Clinical Testing Of Drugs

Clinical drug trials: what is it?

Before they are approved in Austria, new drugs or vaccines must be tested for their effectiveness, side effects and safety in clinical trials. Clinical trials are used to determine whether a drug is effective and safe. Before performing clinical trials on humans, so-called preclinical studies must be carried out (in the laboratory or in animal experiments). Preclinical research provides initial information about the mechanism of action, tolerability and dosage of a new active ingredient. Only if no dangerous side effects occur and the preparation can be expected to be effective will a clinical trial be carried out on humans.

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• Increase chances of recovery
• Difference from non-interventional studies
• Phases of clinical drug proving
• How long does the clinical trial take?
• Course of a clinical study
• Safety in Conducting Clinical Studies
• Interface between research and therapy
• Whom can I ask?
• How are the costs going to be covered?

Increase chances of recovery

The spectrum of clinical drug trials ranges from the first-time use of new substances in humans to the collection of long-term data on the safety of drugs that have already been approved. Innovative therapies can increase the chances of recovery, while patient safety is guaranteed through strict approval procedures and continuous monitoring. The study participants, for their part, help to ensure that more effective drugs can be checked, taking into account the latest scientific findings, and then used.

Difference from non-interventional studies

According to the German Medicines Act (AMG), clinical drug trials are differentiated from so-called non-interventional studies (NIS). These studies were formerly called post-use studies. In order to be able to carry out NIS, the medicinal product must have already been approved and use must only take place according to the conditions of this approval. There must be no additional examinations outside of the routine. NIS must also be reported to the authorities.

Phases of clinical drug proving

Clinical drug trials usually go through four phases. The requirements for the approval of clinical drug trials are uniformly regulated in Europe. New, not yet approved preparations are usually first tested on healthy people and then checked for effectiveness and side effects on people with the disease to be treated. The ideal dose is determined, and studies are carried out again if the therapeutic area of use is expanded. Only when one phase has been successfully completed can the next begin. Study phases can also be canceled for serious reasons. Close medical supervision is carried out during each clinical trial.

Phase I: compatibility & safety study

Performed on healthy people. Based on the findings of the preclinical research results, a new active ingredient is tested for general harmlessness (including the exclusion of dangerous side effects) and degradation in the human body. In addition, maximum doses are determined.

Possibly. People with illnesses are also included in this phase in order to research the metabolism in the case of a certain illness or if administration to healthy people is not justifiable. Even if clinical benefit is possible in individual cases, phase I studies by definition have no therapeutic objective.

Phase II: First review of effectiveness and dose determination

Execution on patients for an initial effectiveness test (IIa). The correct dose (IIb) is also determined in this phase. The study participants are often divided into groups: one receives the new drug, another a standard drug that has already been successfully used or a placebo.

Phase III: Proof of effectiveness and safety (approval studies)

Carried out on patients in order to confirm the effectiveness and to determine the frequency of side effects. Long-term comparative studies are used to determine whether the active ingredient has any advantages over established active ingredients. These studies are almost always carried out in a controlled and blinded manner. The data from these phase III studies form the basis for subsequent approval.

Phase IV: Further knowledge about approved drugs

Carrying out examinations of already approved drugs in the case of additional extensions in therapeutic use as well as further observation in order to collect data from practice. Other possible interactions with other drugs can also be determined in this way.

How long does the clinical trial take?

Phases I to III of the clinical trial up to approval take an average of six years. In certain situations, the clinical trial can be carried out more quickly, e.g. in the event of a pandemic such as the corona pandemic. Then it is possible to go through several phases in a joint study project one after the other (e.g. phase I / II studies or phase II / III studies). Instead of the usual final study reports, interim reports are submitted to the authorities and the ethics committee, so that the monitoring of safety is still guaranteed. The overall project will become more complicated and comprehensive, but the development of a drug or a vaccine can be completed more quickly.

Course of a clinical study

Clinical trials must be approved by the national authority and ethics committees before they can be conducted. The national authority in Austria is the Federal Office for Health Safety (BASG). A new form of treatment must always appear sensible and ethically justifiable and have a prospect of effectiveness. The course of the respective examination is precisely recorded in a study protocol. The study protocol must be observed by everyone involved in the study. If changes are made, they must again be approved by the authorities and ethics committees. The study protocol stipulates, among other things:

• Clarification of the question of the study
• Type of study (“design”) and phase
• Definition of the study participants (e.g. within the framework of strict inclusion and exclusion criteria)

A detailed informative discussion takes place before the start of the course. Participation in the study must be voluntary and requires a written declaration of consent. Study participants can end the study at any time. You do not need to give reasons for this. The patient must not suffer any treatment disadvantages as a result.

Since July 21, 2014, the results of clinical studies have to be entered in the European register at the European Medicines Agency.

Safety in Conducting Clinical Studies

Clinical studies are carried out according to international standards (Declaration of Helsinki, Good Clinical Practice / Good Clinical Practice). The study criteria must be scientifically proven. Correct implementation will be checked by the BASG prior to approval and will be monitored during the course of the study. The study team must be professionally qualified and have special knowledge to conduct clinical studies. There are specific advanced training courses for investigators as well as study nurses or study coordinators. The personal data of the test persons must be treated confidentially. The BASG can inspect the study records as part of an inspection in order to check the documentation. Anyone involved in the process of studying is bound to secrecy.

Interface between research and therapy

Clinical trials are the crucial interface between innovative research and successful therapy. They give patients direct access to the latest therapeutic developments. Clinical trials thus offer the opportunity to benefit directly and promptly from current research results.

Study participants are looked after very intensively and individually. Clinical trials are usually carried out in university clinics or other specialized treatment centers.

National information center for cancer studies

Clinical studies also play a major role in cancer research. One of the goals anchored in the “Austrian Cancer Framework Program” is to encourage early participation by cancer patients in appropriate clinical studies, regardless of where they live and their socio-economic situation. The national information center for cancer studies, which is set up at the GÖG (Gesundheit Österreich GmbH), provides independent, objective and competent information on ongoing clinical studies. The information center is aimed at doctors who are looking for the right study for their oncological patient, but also at scientists (e.g. for networking). If you are a patient,Please contact your treating doctor in this regard. In addition, the Austrian Cancer Aid offers detailed information on this topic in its “Clinical Studies” brochure.

Whom can I ask?

If you would like to find out whether participating in the study is an option for you, discuss your concerns with your treating doctor.

How are the costs going to be covered?

Study participants usually incur little or no costs. These are usually borne by study sponsors or financed through research grants.