Here you will find answers to the most frequently asked questions about study participation.
A clinical trial is a systematic investigation on humans (healthy volunteers or patients) to gain new insights into the diagnosis and treatment of diseases. The tests are carried out according to a protocol that contains all the information about the study. A carefully planned study can reliably determine the efficacy and tolerability of a drug or the suitability of a diagnostic procedure.
The study participants receive intensive medical care during the study and are under special legal protection. For example, study participants must be fully informed about the potential benefits and risks of participating in a study project.
In Switzerland, all clinical trials must be reviewed and approved by the relevant cantonal ethics committee. In addition, studies with medicines and medical devices are reviewed by the Swiss health authorities (Swiss Agency for Therapeutic Products, Swissmedic) .
In Switzerland and many other countries, new medicines are subject to defined procedures that must be completed before they can be routinely administered or dispensed to patients. Before a drug can be launched on the market, the regulatory authorities require proof of its efficacy and safety. This proof is provided by clinical trials. A drug goes through 3 test phases before it is approved for the market:
In Phase I, the tolerability and safety of a substance are typically investigated in healthy volunteers (10-100 people).
In Phase II, the tolerability and efficacy of a substance are tested on an extended group of patients and the effective and safe dose is determined (50-500 people).
If the results from phase II were satisfactory, the efficacy and therapeutic benefit in comparison to an established therapy will be tested on a larger patient population (up to 10,000 patients) in a third study phase. Following successful completion of Phase III, an application for marketing authorization for the drug will be submitted to the pharmaceutical authorities.
Drugs that are approved and on sale are monitored on the market in order to discover (possibly new) side effects, assess the risk-benefit ratio and/or determine the therapeutic value for certain patient groups in everyday practice.
Before new medical ideas or findings can be adopted in routine treatment or diagnostics, they must be scientifically tested. Such a review takes place within the framework of clinical studies. The efficacy, safety and quality of new drugs and medical devices as well as diagnostic and therapeutic procedures can only be assessed if well-planned clinical trials are carried out. Clinical studies are also used to gain insights into the causes and progression of diseases.
Although enormous progress has been made in the field of medicine in recent years, there are still no satisfactory treatment options for many diseases. Intensive and extensive medical research activities are always necessary to ensure that effective therapies can also be offered for these diseases in the future.
Before patients/subjects decide to participate in a clinical trial, they receive written information about the trial. In addition, patients/subjects are informed in detail about all contents and aspects of the study in a consultation with the supervising physician.
The protection and safety of study participants is a top priority in clinical trials. Right from the planning stage, every effort is made to minimize or exclude the risks of a new drug or treatment procedure when used in humans. Clinical trials are planned in accordance with international quality standards and conducted by experienced personnel. Nevertheless, treatment as part of a study can be associated with unpleasant and, in rare individual cases, serious adverse effects. However, close medical monitoring ensures that treatment is discontinued immediately if such effects occur.
Before a clinical trial is allowed to start, it is carefully reviewed by ethics committees for its scientific, medical and ethical aspects and monitored by authorized personnel who are not part of the study team. These independent control bodies serve to protect and ensure the safety of the study participants. An international standard exists for the planning, implementation, documentation and evaluation of clinical trials in the form of the Good Clinical Practice (GCP) guidelines. This also defines the responsibility of the study director for correct study planning and implementation. The principal investigator must have extensive experience in conducting clinical trials. His qualifications are reviewed by the ethics committee.
In addition to the review of the scientific, medical and ethical aspects by the ethics committees, all clinical trials must be covered by insurance to compensate trial participants for any damage they may suffer in connection with the clinical trial.
The study participants give their consent for their medical data to be viewed by authorized persons from the drug manufacturer, the ethics committee and Swissmedic for the purpose of checking that the study has been conducted correctly. The confidentiality of this data is strictly maintained.
Patients/subjects have the right to be fully informed about the study. Only a fully informed patient/subject who has previously signed a written declaration of consent to participate in a study may be included in a study. Patients/subjects are free to decide whether or not they wish to participate in a study. You can withdraw from participating in the study at any time without providing reasons, and this withdrawal will not result in any treatment disadvantages thereafter.
By signing the consent form, patients/subjects agree to participate in the study. Patients/subjects are expected to adhere strictly to the instructions of the supervising study personnel (e.g. physician) during participation in the study. This includes attending the scheduled examination appointments and, in the case of drug studies, the regular use of the medication. Patients must inform the attending physician immediately of any changes in their state of health. The same applies if they are taking new medication.
Participation in a clinical trial has numerous advantages: