Login Register Cart 0
Generic placeholder image

Reviews on Recent Clinical Trials

Editor-in-Chief

ISSN (Print): 1574-8871
ISSN (Online): 1876-1038

Back
Journal Home About Journal Editorial Board Journal Insight Current Issue Volumes/Issues
Subscribe
General Review Article

Role of the Clinical Data Managers During the COVID-19 Pandemic: An Overview

Author(s): Rishitha Sajja*

Volume 18, Issue 1, 2023

Published on: 29 December, 2022

Page: [41 - 45] Pages: 5

DOI: 10.2174/1574887118666221208123724

Price: $65

conference banner
Abstract

Background: The COVID-19 pandemic has significantly changed the implementation of clinical trials. A large focus has been directed on clinical trial design, timeline, and best practices. It has led clinical trial study teams to update the existing processes and perform a risk assessment to mitigate the impact of the COVID-19 pandemic according to ICH-GCP (Good Clinical Practice) requirements. Data management plays a crucial role in understanding the study team's needs and developing innovative solutions. The Clinical Data Manager (CDM) is a core clinical trial Study Team member, responsible for promptly collecting, managing, and delivering complete, highquality data.

Objective: The COVID-19 pandemic required the Clinical Data Manager (CDM) to respond to changing needs by adapting data collection tools, data review strategies, and data management processes to answer new questions and address new challenges. CDMs became responsible for identifying how the COVID-19 pandemic impacted current data management processes and documentation and implementing changes to reflect new ways of working. The present article reviews the impact of the COVID-19 pandemic on clinical trials and the solutions adopted by the Clinical Data manager.

Conclusion: The collection of COVID-19-related data points provides a better understanding of patient safety during the pandemic and proactively fulfills the growing regulatory interests. Strategies and innovative solutions adopted by the Clinical Data Manager serve as guidance for the clinical research team during the crisis to make the trials more robust and patient-centered.

Keywords: COVID-19, pandemic, clinical data manager, data management, clinical trials, data collection, data review, data quality.

