Clinical trials in developing countries: Discussions at the '9th International Symposium on Long Term Clinical Trials', London, UK, 19-20 June 2000
Current Controlled Trials in Cardiovascular Medicine
1468-6708
Meeting report Clinical trials in developing countries: Discussions at the 9th International Symposium on Long Term Clinical Trials, London, UK, 19-20 June 2000 Rachel N Johnatty
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This symposium provided a useful forum for the discussion of issues relating to the design and conduct of clinical trials. There is a need for greater awareness of the complexity of modern day trials, in which a host of statistical, logistical, regulatory and ethical issues are involved. Issues discussed ranged from the effect of sample size on the outcome, and subgroup analysis, to defining and maintaining discrete endpoints. Some useful debate centred on the use of meta-analysis and the current limitations of combining information from different data sets. This brought up the subjects of trial registries and raw data repositories for all clinical trials. Progress and relevance of the Cochrane collaboration were reviewed. The economics of clinical trials was another important topic. Regulatory issues such as the role of data and safety monitoring boards (DSMB) and the guidelines in place for effective data monitoring and progress analysis were discussed. Representatives of government organisations and industry gave both European and American perspectives. This report however focuses specifically on the section devoted to the subject of clinical trials in developing countries.
clinical trial; developing countries; ethics; publishing; symposium
Introduction
The symposium was organised by the Clinical Trials and
Evaluation Unit, Royal Brompton and Harefield NHS Trust
(UK), in collaboration with The National Heart and Lung
Institute (UK) and The Maryland Medical Research
Institute (USA), and was held at the Royal College of
Physicians, London (UK). The theme was Advanced issues in
the design and conduct of randomised clinical trials.
Approximately 250 delegates attended from around the
world. It brought together key people involved at the
practice end of clinical trials (co-ordinators, medical personnel,
epidemiologists), scientists, members of regulatory
bodies, industry representatives, publishers, statisticians
and data analysers. The symposium was divided into eight
sessions addressing a range of topical and challenging
issues in clinical trials: economic evaluation; use of
baseline data; innovative designs; the role of data and safety
monitoring committees; sample size issues in clinical
trials; meta-analysis as a guide to clinical practice;
regulatory issues; and trials in developing countries.
The subject of clinical trials in developing countries was
introduced briefly during the keynote address and
covered in more detail in a session devoted to it. Two
Current Controlled Trials in Cardiovascular Medicine Vol 1 No 1 Johnatty
speakers, Baruch Brody and Salim Yusuf, gave their
views on ethical and organisational issues, using
specific examples of trials carried out in developing
countries. Richard Smith of the British Medical Journal
addressed the subject of research and the publication
of data from developing countries, highlighting the
problems faced and outlining possible solutions.
Keynote address: Clinical trials in the new
millennium
Professor David DeMets (University of Wisconsin-Madison,
USA) outlined the role of the randomised clinical trial (RCT)
in the advancement of medical technology and therapeutics,
and how it has evolved over the 50 years since it was first
introduced. Statistical methodology and information
technology have been developed to improve collation,
monitoring, analysis and access to the huge quantities of data
involved in todays large international multi-centre trials.
The prospect for clinical trials has changed in recent
years. In the USA, for example, government funding has
been levelling out except in few key areas, such as breast
cancer and AIDS research. The role of industry is
increasing, often in partnership with academic institutions.
Political and public interest in new clinical trials is also rising.
Investors and many patient advocacy groups keenly
monitor trial activity, and new policies on trial monitoring
are being debated in the US Congress.
In this changing environment existing standards need to
be re-evaluated in particular areas of medical technology
such as medical devices, new procedures and alternative
medicine, which DeMets felt were not properly regulated.
He stressed that the development of revised standards
should not result in high costs for industry, which have
become a problem in the testing and approval of new
drugs. DeMets also pointed out emerging areas likely to
affect medical technology, such as the potential impact (...truncated)