Draft guidance on clinical trials recognises needs of non-commercial research
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《英国医生杂志》
Academic researchers are cautiously welcoming new draft guidance on clinical trials published recently by the European Commission.
They are pleased that, for the first time, guidance makes specific mention of the particular value and needs of non-commercial clinical trials. They had feared that the previous directive might restrict certain trials or place unnecessary restrictions on studies comparing one existing drug with another where the risks were relatively low.
The new guidance is a redraft of the original European Union clinical trials directive (2001/20/EC), which was set up to harmonise approval and monitoring of commercially sponsored clinical research in different EU countries and to set pan-European standards of protection for all participants in clinical trials. The directive was adopted in 2001, but member states had until 1 May 2004 to incorporate it into their domestic legislation.
During this interval several non-commercial research organisations, including Britain抯 Medical Research Council and Cancer Research UK, warned that some of the recommendations—such as the need for a sole sponsor to carry all liability for a trial and very detailed monitoring even for trials of drugs that are already licensed—could stifle academic research if governments applied them rigidly.
They warned that the resulting increase in costs of conducting trials, together with the limited public funds available, would inevitably result in fewer non-commercial trials being funded. The new draft seems to have taken account of these concerns.
Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, said: "The draft provides member states with sensible flexibility in many areas of detail. It is not the prescriptive, one-size-fits-all diktat that many had feared."
The new draft directive from the European Commission recognises, for the first time, the value of clinical trials not carried out by drug companies in the investigation of medicinal products for human use. It notes, "Non-commercial clinical trials conducted by researchers without the participation of the pharmaceutical industry may be of great benefit to the patients concerned."
The draft guidance also acknowledges that some of the requirements for non-commercial research may be different from those for trials of new drugs funded by drug companies. Academic researchers had been concerned that the previous guidelines required a sole sponsor, which they felt did not fit the collaborative approach generally adopted in publicly funded multicentre trials.
The new draft states: "The conditions under which the non-commercial research is conducted by public researchers, and the places where this research takes place, make the application of certain of the principles of good clinical practice unnecessary or guaranteed by other means."
Academic researchers were also concerned about the introduction of rigid approaches to monitoring and pharmacovigilance, which they considered to be inappropriate in many trials of marketed drugs.
Professor Evans, who was a member of a joint working body of the Medical Research Council and the Department of Health that was set up to consider the impact of the EU directive on academic research, commented: "The new draft acknowledges that risks of trials differ and that the precise way in which risks are controlled, so that patients are safe and trials are reliable, should be specific and proportionate to the risks. In particular, trials that examine the effectiveness of existing medicines—and these are usually non-commercial trials—have lower risks than trials of new products."
The European Commission has invited feedback on its draft proposal, which will be used to finalise the proposal. Comments should be sent before 30 July 2004.(London Susan Mayor)
They are pleased that, for the first time, guidance makes specific mention of the particular value and needs of non-commercial clinical trials. They had feared that the previous directive might restrict certain trials or place unnecessary restrictions on studies comparing one existing drug with another where the risks were relatively low.
The new guidance is a redraft of the original European Union clinical trials directive (2001/20/EC), which was set up to harmonise approval and monitoring of commercially sponsored clinical research in different EU countries and to set pan-European standards of protection for all participants in clinical trials. The directive was adopted in 2001, but member states had until 1 May 2004 to incorporate it into their domestic legislation.
During this interval several non-commercial research organisations, including Britain抯 Medical Research Council and Cancer Research UK, warned that some of the recommendations—such as the need for a sole sponsor to carry all liability for a trial and very detailed monitoring even for trials of drugs that are already licensed—could stifle academic research if governments applied them rigidly.
They warned that the resulting increase in costs of conducting trials, together with the limited public funds available, would inevitably result in fewer non-commercial trials being funded. The new draft seems to have taken account of these concerns.
Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, said: "The draft provides member states with sensible flexibility in many areas of detail. It is not the prescriptive, one-size-fits-all diktat that many had feared."
The new draft directive from the European Commission recognises, for the first time, the value of clinical trials not carried out by drug companies in the investigation of medicinal products for human use. It notes, "Non-commercial clinical trials conducted by researchers without the participation of the pharmaceutical industry may be of great benefit to the patients concerned."
The draft guidance also acknowledges that some of the requirements for non-commercial research may be different from those for trials of new drugs funded by drug companies. Academic researchers had been concerned that the previous guidelines required a sole sponsor, which they felt did not fit the collaborative approach generally adopted in publicly funded multicentre trials.
The new draft states: "The conditions under which the non-commercial research is conducted by public researchers, and the places where this research takes place, make the application of certain of the principles of good clinical practice unnecessary or guaranteed by other means."
Academic researchers were also concerned about the introduction of rigid approaches to monitoring and pharmacovigilance, which they considered to be inappropriate in many trials of marketed drugs.
Professor Evans, who was a member of a joint working body of the Medical Research Council and the Department of Health that was set up to consider the impact of the EU directive on academic research, commented: "The new draft acknowledges that risks of trials differ and that the precise way in which risks are controlled, so that patients are safe and trials are reliable, should be specific and proportionate to the risks. In particular, trials that examine the effectiveness of existing medicines—and these are usually non-commercial trials—have lower risks than trials of new products."
The European Commission has invited feedback on its draft proposal, which will be used to finalise the proposal. Comments should be sent before 30 July 2004.(London Susan Mayor)