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Potential Risks and Mitigation Strategies Before the Conduct of a Clinical Trial: An Industry Perspective
Seema Bhagat, Vaibhavi K Kapatkar1, Meenakshi Mourya
1Wockhardt Limited, Wockhardt Towers, Bandra Kurla Complex, Mumbai - 400 051 (India). vkapatkar@wockhardt.com.
Abstract:
Conduct of clinical trials has undergone substantial changes over the last two decades. Newer markets, evolving guidelines and documentation and high cost involved in conducting the trials have led pharmaceutical companies to prepare a risk mitigation plan. Extensive monitoring of potential risks is an essential element of clinical trials which helps to ensure quality and integrity of a clinical investigation. Every clinical trial has pre (before the trial), conduct and post phase. This article which has been developed as a result of extensive research at ground level by a reputed pharmaceutical company to identify the potential stages of risks that could affect the overall quality and safety of a trial and its outcome during the pre-phase of trial (the stage of the trial where the study design is being planned before initiation of the clinical trial). It includes risks associated with basic study concept, protocol design, Confidential Disclosure Agreement (CDA) and Clinical Trial Authorization (CTA) application signing, vendors of central drug laboratory, site and investigator selection, Clinical Research Coordinator (CRC) meet, Informed Consent Form (ICF), Case Report Form (CRF)/ Status Report Form (SRF) preparation, Ethics Committee (EC) submission, etc. have been highlighted. The risk based mitigation strategy (to develop an effective risk monitoring plan before staring a clinical trial) has also been suggested by authors. A well-tailored and integrated plan, recognition of potential risks and their mitigation strategy can result in the pre exclusion or end to end solution of all the risks associated with pre- phase of clinical trials.
Insights
This study identifies potential risks during the pre-phase of clinical trials, offering a risk-based mitigation strategy. Proactive risk management ensures trial quality and safety from the outset.
Area of Science:
- Clinical trial management
- Pharmaceutical research
- Regulatory affairs
Background:
- Clinical trial conduct has evolved significantly due to new markets, changing regulations, and high costs.
- Pharmaceutical companies increasingly require robust risk mitigation plans for clinical investigations.
- Ensuring the quality and integrity of clinical trials necessitates extensive monitoring of potential risks.
Purpose of the Study:
- To identify potential risks during the pre-phase of clinical trials.
- To highlight risks associated with study concept, protocol design, and regulatory submissions.
- To propose a risk-based mitigation strategy for clinical trial planning.
Main Methods:
- Extensive ground-level research conducted by a pharmaceutical company.
- Identification of risks across various pre-trial stages.
- Development of a risk-based mitigation strategy.
Main Results:
- Detailed risks identified in the pre-phase, including protocol design, vendor selection, and Ethics Committee submissions.
- A risk-based mitigation strategy for effective risk monitoring is proposed.
- Proactive risk identification and mitigation can prevent or resolve pre-trial issues.
Conclusions:
- A comprehensive risk-based approach is crucial for successful clinical trial planning.
- Addressing pre-trial risks proactively ensures overall trial quality and safety.
- Integrated risk management plans are essential for pharmaceutical companies.
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