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Editorial
. 2022 Jul-Sep;68(3):129-130.
doi: 10.4103/jpgm.jpgm_326_22.

Under-reporting of safety data - cause for concern

S Gajbhiye  1
Affiliations
Editorial

Under-reporting of safety data - cause for concern

S Gajbhiye. J Postgrad Med. 2022 Jul-Sep.
No abstract available

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Conflict of interest statement

None

Comment on

References

    1. Food and Drug Administration. Guidance for Industry and Investigators: Safety Reporting Requirements for INDs and BA/BE Studies. Food Drug Adm. 2012;32 Available from: https://www.fda.gov/files/drugs/published/Safety-Reporting-Requirements-... . [Last accessed on Apr 2022 Apr 07]
    1. Sil A, Das N. Ethics of safety reporting of a clinical trial. Indian J Dermatol. 2017;62:387–91. - PMC - PubMed
    1. Konwar M, Mamde A, Patankar P, Thatte UM, Gogtay NJ. An audit of safety reporting in randomized controlled trials over a five-year period in a high impact factor journal. J Postgrad Med. 2022;68:133–7. - PMC - PubMed
    1. Heneghan C, Goldacre B, Mahtani KR. Why clinical trial outcomes fail to translate into benefits for patients. Trials. 2017;18:122. - PMC - PubMed
    1. Rodgers MA, Brown JVE, Heirs MK, Higgins JPT, Mannion RJ, Simmonds MC, et al. Reporting of industry funded study outcome data: Comparison of confidential and published data on the safety and effectiveness of rhBMP-2 for spinal fusion. BMJ. 2013;346:f3981. - PMC - PubMed