Patients involved in clinical trials benefit from their treatment, but recruiting more patients to take part is a challenge.
09 May 2004 Posted in News Release By Press Office
This issue is highlighted in the ABPI's newly-published report of its seminar Current Issues in Clinical Trials held at BMA House to explore issues related to clinical trials.
"The scientific support for trials is solid and the subject of constant scrutiny and change. The ethical basis for volunteering is also well established. Participation on clinical trials has been shown to be generally beneficial for the patients involved, but the number of patients participating remains relatively low," Dr Pablo Fernandez, senior vice president of Clinical Research Europe, PharmaNet, told the meeting.
"Recruitment remains a challenge. There are various mechanisms for finding recruits, such as public information campaigns, raising patient group awareness of the availability of clinical trials, and publicity, for example, collaboration with patient groups, information leaflets in GP surgeries, press announcements and listing on the appropriate websites."
Dr Fernandez continued: "Once a patient has been recruited for a clinical trial, the regulatory requirements are strict and adhered to by all main countries around the world. They are set out in the International Conference on Harmonisation Good Clinical Practice guidelines and the World Medical Association Declaration of Helsinki.
When the trial is concluded all data has to be included in the analysis of results and in the final report. Reports of all trials are provided to the medicines agency - the MHRA in the UK, the EMEA for the EU. Subsequently, trial data are presented at scientific meetings and published, ensuring scientific scrutiny of the research methods and results, whether positive or negative.
Robert Meadowcroft, Director of Policy, Research and Information at the Parkinson's Disease Society, said that one reason why there was a low level of participation in trials was because people did not have the information on how to get involved. The Society occasionally had to advise people desperate to take part in trials before the trials were properly set up.
"A lack of feedback to participants about trials is a frequent issue - they want to know what the end date is, where the results will be published, what the outcomes were etc. Expert patients who are better informed and more confident about their treatment are more likely to benefit from it.
"People need to be more aware of the process and of the importance of clinical trials. That will mean they will have more questions for those who design the trials, but that is a welcome development. In summary, there is a need for more and better information and genuine consultation," said Mr Meadowcroft.
For further information, please contact: ABPI Press Office 020 7747 1410