Figer Brinal H, Sapra Keyur P, Gogtay Nithya J, Thatte Urmila M
Department of Clinical Pharmacology, Seth Gordhandas Sunderdas Medical College and KEM Hospital, Mumbai, Maharashtra, India.
Perspect Clin Res. 2020 Jan-Mar;11(1):13-17. doi: 10.4103/picr.PICR_122_18. Epub 2019 May 14.
In pharmaceutical industry funded clinical studies (PIS), there is rigorous monitoring to ensure adequate and accurate data documentation. In comparison, the investigator-initiated studies (IIS) often lack in resources and may not follow such quality checks. At present, very limited data on the existing deficiencies in documentation for IIS are available. Hence, the present study assessed data quality in IIS relative to those funded by the industry to identify and address issues in data documentation.
We evaluated records of 1276 participants in 13 studies (5 - industry sponsored and 8 - investigator initiated) conducted during 2009-2015 using a prevalidated checklist. The percentage total scores for overall documentation and general trial-related and patient-specific documents were calculated. The percentage total scores within the patient-specific documents were also calculated and compared. Between-group score analysis was done by Student's -test using GraphPad InStat version 5.0.
The mean (standard deviation [SD]) percentage total score for the IIS was 80.96 (13.26) and that for PIS was 98.77 (1.84) ( = 0.01). For IIS, the total percentage scores ranged from 63% to 100% while it was above 95% for all PIS. For general trial-related documents, the mean (SD) percentage total score for IIS was 90.39 (13.26) while that for PIS was 97.38 (0.92) ( > 0.05). In the patient-specific documents, IIS scored 80.52 [14.41] versus 98.95 (1.98) for PIS ( = 0.016). The scores for IIS versus PIS (70.22 [21.6] and 99.36 [1.43]) within patient-specific documents were significant only for admission criteria ( = 0.016).
Quality of IIS needs to be addressed by greater oversight and periodic quality control assessments.
在制药行业资助的临床研究（PIS）中，有严格的监测以确保充分且准确的数据记录。相比之下，研究者发起的研究（IIS）往往缺乏资源，可能不会进行此类质量检查。目前，关于IIS现有记录缺陷的可用数据非常有限。因此，本研究评估了IIS相对于行业资助研究的数据质量，以识别和解决数据记录中的问题。
我们使用预先验证的检查表评估了2009年至2015年期间进行的13项研究（5项由行业赞助，8项由研究者发起）中1276名参与者的记录。计算了总体记录以及与试验相关的一般文件和患者特定文件的总分百分比。还计算并比较了患者特定文件中的总分百分比。使用GraphPad InStat 5.0版本通过学生t检验进行组间得分分析。
IIS的平均（标准差[SD]）总分百分比为80.96（13.26），PIS为98.77（1.84）（P = 0.01）。对于IIS，总分百分比范围为63%至100%，而所有PIS均高于95%。对于与试验相关的一般文件，IIS的平均（SD）总分百分比为90.39（13.26），而PIS为97.38（0.92）（P>0.05）。在患者特定文件中，IIS得分为80.52[14.41]，而PIS为98.95（1.98）（P = 0.016）。IIS与PIS在患者特定文件中的得分（70.22[21.6]和99.36[1.43]）仅在入院标准方面存在显著差异（P = 0.016）。
需要通过加强监督和定期质量控制评估来解决IIS的质量问题。
