The Austrian Medicinal Products Act (Arzneimittelgesetz, AMG) distinguishes between two categories for investigation of medicinal products with the aim of describing their efficacy or safety:
- Clinical trials of medicinal products according to §2a Abs.1 AMG as amended and
- Non-interventional studies (NIS, formerly observational studies) according to §2a Abs.3 AMG as amended.
Both forms of study serve to answer scientific questions.
In order to carry out a NIS, the medicinal product needs to be authorised and used strictly in accordance with the requirements of the Summary of Product Characteristics (SmPC). Furthermore, there can be no examinations outside the routine or other burdens for the patients. In contrast to this, in clinical trials authorised and unauthorised medicinal products can be researched, and additional and burdensome investigations are permitted.
Phases of Clinical Trials
Clinical trials are divided into phases to describe the state of development of the product under investigation. Phase I is the earliest phase and includes studies with first administration in humans (FIH). While Phase I primarily focuses on possible adverse effects of the drug, Phase II already investigates possible therapeutic effects. Phase III studies are also referred to as confirmatory or pivotal studies, since the outcome of these studies is decisive for later marketing authorisation. Phase IV studies describe the investigation of medicinal products already authorised if the authorised therapeutic use is extended by additional investigations.
Regulatory requirements for the conduct of drug studies
Clinical trials of medicinal products need to be approved by the Federal Office for Safety in Health Care before they can be initiated. A positive vote by the concerned Ethics Committee is a prerequisite for approval. The rules for clinical trials are harmonised in Europe and are based on the common laws of the Union.
Non-interventional studies are nationally regulated and only need to be reported to the Federal Office. A vote of the Ethics Committee is optional, but recommended. In case of doubt, the Federal Office is authorised to decree the referral to an ethics committee.
Authorities and ethics committees have an important control function to ensure comparable standards in studies of medicinal products to guarantee patient safety as far as possible.
Rights of the study participant
Patients participating in a study must explicitly agree to participate. This consent is given after a full and comprehesive explanation by the investigator and a thorough review of the patient information and the signing of the informed consent form. Detailed contact information is an essential part of patient information. In the event of ambiguities, the patient must be given the opportunity to contact another person (e.g. the investigator or patient advocate). A patient can opt out of a clinical trial at any time without giving a reason and with the best medical care available.