Assistant Professor, Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Parel, Mumbai 400 012 INDIA.
Associate Professor, Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Mumbai, 400012, INDIA.
Indian J Med Ethics. 2020 Apr-Jun;V(2):119-123. doi: 10.20529/IJME.2020.025.
Protocol non-compliance in clinical research studies is common and can affect both patient safety and data integrity. There are no published studies which actively looked for non-compliance. The present study was carried out, against this background, with the objective of assessing the proportion of protocol non-compliance and evaluating those aspects of protocol where there was non-compliance.
The study completion reports that were submitted to the institutional ethics committee for the period January 2017 to December 2017 were compared with the approved protocol. A checklist for recording protocol non-compliance was developed, which was validated by five experts and consisted of a 12-point checklist with responses such as yes, no, not applicable, and insufficient information.
Out of 193 studies, prospective observational studies were n = 120 (62.17 %), retrospective studies were n = 39 (20.21%), interventional studies n = 28 (14.51 %), and observational studies with both prospective and retrospective study design were n = 6 (3.11%). The study objective was modified in n=18 (9.32%) studies. Only n = 14 (7.24%) satisfied the selection criteria. Six studies (3.10%) did not collect the data as mentioned in the protocol. Fifty-eight studies (30.05%) did not achieve the calculated sample size, whereas n = 78 (40.41%) did not complete the study as per the stipulated study duration. Contrary to 180 protocol deviations found in this study, only 14 protocol deviations were reported by the principal investigator. Aspects like blinding and randomisation, which are relevant to interventional studies (n = 28), showed 100 % compliance.
The research protocol is not adhered to in all aspects. Adequate training to investigators will help prevent non-compliance and enable us to conduct studies with higher ethical and scientific integrity.
临床研究中方案违背是常见的，可能会影响患者安全和数据完整性。目前还没有发表的研究主动寻找方案违背的情况。本研究正是在这一背景下进行的，旨在评估方案违背的比例，并评估方案违背的方面。
将 2017 年 1 月至 2017 年 12 月提交给机构伦理委员会的研究完成报告与批准的方案进行比较。制定了一份记录方案违背的检查表，该检查表由五名专家进行了验证，包括 12 个要点的检查表，回答为是、否、不适用和信息不足。
在 193 项研究中，前瞻性观察性研究 n=120（62.17%），回顾性研究 n=39（20.21%），干预性研究 n=28（14.51%），前瞻性和回顾性研究设计的观察性研究 n=6（3.11%）。有 n=18（9.32%）项研究修改了研究目的。只有 n=14（7.24%）项研究符合入选标准。有 n=6（3.10%）项研究未按方案收集数据。有 n=58（30.05%）项研究未达到计算的样本量，而 n=78（40.41%）项研究未按规定的研究时间完成研究。在本研究中发现了 180 项方案偏离，但只有 14 项方案偏离由主要研究者报告。与干预性研究相关的方面，如盲法和随机化，均达到了 100%的依从性。
在各个方面都没有严格遵守研究方案。对研究者进行充分的培训将有助于防止违背，并使我们能够进行更高伦理和科学完整性的研究。
