Clinical Studies – get familiar with the unknown
Clinical trials have been on everyone’s lips since the global pandemic at the latest. Drugs and active substances to combat certain diseases are to be produced as quickly as possible but without endangering patient health and safety. This calls for clinical trials in which each drug is tested for its efficiency and safety before it is marketed. Doerthe Bassfeld, Clinical Research Manager at Medinova AG, provides an insight here for better understanding.
Efficiency and safety
Clinical trials are essential to answer specific questions about a drug/product’s application, indication and mode of action. They show how the treatment can improve the patient group’s quality of life.
Clinical trials are conducted to investigate a product on its own or in comparison with another preparation. Two products can be tested directly together, both containing an active ingredient. This is referred to as comparative trials, which are intended to prove the superiority of one of the two products.
In order to prevent possible misleading treatment effects from influencing the result, a preparation without an active substance is often included in the clinical trial. This is called a placebo.
Clinical trial phases
Phase 1 is a study with a very small group of test subjects. The product’s compatibility and safety are thoroughly investigated during this phase. These investigations may include technical measurements, blood sampling, patient examinations and observations by medical staff.
The dosage, efficacy and safety of the products are researched again on a larger number of test subjects suffering from the disease under investigation in phase 2.
The third phase is intended to confirm the results of the first two trial phases in a significantly higher number of test subjects.
Even products already on the market are still tested in clinical trials. In a phase 4 trial, observational studies of a drug/product are conducted continuously to investigate its safety and efficiency.
The production and research of new drugs in particular, requires years of precise trials and often takes 10 years. Negative results for a product in one of the clinical phases prevent approval of the next phase.
At the end of each clinical trial, all the collected data are evaluated and the results are published in the relevant scientific journals, presented at congresses and listed in international registries, the EudraCT (European Union Drug Regulating Authorities Clinical Trials).
Medinova clinical trials
International phase 1-4 trials are carried out on test subjects and patients at Medinova AG. The key focus is always the participants/patient’s compliance with the strict safety standards and all the test centres’ quality and ethical standards. All Medinova clinical trials are conducted by qualified medical professionals in hospitals and practices in various countries.
The successful conduct of clinical trials requires close cooperation with the Regulatory Affairs, Marketing and Medical Affairs departments at Medinova. Concepts are developed together and consultations are held with medical experts to develop a trial protocol.
The trial protocol defines how the respective trial is to be conducted, which drugs are being tested, how many test subjects will take part, which tests are required and how long the study will last.
“We are proud that our research work contributes to new findings and treatment options not only in Switzerland but also internationally,” says Ms Bassfeld, Clinical Research Manager at Medinova AG.