Access to every trial dataset is crucial
http://www.100md.com
《英国医生杂志》
EDITOR—Herxheimer's pleas for access to industry's trial data1 reminded me that I wrote to the Department of Health two or three years ago, "demanding" that all clinical trials be published either in a journal or on a company website within two years of completion. I had a less than satisfactory response which boiled down to "we can't do anything about it."
As a urologist interested in functional lower urinary tract problems (overactive bladder and possible prostatic obstruction) I have worked with many companies' "competing interests declared." In the light of this experience I approached the argument from a different perspective, that of the patients' altruism in taking part in any trial. English patients are often very committed to helping the advancement of knowledge by taking part in clinical trials and will often say "Yes, if it will help others I would like to take part." I made additional efforts to involve the Patients Association, a journal of medical ethics, and a body overseeing ethics committees in the United Kingdom, but didn't make progress.
I believe the way forward is for ethics committees to stipulate that companies must agree to publish results of any trial for which ethical approval is given. Further, ethics committees could register all trials in a single register administered by a government body, perhaps the National Institute for Clinical Excellence (NICE).
Research is important and, as Herxheimer says, it is crucial that we all have access to every trial dataset in a form that is useful, such as advised by CONSORT.
Paul Abrams, professor of urology
Bristol Urological Institute, Southmead Hospital, Bristol BS10 5NB paul_abrams@bui.ac.uk
Competing interests: None declared.
References
Herxheimer A. Open access to industry's clinically relevant data. BMJ 2004;329: 64-5. (10 July.)
As a urologist interested in functional lower urinary tract problems (overactive bladder and possible prostatic obstruction) I have worked with many companies' "competing interests declared." In the light of this experience I approached the argument from a different perspective, that of the patients' altruism in taking part in any trial. English patients are often very committed to helping the advancement of knowledge by taking part in clinical trials and will often say "Yes, if it will help others I would like to take part." I made additional efforts to involve the Patients Association, a journal of medical ethics, and a body overseeing ethics committees in the United Kingdom, but didn't make progress.
I believe the way forward is for ethics committees to stipulate that companies must agree to publish results of any trial for which ethical approval is given. Further, ethics committees could register all trials in a single register administered by a government body, perhaps the National Institute for Clinical Excellence (NICE).
Research is important and, as Herxheimer says, it is crucial that we all have access to every trial dataset in a form that is useful, such as advised by CONSORT.
Paul Abrams, professor of urology
Bristol Urological Institute, Southmead Hospital, Bristol BS10 5NB paul_abrams@bui.ac.uk
Competing interests: None declared.
References
Herxheimer A. Open access to industry's clinically relevant data. BMJ 2004;329: 64-5. (10 July.)