Clinical studies
Clinical trials are necessary for the development of new medicinal products, but also for testing and expanding the areas of application of already authorised medicinal products. The realisation of studies is closely linked to legal framework conditions:
- Medicinal Products Act
- Drug Trial Guidelines
- Principles for the proper conduct of clinical trials of medicinal products
Therapeutic or therapeutic trial A therapeutic or therapeutic trial is not primarily for research purposes. A doctor is responsible for treating patients with medicinal products that are not yet authorised or not yet authorised for this area of application. There must be plausible, scientifically substantiated theories that make a cure or an improvement in the patient's condition appear possible. There is no alternative treatment. The patient must be informed by the doctor and give his/her consent.
Dr. Lenka Taylor
Pharmacist
(Pharmacy of the Heidelberg University Hospital)
Specialist pharmacist for clinical pharmacy
Clinical studies, analytics, GMP/QMS officer
Qualified person Manufacturing company
Dr. Eva Over
Pharmacist
(Pharmacy of the Heidelberg University Hospital)
Specialist pharmacist for clinical pharmacy, infectiology
ABS expert (DGI)
Clinical studies
Phases of the clinical trial
Phase 1: Before phase 1 begins, test tube and animal experiments are carried out. This is followed by the initial use of a drug on a small number of healthy test subjects. Knowledge is gained about the absorption, distribution, degradation and excretion of substances in the human body.
Phase 2: The substance is tested for the first time on a small number of patients. Findings are obtained to clarify the potential clinical efficacy and tolerability. The optimum dose is also determined.
Phase 3: This phase serves to prove the efficacy, tolerability, safety and correct indication of the potential drug
Phase 4: A broad test of the already authorised drug is carried out. Further knowledge is gained on the risk-benefit ratio.
Tasks of the pharmacist during the clinical trial
- Randomisation and blinding of the trial
- Ready-to-use preparation of the trial product and distribution
- Participation in the preparation of the trial protocol
- Drug information on the drug to be tested
- Practical investigations into the stability and compatibility of the medicinal product to be tested
- Careful and accurate documentation of the medicinal products dispensed to patients
- Receipt and proper storage of the test product, control of stock levels
- Labelling of the test products
- Storage, return and disposal of unused test products and corresponding documentation
Advantages
The co-operation of the hospital pharmacy in the clinical trial in the hospitals has the following advantages for the groups involved:
- The sponsor has a central contact person on site who can be contacted at any time
- The sponsor can request all relevant quality management documents at any time
- The investigator can concentrate on testing the drug and its effects on the patient
- The patient, sponsor and investigator can be sure that the trial medication is produced according to validated, documented and high-quality criteria
- criteria
- The hospital pharmacist contributes his specialised know-how in the field of manufacturing, documentation and quality assurance.