Clinical trials are the backbone of modern medicine. Without clinical trials, we would not know the correct dosage to use, for which indications a drug works or what the side effects, contraindications and possible interactions are.
Due to many laws and regulations that have been implemented over the last century (Nuremberg Code, the Declaration of Helsinki, GCP) clinical trials have been developed to be as ethical and unbiased as possible.
Despite all this - what do Medical Doctors actually know about clinical trials and what exactly is taught at medical school?
At the Medical University of Vienna, we briefly touch on the subject in our second year, in a class called SSM1 (special study module) as confusing as the name is, we learn about the basic design of clinical trials phase I-IV, how to research on PubMed and in conjunction we write a brief review about a research topic of our choosing. The module concludes with a short written exam.
A year later, we take a class on statistics, though we do not go into great detail. This class mostly talks about which statistical methods we will need later on in our doctoral thesis (T-test, X-squared test, P-value, how to use SPSS).
After this class, Students usually start the search for their doctoral thesis by contacting various Departments and Professors, usually in the AKH (Vienna General and University Hospital). This can be in form of a prospective trial or fundamental research in the lab, but most students prefer to work on a retrospective data analysis, because this usually requires less time and effort.
In our fourth year we take 2 more classes of our choosing to help us with our thesis. Most students will take another statistics class and one more from a broad range of classes (experimental trial design, qualitative methods, reproducible research, clinical epidemiology, molecular bio-analytics and many more).
All 3 types of thesis require an application to the local Ethics Committee – this is where many Students struggle, because the requirements for the Ethics Committee are quite strict, and most Students do not get an approval until their third or fourth application, especially because they have no prior experience with applications to Ethics Committees.
Because less than 30% of Students are part of a prospective trial, we do not come into contact with clinical trials at all. This unfortunately means we know little about randomization, blinding, bias, patient recruitment, regulatory requirements, monitoring and many other really important aspects of clinical trials. Once we are Medical Residents, especially in larger hospitals or university hospitals, we may take part in clinical trials as Investigators, but many will probably never come into contact with clinical trials.
This can often be a reason why Pharmaceutical Companies and CROs have trouble working with Doctors. This is where communication is really important, because Doctors are not always aware of the process of a study.
Nevertheless, most medical schools are continuously improving their curriculum, and there is definitely a positive trend of teaching more about research and clinical trials. This will undoubtedly help Pharmaceutical Companies and CROs work more efficiently with Hospitals and Clinics in the future.