Bhagat Seema, Kapatkar Vaibhavi K, Mourya Meenakshi, Roy Sucheta, Jha Shailendra, Reddy Rajasekhar, Kadhe Ganesh, Mane Amey, Sawant Sandesh
Wockhardt Limited, Wockhardt Towers, Bandra Kurla Complex, Mumbai - 400 051 (India).
Rev Recent Clin Trials. 2016;11(1):47-55. doi: 10.2174/1574887110666151005110751.
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.
在过去二十年中，临床试验的开展发生了重大变化。新市场的出现、不断演变的指南与文件要求以及开展试验所需的高昂成本，促使制药公司制定风险缓解计划。对潜在风险进行广泛监测是临床试验的一个基本要素，有助于确保临床研究的质量和完整性。每项临床试验都有前期（试验前）、开展阶段和后期。本文是一家知名制药公司在实地进行广泛研究的成果，旨在确定在试验前期（即临床试验启动前研究设计正在规划的阶段）可能影响试验整体质量、安全性及其结果的潜在风险阶段。文中重点介绍了与基础研究概念、方案设计、保密协议（CDA）和临床试验授权（CTA）申请签署、中央药物实验室供应商、试验地点和研究者选择、临床研究协调员（CRC）会议、知情同意书（ICF）、病例报告表（CRF）/状态报告表（SRF）编制、伦理委员会（EC）提交等相关的风险。作者还提出了基于风险的缓解策略（即在启动临床试验前制定有效的风险监测计划）。一个精心定制且整合良好的计划、对潜在风险的识别及其缓解策略，能够预先排除或端到端解决与临床试验前期相关的所有风险。
