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European Medicines Agency will resume making Clinical Study Reports available in 2023

Europe's medicines regulator is planning to revive one of the agency's flagship transparency programmes during the coming year, TranspariMED has learned.


UPDATE 25 January 2023: Pink Sheet reports that:


"In the first phase, the EMA is considering publishing clinical data that was used to support initial marketing authorizations for medicines containing new active substances. The plan is to further expand the scope of CDP [clinical data publication] in a second phase. With respect to legacy procedures – ie procedures undertaken while the CDP policywas suspended – these will be addressed later."


According to Pink Sheet, EMA did not commit to a starting date, but noted that it wanted to "further build on its existing collaboration with Health Canada under which the two agencies have been working closely on the publication of clinical data on COVID-19-related products."


In 2016, the European Medicines Agency became the first medicines regulator worldwide to proactively make Clinical Study Reports (CSRs) available to independent researchers. These highly detailed documents provide a wealth of information on the design, conduct and outcomes of clinical trials that cannot be found anywhere else.

--> For more information on CSRs, see this annotated bibliography by TranspariMED <--


Transparency on ice


However, the transparency programme - called Policy 0070 - was put on ice in December 2018 due to staff shortages when EMA moved its headquarters from London to Amsterdam.


During the pandemic, the programme remained largely frozen, with EMA limiting access to CSRs to Covid treatments and vaccines as part of its "exceptional [transparency] measures for COVID-19 medicines".


Getting back on track


EMA plans to soon resume making Clinical Study Reports available to independent researchers.


According to a public summary of a December 2022 EMA Management Board meeting:


"EMA’s work programme for 2023 foresees the gradual lifting of business continuity measures that were implemented in the course of the Agency’s relocation and had to be maintained since 2020 to cope with the COVID-19 pandemic..."


"[T]he Agency will seek opportunities to gradually reinitiate previously suspended or reduced activities, notably implementing a phased restart of clinical data publication (CDP) for centrally authorised medicines beyond the scope of COVID-19."


However, EMA did not reveal the exact date on which Policy 0070 will be relaunched:


"The Board noted that, in case of significant changes to the business continuity status, the programming document will be amended accordingly."


Good news for European patients


EMA's resumption of the programme is likely to be warmly welcomed by transparency advocates and patient groups across Europe.


Till Bruckner, founder of TranspariMED, said:


"This is good news for medical researchers and patients across Europe. The European Medicines Agency's resumption of this groundbreaking programme will help to cement the agency's reputation as a global leader in clinical trial transparency."


"Science thrives on transparency. More access to medical data today means better treatments tomorrow."


"The fact that the European Medicines Agency provided access to Clinical Study Reports for Covid medicines throughout the pandemic, despite a deluge of competing priorities, highlights that European regulators recognise the substantial scientific and public health benefits of allowing third parties to scrutinise and independently evaluate these key documents."


"Today, European scientists already have access to highly detailed information on Covid-related clinical trials. Soon, European researchers focusing on cancer and all other diseases will enjoy the same level of access to medical information."


Canada's regulator also proactively makes Clinical Study Reports public. America's FDA still keeps these documents firmly locked away.


For more information on CSRs in general, see this annotated bibliography by TranspariMED.

More information on Europe's Policy 0070 here.


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