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Clinical studies are planned and financed by a sponsor, a pharmaceutical company.The studies will be conducted in study sites. A study site can be a private practice, a hospital, an institute or a SMO. The study physician conducts the clinical trial on site. If a clinical trial is performed at several centers ("multicentric study"), one of the participating study physicians is appointed Head of the Clinical Trial (LKP). He is responsible for the overall medical responsibility of the clinical trial and is involved in the submission of the documents to the ethics commissions. More rarely, studies are also carried out with the participation of only one center (monocentric study).
This includes necessary preparations before the study starts as well as the inclusion of suitable patients in the study, treatment of patients, data collection and ensuring the quality of work throughout the study period.
The Participation in a clinical study as a doctor is associated with additional work at the study center, but also has many advantages: The doctor has the opportunity to actively participate in the research and development of new medicines. He gains additional experience by participating in clinical trials and may gain additional qualifications. (e.g., by acquiring a GCP certificate in preparation for the clinical trial) [GCP = Good Clinical Practice]. He can gain experience at an early stage with new drugs or new treatment options for personal practice. Studies can help to understand diseases more precisely and improve them.
In an interventional study, the patient is treated according to a study protocol. This protocol specifies which patients may be included in the study (inclusion and exclusion criteria) and how they should be treated. Intermittent interventional studies are often duplicated and randomized. Interventional studies are mainly used to develop and test new, innovative drugs that have not yet been approved for use on the patient, or already approved drugs whose safety and efficacy is to be investigated in new indications or patient groups.
A non-interventional study ('NIS') is a medical study regulated by the German Medicinal Products Act (§ 4 (23), third sentence, AMG), which can even be made by the licensing authorities via § 63 f and g AMG. The data obtained in the NIS under naturalistic conditions (practice routine) supplement the evidence of experimental data from clinical trials and contribute significantly to the monitoring and evaluation of the benefit / risk profile of medicinal products. There is no pre-defined test plan that prescribes to the physician a specific treatment of the patient, but is based on a so-called observation plan. The overall treatment, diagnosis and observation of the patient is carried out according to the medical practice. The results are analyzed descriptively and exploratively.
All studies in interventional clinical trials require proof of good clinical practice (GCP) training. The required GCP certificate is usually prepared after attending a 2-day course. At each study center, a main study physician as well as a substitute with a comparable qualification are needed. In addition, it is recommended that there is a person who acts as a study nurse, and that the study physicians in carrying out the study.
For participation in non-interventional studies, the o.g. Prerequisites are not necessary because it is an observation of the routine treatment.
Together we can implement, organize and initiate the clinical study from a pharmaceutical sponsor into your business.
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