“Is there a form I could fill out to provide my feedback?”
The silence in the room was deafening.
I exhaled with a furrowed brow, feeling extremely disappointed, wanting to stand up and apologize on behalf of the entire room that was seated so quietly. Apologize for the practices, procedures, and ideologies that had failed this woman panelist on stage, and so many others. Apologize on behalf of an industry that is advancing on so many levels, yet dropping the ball in too many priceless ways.
“Is there a form I could fill out to provide my feedback?”.
This simple question came from a vibrant young woman who just delivered a powerful narrative that brought a quiet room to a roar with the applause of a standing ovation. This young woman detailed her harrowing patient experience of dying of advanced cancer to a tremendous success story reveling in the miraculous power of personalized medicine. She is years post the clinical trial that saved her life.
“Is there a form I could fill out to provide my feedback?”.
If she hadn’t stood at the podium and told us her story, no one would’ve known the horrors she witnessed, felt, experienced, or thought. If she hadn’t stood on the stage and articulated her story, no one would have known about her difficulties of finding the trial that saved her life. Without her story, no one would’ve heard her suggestions for improvement. If she just sat in her seat like every other member of the audience, no one would’ve known how scary, how exhausting, and how painful her journey was. Thank goodness she was invited to share her story! Otherwise, she’d just be another anonymous clinical trial endpoint successfully met.
It’s gravely concerning that after participating in a successful trial, no one invited her to help improve the process. If an educated, well-spoken, personable individual with a miraculous response to a cutting-edge therapy isn’t included in the enhancement, refinement, and co-design of clinical trials, who will be?
It’s common to hear from patients that they are not asked for their insights during or after participation in clinical trials. There is an aura of reverence surrounding people who have participated in trials. These individuals have made a profound sacrifice and leap of faith. Trial participants have agreed to introduce a foreign substance, a hypothesis, into their body, realizing that this unknown may save their life, end it, or run the gamut of all of the possibilities in between.
Imagine being diagnosed with terminal cancer, being sent home to die. Shattered. In physical, mental, and spiritual pain. Would you risk trusting an unknown therapy and introducing it into your frail, already dying body? Could you picture yourself taking an experimental agent and hoping for the best? How many of us are truly brave enough to put our trust and fate into the hands of science? Wouldn’t you agree that these experiences are profound, rare, and worth their weight in gold to thoroughly comprehend?
There are over 21,000 clinical trials listed in clinicaltrials.gov as recruiting in the US. Were these trials designed to be tailored to the lives of the people living with a diagnosis and inclusive of all lives with a diagnosis? It depends on whether the expertise of patients and carepartners were included throughout the continuum of the clinical trial life cycle.
Over the last year, it’s been my personal curiosity to ask members of pharma if their company includes patients in the clinical trial life cycle. When I broach the subject, there is a broad spectrum of reactions, the majority of which are accompanied by clear discomfort, agitation, defensiveness, dismay, and confusion. These responses all fall into an ambiguous gray area. Here are 50 answers I have received in response to the question: Does your company include patients’ expertise and insights in the clinical trial life cycle, from study design planning, during trial implementation, after trial closeout, and post-launch of product?
1. There are compliance issues.
2. There are regulatory hurdles.
3. What business incentive is there to do that?
4. Patients don’t know anything about clinical trial design, management, or operations.
5. We don’t have a budget for that!
6. The FDA doesn’t require patient feedback or insights in the clinical trial process for drug approval.
7. (Look of confusion)
8. Our company is patient-centered. We don’t need patient insights.
9. We don’t have the staffing to do that.
10. Pharma doesn’t traditionally speak with patients.
11. Our stringent timelines cannot accommodate this.
12. Where would we find patients to participate?
13. (eyes narrowing) Are you one of those patient activists?
14. Patients aren’t well spoken.
15. Patients aren’t professional enough to participate in these conversations
16. Our legal team would go into cardiac arrest.
17. We do not have the technology in place to do this.
18. It sounds like a great idea but upper management would never approve.
19. Our marketing team is working on a campaign.
20. We only work with non-profits.
21. It’s on the backburner for this fiscal year.
22. This is a conflict of interest.
23. We’re one of the top biopharmaceutical companies in the industry. We know what we are doing.
24. Do you know how much it costs to execute a clinical trial?
25. (eye roll)
26. Our clinical operations team runs like a well-oiled machine.
27. Do you have any references or data to support the benefit of including patients in clinical trial design?
28. Patients are unreliable and volatile.
29. That’s a waste of time.
30. Working with patients is a pain in the @ss.
31. How could pharma work with patients? They don’t trust us!
32. Sounds great in an ideal world, but we have pressing deadlines to meet.
33. Patients have their own agenda and won’t collaborate.
34. We can’t base our clinical trials on patient complaints.
35. Our company runs successful trials and gets approvals without patients involved in the process.
36. That’s another trend that will phase out soon.
37. Whose responsibility would that even fall under at our company?
38. We are watching to see how other companies are doing it.
39. Those tactics are for companies that can afford the “bells and whistles”.
40. We tried. It didn’t work.
41. We are too small of a company to implement this.
42. We don’t need more paperwork.
43. What is the return on investment?
44. We’ll talk to patients but we can’t pay them.
45. We are too big of a company, with locations all over the world. How could we coordinate this?
46. We are so overwhelmed, we can’t take on another initiative.
47. Is there a standard operating procedure for implementing this?
48. What happens if they all start talking about the adverse events of their treatments?
49. How can we trust patients?
50. Our investors don’t care about patient-centered practices and co-design. They want drugs going to market.
Pharma’s 50 shades of gray does not run industry wide. There are pioneers who are committed to changing the status quo, actively working with patients and including them on many fronts. It is evident that these trailblazers are excited by their partnerships with patients. They speak loudly and proudly about their patient-centered initiatives, with an enthusiasm that is invigorating and resounding. They acknowledge that this isn’t a just a nice gesture or outreach program. Partnering with patients is solid business sense. Collaborating with patients bridges silos, brings meaning to daily work, and creates unique opportunities for experiential learning.
It is important to note that those within pharma who collaborate with patients are more open to leveraging technology and machine learning, discussing mobile health, digital platforms, and telehealth, exploring benefits of utilizing blockchain, as well as recognizing the importance of patient-reported outcomes. Coincidental? Absolutely not. There is unprecedented value and power in including patients in optimizing the drug lifecycle. Augmenting trials to patients’ values, preferences, and needs is a solid win on all fronts. Do not mistake this as another passing trend!
Is your company somewhere in the 50 shades of gray? What is holding you back? Is your company a pioneer in being authentically patients first and collaborating with patients? How can early adopters share best practices to eliminate every single one of these 50 gray areas so as to collectively move the industry forward to being truly patients first?
