Course in clinical trial methodology opens new doors for pharmacists

During a clinical drug trial, the desired and undesirable effects of a drug are studied. The work is often carried out in collaboration between the developer of the substance, healthcare and specialised contract research companies. The process is complex and requires access to several different skills. At Uppsala University, the subject is taught in the course Clinical Trial Methodology.

“Clinical trials unite a number of organisations, but many professionals find their way here via professional detours. Here was a shortage in higher education that we are filling with this course, where we during five weeks present an overall introduction to the area,” says Ulrika Simonsson, Professor of Pharmacokinetics at Uppsala University.

Each week focuses on a specific step in the process. The course begins with Scientific information where employees from Uppsala University Library and The Language Workshop teach how to search for and present data. The second week lectures are given by experts at the Swedish Medical Products Agency and Pharmetheus AB in Good clinical practice and Regulations. Thereafter, the participants study Practical execution, Study design and Trial protocol.

“Exploring a theme for four days before one day of applying our new knowledge is extremely effective. Equally inspiring is to meet so many professionals with up-to-date knowledge. Five weeks was enough to arouse my interest in a career path I did not even know existed, and today I am doing my degree project in pharmacometry with elements of clinical trial methodology. Several of my fellow students at the course also talk about exploring the field further,” says Kristin Augustsson, pharmacy student at Uppsala University.

A number of regional organisations working with clinical drug trials are actively involved in the course. In addition to the organisations already mentioned, Uppsala Clinical Research Center and the Hospital Pharmacy (Sjukhusapoteket) are engaged in the teaching. Also carrying a prominent role during the course is Clinical Trial Consultants AB, a company offering, among other things, advice on early clinical trials. Coworker Erik Rein-Hedin provides lectures on virtual moments in clinical trials, an area that has been brought further to the fore during the pandemic:

“I am a doctor, currently working as a Clinical Research Physician. In my role, I plan future studies, am responsible for ensuring the participants' rights, well-being and safety during the study and ensure that everything is carried out according to the protocol. Our operations spans several different competencies, many of my colleagues have a pharmaceutical background and I really recommend this course to all pharmacy students with an interest in clinical drug development, as it may be the first step in a career that contributes to taking the pharmaceutical research forward.”

The course Clinical Trial Methodology was launched in the autumn of 2019. The interaction between Uppsala university and its external partners has from the start been a key element in the course. One of the most appreciated moments is the speed dating where participants have the opportunity to face-to-face ask questions to representatives for companies and authorities.

“Both students and employers are extremely positive about this opportunity to develop new networks, and the fact that we during the past year have met online has rather opened further doors. Our next course starts 1 November. For this we are preparing a partial return to campus, and by weaving in our new digital experiences, we have the ambition to improve the content to yet another level,” states Ulrika Simonsson.