ABSTRACT
PURPOSE: 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. MATERIALS AND METHODS: 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 t-test using GraphPad InStat version 5.0. RESULTS: 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) (P = 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) (P > 0.05). In the patient-specific documents, IIS scored 80.52 [14.41] versus 98.95 (1.98) for PIS (P = 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 (P = 0.016). CONCLUSION: Quality of IIS needs to be addressed by greater oversight and periodic quality control assessments.
