What is evaluated in clinical studies?
Before new drugs can be used in routine clinical practice, they must be extensively tested. Clinical studies are investigating whether new drugs or procedures are safe, tolerated and effective. The test agent can, in principle, begin at any point in medical treatment: it can be used, for example, the prevention, early detection, diagnosis, or treatment of a disease.
In the case of new drugs, the therapeutic efficacy needs to be proven. The effectiveness is, what is the Benefit for patients or patient by taking the Means. An effective drug can shorten the duration of illness or prevent a disease break out at all.
What studies are there?
Before a drug is clinically tested, are carried out preclinical studies in laboratories. Only when these Tests are positive, it will start the clinical Phase in patients. New drugs are always tested in four successive stages.
In Phase 1 studies , the safety, tolerability and dosing of a new compound tested. The number of participants is usually small, since there is no experience with the new substance in humans. The participants are, in General, patients with advanced cancer for which there is still no effective therapy.
In Phase 2 studies , the efficacy and tolerability of the new substance tested. The number of participants is larger and now includes about 30 to 150 subjects. In Oncology, patients with certain tumor take part in disorders in these studies.
In Phase 3 studies is usually the evidence of Efficacy provided. The study has strict inclusion and exclusion criteria and is usually randomized, controlled and multi-centered (definitions see below). The results of these studies are used as the basis for the approval of a new Drug.
Phase 4 trials occur after approval and are on a few thousand patients, made. The studies to detect rare side effects or interactions with other medications.
Therapy optimization studies have the goal of best Oncology treatments to improve. Approved drug be dosed new or combined in order to improve the quality of life of patients.
What it has with the ethics Commission?
Ethics committees there are, among other things, at each University. They see themselves as independent, superordinate control organ and is composed of Doctors, lawyers, but also non-medical readers. Each study requires the approval of an ethics Committee. The panel will examine very carefully whether all the protective provisions are complied with and whether the patients may be exposed to unnecessary risks.
Risk Factor Smoking
Approximately 19 percent of all preventable cases of cancer are attributable to cigarette. Smoking is considered the most important preventable risk factor in the development of cancer. Also, passive smoke poses a risk.
Smokers develop more lung cancer than non-smokers. Around nine out of ten men with lung cancer have contracted the disease, probably from Smoking. For women, there are six out of ten people Affected. In addition, there are correlations with many other types of cancer, such as oral cavity, esophagus, or larynx cancer.
So you lower your risk:
Stop with the Smoking. A stop Smoking is worth it at any age. The following applies: The earlier in the life is omitted, the greater the positive effect. Ten years after the last cigarette the risk of certain cancers, decreases diseases, such as the mouth, trachea and esophagus cancer. The risk to develop lung cancer, decreases in comparison to people who have smoked to the half.
What are the potential benefits of participating in a clinical trial brings?
For cancer patients, studies are associated with the Chance to get early access to new treatment options, there are, as yet, in routine clinical practice. May be new drugs or therapeutic approaches bring advantages. Moreover, patients cared for in studies to be particularly intense, closely and in accordance with the methods treated are monitored, the quality are secured.
What are the possible disadvantages are there to consider?
New drugs or methods, bergen, under certain circumstances, unknown risks or side-effects. Treatment does not guarantee success – possibly the untested therapy or method works even worse than the usual procedure. The participation in a study requires time. Some study participants may perceive the frequent and extensive examinations, as a burden.
What technical terms such as “randomized” and “controlled”mean?
How reliable and meaningful the results of a study depends on the study design. The design of the study in turn depends on the research question of the study. To determine the effectiveness of a new drug, studies should be controlled, for example, randomized and double-blind.
Who can participate in a clinical trial?
Clinical trials are run according to a defined study Protocol. This is, among other things, what people are able to participate in the study (inclusion criteria), but also, for whom the study is not eligible (exclusion criteria). Due to the requirements of the study statement should be stronger or the potential harm of inappropriate participants will be averted. The criteria can relate to, according to the German cancer research center (DKFZ), among other things, the type of tumour, the stage of the disease, the age or previous treatments.
It may happen that an ongoing study is terminated prematurely?
Yes. This is for instance the case, if the drug shows a superior effect, and the participants would be at a disadvantage in the control group this. Also in the case of serious side effects, the study is terminated. It may happen also that while the study shows that the new drug is less effective than the old treatment option. Also in this case the study is ended prematurely.
What are my rights as a study participant?
At the top of the right detailed Information. The doctor is obliged to study participants about the possible Benefits and possible disadvantages of the study to clarify. The study participant agrees, in the connection in writing. The collected medical data are strictly confidential and may only be evaluated anonymously. During the study, significant side effects, is obliged the physician to stop the treatment. A special insurance (clinical trials insurance) protects participants in the event of a damage to health.
If I decide for a study: do I Need to then pull through to the end?
No. Clinical trials can be terminated at any time, without having the disadvantages to expect. After the patient can discuss with the treating Doctors, which further therapy options for you are eligible.
What are my obligations as a study participant?
With the signature of the patient of the proposed treatment to the voices and commit to the treatment and appointment schedule. Symptoms or health changes occur, you should inform the study doctor. The same shall also apply if subjects are taking other medicines that are part of the study.
I’m thinking about to participate in a study. And now?
If you are on the search for a suitable study, talk to your doctor or your Doctor and get rid of all the issues you deal with. You ask: “What are the possible advantages are, for me, arising out of participation in the trial?” A list of frequently asked questions there are in the Blue guide “Clinical studies” of the German cancer aid and the German cancer society. Also self-help groups are often well informed and can provide information about upcoming studies. Information about ongoing studies in Germany, there are also on the website of the German register of Clinical studies (DRKS).
Sources: info sheet of the DKFZ, “Clinical trials: What should I know?” / Blue guide “Clinical trials” / German cancer society: Clinical trials in cancer therapy – information for patients
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