Patients' interests: paramount in randomised trials
http://www.100md.com
《英国医生杂志》
EDITOR—Patients and the public recognise the need for large randomised trials. Trialists must also recognise the responsibilities they owe to their study participants. There has been some debate on whether these responsibilities are always fully discharged.
The early stopping of the MA17 trial, with data released to the media before the trial participants or health professionals had been given time to assess the implications, led to speculation in the medical press about how far patients' interests were being considered.1 Similarly, recent articles have alleged that several pharmaceutical companies may have withheld product safety data, ranging from harmful effects of paroxetine in adolescents, to cardiovascular events associated with rofecoxib, with consequent speculation about the possibility of similar adverse effects from other COX-2 inhibitors.2 3
Sir Tom McKillop, the chief executive officer of AstraZeneca, said: "If we put consumer protection as the only thing the regulator needs to worry about, that will be a huge block to progress and innovation."4 This may dissuade potential trial participants from entering studies because of a perceived (or real) lack of concern for their welfare and rights.
Research must be based on collaborative partnerships between patients and professionals in industry and academia—a key objective of the National Cancer Research Institute. This approach will help ensure the proper conduct of clinical studies, reduce treatment uncertainties, help patients to understand potential risks and benefits, and improve the public perception of clinical research.
Tony Stevens, consumer liaison lead
t.stevens@ncrn.org.uk, National Cancer Research Network, Cookridge Hospital, Leeds LS16 6QB
Roger Wilson, chair, National Cancer Research Institute Consumer Liaison Group
National Cancer Research Network, Cookridge Hospital, Leeds LS16 6QB
Competing interests: None declared.
References
Baum M. Current status of aromatase inhibitors in the management of breast cancer and critique of the NCIC MA-17 trial. Cancer Control 2004;11: 217-21.
Singh D. Merck withdraws arthritis drug worldwide. BMJ 2004;329: 816-2. (9 October.)
Horton R. Vioxx: an unequal partnership between safety and efficacy. Lancet 2004;364: 1287-8.
Man of science with a passionate belief in innovation. Independent 2004 October 9: 59.
The early stopping of the MA17 trial, with data released to the media before the trial participants or health professionals had been given time to assess the implications, led to speculation in the medical press about how far patients' interests were being considered.1 Similarly, recent articles have alleged that several pharmaceutical companies may have withheld product safety data, ranging from harmful effects of paroxetine in adolescents, to cardiovascular events associated with rofecoxib, with consequent speculation about the possibility of similar adverse effects from other COX-2 inhibitors.2 3
Sir Tom McKillop, the chief executive officer of AstraZeneca, said: "If we put consumer protection as the only thing the regulator needs to worry about, that will be a huge block to progress and innovation."4 This may dissuade potential trial participants from entering studies because of a perceived (or real) lack of concern for their welfare and rights.
Research must be based on collaborative partnerships between patients and professionals in industry and academia—a key objective of the National Cancer Research Institute. This approach will help ensure the proper conduct of clinical studies, reduce treatment uncertainties, help patients to understand potential risks and benefits, and improve the public perception of clinical research.
Tony Stevens, consumer liaison lead
t.stevens@ncrn.org.uk, National Cancer Research Network, Cookridge Hospital, Leeds LS16 6QB
Roger Wilson, chair, National Cancer Research Institute Consumer Liaison Group
National Cancer Research Network, Cookridge Hospital, Leeds LS16 6QB
Competing interests: None declared.
References
Baum M. Current status of aromatase inhibitors in the management of breast cancer and critique of the NCIC MA-17 trial. Cancer Control 2004;11: 217-21.
Singh D. Merck withdraws arthritis drug worldwide. BMJ 2004;329: 816-2. (9 October.)
Horton R. Vioxx: an unequal partnership between safety and efficacy. Lancet 2004;364: 1287-8.
Man of science with a passionate belief in innovation. Independent 2004 October 9: 59.