4 research outputs found
Scarce quality assurance documentation in major clinical trial registries for approved medicines used in post-marketing clinical trials
BACKGROUND:
This research reviewed major Clinical Trial Registries (CTRs) and assessed the availability of fields on quality assurance for approved medicines used as Investigational Medicinal Products (IMPs) in phase-IV clinical trials.
// METHODS:
Two reviewers independently assessed CTRs of International Committee of Medical Journal Editors (ICJME) and of WHO platforms. Each CTR was checked by two reviewers on availability of fields on brand name; manufacturerâs name; approval status; approving authority; compliance with Good Manufacturing Practices; and quality testing. In case of discrepancy, consensus was sought between the two reviewers.
// RESULTS:
Of 19 identified CTRs, 8 and 6 belonged to WHO and ICMJE, respectively, while 5 were equally part of both platforms. All CTRs had an âinterventionâ field where data on IMPs and IMP comparators are captured. The Canadian CTR used âdrug nameâ rather than âinterventionâ. The EU, Peruvian, and UK CTRs had fields for âbrand nameâ. But only the EU CTR had fields for âmanufacturerâs nameâ, âapproval statusâ, and âapproving authorityâ. None of the CTRs had fields on âcompliance with Good Manufacturing Practicesâ or âquality testingâ.
// CONCLUSION:
This study demonstrates that none of the CTRs of ICMJE and ICTRP platforms has adequate fields to establish that the source of post-marketing IMPs is of assured quality. This is astonishing given the lengthy requirements in WHO and ICMJE guidelines. Considering the relation between IMP quality and safety of clinical trial participants, the gap of quality assurance fields should be bridged at CTRs concurrently to adjustments of WHO and ICMJE guidelines on CTRs. Specifically, IMP quality testing addressing issues on IMP appearance, impurities, microbial contamination, and dosing should be conducted and reported before, during, and after clinical trial conduct. Until adoption of these measures, the EU CTR should be preferred for registration of phase-IV clinical trials conducted in countries lacking stringent regulatory capacities