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Press Release

Clinical trial transparency reaches highest recorded level

ABPI
Posted on: 19 Dec 17

Timely reporting of results from pharmaceutical company-sponsored clinical trials for newly approved medicines has reached the highest recorded level of 93%, according to a new study published in the peer-reviewed journal Current Medical Research and Opinion (CMRO).

The ABPI-sponsored study – Clinical trial transparency update: an assessment of the disclosure of results of company-sponsored trials associated with new medicines approved in Europe in 2014 – is the latest in a series covering all trials in patients associated with all 142 new medicines approved by the European Medicine Agency (EMA) over a continuous six-year period (2009-2014).

This research, coupled with assessments of the previous five years, indicates that the disclosure rate of industry-sponsored clinical trials at 12 months has significantly improved year on year from 71% in 2009 to 93% in 2014.

Dr Sheuli Porkess, ABPI’s Interim Executive Director of Research, Medical and Innovation said:

“This final study further demonstrates industry’s commitment to transparency. Disclosure rates of company-led clinical trials have significantly improved over time and, given the trend, we should expect them to continue to rise as companies strive for timely publication of results.

“Our goal now is to bring together the wider clinical research community to ensure trial data is published accessibly for the benefit of patients, clinicians and researchers.”

This study, the last to be conducted by Livewire Editorial Communications on behalf of the ABPI, assessed all completed company-sponsored trials in patients related to all 32 new medicines, licenced to 22 different companies, and approved by the EMA in 2014 and shows that of the 542 evaluable company-sponsored clinical trials:

  • 93% (505) had been disclosed on a registry or in scientific literature within 12 months of first regulatory approval or trial completion.
  • 96% (518) had results disclosed by the end of the study at 31 July 2016.

Dr Bryan Deane, who led the study, added:

“With disclosure rates approaching 100% and just 4% of trials remaining undisclosed at the end of this study, it is clear the industry is maintaining the improvement in transparency demonstrated in our earlier studies. Looking to the future, the industry should work with the scientific community on how best to ensure this information, at the right level of detail, is accessible and understandable to various audiences.”

The study highlights a number of ways in which disclosure rates could be improved or more easily tracked and accessed in future years:

  • Routine inclusion of clinical trial registration numbers in publication abstracts or PubMed indexing in line with ICJME* and WHO recommendations** to support precise disclosure rates.
  • Consideration of the waste of resource associated with the increase in duplication across registries
  • Inclusion of a standard component of the due diligence process when licensing or acquisition deals are in negotiation to support simpler tracking of responsibility for publication of clinical trial data.

These and other topics will be the basis of a multi-stakeholder roundtable, hosted by the ABPI, in the New Year considering the next steps in making the results of clinical research more accessible.

Editor's Details

Mike Wood
PharmiWeb.com
www.pharmiweb.com
editor@pharmiweb.com

Last updated on: 19/12/2017

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