ISDB response to the public consultation on the transparency rules for the operation of the Clinical Trials Regulation (CTR) and its Clinical Trials Information System (CTIS)
The ISDB has recently responded to a public consultation from EMA, the Heads of Medicines Agencies and the European Commission on the Clinical Trials Regulation and its information system. You can consult the whole content of this statement at: https://www.isdbweb.org/publication/documents-of-interest/isdb-response-to-the-public-consultation-on-the-clinical-trials-regulation-and-its-information-system
Access to regulatory documents
Dr. Juan Erviti, former DTB Navarre coordinator and ISDB secretary, has recently presented a webinar at Therapeutics Initiative on “The need for access to regulatory documents for better drug assessment“. The video is freely available at https://www.youtube.com/watch?v=LTk4bbQnBX0
ISDB Strategic Plan
As part of a strategic plan for ISDB, the executive committee has launched two subgroups to reflect ISDB’s membership and on its mission and activities. On-line meetings will take place during 2023. The groups are expected to make recommendations by end 2023. Stay tuned!
ISDB mobilization in support of Australian Prescriber
In a letter sent to the Australian Health Minister, ISDB expressed its concerns about the future existence of the independent drug bulletin “Australian Prescriber”. The Australian government has cut the funding of NPS MedicineWise, a public agency with a mandate to support quality use of medicines and the current publisher of Australian Prescriber, and to put the journal out to tender. In a response letter, the Australian Health Minister wrote that the Government is committed to safeguarding Australian Prescriber’s editorial independence, quality standards, and role as a trusted information source.
The international network RIAT – Restoring Invisible and Abandoned Trials – recently published a re-analysis of the FOURIER trial (evolocumab vs placebo in secondary cardiovascular prevention). Authors, also belonging to ISDB members in Canada and Spain, assessed regulatory data and observed inconsistencies between the information in the Clinical Study Report and that in the 2017 primary trial results publication. A second RIAT re-analysis led by Spanish ISDB members has also been published recently, focused on a misreported trial on Plasma Rich in Growth Factors for knee osteoarthritis.