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A new information booklet for patients has been produced that emphasises the advantages of taking part in clinical trials and the safety precautions that are taken.
Launched by the UK Clinical Research Collaboration, the booklet—together with an accompanying leaflet—also recommends the questions to which patients should seek answers when considering taking part in trials, and it describes the label “guinea pig” as misleading.
“Clinical trials are the best way to compare different approaches to preventing and treating illness and health problems. Without trials, there is a risk that people could be given treatments which have no advantage, waste resources and might even be harmful,” says the booklet, Understanding Clinical Trials.
The companion information leaflet, Clinical Trials: What They Are and What They're Not, emphasises the need for trials and that they should be safe.
In a reference to a clinical trial of an anti-inflammatory drug that led to patients being treated in intensive care (BMJ 2006;332:677-8 doi: 10.1136/bmj.38797.635012.47) it says, “In March 2006 there was publicity and concern surrounding a trial in which six volunteers became seriously ill. This was an extremely rare event, which is one reason why it attracted such intense interest.”
It adds, “Each trial is designed to keep risk to a minimum. Doctors and researchers only ask people to take part who are suitable for the treatments being compared. Participants are monitored carefully throughout and their safety and well-being prioritised.”
The publications also point out that drug companies are insured, so compensation may be paid if a patient is damaged by a drug. “Trials funded by other organisations may not have this kind of insurance,” it says, “but a payment may be made if something does go wrong. Before giving your consent to take part in a clinical trial you may want to find out exactly what arrangements have been made for compensation.”
The booklet carries information about the different types of clinical trial carried out in the United Kingdom. It also explains about informed consent and confidentiality. On the question of payments, it says that when volunteers receive money it is to cover expenses, loss of earnings, or their time.
The leaflet gives answers to some common questions patients have about clinical trials, including why they are needed and what the role of drug companies is. The booklet gives a more detailed explanation of what clinical trials are and how they are set up and run. It is designed to provide the type of information people need when considering taking part in a clinical trial.
The Association of Medical Research Charities helped develop the publications. Its chief executive, Simon Denegri, said, “I believe they fill an important information gap. We have good information on clinical trials in certain areas such as cancer, but there is a lack of general information for patients and the public about trials in other areas of health and disease.
“We know from our member charities that patients are increasingly asking about clinical trials: they want to know what they entail and how they can become involved.”
The booklet and leaflet are available at .www.ukcrc.org/publications/informationbooklets.aspx