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The European Association for Clinical Pharmacology and Therapeutics
(EACPT) was very concerned to read in this journal about the reported
degree of over-regulation that was experienced by some doctors in training
in the United Kingdom following the request for permission to undertake a
clinical trial (1). Even though the initial report was anecdotal, the
article does point to a more widespread problem in approving of clinical
trials. While trainees in many medical specialties undertake clinical
trials as part of their training, only in clinical pharmacology and
therapeutics (CPT) is the involvement in a clinical trial such a
fundamental part of the learning experience for a trainee in the
specialty.
Since the EACPT was founded in 1993 (2), the association has worked hard
to help develop CPT in Europe particularly in the developing countries in
Eastern Europe. Over the years since then the United Kingdom has been seen
by EACPT as one of those countries where the discipline of CPT was
particularly effective and the situation in the UK has often been held up
as a model for those developing countries.
At its recent meeting in Stockholm the EACPT Executive Committee discussed
the problem of getting permission to undertake a clinical trial and it was
clear from those countries represented around the table that the problem
was predominantly a United Kingdom issue. Representatives of seven
countries stated that clinical trials were nearly always fully approved in
their country within 60 days of the application being made and this
included action by the regulatory body and any necessary approval by an
ethics committee or hospital authority. This is in line with a recent
paper, comparing the time from application to approval of multicenter
clinical trials in European countries, in United States and Australia (3).
Interestingly the time for approval in European countries following the EU
clinical trials directive (4) was longer than in other European countries
that were not following that directive (75 days versus 59 days). The
prolonged time for approval of clinical trials may be due to over-regulation due to following the rules or to incapacity to implement the
rules. The impression given in the paper by Stewart et al. (1) is that the
latter reason is the cause of the delayed approval time in their case. The
time for approval in the European study (3) is much shorter in both arms
of the study than in the situation outlined by Stewart et al. (1). More
information on this topic will be forthcoming at a European meeting in
Brussels in December (5).
The data presented in the letter (1) is limited in size but if the problem
of over-regulation is as widespread as the authors maintain then the EACPT
hopes that action will be taken urgently to correct an obvious over-regulation of clinical trials in the UK by learning the lessons from other
countries in Europe so that young clinical pharmacologists can be readily
recruited and trained. Only then will the discipline in the UK be restored
to its former status as one which other European countries can learn from.
References
1 Stewart PM, Stears A, Tomlinson JW, Brown MJ. Regulation -The real
threat to clinical research. BMJ 2008;337:a1732
2 Orme M. European Association for Clinical Pharmacology and Therapeutics.
Eur J Clin Pharmacol 1993;45:295-296
3 Heerspink HJL, Dobre D, Hillege HL, Grobbee DE, et al. Does the European
clinical trials directive really improve clinical trial approval time?
Brit J Clin Pharmacol 2008;66:546-550
Over-Regulation of Clinical Trials - A UK Problem?
The European Association for Clinical Pharmacology and Therapeutics
(EACPT) was very concerned to read in this journal about the reported
degree of over-regulation that was experienced by some doctors in training
in the United Kingdom following the request for permission to undertake a
clinical trial (1). Even though the initial report was anecdotal, the
article does point to a more widespread problem in approving of clinical
trials. While trainees in many medical specialties undertake clinical
trials as part of their training, only in clinical pharmacology and
therapeutics (CPT) is the involvement in a clinical trial such a
fundamental part of the learning experience for a trainee in the
specialty.
Since the EACPT was founded in 1993 (2), the association has worked hard
to help develop CPT in Europe particularly in the developing countries in
Eastern Europe. Over the years since then the United Kingdom has been seen
by EACPT as one of those countries where the discipline of CPT was
particularly effective and the situation in the UK has often been held up
as a model for those developing countries.
At its recent meeting in Stockholm the EACPT Executive Committee discussed
the problem of getting permission to undertake a clinical trial and it was
clear from those countries represented around the table that the problem
was predominantly a United Kingdom issue. Representatives of seven
countries stated that clinical trials were nearly always fully approved in
their country within 60 days of the application being made and this
included action by the regulatory body and any necessary approval by an
ethics committee or hospital authority. This is in line with a recent
paper, comparing the time from application to approval of multicenter
clinical trials in European countries, in United States and Australia (3).
Interestingly the time for approval in European countries following the EU
clinical trials directive (4) was longer than in other European countries
that were not following that directive (75 days versus 59 days). The
prolonged time for approval of clinical trials may be due to over-regulation due to following the rules or to incapacity to implement the
rules. The impression given in the paper by Stewart et al. (1) is that the
latter reason is the cause of the delayed approval time in their case. The
time for approval in the European study (3) is much shorter in both arms
of the study than in the situation outlined by Stewart et al. (1). More
information on this topic will be forthcoming at a European meeting in
Brussels in December (5).
The data presented in the letter (1) is limited in size but if the problem
of over-regulation is as widespread as the authors maintain then the EACPT
hopes that action will be taken urgently to correct an obvious over-regulation of clinical trials in the UK by learning the lessons from other
countries in Europe so that young clinical pharmacologists can be readily
recruited and trained. Only then will the discipline in the UK be restored
to its former status as one which other European countries can learn from.
References
1 Stewart PM, Stears A, Tomlinson JW, Brown MJ. Regulation -The real
threat to clinical research. BMJ 2008;337:a1732
2 Orme M. European Association for Clinical Pharmacology and Therapeutics.
Eur J Clin Pharmacol 1993;45:295-296
3 Heerspink HJL, Dobre D, Hillege HL, Grobbee DE, et al. Does the European
clinical trials directive really improve clinical trial approval time?
Brit J Clin Pharmacol 2008;66:546-550
4 Directive 2001/20/EC of the European parliament and of the Council.
www.eortc.org/Services/Doc/clinical-EU-directive-04-April-01.pdf.
5 European Forum for Good Clinical Practice - Conference on the impact on
clinical research of European legislation. Brussels December 2nd 2008
Prof Ingolf Cascorbi, Chairman
Prof Michael Orme, Past-Chairman
Prof John R. Cockcroft, Secretary
on behalf of the EACPT Executive Committee
Competing interests:
None declared
Competing interests: No competing interests