Authored by Sherry Reuter
Interview with a Patient…
We often talk about the challenges of Patient Recruitment and Retention in conducting clinical trials and speculate on ways to improve our performance. But how often do we go straight to the source to talk to study subjects about how we could do better?
I decided to do exactly this and conducted an interview with a woman who has participated in six clinical trials, so she has plenty of experience from which to tell us the good and the bad of how we treat study participants.
“I don’t want to seem negative or ungrateful for the researchers’ time. I really am a proponent of clinical trials, especially for the sake of my family, but sometimes they are just hard to take. Which of these do you think really happened to me during clinical trials? Mark True or False for which you think really happened:
1. I had been diagnosed very recently, and wanted a second opinion. I called to be in a clinical trial, and they asked me on the phone if they might get my brain when I died. True/False___
2. I have been in six trials, most of them do not help with expenses, so I have to pay costs of the flight, hotel and food for myself and caregiver, which equals around $3,000- $4,000 for each study, at least $20,000 in total for all the trials in which I have volunteered. True/False___
3. I paid for a plane ticket to fly to a study site for a 5 day study, after I was there 3 days, they decided that I didn’t have the diagnosis under study and sent me home without enrolling me in the trial even though I had previously been diagnosed with it..True/False__
4. Later that year, the same group asked if I would be in their film. Why? They said I didn’t have it. The genetic counselor asked why I wanted that diagnosis instead of what they said I had. I didn’t want either! True/False____
5. When signing in for a new study, they had my caregiver sign the paperwork, rather than me, even though I was competent. True/False___
6. I asked the researcher if he had talked to my primary doctor who had diagnosed me, he said yes. I said, that is funny, I didn’t sign paperwork allowing you to do that. True/False___
7. I was to be the “Show and Tell” for about 20 fellows, but they did not inform me in advance. True/False___
8. I phoned ahead asking how much time out of the seven 8-hour days (8 hours) I would be able to speak with the Investigator because I had a number of questions. They said 1/2 hour in the beginning and 1 hour at the end, only 11/2 out of 56 hours! True/False___
9. At one study visit, the Investigator asked why I would want to know if my condition was a family mutation or a sporadic event. True/False___
10. Another Investigator debated me on whether I was really incontinent. True/False__
11. Having any form of dementia carries with it a certain stigma. Some language used has been “possessed”, “Bizarre” and “Why don’t you just drop her off at an ER?” True/False___
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How many of these incidents do you think actually happened to this study volunteer?
Sadly, all of them did.
Although it is especially difficult when ill to exert the energy to continue to actively spread the word about her diagnosis, she has creatively found ways to do so, even making a movie about it.
She still values clinical research, for it is the only source of hope for future understanding of her illness and treatment for her, her relatives and others suffering from the same condition.
About the Author
Sherry Reuter is President of Sherry Reuter & Associates, LLC, a consulting firm that focuses on the conduct of clinical trials, Site Selection, Study Start Up, Training, and Patient Recruitment and Retention. Sherry may be contacted at sreuter@gwu.edu or 203.775.6031.
Image: Danilo Rizzuti / FreeDigitalPhotos.net
{ 6 comments… read them below or add one }
I was excited to see the title of Ms. Reuter’s post and immediately clicked to read it.. Having completed reading, I was aghast, although not surprised, but wished the patient had gone into more detail on some of her positive experiences. While we can continue to learn from these awful experiences, none of us think WE would ever commit these thoughtless (and some borderline or outright non-compliant) incidents. But knowing what makes a truly positive experience for a patient could perhaps help us appropriate budgets more realistically, train staff more specifically, or create innovative motivational opportunities. At least I’d like to think so. I applaud this patient for her fortitude!
Dear Michelle,
Thank you so much for your comments. As you point out, study staff do SO much right!
While hearing of such negative practices seems shocking, and I believe they are rare, we can indeed learn from them.
I agree that a balanced approach is most beneficial in helping us all, so would appreciate everyone reading to post both the good and not-so-good practices they know of or can think of.
I will contact the study subject I interviewed and ask her to tell us the positive things that site staff have done and welcome others to do this as well and share the information with the group.
Kind regards,
Sherry
Sherry – It’s great that we can gain these perspectives from interviewing people after they have participated in a trial. Great job! How great would it be if we could capture the site-patient dialogue as they take place and analyze them on an ongoing basis to ensure things like these can be addressed, clinical trials can be done more effectively and efficiently, and patients’ experiences can be improved? This CAN be done. Let’s chat about it. I’ll email you later today to check your schedule.
Hi Ken,
Thanks for reading the blog and for your comments.
Operating more patient-centrically should go a long way in improving the clinical research enterprise.
Yes, let’s talk soon!
Kind regards,
Sherry
Dear Sherry:
Your summary of this clinical trial participant was very interesting. As a clinical trial manager, I hope that most study subjects don’t have this many negative experiences. The sponsor strives to make the consent form clear for the average person, amd tries to include a small budget for travel to the study site. Most trial managers & monitors do check that either the Principle Investigator or Sub-Investigator are clearly involved in the clinical trial progress. Monitors need to check that an investigator at each site is closing watching their study patients, that the patient is comfortable with the lab tests, physicals, study visits and drug administration. Subjects should have their questions answered at every study visit. It’s ‘all about the patient’ from both the sponsor and study site point of view. Most study coordinators work really hard to ensure a positive experience for their study subjects.
Dear Diane,
Thank you so much for your response, and I agree with you that the vast majority of study sites are staffed by hard working, dedicated people. When I contacted the subject I interviewed and asked her about positive things study staff do, she provided a list which will be published in the near future.
While most study participants state their experience was positive and that they would volunteer in a clinical trial again, these types of “strange but true” reports are provided to sites that want to continually perform even better.
What could be helpful to sites would be a list of tips contributed by all sites to combine into a list of shared ‘best practices.’ You have already mentioned some good ones in your message, and I hope you will send more, and that others will add to that list. I will combine all the ideas into one list of ‘Tips for Good Customer Service at Study Sites.”
Thank you,
Sherry