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For 20 years, I have worked online to get patients into clinical trials. That is not my whole job, but it is an important part of it.
I help the online members of Smart Patients Inc. (Mountain View, California) to understand why they should consider a clinical trial, even when their condition has just been diagnosed and they have had no treatment. We learn how to search for member-specific trials because most doctors only talk about their own trials—if they mention trials at all. Patients can learn to find and get into clinical trials without a doctor. They just need some guidance.
We talk about deciphering trial requirements. We talk about whether patients can travel and where. We talk about finding the best trial for them, and then we hope. We hope they find a promising trial and can get into it in a reasonable amount of time. It is not easy.
You, as researchers, know what you are looking for in a clinical trial: quantifiable, valid, reproducible data, data that we all hope will show better ways of treatment.
However, in the entire history of the world, no patient has ever said, “I want to be a data point.”
What are patients looking for or hoping for in the outcome of a clinical trial? They want to be in a group that receives effective treatment. They know not everyone will, but that is what they hope for.
They hope the treatment is better than what is available outside the trial. A trial may be their only hope for treatment, or a trial may be the only treatment they can afford.
But here they are, the hopeful patients. Why are there so few of them? I am doing my best to bring them to you.
As researchers, you need to understand how difficult and inconvenient it is for patients to be in a clinical trial. There is so much rigamarole just to get in. If a trial is close to home and close to opening, patients may be told “It’s coming, it’s coming, it’s coming soon—oh, sorry! There’s no slot left for you.” So many letdowns. So many roadblocks.
When patients finally get into a trial, they face travel and parking, innumerable appointments, extra testing and extra scans, and the treatment itself. Patients may need to travel by plane just to get their blood drawn. To join a trial requires really powerful motivation.
When you design a trial, could you be more aware of the inconvenience patients will face? Better yet, ask patients to help you design it. Make trials more convenient, more patient-friendly.
Can you provide better contacts on the Clinical Trials Web site, so when patients call they are not told, “I have no idea what you’re talking about”? Keep your trial listing up to date. Make sure there is someone there with answers. Make sure patients' calls are returned. Use email for consent forms and trial schedules. Make things easier for your patients.
Read your own trial write-ups, forms, and documents. Read them again. Have other people read them. Would you understand the documentation if it were someone else’s trial? Here again, patients can help and would love to do so.
Ask patients how trials could be more welcoming. Most trials are supportive once the patient has joined, and the attendant treatment is great—the best surveillance and care they will ever receive. But getting in? Wow! Jump through the hoops. Hurry up and wait! It takes forever! Or, at least, it seems that way when waiting for treatment to begin.
Can you streamline the intake process? If there are delays, can you communicate approximately when your trial might actually start? Making desperate patients wait for a trial that may never open is not good. It destroys hope, and worse, it destroys trust.
Then, when the patient leaves the trial for whatever reason, could you not drop them like yesterday’s trash? You were their lifeline. Please do not just cut them off.
In summary, the following concerns matter to patients in treatment:
• Timely treatment.
• Convenient treatment.
• Reasonable requirements.
• Thorough, thoughtful, understandable communications.
• Considerate treatment not just during the trial but before and afterwards.
Having patient input all along the line can help both researchers and patients get what they want.
In the end, what matters most to patients is results, not only their own personal results, which of course they hope are good, but also how the trial turned out. They hope, along with you, to make a difference to future patients.
Even if your trial does not meet its endpoints, let the world know. Learning what does not work is just as important as learning what does work.
These things matter.
Please note: The author has reported that she has no relationships relevant to the contents of this paper to disclose. Ms. Martinez is a Patient Advocate and online community coordinator at Smartpatients, Denver, Colorado. This Perspective was presented at the Cardiovascular Clinical Trials Conference, November 29, 2018, Washington, DC.
- 2019 American College of Cardiology Foundation