV-2. Malays J Pathol. 2020;42:3-11.

Rabaan AA, Al-Ahmed SH, Haque S, Sah R, Tiwari R, Malik YS, Dhama K, Yatoo MI, Bonilla-Aldana DK, Rodriguez-Morales AJ. SARS-CoV-2, SARS-CoV, and MERS-COV: A comparative overview. Infez Med. 2020;28:174-84.

Fleming TR, Labriola D, Wittes J. Conducting Clinical Research During the COVID-19 Pandemic: Protecting Scientific Integrity. JAMA. 2020.

Zhai P, Ding Y, Wu X, Long J, Zhong Y, Li Y. The epidemiology, diagnosis and treatment of COVID-19. Int J Antimicrob Agents 2020;55:105955.

Dean-Love P. Clinical Research Infection Control Guidelines in the times of COVID-19: The University of Kansas Medical Center, 2020.

Coronavirus (COVID-19), 2020. Available at: https://www.covid19treatmentguidelines.nih.gov/. Accessed on 20 January 2021.

Turner JR. New FDA Guidance on General Clinical Trial Conduct in the Era of COVID-19. Ther Innov Regul Sci. 2020;54:723-4.

Agency EM. Guidance on the Management of Clinical Trials During the Covid-19 (Coronavirus) Pandemic. In: Union E, ed. Brussels, Belgium. 2020;1-21.

Padala PR, Jendro AM, Padala KP. Conducting Clinical Research During the COVID-19 Pandemic: Investigator and Participant Perspectives. JMIR Public Health Surveill. 2020;6:e18887.

Ranney M, Griffeth V, Jha A. Critical Supply Shortages — The Need for Ventilators and Personal Protective Equipment during the Covid-19 Pandemic. N Engl J Med. 2020;382.

Yanow SK, Good MF. Nonessential Research in the New Normal: The Impact of COVID-19. Am J Trop Med Hyg. 2020;102:1164-5.

Czeisler ME, Tynan MA, Howard ME, Honeycutt S, Fulmer EB, Kidder DP, et al. Public Attitudes, Behaviors, and Beliefs Related to COVID-19, Stay-at-Home Orders, Nonessential Business Closures, and Public Health Guidance - United States, New York City, and Los Angeles, May 5-12, 2020. MMWR Morb Mortal Wkly Rep. 2020;69:751-8.

Nicola M, Alsafi Z, Sohrabi C, Kerwan A, Al-Jabir A, Iosifidis C, Agha M, Agha R. The socio-economic implications of the coronavirus pandemic (COVID-19): A review. Int J Surg. 2020;78:185-93.

Greenhalgh T, Wherton J, Shaw S, Morrison C. Video consultations for COVID-19. BMJ. 2020;368:998.

Byrd JB, Bello N, Meyer MN. Pandemic Pandemonium: Pausing Clinical Research During the COVID-19 Outbreak. Circulation. 2020;141:2045-7.

Administration USFaD. FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency. In: Administration USFDA, ed. 2020;1-34.

Prevention CDCA. Information for Healthcare Professionals about Coronavirus (COVID-19), 2020. Available at: https://www.cdc.gov/coronavirus /2019-ncov/hcp/index.html. Accessed on 20 January 2021.

Environment KDoHa. Ad Astra: A Plan to Reopen Kansas, 2020. Available at: https://governor. kansas.gov/governor-laura-kellys-ad-astra-a-plan-to-reopen-kansas-speech/. Accessed on 20 January 2021.

Girod DA, Simari RD, Barohn RJ. EVC Campus Update: Suspension of Non-Essential Research for all Campuses: The University of Kansas Medical Center, 2020.

Dean-Love P. Guidelines for COVID-19 prevention in research Laboratories (BSL1 and BSL2 Research) The University of Kansas Medical Center, 2020.

Downloads

Published

2021-04-22

How to Cite

Krueger, K. J., Rahman, F., Shen, Q., Hiebert, J. B., & Pierce, J. D. (2021). Clinical trial visits in the age of COVID-19: implementation of research participant safety measures. International Journal of Clinical Trials, 8(2), 167–173. https://doi.org/10.18203/2349-3259.ijct20211466