Special Series In Oncology: Informed Consent for clinical trials
Focus on Clinical Trials
In the last post, we discussed obtaining informed consent for standard of care therapies. In this post we will add a layer of complexity and discuss obtaining informed consent for clinical trials. This post is an opinion piece, meaning this is how I have evolved to conduct an informed consent process that involves clinical trials.
Why is this a separate discussion?
Let’s first define why this is a separate topic.
First and foremost, regardless of which setting (academic or community) you will be offering clinical trials - the difference is how many trials and phase of trials. In an academic practice, you may be offering phase 1 to phase 3 studies, and for community practice, you would be offering phase 2 and 3 studies. Many institutions will encourage and even incentivize oncologists to offer trials, so we may have an institutional bias.
For example, I serve as an institutional principal investigator (PI) for many studies. Thus, I have an inherent bias in success of the study. I may even get academic credit in terms of authorship on publications (which go on my CV and is part of my promotion requirements). Digging a bit deeper though, I also elected to serve as a PI, so I have a belief in the hypothesis of the trial. Some biases may be non-scientific (CV building) whilst others are scientific.
Secondly, patients have specific beliefs about clinical trials that may or may not be accurate, and may interfere with an informed consent process. Some of these include the idea of “being a guinea pig” or “getting a placebo” or even some generational beliefs about how trials had abused minority patients in the past. Some of these beliefs are completely accurate and true. (See Tuskegee Syphilis Study) and reflect on the evolution of using Good Clinical Practice (GCP) for clinical research.
So, how do you account for your bias and the patient’s bias in order to have an honest discussion about clinical trials? How do we ensure that patients hear about their options and review them with appropriate rigor?
Review of Informed Consent
Let’s review the standard process from the last post.
Patients are given information (facts) about their health condition and then presented with options in an unbiased manner
They are given information on risks, benefits of each of the options, including the option to not pursue any diagnostic or therapeutic intervention
Provide opportunities to ask questions and provide answers fully
Provide time for them to process the information and then make a decision after ALL of their questions have been answered to the best of our abilities
Finally, sign an informed consent document stating that they have been informed of their above and they have understood their choices, the risks and benefits, and alternatives, and wish to proceed with the proposed treatment.
Acknowledging our biases
To overcome a bias, we have to first acknowledge that the biases exist.
For me, it is about understanding my biases. One of my reasons for choosing academic oncology practice was to be able to advance care of patients with cancer with clinical trials. If you study the background section of each of the studies, it will review the current gap in our knowledge OR need for improving cancer outcomes. For example, most cancers with metastasis are still not curable and improving efficacy of therapies will advance science and care. For cancers like testicular cancer, where the cure rates are so high, improving the tolerance and minimizing toxicities are still important objectives for cancer therapies.
With that in mind, offering trials to improve cancer outcomes (efficacy of therapy, minimization of symptoms and side effects etc.) are of great value for our patients and future patients.
I discuss my biases in a straightforward and honest manner using simple words.
“I work at the cancer institute where we value research and realize that there is much work to be done to improve cancer outcomes.”
“clinical trials play an important role in finding better ways to deliver cancer care, to find better treatments (that either work better to fight cancer or cause less side effects).”
I do provide my input about “the why” of the particular clinical trial (what the study objectives are and what is involved) as part of the overview. As one of the readers,
pointed out in the last post, we do need to provide our recommendation (I will discuss this in more detail in the next post in this series).Understanding and Overcoming Patient Biases
To overcome a bias, we must know they exist.
To understand the biases patients present with, I ask them about their understanding of clinical trials as part of my history taking, using such questions as:
“What do you know (or have heard) about clinical trials?”
“What are your thoughts on clinical trials?”
“On your research, have you come across role of clinical trials?”
Occasionally, when I sense there is reluctance, I use normalizing words to encourage them to tell their thoughts.
“Some people feel that trials are like being “tested on” or being a “guinea pig”. What do you think?”
“Have you or someone you know been part of a clinical trial?”
Once I have heard their views and if there are any views that are not accurate, I ask their permission to address it.
“You just mentioned that “you don’t want to be a guinea pig” or “you don’t like the idea of getting placebo”. Is it ok if I talk a bit more about it?”
I may ask a clarifying question as well.
“Can you tell me what do you mean by “being a guinea pig?””
Guinea pig, many times, can be used as a derogatory term with its negative connotation. If that is how it is expressed by the patient, then I address it.
I highlight how I view clinical trials (as above). I also explain how we use the knowledge from clinical trials to form “new standard of care.” I am clear to state that today’s standard of care was yesterday’s clinical trial.
“We discussed standard of care therapies, they were clinical trial X years ago.”
The intent is for patient “listen to the option” not to necessarily change their mind or to enroll.
Here, we used “Ask-Tell-Ask”, or part of SPIKES.
Some patients have a different bias, they come for clinical trials and are ready to sign. Informed consent process requires them to evaluate their options and weight the risk and benefits of each therapy. To accomplish that, I discuss the clinical trials and standard of care along with risk and benefits of each. As stated in the earlier post, I (almost) never have patients sign a consent the day they are given information on the treatment choices.
Summary of my work flow:
Ask
During history taking, I try to understand their view of clinical trials (whether they have heard of clinical trials, whether they have any specific views on it).
Tell
If they came for a clinical trial, I try to have them explain their standard of care (SOC) choices and their concerns about SOC. I never presume that just because a patient came for a clinical trial means that they have understood their choices.
If they came for routine care, I discuss SOC options and clinical trials.
I use the four questions (from Oncology 101) and when discussing treatment options, provide both SOC and trial choices (there may be more than one).
I explain the choices and then provide written information to review.
Ask
To ensure they understood their choices, asking them to describe what they have heard is ideal (teach-back method).
Once they have reviewed the information (at least 24 hours), and all of the questions have been answered, I will invite them to sign an informed consent.
Before signing an informed consent form, ensuring all the questions have been answered is important.
Conclusion
Informed consent for clinical trials requires us to understand and then acknowledge biases in our conversation (including our biases and patients’ biases). Acknowledging ours and inquiring and addressing patient’s biases will allow patients to appropriately evaluate clinical trials as a choice for them.