Rodger Williams

June 25, 2019

DOS 741: Protocols and Clinical Trials
Discussion 2: Participation in clinical trials
Question: Why do you think more people don’t participate in clinical trials?

Clinical trials are designed to gain knowledge from varying the methods to treat disease. Why
then are there less than 3% of adults participating in trials?1
Think about the informed consent that is used in your department. If you look closely, the body
is the same with the heading or disease type the main difference. It covers some of the conditions
that the patient may encounter and warn of some of the more common side effects, but does it go
into the detail that is necessary for a patient to consent to the treatments they are about to
undergo. With such a canned form, is there consideration as to the individual patient that is
being consented? Does your consent address the patient’s age, their mental capability or their
present physical condition?
In order for a consent to be individualized it must consider several factors: 1) it must have
pertinent information for the patient, but not too much, 2) it must be understood by the
participant, 3) it should be formatted to emphasize the content of the consent and 4) adding
graphics can enhance the understanding.2 I think that all too many times the consent that the
physician reviews with the patient is ‘quickly’ gone over and the patient is overwhelmed with the
information they are given. I believe that we should slow down the process of treatment
schedule. The patient has so much thrown at them without time to digest the information and be
sure that they understand what they are about to embark on.
It’s this reason why the vast majority of patients do not want to participate in a protocol. There
is a lack of understanding and the professional staff is too quick to move through the process
without the patient knowing what will come next.
References

1. Lenards N, Clinical Trials Lead to Advances in Cancer Care. [SoftChalk]. La Crosse,

WI: UWL Medical Dosimetry Program; 2018
2. Soper R. Many Patients Do Not Understand Informed Consent Fully. Radiation
Therapist. Fall 2016, Volume 25, Number 2. 223-226