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
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!