An instruction has been issued to all those performing clinical trials using hydroxychloroquine to treat or prevent COVID-19 to stop recruitment of any new patients by the MHRA in the UK.
An instruction has been issued to all those performing clinical trials using hydroxychloroquine to treat or prevent COVID-19 to stop recruitment of any new patients by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom.
According to a June 16, 2020 press release, the UK regulatory body has made the decision to suspend trial recruitment following advice from the Commission on Human Medicines, which has reviewed trial data. The RECOVERY trial was included in the data for review, which demonstrated no meaningful mortality benefit in hospitalized patients with COVID-19 being treated with hydroxychloroquine.
“We have told those conducting clinical trials using hydroxychloroquine to treat or prevent COVID-19 to suspend recruitment into their trials,” said Dr. June Raine, MHRA’s CEO, in the press release. “Neither hydroxychloroquine nor chloroquine are licensed to treat COVID-19 related symptoms or to prevent infection. It is important to note that patients taking hydroxychloroquine and chloroquine to treat other health conditions can continue to do so, as advised by their healthcare professional, as the balance of benefits and risks remains favorable in the licensed uses.”
Source: MHRA
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.