title: Potential Risks and Mitigation Strategies Before the Conduct of a Clinical Trial: An Industry Perspective.
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.
authors.forename: Seema
authors.initials: S
authors.lastname: Bhagat
authors.affiliation: Wockhardt Limited, Wockhardt Towers, Bandra Kurla Complex, Mumbai - 400 051 (India). vkapatkar@wockhardt.com.
authors.forename: Vaibhavi K
authors.initials: VK
authors.lastname: Kapatkar
authors.forename: Meenakshi
authors.initials: M
authors.lastname: Mourya
authors.forename: Sucheta
authors.initials: S
authors.lastname: Roy
authors.forename: Shailendra
authors.initials: S
authors.lastname: Jha
authors.forename: Rajasekhar
authors.initials: R
authors.lastname: Reddy
authors.forename: Ganesh
authors.initials: G
authors.lastname: Kadhe
authors.forename: Amey
authors.initials: A
authors.lastname: Mane
authors.forename: Sandesh
authors.initials: S
authors.lastname: Sawant
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D004341:Drug Evaluation; D017041:Ethics Committees