Clinical trials and research - When things go wrong
- Introduction
- Types of research
- How research addresses what we don't know
- What are clinical trials?
- Different stages of trials
- About fair tests
- Getting involved in health research
- Joining a clinical trial
- Finding out about the results
- Why all research should be registered
- Systematic reviews and meta-analyses
- How trials are regulated
- Ethics committees
- Data monitoring committees
- When things go wrong
- Sheilas-story
- 'The nurse made sure I understood the risks'
- 'I'm here because of women who took part in research'
- 'I thought it might help me or someone else'
- 'I want people to find better medicines'
- 'I can control my Parkinson's thanks to animal research'
- 'I'm lucky I found a trial that was so right for me'
Medical research and clinical trials are carried out by healthcare professionals whose training and everyday work is focused on the care of patients.
This work is regulated by laws and codes of conduct, and approved by local research ethics committees, whose purpose is to protect the interests of people taking part in the research.
Generally, clinical trials are safe, but sometimes things can go wrong.
The TGN1412 trial at Northwick Park
In March 2006, six men had severe and life-threatening reactions during a clinical trial. They were in a private research unit in northwest London involved in a trial for an experimental treatment that might have been developed to treat leukaemia or rheumatoid arthritis.
The trial was the first time the treatment, called TGN1412, had been used in people (a "first-in-man" trial). All previous research on TGN1412 had been in animals.
The men had serious symptoms, including vital organ failure, fever, and low blood pressure (hypotension). They had to be treated in the intensive care unit at the NHS Northwick Park Hospital in Middlesex. The men survived, but their health was permanently compromised.
A detailed investigation into what went wrong recommended many changes to the way first-in-man trials are carried out. Those recommendations have now been put in place.
What happened to the six men in the trial was widely reported in the media. It was shocking, but highly unusual. Nothing of the same scale has been reported before or since in the UK.
All first-in-man studies are now carried out much more cautiously, particularly those that use new types of treatment with possibly unpredictable side effects.
With research carried out in the NHS, researchers are likely to have a good idea of the possible benefits and side effects of treatment. Researchers have to make the medical background clear and describe details of any new treatments or other interventions being carried out.
Read more about the expert report on first-in-man trials.
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