Generic placeholder image

Reviews on Recent Clinical Trials


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

Review Article

An Industry Perspective on Risks and Mitigation Strategies Associated with Post Conduct Phase of Clinical Trial

Author(s): Seema Bhagat*, Vaibhavi K. Kapatkar, Ashish Mane, Colette Pinto, Devang Parikh, Gaurav Mittal and Rishi Jain

Volume 15, Issue 1, 2020

Page: [28 - 33] Pages: 6

DOI: 10.2174/1574887114666191016103332

Price: $65


Objective: To discuss the potential risks and their mitigation strategies in the post-conduct phase of the trial.

Background: Risk management is very important for the clinical trial (CT) to ensure that the trial delivers its desired outcome(s) in terms of achieving protocol objective and regulatory compliance.

Methodology: Experienced members of the clinical operation team of a pharmaceutical major underwent a series of sessions to identify risks associated with the post-conduct phase of CT and developed mitigation strategies based on own experiences and guidance documents. The risks were categorized into major, minor and critical risks.

Results: In the post-conduct phase of a clinical trial, critical risk identified were; failure to communicate to the stakeholder about premature termination of the trial, mismatch of statistical analysis results and protocol objective/ regulatory requirement, clinical study report (CSR) noncompliant with regulatory requirements or delay in CSR preparation. Safety checks suggested to mitigate these risks including the development of related checklist or shell of relevant documents and its review by clinical development, quality assurance (QA) and regulatory affairs (RA) team prior to finalization. Additionally, six major and five minor risk areas were identified and safety checks were suggested.

Conclusion: Sponsors must act proactively to ensure a systematic approach to conduct various post conduct trial activities and the plans to mitigate the risks that could affect the quality and outcome of the clinical trial.

Future Perspective: A close coordination with all stakeholders for timely anticipation of risks and execution of mitigation strategies are required for successful CT outcomes.

Keywords: Clinical trial, mitigation plan, post conduct phase, quality assurance (QA), regulatory affairs (RA), risks.

Graphical Abstract
Benta D, Podean IM, Mircean C. On best practices for risk management in complex projects. Inf Econ 2011; 15: 142.
Group IEW, Ed. ICH harmonized tripartite guideline, Quality risk management Q9. International Conference of Technical Requirements for Registration of Pharmaceuticals for Human Use
Grimes DA, Hubacher D, Nanda K, Schulz KF, Moher D, Altman DG. The Good Clinical Practice guideline: A bronze standard for clinical research. Lancet 2005; 366(9480): 172-4.
[] [PMID: 16005342]
Murakami M. 2011. ISO14155: 2011- Clinical investigation of medical devices for human subjects- Good Clinical Practice. ISO TC194 WG4 PMDA Japan. Available from: http://www.imdrf. org/docs/imdrf/final/meetings/imdrf-meet-160913-brazil-iso14155-2011.pdf
Transforming Clinical Research in the United States. In: Challenges and Opportunities: Workshop Summary Institute of Medicine (US) Forum on Drug Discovery, Development, and Translation Washington (DC). US: National Academies Press 2010.
Ghone A. A blog on Risk Assessment In Clinical Trials – Well Begun Is Half Done. Global Services, MakroCare USA. Available from:
Overview of Drug Development: Regulator’s Perspective Presentation to APEC Preliminary Workshop on Review of Drug Development in Clinical Trials. Available from: fileadmin/Public_Web_Site/Training/GCG_-_Endorsed_Training_ Events/APEC_LSIF_FDA_prelim_workshop_Bangkok__Thailand_Mar_08/Day_1/Clinical_Dev_Plans_-_Celia_Lourenco.pdf
Ansmann EB, Hecht A, Henn DK, et al. The future of monitoring in clinical research - a holistic approach: Linking risk-based monitoring with quality management principles. German Medical Science:GMS e-journal 2013. 11: Doc04.
OECD recommendation on the governance of clinical trials. Available from:
Macri M. Managing clinical trial risk: It's a tough job, but one person has to do it.
Eric P. Brass. Letter to editor: Premature termination of clinical trials. JAMA 2003; 290-595.
Hecht A, Busch-Heidger B, Gertzen H, et al. Quality expectations and tolerance limits of trial master files (TMF) - Developing a risk-based approach for quality assessments of TMFs. Ger Med Sci 2015; 13: Doc23.
Bhagat S, Kapatkar V, Katare S, et al. Potential risks and mitigation strategies during the conduct of a clinical trial: An industry perspective. Rev Recent Clin Trials 2018; 13(1): 52-60.
[] [PMID: 29165094]
Summaries of the presentations from workshop on risk based quality management in clinical trials by Europeamn Medicines Agency (EMEA). 2013. Statistical aspects of quality by design in clinical trials. Available from: document_library/Other/2014/07/WC500169621.pdf
Bhagat S, Kapatkar VK, Mourya M, et al. Potential risks and mitigation strategies before the conduct of a clinical trial: An industry perspective. Rev Recent Clin Trials 2016; 11(1): 47-55.
[] [PMID: 26435140]
EMEA. Compliance and Inspection Reports: Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP. Available from: https:// ted_en.pdf
Lièvre M, Boyd K, Ménard J, et al. Premature discontinuation of clinical trial for reasons not related to efficacy, safety, or feasibility Commentary: Early discontinuation violates Helsinki principles. BMJ 2001; 322: 603-6.
Guideline IHT. Structure and content of clinical study reports E3. Curr Sep 1995; 4: 24.
Alfaro V, Cullell-Young M, Tanovic A. Abbreviated clinical study reports with investigational medicinal products for human use: Current guidelines and recommendations. Croat Med J 2007; 48(6): 871-7.
[] [PMID: 18074423]
Shroff G, Gupta R. Human embryonic stem cells in the treatment of patients with spinal cord injury. Ann Neurosci 2015; 22(4): 208-16.
[] [PMID: 26526627]
ICH harmonised tripartite guideline: guideline for good clinical practice E6 (R1). International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Washington, DC. 1996.
Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals. Available from:
Yao B, Zhu L, Jiang Q, Xia HA. Safety monitoring in clinical trials. Pharmaceutics 2013; 5(1): 94-106.
[] [PMID: 24300399]
Chappell P, Knirsch C, Jose Alvir J, et al. Risk assessment and mitigation a quantitative approach to enhancing risk assessment and mitigation in drug development. Appl Clin Trials 2012; 21: 1.
Premature Termination Or Suspension Of A. Trial. Good Clinical Practice Network. Available from,
Collins FS, Tabak LA. Policy: NIH plans to enhance reproducibility. Nature 2014; 505(7485): 612-3.
[] [PMID: 24482835]
Recommendation on the content of the Trial Master File and Archiving. Available from: files/files/eudralex/vol-10/v10_chap5_en.pdf
Poensgen M. Understanding True eTMF Requirements: Meeting Today’s Expectations of Industry and Regulatory Agencies. A white paper by ArisGlobal. Available from: https://www.
Harald Landen Dm, DR rer nat. Risk Management Planning & Mandated Post-Authorization Studies by Prahealthsciences. Available at: _Planning_and_Mandated_Post-Authorization_Studies.pdf

Rights & Permissions Print Export Cite as
© 2022 Bentham Science Publishers | Privacy Policy