My colleagues and I attend several international conferences every year. We are particularly interested in discussions surrounding clinical trial participants and patient engagement, as this is an area where Imperial is involved with support for our sponsor and CRO clients.
It’s reassuring to see and hear more emphasis on meeting the patients’ needs, engaging with patients, and supporting them in their clinical trial experience. That being said, as both a patient and a patient advocate, I hear from hundreds of patients on a daily basis, and their comments suggest there are many trials that aren’t making the patient experience a priority.
What is the reality of the patients’ personal experience?
I recently spoke with four oncology trial participants who had participated in different clinical trials worldwide:
- Koen (Grave, Netherlands)
- Lucy (London, England)
- Marilyn (Swansea, Wales)
- Michele (Grand Rapids, Michigan)
It was a lively and illuminating discussion. This virtual focus group shed light on the patient experience, and two key points came through strongly:
- Patient engagement tools are essential to motivate participants and make them feel valued
- Participation requires a strong personal dedication to the trial
Almost without exception, they spoke positively about being able to take part in clinical trials, about the teams looking after them, and about the hope that taking part in trials gave them.
They also shared their challenges. The patients’ accounts reinforced my position that effective patient engagement is a requirement for every trial, and the trials industry must actively commit to robust patient engagement programs.
Joining the trial
The four found out about trials through a variety of sources: surgeons, hospital staff, and social media.
Lucy saw the trial as potentially superior to conventional treatment. “It’s really tricky because, particularly for Stage 4 cancer patients, when you’re entering a trial, the main thing is, does this have the potential to keep me alive longer, and that is the number one thing,” she said.
An aspect of the trial that appealed to Koen was the regular monitoring of his health. “It was not a mandatory option because I could also choose to do nothing and wait and see,” he said. “The ways they follow up on you are way better when you’re participating in the trial than if you don’t. That is something that is maybe not emphasized a lot.”
I asked our clinical trial participants if they received any printed or digital information about the trial after they joined. I received a variety of answers.
Koen received printed information about the trial and about Dutch legislation, insurance, and trial participation risks.
Michele told me, “They did send me a PDF file, and I remember it being very medically dense. I really didn’t understand it.” She looked for information online and found a research website that featured study information for researchers. “That’s where I saw the information, and that was all I saw online about it.”
Lucy described the contrast between joining a trial and later changing to an approved treatment:
I was given verbal information, but I don’t remember being given any written information. I was quite shocked when I went to a different treatment, when I moved onto an approved treatment, I was given a glossy magazine about it, and I remember at the time going, wow, this is exciting, because I definitely didn’t get it with the first trial.”
All four patients I spoke with, and indeed almost every clinical trial participant I speak with online, expresses interest and curiosity about trial participation.
The industry issues with recruiting for trials are less about patients not wanting to take part but more about the need for better communication. Finding clear and effective ways to tell patients about clinical trials, and using well-presented, suitable methods to explain the key information about the trial itself, will help the patient more easily make decisions about participation.
The study participant’s financial burden
Trials can be expensive with many hidden costs. How did sites handle reimbursements?
Koen was reimbursed for travel expenses but noted he had to keep detailed records and submit reimbursement forms with receipts. “It was limited to parking lots, train tickets, bus tickets, or mileage,” he said.
Lucy found out about travel reimbursements almost by accident. She said, “I’m not sure that anyone particularly told me that, but I realized that other people were doing it.”
Michele found that while the study treatment injection was provided at no cost, monthly blood draws were the responsibility of her or her insurance company. When the calendar year changed, her deductible reset, and she was suddenly paying out of pocket for blood draws for the study. “I’m being faced with this $1,200 bill for these blood tests,” Michele told me. “And the only reason I’m getting these blood tests is so I can get this injection for the trial, and I don’t even know if it’s the real thing or not.”
Michele said she would have been more likely to stay with the trial if her blood tests had been covered. “I had so many bills already, oh and, this is another one I just can’t do it.” So she left the trial.
Reimbursement or a clinical trial participant stipend, in general, is a difficult area both in terms of perception and regulation.
When designing trials at the protocol stage, potential patients should be consulted about what they need and what the burden of participation might be.
- Have you considered consolidation of study activities to reduce the number of separate times a patient needs to visit the trial site?
- Hybrid and remote solutions are always welcomed and encouraged, although most patients I speak with don’t want a completely decentralized trial and want to see the medical professional in person occasionally.
- Are all hidden costs or reimbursement options clearly explained, and preferably written down for the patient, so they are aware of this prior to consent?
- Make reimbursement that helps minimize the cost of travel, an easy process for both the clinical trial participant and the site, and make sure the trial participants know about it.
- Patients frequently choose not to participate in a trial if the financial burden is too high. Consider how to minimize that burden to improve recruitment.
Participant engagement tools
All said they would have appreciated comfort items, tokens of appreciation, or thank you cards. With the exception of Koen, such items were not provided.
