Medical Professionals Are Starting To Debate Clinical Trial Eligibility Standards

According to an article from the Chicago Tribune, many medical specialists are coming to the realization that the eligibility criteria for clinical trials should be reassessed. The problem is that these standards can exclude many desperately ill people from the trials. Take the case of Carly Bastiensen as an example. When she was only 29-years-old, she was diagnosed with advanced pancreatic cancer, a rare and aggressive cancer you can read more about here.
Doctors told her that she did not have much time and that her options for treatment were limited because of the advanced state of the cancer. She was diagnosed in January 2016. While her death from the pancreatic cancer was practically inevitable, Bastiensen was told that the best change she had to prolong her life was to participate in a clinical trial. Unfortunately, there were no trials willing to accept her. In this case, her liver function prohibited her participation.

It is important to note that setting controls for a study are essential for its scientific integrity. That is precisely what these eligibility parameters do. They are meant to exclude people who may have other complications or be taking other medication for an unrelated health problem. This is so that any effects, good or bad, can be attributed as an effect of the therapy being tested.

Unfortunately, the standards for many clinical trials have become increasingly narrow. Bastiensen tried to participate in six different trials and was rejected for each one. She died this past November. Eligibility criteria are usually written by the trial sponsor, which is often the company developing the drug being tested. It is perfectly possible that eligibility criteria can be set in such as way that only patients that will respond well are selected. The end result of this is a treatment that is helpful to a very limited number of patients because when there are too many controls the participants are no longer representative of the larger patient population.

In addition, there are also certain populations of people that have historically been excluded from clinical trials. For example, people that are HIV positive, who are killed by cancer more than anything else, are excluded, even when their condition has stabilized and their health is good. People under eighteen are also excluded despite the fact that adults and children process most treatments in the same manner. Former cancer patients, who may have been treated years or decades earlier and have little chance of relapse, are usually excluded also. This exclusion prohibits many older people from trials.

Part of the problem is that newer criteria are often added for certain trials but older ones are rarely removed, even when they have little relevance to the study. While they are absolutely essential to maintain scientific standards, eligibility criteria are clearly due for some reevaluation.


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