In the case of clinical trials, research can only take place where the foreseeable risks and inconveniences to the prospective trial participants/patients are outweighed by the potential benefits for them and for future patients. In certain cases a patient may explicitly support a study and support invasive treatment that may be very harmful if, due to the particular circumstances (e.g. s/he is terminally ill), s/he feels that it is worth taking a significant, potentially life-threatening risk.
Most clinical research studies should be undertaken in accordance with the Research Governance Framework for Health and Social Care.
The European Union Clinical Trials Directive 2001/20/EC (EUCTD) was published in 2001, and provides a framework which sets out how clinical trials investigating the safety or efficacy of a medicinal product in humans must be conducted. It includes medicinal trials with healthy volunteers and small scale or pilot studies.
The EUCTD was introduced to harmonise research activity in clinical trials throughout the European Community by establishing clear, transparent procedures. The EUCTD was transposed into UK law as the Medicines for Human Use (Clinical Trials) Regulations 2004 which came into force 1st May 2004.
The European Union Clinical Trials Directive (2001/20/EC) defines a CTIMP as:
"Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational medicinal product(s), and/or to identify any adverse reactions to one or more investigational medicinal product(s) and/or to study absorption, distribution, metabolism and excretion of one or more investigational medicinal product(s) with the object of ascertaining its (their)safety and/or efficacy."
The aims of the Directive are to:
- Set standards for the protection of subjects participating in clinical trials subjects
- Requires Member States to establish ethics committees on a legal basis
- Cover certain Licensing Authority procedures for commencing a clinical trial and lay down standards in relation to IMPs.
- Harmonise regulation and conduct of clinical trials undertaken by Member States.
It also requires clinical trials to be conducted in compliance with the principles of good clinical practice (GCP). There is a separate Good Clinical Practice Directive (2005/28/EC)laying down the GCP standards that must be followed.
Any University researcher wanting to undertake a clinical trial is advised to contact the Warwick Clinical Trials Unit.
Warwick Clinical Trials Unit (WCTU) is an academic unit undertaking clinical trials addressing real issues of local, national and international importance.
Randomised controlled trials are developed in selective, focused areas that are consistent with the research strategy of Warwick Medical School.
Multi-centre trials are run in close collaboration with local NHS Trusts and clinicians. Trials are subjected to rigorous external peer review and efficiently managed, to ensure high quality results.
If undertaking a clinical trial please ensure that the trial is covered under the University's insurance policy, if your trial falls within the exclusions of the policy or if you are unsure if the trial is covered, please contact your R&IS Departmental Officer who will be able to advise and and arrange for additional premiums as necessary.