Clinical trials internet resource
November 2004
End of trial
At the end of the recruitment and treatment phases of a clinical trial, the experimental treatment may be withdrawn. In rare circumstances problems can arise when patients wish to continue with a treatment that has benefited them in the trial, but which is not yet available for general use. Some drug treatments can be provided on a named patient basis, or by means of a doctor’s exemption certificate from the Medicines and Healthcare products Regulatory Agency.
Another issue is that of licensed drugs after the end of a trial. It is good practice for the commercial organisation that is sponsoring a trial to agree to provide the drug free of charge to trial participants beyond the life of the trial. Otherwise, either the drug has to be withdrawn or the local NHS community will have to pay.
If at any point during a trial the results suggest harm or risk to participants, the trial must be halted. The GMC guidance states that any adverse findings must be reported “to those participants who are affected, to those responsible for their medical care, to the research sponsor and primary funder and to bodies responsible for protecting the public, such as the Medicines Control Agency or other licensing bodies”.
Dissemination of results from clinical trials is usually through publication in peer reviewed journals. It has become increasingly accepted that the patients who participated in the study, as well as the study’s sponsors, should be informed of the study results where possible.