|A containing the recent OECD Recommendation on the Governance of Clinical Trials and its explanatory memorandum is now available. This major initiative for facilitating medical research and improving public health stems from the extensive work of an expert group of the OECD Global Science Forum.|
Medical research involves testing new discoveries by carrying out carefully controlled investigations on patients - known as clinical trials. This includes testing new medicines or new therapies, as well as optimising existing medicinal products and procedures to improve health and welfare. Many of these trials are driven by pressing public health needs and scientific opportunities that do not offer a strong business case to private companies. This can be due to the small number of patients affected (e.g. orphan diseases such as cystic fibrosis), to insufficient profitability of the treatments (e.g. paediatric therapies, pathologies in developing countries) or because the objective is simply to improve existing procedures and prescriptions (e.g. finding the optimal drug combination or timing).
Tight national regulations have been introduced over time to ensure patient safety and methodological quality. Depending on the country and on the nature of the trial, supervision is either based on specific legislation, on rules originating from the competent authorities, or merely on ethical guidelines. As a result, applicable regulatory mechanisms differ widely across countries. The current administrative complexity is such that it leads many well-conceived clinical trials aimed at addressing important public health problems to either not be conducted or to be so delayed that their impact is dramatically reduced.
In addition to the challenges presented by the existing national regulatory complexity, many clinical trial investigators have to abide by administrative requirements that are poorly adapted to the nature of their study. Existing regulations have mostly been developed to guide the conduct of traditional trials for new medicines, which present an unknown risk for patients. They are often less suited to address many academic trials that use drugs that are already marketed and often present lower risks.
To facilitate international co-operation in clinical trials on medicinal products, particularly for trials initiated by academic institutions, in December 2012 the OECD Council adopted a set of principles calling for improved consistency among national regulations and their interpretations, and on streamlined procedures for the oversight and management of clinical trials. This framework introduces a risk-based oversight and management methodology for clinical trials. It combines a stratified approach that is based on the marketing authorisation status of the medical product and can be applied in a common manner across countries’ regulatory frameworks, with a trial-specific approach that considers other issues such as the type of populations concerned by the trial, or the informed consent of the patients.
The Recommendation is available in the database of OECD instruments. It is also available in a that includes an explanatory memorandum which provides general background information on the issue, explains and elaborates on the principles, and facilitates their implementation.
This Recommendation follows on an extensive work of the OECD Global Science Forum on the hurdles encountered by the clinical research community in setting up international clinical trials. Its findings and policy recommendations were published in late 2011 (see report) and included other major issues such as on the need for better training of clinical staff and improved patient involvement in clinical trial processes which are now being addressed by the World Health Organisation.