Clinical trials
More common in the US than in the UK, clinical trials can be offered by reputable research centres, aligned with hospitals. A clinical trial is a medical research study, which involves people. Typical cancer clinical trials will research drugs, screening, diagnosis, treatments and controlling symptoms.Enrolment may be limited and there are usually specific criteria for entering a clinical trial. These would relate to age, type of condition, geographical location, what treatments you may have had already to name a few.
Clinical trials come in four phases (adapted from http://www.cancerhelp.org.uk/trials):
- Phase 1 trials look at whether a trial treatment is safe or has any harmful effects. The research team will also find out the best dose to use.
- Phase 2 trials look at how well a treatment works. Only a treatment that has got through these 2 phases goes into phase 3 testing.
- Phase 3 trials test a new treatment against the existing standard treatment. If it gives better results, it may become the new standard treatment.
- Phase 4 trials are carried out after a drug has been licensed. They collect information about side effects, safety and the long term risks and benefits of a drug.
What are the benefits and risks of participating in a clinical trial?
(adapted from http://clinicaltrials.gov)Benefits
Clinical trials that are well-designed and well-executed are the best approach for you to:
- Play an active role in your own health care.
- Gain access to new research treatments before they are widely available.
- Obtain expert medical care at leading health care facilities during the trial.
- Help others by contributing to medical research.
There are risks to clinical trials.
- There may be unpleasant, serious or even life-threatening side effects to experimental treatment.
- The experimental treatment may not be effective.
- More of your time and attention might be needed than an existing standard treatment, such as trips to the study site, more treatments, hospital stays or complex dosage requirements.
What you should consider before participating in a trial.
You need to know as much as possible about the clinical trial and feel comfortable asking questions about it, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for you to discuss with your doctor.
- What is the purpose of the trial?
- Who is going to be in the trial?
- Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?
- What kinds of tests and experimental treatments are involved?
- How do the possible risks, side effects, and benefits in the study compare with my current treatment?
- How might this trial affect my daily life?
- How long will the trial last?
- Will I need to stay in hospital?
- Who will pay for the experimental treatment?
- Will I be reimbursed for other expenses?
- What type of long-term follow up care is part of this study?
- How will I know that the experimental treatment is working? Will results of the trials be provided to me?
- Who will be in charge of my care?
For more information on clinical trials and current trials, have a look at these websites:
http://www.cancerhelp.org.uk/trials/trials/default.asp
http://www.cancerhelp.org.uk/trials/understanding/default.asp?page=51
http://groups.eortc.be/brain/html/trials.html (a European site, but is a multidisciplinary and international group of specialists)
http://www.virtualtrials.com/ (a US site, specifically focused on brain cancer)
http://www.healthtalkonline.org/medical_research/clinical_trials (This resource features patients talking about their experiences of being the subject of clinical trials and is well worth a visit).
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