Scarce quality assurance documentation in major clinical trial registries for approved medicines used in post-marketing clinical trials
ConclusionThis study demonstrates that none of the CTRs of ICMJE and WHO 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 befor...
Source: Trials - April 10, 2019 Category: Research Source Type: clinical trials
PROMES: A Clinical Study in Which Researchers Want to Learn More About the Safety Profile of MESIGYNA (Norethisterone Enantate 50 mg and Estradiol Valerate 5 mg) Used as a Medication to Prevent Pregnancy for Adult Women in Reproductive Age in the Peruvian Population at the Outpatient Clinic.
Condition: Contraceptive Effectiveness Intervention: Drug: Norethisterone enantate/estradiol valerate (Mesigyna, BAY98-7040) Sponsor: Bayer Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - April 3, 2019 Category: Research Source Type: clinical trials
