A comparative study to evaluate quality of data documentation between investigator-initiated and pharmaceutical industry-sponsored studies

Perspectives in Clinical Research
Brinal H FigerUrmila M Thatte

Abstract

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 t-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) (P = 0.01). For IIS, the total percentage scores ranged from 63% to 100% while it was above 95% for all PIS. For general tria...Continue Reading

References

Jul 7, 2011·Perspectives in Clinical Research·Chitra Bargaje
Dec 7, 2011·Perspectives in Clinical Research·Arun Bhatt

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