Kuyare S S, Marathe P A, Shetty Y C, Kamat S K, Katkar J V, Thatte U M
Department Pharmacology and Therapeutics, Seth GS Medical College, Charya Donde Marg, Parel, Mumbai, Maharashtra, India.
J Postgrad Med. 2014 Jan-Mar;60(1):46-50. doi: 10.4103/0022-3859.128808.
Some investigators on receiving queries from Institutional Ethics Committee (IEC), either leave the queries unanswered or withdraw their studies. The present study was conducted to assess the queries raised by two IECs after reviewing studies that were not initiated and to identify reasons for the same. Clinical Trials Registry-India (CTRI) website was checked to review approval status of these studies at other sites.
A retrospective analysis of studies (submitted between January 2006 and December 2011) not initiated by investigators on receiving queries from IECs were identified. The nature of of these studies: whether sponsored (pharmaceutical industry (pharma)/government/investigator initiated), single-centre/multi-centric, and queries raised were analyzed. Status of multi-centric trials; not initiated at our site was checked at CTRI. Data was analyzed using descriptive statistics.
A total of 219/2075 (11%) studies were not initiated. The proportions in pharma sponsored, investigator initiated, and government sponsored were 33%. 7.4%, and 8%, respectively. Out of a total of 1676 queries, the maximum queries were related to ethics (42%) and the least were administrative (7%). The largest proportion of queries in the pharma studies was ethical (47%), whereas majority were scientific queries (45.5%) for the investigator initiated studies. Twenty-one of the 94 multi-centric studies not initiated at our site were found registered at the CTRI and were ongoing or completed at 2-55 sites.
Inability of investigators to defend studies due to lack of good clinical research practice (GCP) and research methodology training or unwillingness of sponsors to comply with local IEC requirements could be potential reasons for studies remaining uninitiated. Continued GCP training of investigators and IEC members and development of uniform ethical review standards across IECs are strongly recommended.
一些研究者收到机构伦理委员会（IEC）的询问后，要么不回复询问，要么撤回他们的研究。本研究旨在评估两个IEC在审查未启动的研究后提出的询问，并确定其原因。通过检查印度临床试验注册中心（CTRI）网站来查看这些研究在其他机构的批准状态。
对2006年1月至2011年12月期间研究者收到IEC询问后未启动的研究进行回顾性分析。分析这些研究的性质：是否为资助研究（制药行业/政府/研究者发起）、单中心/多中心研究以及提出的询问。检查多中心试验在CTRI上的状态；在我们机构未启动的多中心试验在CTRI上的状态。使用描述性统计方法分析数据。
共有219/2075（11%）项研究未启动。制药行业资助、研究者发起和政府资助的研究比例分别为33%、7.4%和8%。在总共1676项询问中，最多的询问与伦理相关（42%），最少的是行政相关（7%）。制药研究中最大比例的询问是伦理方面的（47%），而研究者发起的研究中多数是科学询问（45.5%）。在我们机构未启动的94项多中心研究中，有21项在CTRI上有注册，并且在2至55个机构正在进行或已经完成。
研究者因缺乏良好的临床研究规范（GCP）和研究方法培训而无法为研究辩护，或者资助者不愿意遵守当地IEC要求，可能是研究未启动的潜在原因。强烈建议持续对研究者和IEC成员进行GCP培训，并制定统一的IEC伦理审查标准。
