Guidance and Useful Links Link to the e-Library
Link to the WHO Clinical Trials
A clinical trial is a research study in human volunteers to answer specific health questions.
Prior to testing on humans clinical trials involving new drugs are subject to rigorous testing in the laboratory (pre-clinical trials) for which animals are used. Research using animals is essential to produce sufficient evidence of efficacy and safety before proceeding to trials involving humans.
As trials involve human subjects, there are many laws, directives and regulations put in place to protect subjects from potentially harmful medicines/processes. The laws put in place cover many aspects of trials such as how, when and where they are conducted for example:
- trials being conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and are consistent with Good Clinical Procedures (GCP) and the applicable regulatory procedures
- before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual
- a trial should only be initiated if the benefits justify the risks
- the rights, safety and well-being of the trial participants are the most important consideration and should prevail over all other interests of science and society
- clinical trials should be scientifically sound and described in a clear detailed protocol
From a medicinal aspect, clinical trials involving biological substances, gene therapy or radiopharmaceuticals have specific guidance and regulations in place for the management of these toxic products. When a clinical trial is taking place in a hospital all Investigational Medicinal Products (CTIMPs) should be stored and dispensed by the hospital pharmacy and managed according to ICH GCP Guidelines.
Various aspects of trials, such as those mentioned, all have to carefully controlled and monitored. As we have seen review and initiation of a clinical trial can be a complex and lengthy process.
The following documents are readily available as a reference source, to help support professionals in carrying out trials safely and legally and to allow professionals to be confident in the choices and protocols they devise for clinical trials.
To access further guidance please click on the external links below:
- The Royal Pharmaceutical Society (RPSGB)
- RPSGB: Practice Guidance for Pharmacy Services on Clinical Trials.
- Harman J. The Concept and Implementation of Good Clinical Practice in Trials. The Pharmaceutical Journal ( 10th May) 2003;653-657.
- Harman R. The Regulation of Clinical Trials in the United Kingdom.The Pharmaceutical Journal: (1st November) 2003;618-622.
- The Chief Scientist's Office (CSO)
- The Research Governance Framework for Health and Social Care (2nd Edition)
- DH: Information on archiving
- DH: Action To Raise Standards Of Clinical Trials In The NHS
- DH: Guidance on good clinical practice and clinical trials in the NHS - MISC (2000)13
- The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
- ICH Guideline on GCP (E6)(R1)
- The Medical Research Council
- The Medical Research Council (MRC) Guidelines for Good Clinical Practice in Clinical Trials
- The British Oncology Pharmacists' Association BOPA: Position statement on the packing of oral cytotoxic medicines for clinical trials: July 2005