Including patients in decisions about drugs


Companies and authorities sometimes involve individual patients and patient representatives in their decisions. By using preference studies, we can find out what larger groups of patients think about drugs. And how they weigh the good and the bad against each other. But what do patients think about being included in these decisions? In her PhD project, Karin Schölin Bywall, interviewed Swedish patients with Rheumatoid Arthritis to find out what they think about patient involvement in decisions taken by the authorities that approve drugs.

Karin Schölin Bywall, PhD student, Uppsala Universty
Karin Schölin Bywall, PhD student, Uppsala Universty

Karin Schölin Bywall’s study was recently published in The Patient. Patients in her study emphasized three things. First, that preference studies can create possibilities for patients to actually take part in decisions. Secondly, that results from preference studies are important in all the stages of developing a new drug. And third, that patients that are part of preference studies have to be well informed about three things: the purpose of the study, how the results will be used, and how the drug works.

The participants in her study believe that they should have a right to influence decisions about what drugs should be approved. They also said that it is important that decision-makers take patient’s opinions into account. Especially since patients might have a different opinion about what is a valuable benefit, or an undesired risk.

The patients she interviewed thought that preference studies could help authorities to include patient’s needs, life-style and health in their decisions. Overall, they were positive to using preference studies in decisions at different stages of the life-cycle of a drug: from development through evaluation and approval, to when the drug is on the market and available to patients. But some of them were skeptical towards the companies that develop drugs. And doubted whether it is good to involve the companies that develop drugs early on in the process.

By Josepine Fernow

Read article: Bywall, K.S., Veldwijk, J., Hansson, M.G. et al. Patient Perspectives on the Value of Patient Preference Information in Regulatory Decision Making: A Qualitative Study in Swedish Patients with Rheumatoid Arthritis, Patient (2018), First online 15 November 2018, doi:

This text was originally published by the Centre for Research Ethics & Bioethics (CRB) at Uppsala University

About Karin Schölin Bywall and PhD students in PREFER

Karin Schölin Bywall is part of the PREFER project. The results presented in this paper are part of her PhD thesis project at Uppsala University and the Mind the Risk project.

Several PhD students are involved in the PREFER project. The students have their own PhD projects with specific thesis topics that all relate closely to PREFER. Students are involved in project activities and will publish several papers within the PREFER framework. Students also work closely with both stakeholders, public and private partners to inform their work.

Last modified: 2021-11-10