Prioritizing Risk

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The NIH’s National Library of Medicine outlines some of the benefits and risks for volunteers when participating in a clinical trial (Links to an external site.).

Clinical trials are medical studies that involve people like you. They help find new ways to prevent, detect, or treat diseases that are safe and effective. The National Heart, Lung, and Blood Institute (NHLBI) leads and supports many studies aimed at preventing, diagnosing, and treating heart, lung, blood, and sleep disorders. Clinical trials are an important part of the research spectrum. The idea for a clinical trial often starts in the lab. After researchers test new treatments or procedures in the lab and in animals, the most promising treatments are moved into clinical trials. As studies about new treatments move through a series of steps called phases, researchers learn more information about the treatment, its risks, and its effectiveness.

How would you assess whether the potential benefits of a clinical trial outweigh the potential risks?

Benefits may include accessing new medical treatments and contributing to groundbreaking research that will help others. But some risks, including the possibility of undesirable side effects, are inherent in the conduct of clinical trials.

I’m a competitive debater, and at the very end of each debate round, we do something called “impact weighing”. We take some of the most important points brought up in the round, identify the conflict and explain why whichever side we’re arguing for is better than the other. When weighing, we use several different criteria. Asked the question on how I would assess if the potential benefits of a clinical trial outweigh the potential risk, I would use the same criteria I do in debate rounds.

I would first consider Magnitude. How severe are the impacts? If we have identified risks, how big they? And vise versa with the benefits. Which is bigger? Then we ask ourselves the question of scope and probability. How broadly would the impacts made by the anticipated benefits or risks be felt across a population or even on the global scale? And how likely are the anticipated benefits and risk?

After assessing these three categories, I’d move on to considering the timeframe and reversibility. Are the anticipated benefits or risks short term or long term? Will the risks come up immediately or later? Can the harms be undone?

Having multiple criteria to weight the benefits against the risk allows thorough evaluation. For instance, what if we know that there is a risk that there may be short term ramifications but there are certain benefits long term? How do we determine if it is worth taking the risk?

Here, we weighted on the timeline criteria. We can answer unresolved questions by looking at the other factors (magnitude, scope, probability, etc.)

Categories: Clinical