The concept of a risk/benefit ratio is to acknowledge that the most promising rewards come at a price. Immunotherapy for example, extracts, amplifies, and expands a patient’s own white blood cells (WBCs) so that they can be infused back into the patient to treat diseases/conditions such as cancer, HIV, hepatitis, etc. The risk present in this field of study is the possibility of the WBCs becoming overly-aggressive, resulting in them attacking the patient rather than treating them. Another risk in immunotherapy is that something could go wrong during manufacturing/processing that can result in the infusion getting scrapped. This results in time lost that the time-sensitive patient could have spent reaching out to alternate treatments. Although there is significant risk present in immunotherapy, the benefit yields enhanced treatment capabilities for the most debilitating diseases, which therefore allows it to undergo further research in clinical trials. One similar immunotherapy technique (the KYMRIAH) has actually been commercialized in 2017 by Novartis, demonstrating how the benefit outweighs the risk (1).

One effective method for optimizing the risk-benefit ratio over a product’s life cycle is to take future risk into consideration as early as possible (2). Future risk includes subcategories such as statistical risk, which is risk based on statistical analysis that a company may present to an insurance company when determining its premiums. Projected risk makes estimations based on previous models/studies that are considered relevant. Perceived risk is risk based on the intuition of the team members involved in the project. Are there any other ways to evaluate future risk to prevent potential complications? Is there such a thing as being too cautious when it comes to presenting risk during the planning phase of a project? Who is responsible for determining whether a risk outweighs the benefit or vice versa?

References:
(1) Alex Philippidis.Human Gene Therapy.Jan 2014.ahead of print http://doi.org/10.1089/hum.2013.2526
(2) Yokata, Fumie “Value of Information Analysis in Environmental Health Risk Management Decisions: Past, Present, and Future” (June 2004) https://doi.org/10.1111/j.0272-4332.2004.00464.x