OECD wades into clinical trials debate, but statement on public involvement goes awol

The Organisation for Economic Co-operation and Development (OECD) yesterday waded into the increasingly feverish debate about the regulation of clinical trials with a strongly worded recommendation calling on its members to harmonise approval processes.  The recommendation which is worded with the minimum of fuss, is backed by a more detailed explanatory memorandum.

But I am disappointed that the specific recommendation on public involvement from the OECD Global Forum on clinical trials  in October 2011 has not been carried through to inclusion in the documents issued yesterday.  As far as I can see anyway. The Forum had stated the following:

C.3 Increase patient involvement in clinical-trial processes
More direct involvement of patients in the design and monitoring of clinical trials – as well as
their contribution to improve the quality, safety and relevance of clinical research – is of
critical significance for the success and impact of clinical science as a whole.
The roles of patients in clinical trials should be strengthened by means of:
 Mandatory participation of a representative of patients’ opinion in ethics committees
(as such, they would be involved in the decision regarding future risk categories of
clinical trials).
 Consultative and participative role in the planning, design, conduct, dissemination
and implementation of results from clinical science, in part mediated through the
activities of the global networks as well as their regional and local network members
and through other relevant channels.
 Simplified informed-consent documents, containing the vital information for decision
making, using shorter and pedagogically sound explanations.
 Accessible information, for patients, families and the general public. This should
include educational websites, ad hoc documents and open dialogue sessions with
clinical staff at the hospital/clinical unit level, and transparent access to clinical
registers and information databases about planned, ongoing and completed clinical
trials by regulatory authorities.

I’ll do a bit of follow-up and report back!

2 thoughts on “OECD wades into clinical trials debate, but statement on public involvement goes awol

  1. Dear Sir,

    Many thanks for reporting on the recent Recommendation issued by the OECD on the goverance of clinical trials. This text stems from a very active debate among all the stakeholders involved in clinical trials, and should particularly help international collaboration among academic groups which often are prevented to conduct critical studies due to the existing complexity and diversity of administrative requirements.

    You rightly insist on the need to inprove patients’ involvement in clinical trials processes. Because this OECD Recommendation was focused on regulatory procedures, the issue of patient’s role could not be included in much details, although you will notice that it calls for a detailed and individualised risk assessment that should take into account the risks related to patient rights.

    Regarding the earlier and broader recommendation on patients’involvement you refer to, which was described in the first report of the Global Science Forum (http://www.oecd.org/sti/sci-tech/49344626.pdf), I am happy to inform you that this topic has not been forgotten. It is now one of the main issues included into a potential follow on activity driven by the World Health Organisation. Indeed, following this activity, we felt at OECD that the WHO might be more efficient to adress this topic, considering their previous experience in this area. A potential new activity which would adress both the need for better training, the development of accreditation systems standards and guidelines for better patients’ involvement was therfore discussed with WHO, which agreed to take the lead on this project. It is now looking for funding sources to get started, and we are confident it will deliver very useful and concrete results in the near future.


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