Session: Regulatory and Research Governance Issues in
Clinical Trials
In recent years there has been an increase in
the regulatory and research governance burden for clinical trials
in the UK. This has been driven by the translation of the EU
Directive on clinical trials into UK law through the Clinical
Trials Regulations which, although only relevant for trials of
Investigational Medicinal Products (IMPs), has also had an impact
on trials of other interventions. In parallel, the NHS Research
Governance Framework which applies to all research within the NHS
has increased the requirements for research governance for all
types of clinical research. Whilst no one would question the need
to ensure that all research is conducted to the highest standard to
ensure the safety of participants and the reliability of the
results, there are concerns that overly rigorous interpretation of
the regulations has led to excessive and often inappropriate
demands being made on those undertaking non-commercial
trials who do not have a large regulatory affairs department to
support them as in the pharmaceutical industry. There are many
examples of the delays and increased costs of clinical trials as a
result of the regulatory and governance demands.
Aims
- discuss and give examples of the challenges
faced
- illustrate examples of efforts to minimise these demands and
to ensure that management and oversight is proportionate to
the risks to the participants and the results of the trials.
- review the particular challenges of multicentre trials and
those involving more than one EU country
- discuss the Review undertaken by the Academy of Medical
Sciences in 2010
Oral Presentations
Click on the links below to view the presentations.
Streamlining regulation of clinical trials - update on the Academy
of Medical Sciences review and government’s response
Interim reports for data monitoring committee review vs final
reports for regulatory filing
A practical solution to ‘continuing care site’ issues in neonatal
clinical trials