WHO, medicines regulators call on drug manufacturers to open access to clinical data ANI | Updated: May 07, 2021 21:55 IST
Washington [US], May 7 (ANI/Sputnik) : The WHO and the International Coalition of Medicines Regulatory Authorities (ICMRA) urged the pharmaceutical industry to open access to clinical data for all new medicines and vaccines for reasons of overriding public health interest.
Making relevant data on innovative vaccines and medicines readily available will increase public trust in the treatment options, streamline global research efforts, increase data quality and help with healthcare policy making, the document stated. Publication of data allows science to advance faster, by avoiding repetition of unnecessary trials and waste of resources (human and financial). This also brings benefits by improving the efficiency of development programmes and reducing both development costs and time, the official statement said.
Date Time
Statement on transparency and data integrityInternational Coalition of Medicines Regulatory Authorities and WHO
and WHO call on the pharmaceutical industry to provide wide access to clinical data for all new medicines and vaccines (whether full or conditional approval, under emergency use, or rejected). Clinical trial reports should be published without redaction of confidential information for reasons of overriding public health interest.
The COVID-19 pandemic has brought into sharp focus the need for information and data to support academics, researchers and industry in developing vaccines and therapeutics; to support regulators and health authorities in their decision-making; to support healthcare professionals in their treatment decisions; and to support public confidence in the vaccines and therapeutics being deployed.
March 17, 2021
Over the last year, an abundance of clinical research has been undertaken to understand common pathologies of COVID-19 illness, including the high rates of thrombosis and endothelial injury. A new state-of-the-art review notes that while an optimal antithrombotic therapy has yet to be determined and appears to be debatable, the ongoing studies provide needed clues and hope for improving outcomes.
“There is so much heterogeneity in protocols that hospitals are using for their ward patients, for their critically ill patients, and even for outpatients,” said senior author Behnood Bikdeli, MD (Brigham and Women’s Hospital, Boston, MA, and Yale University School of Medicine, New Haven, CT). “Then you have all these studies, with people feeling so strongly about one particular regimen versus the other. We thought: enough is enough. Let s systematically look to see what s out there.”
Research Article
Comparative efficacy and safety of pharmacological interventions for the treatment of COVID-19: A systematic review and network meta-analysis
Min Seo Kim , Contributed equally to this work with: Min Seo Kim, Min Ho An Roles Conceptualization, Data curation, Formal analysis, Investigation, Methodology, Resources, Software, Supervision, Visualization, Writing – original draft, Writing – review & editing
¶‡ MSK and THH share last authorship on this work.
Affiliations Korea University, College of Medicine, Seoul, Republic of Korea, Cheongsan Public Health Center, Wando, Republic of Korea
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