1、The State of Global Clinical Trial Disclosure:What Noncompliance Penalties Are in Place,and How They Are EnforcedMarch 2023White Paper2March 2023 Copyright 2023 Pharma Intelligence UK Limited,a Citeline company(Unauthorized photocopying prohibited)ContentsIntroduction 03Industry Organizations 04The

2、Global Landscape 05In Conclusion 193March 2023 Copyright 2023 Pharma Intelligence UK Limited,a Citeline company(Unauthorized photocopying prohibited)IntroductionThe coronavirus pandemic put clinical trials in the spotlight or hot seat,depending on ones perspective.Around the globe pressure came from

3、 multiple fronts:regulatory agencies,the public,patients,advocates,pharmaceutical industry watchdogs and investors all clamored for increased clinical transparency.The push for accountability has not abated for study sponsors to publish results in a timely manner.However,just as there are numerous r

4、egulatory agencies and guidelines(approximately 90 countries have requirements related to the disclosure of clinical trial data made publicly available on over 30 clinical trial registries),enforcement of clinical trial disclosure requirements varies greatly.While study sponsors have come under fire

5、 for failure to disclose trial information,so too have regulatory agencies.The US National Institutes of Health(NIH)failed to ensure the timely reporting of results in roughly half of the clinical trials it funded in 2019 and 2020,according to areportreleased by the Department of Health and Human Se

6、rvices Office of Inspector General.In some cases,the agency allowed noncompliant researchers to launch new trials.A 2022 Health and Human Services inspector generals office audit of the NIH revealed that of 72 intramural and extramural trials,only 35 submitted results were on time,12 were submitted