Koen appreciated holiday messages. “During Christmastime, they always send a personal postcard, to your home, from the team of the researchers, which is really received well by me personally, because that’s something like emotional support,” he said. “They think of you. But I think it has nothing to do with the trial itself, it’s more with the attitude of the team.”
Lucy said, “I would love to say they sent me a puppy dog… no, absolutely nothing, really nothing.” She is still being monitored in follow-up every 3-6 months with quality of life questionnaires. “Maybe if they ever finish it, there will be a thank you card and a puppy, but I think it’s highly unlikely.”
Patients don’t NEED gifts, comfort items, or tokens of appreciation. Without exception, all of the clinical trial participants I spoke to said such items would not have impacted whether they decided to participate.
However, small gestures like thank you cards have minimal cost yet generate an enormous feeling of gratitude and inclusion amongst patients.
More specific engagement tools can be implemented, like eye masks and blankets where the patient is in hospital for a long duration, and these tokens show a deeper understanding of the patient’s burden. They display a genuine interest in the patient’s comfort and a desire to ensure that the patient’s experience in the study is as positive as possible.
Tokens, no matter how small, can have a dramatic difference in attrition rates because the patient doesn’t feel like a number; they feel more included and valued.
Follow-up after the trial for study participants
The participants were still interested in the trial after they were no longer participating, but each found follow-up was lacking.
Michele said she assumes there was no follow-up because she left the trial before completing it. “I’m actually really curious to find out whether I got the real one or the placebo, and also if the drug that they were testing is going to be coming out.”
Lucy has never received information about the trial but has followed the trial in the scientific press. “When there was more information coming out about the trial and who it worked for and this, that, and the other, that stuff would have been really interesting,” she said. “I just would have liked more access to my own medical information. It seems mad to me that it’s all sitting somewhere, and someone has it.”
Marilyn’s trial participation was discontinued after her liver metastasized. “I did feel, ‘You’re off the trial, that’s it.’” She felt she was no longer important.
A large number of patients I speak with take part in more than one clinical trial.
Patients talk to other patients about trial participation and about the sponsor companies themselves.
If the patient gets an update on the progress of the trial or a follow-up after the trial has concluded with what has happened to the drug, the patient feels included and that they helped to shape the outcome.
That sense of satisfaction, of being involved in research to benefit others, is something that patients talk about. Even if a patient is unable to continue with the study, thank them for the time they were involved, and keep them abreast of the ongoing progress.
Feedback from study participants about trial design
I asked the participants for feedback on how their trial experiences could have been made better.
Lucy said participants need to be treated more respectfully. “My experience particularly with that trial, the thing over time that I became increasingly aware of, is that I felt like as a patient we were very low down on the list of things that really mattered,” she said.
While in the trial, she experienced side effects. “It would have been really useful to know what drugs I was on in order to know how to treat side effects. It wasn’t possible to unblind me because that wasn’t the protocol. They didn’t unblind me until I had progression of my disease, and that was 10 months later.”
Marilyn told me she felt treated like a number and added, “On the feedback forms, they didn’t give enough width to the questions.”
Koen learned about the trial through his surgeon and says he probably wouldn’t have otherwise known about the trial. “At least for life-threatening diseases, why not bring in a system, a mandatory check whether there is an opportunity for a clinical study or not? It’s beneficial for the industry because the recruitment process will be more efficient.”
Patients don’t want to feel like they are just a number or a dot on the chart.
Active engagement can actually help with recruitment in future studies in your portfolio.
Ask patients afterward what it was like to participate in the study and what might have made it better. Learn from the feedback. Evaluate and improve the design of future studies based on this.
If you don’t want to ask for feedback, the greatest message this gives is that the patient’s input or opinion really doesn’t matter or that you are concerned the feedback wouldn’t be positive. Either way, neither of those hint at a successful study.
Lack of requesting feedback is an indicator of shortsightedness. Feedback is an instant and easily implemented engagement tool that can help promote better trial recruitment and retention in the future. In the short term, this would have minimal cost in comparison to the huge gains long term.
Last thoughts about study participants
Clinical trial participants should be thought of as customers, and their feedback should be sought out and applied. They should be a partner in the trial and engaged as valuable resources in making future trials more patient-centric.
In these days of tighter budgets, cuts in patient engagement should not be an option.
Imperial was not involved in the trials these clinical trial participants took part in. We produce an array of items for patient engagement and ship them globally for our clients every day, and would like to think that had we been involved in these trials, the participants would have had more fully positive experiences.
My heartfelt thanks to Koen, Lucy, Marilyn, and Michele for speaking with us about their clinical trials.
If you or your colleagues are working on a study and you believe the patients can be more actively engaged, please let us know. I’d love to talk to you about your study and the ways we can help you better engage with patients to improve recruitment, retention, and most importantly of all — patient (customer) satisfaction!