A Caregiver’s Experience with Clinical Trials, and What Can be Done to Improve Them

In this #TalkClinicalTirals blog, Andrew Spanyi talks to Clinical Trials Ontario (CTO) about his experience with clinical trials as a caregiver for his wife, what he feels are the barriers to recruitment in clinical trials, why he feels a patient centric approach is important, and his advice for people interested in joining a clinical trial.

Can you tell us about your experience with clinical trials?

My wife participated in an oncology clinical trial from 2020 to 2022. This trial targeted patients with metastatic tumors. The clinical trial did help my wife, but our experience in the trial, from recruitment and screening to the study visits, was difficult and frustrating.

Our experience with recruitment was initially based on the consent form. The consent form was 29 pages in length and was designed totally from the perspective of the principal investigator and the pharmaceutical team. It was not patient-friendly nor particularly well written. There was no abstract or “cliff notes” version. Even though my wife had a doctorate and I have a master’s degree – we found it challenging to work our way through it.

The screening process was also difficult. We live in the Niagara region and the trial took place in downtown Toronto. We had to make three visits to Toronto for screening, each lasting between 6 and 8 hours. This was not right, to put a sick person through these long visits in a hospital far from home. The communication from the study team was also lacking during this time. After three screening visits we had to follow up because we had received no indication of whether she was accepted or not.

Our experience did not improve once my wife was enrolled in the trial. During the trial, she had to receive intramuscular injections. The nurses who administered these injections were not properly trained and my wife ended up with bruises on several occasions.

Again, the visits to the hospital in Toronto during the trial were long and burdensome. An ordinary visit began before 8am and would not end until 2 or 3pm. When my wife requested that some of the tests be done locally in Niagara to ease the burden, the reply was that the test had to be done at the study site to minimize potential variations in results.

From a financial point of view, they only offered $35 to cover transportation expenses. We were fortunate that we had the means to stay in a hotel the night before, but if others didn’t have those resources, I wonder how they would have handled it.  

You have been vocal on social media about the barriers to recruitment in clinical trials. What do you see as barriers to recruitment?

Enrolling participants in oncology clinical trials was recognized as a major issue nearly two decades ago. Yet, relatively little progress has been made to date. Researchers have observed that clinical trial recruitment practices have been designed solely from the point of view of the study investigators and the pharmaceutical company. Some of the commonly reported challenges to recruitment include:

  • Overly strict inclusion and exclusion criteria
  • Reluctance to participate if additional biopsies are required
  • Concerns around frequent laboratory testing and office visits
  • The fear of receiving an investigational drug or a placebo

What do you feel could be done to improve the recruitment process and the design of clinical trials?

The traditional mindset of a clinical trial involves viewing the trial as an experiment involving subjects – not patients. This was abundantly clear to me as the caregiver for my wife while she participated in a clinical trial. Pharmaceutical companies and researchers should note that adopting a patient-centric approach would yield significant benefits in improving recruitment and clinical trial results – and would more importantly have a positive impact on millions of lives. I would like study teams to consider the following:

  • Engage patients in developing the draft of the consent document. Patients can provide valuable input on the clarity and readability of the form, and they may advocate for a “cliff notes” version.
  • Deploy digital technologies to broadcast the availability of clinical trials.
  • Scan medical records can pinpoint the most qualified patients.
  • Engage patients to provide valuable input on how the screening process can be made comfortable while still meeting the research requirements of the sponsor.
  • Allow patients to use local resources and testing to lessen the burden of study visits for out-of-town patients.
  • Consider the caregiver’s experience to gain insights from another perspective.
  • Upon releasing a patient from the clinical trial, close collaboration between the study doctor and the local oncologist would serve to produce a more effective transition to the next phase of therapy.

What advice would you give to others interested in participating in clinical trials?

I think more people should participate in clinical trials, but I think they should be more demanding when they do. Patients and caregivers need to be a strong advocate for themselves. Specifically, I think they should:

  • Ask for a “cliff notes” version of the consent form to make it easier to understand.
  • Do not accept long, drawn-out study visits.
  • If more testing or an extra biopsy is asked for, push back, and get clarity on why it is absolutely required for the clinical trial.
  • Ask for financial assistance if needed. Do not accept a token amount of $35, for example.

CTO would like to thank Andrew for sharing his experience in this #TalkClinicalTrials blog. #TalkClinicalTrials is a campaign led by CTO with the goal of building awareness around clinical trials. Explore more stories from the series and join the conversation on social media using #TalkClinicalTrials.


#TalkClinicalTrials is a campaign led by CTO with the a goal of building awareness around clinical trials. Why? Because clinical trials matter to all of us. They help to generate better treatments and technologies and ultimately help shape the future of medicine. Explore more stories from the series and join the conversation on social media using #TalkClinicalTrials.