« Previous Next »
Graphical Abstract

[1]
National Institute for Health Research. DHSC issues guidance on the impact of COVID-19 on research funded or supported by NIHR. 2020. Available from: https://www.nihr.ac.uk/news/dhscissues-guidance-on-the-impact-on-covid-19-onresearch-funded-orsupported-by-nihr/24469
[2]
European Medicines Agency. Guidance on the management of clinical studies during the COVID-19 (Coronavirus) pandemic. 2022. Available from: https://ec.europa.eu/health/system/files/2022-02/guidanceclinicalstudies_covid19_en_1.pdf
[3]
Asaad M, Habibullah NK, Butler CE. The impact of COVID-19 on clinical trials. Ann Surg 2020; 272(3): e222-3.
[http://dx.doi.org/10.1097/SLA.0000000000004113] [PMID: 32541234]
[4]
Upadhaya S, Yu JX, Oliva C, Hooton M, Hodge J, Hubbard-Lucey VM. Impact of COVID-19 on oncology clinical trials. Nat Rev Drug Discov 2020; 19(6): 376-7.
[http://dx.doi.org/10.1038/d41573-020-00093-1] [PMID: 32424343]
[5]
Unger JM, Xiao H. The COVID-19 pandemic and new clinical trial activations. Trials 2021; 22(1): 260.
[http://dx.doi.org/10.1186/s13063-021-05219-3] [PMID: 33832534]
[6]
Hawila N, Berg A. Assessing the impact of COVID-19 on registered interventional clinical trials. Clin Transl Sci 2021; 14(3): 1147-54.
[http://dx.doi.org/10.1111/cts.13034] [PMID: 33769709]
[7]
ICH Harmonised Guideline Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice ICH E6 ICH Consensus Guideline. 2016. Available from: https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf
[8]
Lu Z. Su. Clinical data management: Current status, challenges, and future directions from industry perspectives. Open Access J Clin Trials 2010; 2: 93-105.
[http://dx.doi.org/10.2147/OAJCT.S8172]
[9]
Waterhouse DM, Harvey RD, Hurley P, et al. Early impact of COVID-19 on the conduct of oncology clinical studies and long-term opportunities for transformation: findings from an American Society of Clinical Oncology Survey. JCO Oncol Pract 2020; 16(7): 417-21.
[http://dx.doi.org/10.1200/OP.20.00275] [PMID: 32396491]
[10]
Accelerating SCTU's digital transformation and supporting its COVID-19 trials with unified platform. 2021. Available from: https://www.clinicalleader.com/doc/accelerating-sctu-s-digital-transformation-and-supporting-its-covid-studies-with-unified-platform-0001
[11]
Bouleftour W, Daguenet E, Tinquaut F, Magne N. Impact of COVID-19 outbreak through telemedicine implementation on data reporting during oncology clinical trials. Cancer Invest 2021; 39(1): 15-20.
[http://dx.doi.org/10.1080/07357907.2020.1858311] [PMID: 33258396]
[12]
Chen Z, Chen L, Chen H. The impact of COVID-19 on the clinical trial. PLoS One 2021; 16(5): e0251410.
[http://dx.doi.org/10.1371/journal.pone.0251410] [PMID: 33974651]
[13]
Singh AG, Chaturvedi P. Clinical studies during COVID-19. Head Neck 2020; 1-3.
[PMID: 32428865]
[14]
Walle T, Erdal E, Mühlsteffen L, et al. Feasibility and sociopsychological impact of video consultations in medical oncology – A randomized controlled open label trial. ESMO Open Epub ahead of print
[http://dx.doi.org/10.1101/2020.07.10.20150052]
[15]
Collier EK, Hsiao JL, Shi VY. Conducting clinical trials during the COVID-19 pandemic. J Dermatolog Treat 2020; 31(4): 330-2.
[http://dx.doi.org/10.1080/09546634.2020.1759770] [PMID: 32343162]
[16]
Jeon J, Kim H, Yu KS. The impact of COVID-19 on the conduct of clinical trials for medical products in Korea. J Korean Med Sci 2020; 35(36): e329.
[http://dx.doi.org/10.3346/jkms.2020.35.e329] [PMID: 32924344]
[17]
US Food and Drug Administration: FDA guidance on conduct of clinical studies of medical products during COVID-19 pandemic: Guidance for industry, investigators, and institutional review boards. 2021. Available from: https://www.fda.gov/media/136238/download
[18]
Mooney M, McCaskill-Stevens W. Interim guidance for subjects on clinical studies supported by the NCI cancer therapy evaluation program and the NCI community oncology research program. 2020. Available from: https://ctep.cancer.gov/content/docs/Memorandum_on_Interim_Guidance_for_Clinical_Trial_Activities_Affected_by_the_Novel_Coronavirus-3-13-020.pdf
[19]
The ultimate guide to decentralized clinical trialS: CRO edition. 2021. Available from: https://www.medidata.com/en/cro-partners-guide-to-decentralized-clinical-trials-ebook
[20]
Decentralized trial model pushing research to ‘new standard’: AiCure. 2021. Available from: https://www.outsourcing-pharma.com/Article/2021/07/21/Next-level-tech-elevates-clinical-data-management-AiCure#
[21]
Modernizing clinical data management to be scalable, flexible, and intelligent. 2021. Available from: https://www.medidata.com/wp-content/uploads/2021/09/Modernizing-Clinical-Data-Management-White-Paper-Jun-21-1.pdf
[22]
Clinical intelligence solution. 2021. Available from: https://www.anjusoftware.com/ta-scan
[23]
ASCO coronavirus resources. 2021. Available from: https://www.asco.org/asco-coronavirus-information
[24]
Health research authority. Informing participants and seeking consent. 2021. Available from: https://www.hra.nhs.uk/planningand-improvingresearch/best-practice/informing-participants-andseeking-consent/

Rights & Permissions Print Cite
Article Metrics
17
2
Wayfinder Image
© 2024 Bentham Science Publishers | Privacy Policy