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Understanding Clinical Research. Renato D. Lopes, Editor, Robert A. Harrington, Editor. Search Textbook Autosuggest Results. Show Chapters Hide Chapters.
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- Understanding Clinical Research | Inserm - From science to health
Despite its name, non-interventional research Category 3 involves procedures or interventions defined by law. It includes observational research: studies observing treatment compliance, the tolerance of a medicinal product once it is on the market, the practices of one treatment center compared with those of another, etc. Research is led and supervised by an investigator doctor, healthcare professional or person qualified in the field concerned by the research who must:.
Nevertheless, a regulatory framework requires that those having supplied their samples or data be protected. For further reading, visit Notre Recherche Clinique in French. Home Research at Inserm Clinical Research. But this healthcare research field is much broader than that, with clinical research also used to, for example: identify molecular or cellular mechanisms implicated in diseases which may then lead to the identification of new therapeutic targets , identify genetic or environmental risk factors which may then lead to the deployment of prevention strategies , compare existing diagnostic or therapeutic approaches which may then be useful in the preparation of patient treatment guidelines.
Three research categories. For more information on what clinical trials involve Interventional research with minor obligations and risk Interventional research with minor obligations and risk Category 2 may include minimally invasive procedures or interventions , the list of which is defined by law blood samples within certain volume limits, questionnaires possibly leading to changes in care based on the results, radiological examinations without injection of contrast agent, etc.
Download detailed articles investigating and analyzing current trends in the clinical trials industry and the impact they have on the research community. Clinical Trial Resources Founded in , CenterWatch is a trusted source and global destination for clinical trials information for both professionals and patients. Connect with CenterWatch Us. What is a clinical trial?
Free online course: “Understanding clinical research: behind the statistics”
Please read here to learn more about clinical trial phases. Question 2. Why do clinical trials randomise treatments? This has been particularly challenging as the immuno-oncology drugs offer a treatment with a completely different mode of action to standard treatments like chemotherapy and targeted therapies, and the very real hope is that even if these standard treatments have failed, then immuno- oncology drugs might succeed.
Will I get the new treatment either way? Is there cross-over? If the trial does not allow cross-over, and you could take the standard treatment elsewhere, then there are still good reasons to stay on the trial.
First and foremost your participation will serve to prove the benefit or not of the new treatment versus the standard treatment. Every treatment we have ever been able to prove works for patients has needed brave and generous people to remain on trials. What if I don't receive the newer treatment? Question 3. Is a clinical trial right for me? The decision to take part in a trial should not be taken lightly.
Some people find the added information and complexity of a clinical trial too confusing, frightening or confronting. Some people would rather that their doctor or family decide what treatment is best for them. If you are offered a clinical trial, you do not have to take it. Your treatment will not suffer, your doctors will not disapprove.
It is entirely your choice whether to participate. If you are thinking of joining a trial, you can ask for the following information to help you decide.
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An up-to-date assessment of your condition. Detailed information about the trial, including what treatment is being tested and what taking part could mean for you. What alternative treatments or trials are available. If you would like more suggestions about what questions to ask your doctor before taking part in a trial, please click here. Question 4. Am I right for a clinical trial? You might not be eligible to take part in the trial if: your general health is not good enough you are too unwell you have had previous treatment for your kidney cancer that could affect the results of the trial you have other diseases e.
Sometimes, this testing can turn up new findings that mean you are no longer eligible for the trial. If you are excluded from a trial, you should be told why by your doctor or one of the trial doctors. Sometimes there are logistical reasons for you to be excluded from a trial e. In rare cases, it might be possible for you to travel to a different country to take part. Your doctor should be able to help you explore this option. Question 5. What are the benefits of taking part in a trial?
Apart from access to the new treatment, there are other benefits to taking part in a trial. You will be seen by doctors and nurses who are experts in treating your condition, in hospitals that have the best facilities. The health of people who take part in clinical trials is usually monitored more closely than the health of patients who do not take part in trials. You are making a valuable contribution to medical research. You are taking control of the treatment of your illness. Question 6. What are the risks of taking part in a clinical trial?
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There are many reasons why people are not able to take part in clinical trials. Some common reasons are: no suitable trial is available not being told about the trial by their doctor worries about being given placebo treatment placebos are rarely used in kidney cancer trials logistical problems e. Question 8. What do all these words and phrases mean? Adjuvant therapy. Adjuvant therapy If a cancer has been completely removed during an operation, there is still a chance that it can recur, due to tiny seeds from the cancer that spread.
Best supportive care. Best supportive care This means a patient receives treatment to alleviate their symptoms, but no specific treatment against the cancer. Blinded Blinding means concealing the allocation of which treatment the patient is taking. Consent Patients who wish to take part in a clinical trial must be extremely well informed about all aspects of the trial.
Control arm. Control arm The group of patients who take the standard therapy, or if no therapy is proven useful in this situation, then patients may take a placebo, or best supportive care. Double-blind study. Double-blind study Neither the doctor nor the patient knows if they are in the treatment or control group.
Understanding Clinical Research | Inserm - From science to health
First-line therapy. Open-label study. Open-label study Both the doctor and the patient know which treatment group the patient is in.