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Strengthen clinical trials driven by investigators, Europe research councils say

BMJ 2009; 338 doi: http://dx.doi.org/10.1136/bmj.b1111 (Published 17 March 2009) Cite this as: BMJ 2009;338:b1111
  1. Jacqui Wise

    Medical research councils in Europe have devised a strategy to strengthen clinical trials that are instigated by academic researchers rather than commercial interests.

    The European Medical Research Councils, part of the European Science Foundation, held a series of five workshops to examine the problems that are facing researchers who are conducting clinical trials. The resulting report, Forward Look: Investigator Driven Clinical Trials, lists 26 recommendations to strengthen such research in Europe (see box).

    Investigator driven clinical trials tend to have a much broader scope and potential impact than clinical trials driven by industry. Typical topics include proof of concept studies, comparison of diagnostic or therapeutic interventions, surgical therapies, or new indications for registered drugs.

    Another example of investigator driven clinical trials is research into rare or orphan diseases, such as osteosarcoma and fibrous dysplasia. The commercial returns are often not high enough for drug companies to be interested, and there may be only a few patients in any one country, making research difficult.

    The report recommends that regulations governing clinical research are revised. “We need to simplify the mechanisms and create more incentives for researchers to carry out pan-European studies,” said Carole Moquin-Pattey, head of the European Medical Research Councils and author of the report.

    The report says that central and eastern European countries are facing the same problems as western Europe but they are more acute and extreme. In these countries most clinical trials are run by industry and rarely by academia. The report calls for funds from the European Union to fund clinical research infrastructure in these countries. “We would like to see the best practice of countries like the United Kingdom, France, and Germany shared and replicated in countries in central and eastern Europe,” said Dr Moquin-Pattey.

    The report states that it is vital to attract, train, and keep young scientists in clinical research. To this end a list of models and best practice for training doctors of medicine and doctors of philosophy in different countries should be created.

    Top five recommendations to strengthen investigator driven clinical trials (IDCTs) in Europe

    • Improve the education, training, career structure, and opportunities for scientists involved in patient oriented clinical research

    • Increase levels of funding for IDCTs

    • Adopt a risk based approach to the regulation of IDCTs

    • Streamline procedures for obtaining authorisation for IDCTs

    • Ensure that IDCTs are carried out with an appropriate number of patients to produce statistically reliable results so that trials are correctly powered

    Notes

    Cite this as: BMJ 2009;338:b1111

    Footnotes