Clinical trials provide a robust way of improving treatments for patients. The information they generate saves countless lives. It is a tragic fact that during clinical trials, as in normal practice, some patients will die due to their disease. It is also the case that many treatments for cancer cause severe and sometimes life-threatening side-effects. All our clinical trials are rigorously peer-reviewed and tightly regulated. The MRC is very grateful to the many patients who volunteer to take part in clinical trials while suffering from devastating and life-threatening diseases.

In your article (Widow exposes cancer drug trial death, last week) you referred to an ongoing Medical Research Council clinical trial, known as TE23. This trial is designed to compare the existing standard chemotherapy regimen for the treatment of advanced testicular cancer to an alternative combination of existing drugs to see if this is more effective than the current standard treatment. Both treatments involve bleomycin - currently a standard drug for this type of cancer.

In this clinical trial, as in all others sponsored by the MRC, and in accordance with international standards, the accumulating trial data is reviewed by an independent group – the Independent Data Monitoring Committee (IDMC). This group is provided with information on the outcomes of all trial participants and provides a clear, independent perspective in reaching conclusions about the trial. If, as the trial progresses, there are significant concerns about patient safety or toxicity or if one treatment is clearly better or worse than another, this committee will recommend that the trial is modified or stopped. Serious side effects in clinical trials are also reported to the Medicines and Healthcare products Regulatory Agency (MHRA) which can stop a trial at any time. The IDMC for this trial last met on 19 November 2008, reviewing all the data and recommended that the trial continued.

Your article mentioned that the MRC had withheld information about the number of patients who had died from bleomycin-related toxicity. But while a trial is underway, its coordinators (in this case the MRC Clinical Trials Unit) routinely reveal interim outcome data only to the Independent Data Monitoring Committee. This is internationally accepted practice. The MRC would be strongly criticised if it departed from it. Following completion of the trial, information concerning the outcomes for those in each arm is published, and patients are informed if they wish.

TE23 is a trial in men with advanced cancer. Unfortunately with standard treatment up to half may die of their disease and a small number will experience life-threatening toxicities. We extend our sympathy to those families whose relatives have died while they were in the TE23 trial.

The MRC’s procedures are rigorous, with internationally agreed safeguards in place to protect patients. Our ambition is clear: to help fight life-threatening diseases and improve the prospects and quality of life for patients.

Professor Janet Darbyshire
Director, MRC Clinical Trials Unit
London

Dr Catherine Elliott
Head of Clinical Research Support and Ethics
MRC Headoffice, London