WELCOMING FINAL REPORT ON NORTHWICK PARK CLINICAL TRIALS - HARRIS

2.40.47pm GMT Thu 7th Dec 2006

Welcoming the final report of the Expert Scientific Group examining the design of phase 1 clinical studies, Dr Evan Harris, Liberal Democrat Science Spokesman, said:

"It is critical that confidence in medical research trials is maintained because of the vital contribution they make to human health."

Dr Harris was himself a phase 1 human volunteer in a safety trial for an HIV vaccine.

"One of the reasons why this case was so dramatic is that such instances of serious unexpected side-effects are very rare which is why there should not need to be a problem with regard to insurance in volunteer studies."

In response to accusations of a 'whitewash' from those who took part in the TGN1412 trials, Dr Harris said:

"While I have every sympathy for the men who suffered in the TGN1412 trial, I don't think the litigants or their lawyers have a good case when they claim there has been a cover-up. This thorough report, makes some helpful recommendations for the future and is correct to conclude that there was no negligence in this case."

And in reference to the recommendations made by the report for greater sharing of safety-related information:

"This represents yet another call for the publication of all clinical trials results including all phase I (pilot) studies and negative results. Not to publish such results is a form of systematic fraud which can have serious consequences for the health of human volunteers and patients.

"The recommendation that data from pre-clinical (animal) studies are made openly available for new drugs of this type is welcome in order to help avoid duplication of animal tests, especially those in primates, and to enable the widest possible scrutiny of the adequacy of animal tests on these compounds before they are put into man for the first time."

"What happened in this trial is absolutely not an argument against animal testing. Without animal testing these occurrences would be more frequent."