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Animal Ethics Biosafety Human Research Ethics Research Integrity

Ask the patients about the benefits and the risks – The Ethics Blog (Pär Segerdah | January 2019)

Posted by saviorteam in Human Research Ethics on January 31, 2019
Keywords: Beneficence, Clinical trial, Respect for persons
A large scattering of tablets on top of Australian notes

Almost no medications are without risks of side effects. When new drugs are approved, decision makers must balance risks and benefits. To make the balancing, they use results from clinical trials where the drugs are tested on patients to determine (among other things) efficacy and side effects.

‘Consumer/community’ involvement in research and clinical decision-making is a big thing for us. For example, Gary is the lead investigator on a Hopkins Centre seed-grant project that hopefully will create some resources on this for disability research. Consequently, we’re fans of the idea patients should have a key role in evaluating the seriousness of treatment side-effects and the importance of their benefits

But how do you balance risks and benefits? Is the balancing completely objective, so that all that is needed is results from clinical trials? Or can risks and benefits be valued differently?
.

It has been noted that decision makers can value risks and benefits differently from patients. Therefore, results merely from clinical trials do not suffice. Decision makers also need to understand how the patients themselves value the risks and the benefits associated with treatments of their disease. The patients need to be asked about their preferences.
.

Karin Schölin Bywall is a PhD student at CRB. She plans to carry out preference studies with patients suffering from rheumatoid arthritis. The task is complex, since risks and benefits are multidimensional. Rheumatoid arthritis is a chronic disease with several symptoms, such as pain, stiffness, fatigue, fever, weakness, deformity, malaise, weight loss and depression. Medications can be variously effective on different symptoms, while they can have a range of side effects. Which positive effect on which symptom is sufficiently important for the patients to outweigh a certain level of one of the side effects?
.

Read the rest of this discussion piece

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