By Allison Proffitt 

 

February 12, 2014 | Last week’s Summit for Clinical Ops Executives (SCOPE) in Miami, Fla., was a packed three days of conversations, networking, new products, and brainstorming on the future and direction of clinical trials.

 

Tuesday set the stage for a great event with a patient-focused plenary keynote session. Jamie Heywood, co-founder and chairman of PatientsLikeMe, delivered one of his always-inspiring challenges: to look closely at how we measure our progress in research. Heywood, who comes from an engineering background, stressed that measurement begets treatment. We don’t make treatment decisions until we know what the viral load is, how high the blood pressure is, how limited range of movement has become.

 

“When you can measure what you are speaking about, and express it in numbers, you know something about it. But when you cannot measure it, when you cannot express it in numbers, your knowledge is of a meager and unsatisfactory kind,” Heywood said, quoting Lord Kelvin.

Quantifying results means quantifying the patient experience. Patient experience is about more than just stories, he stressed. “We all say we’re patient-centric,” he said. “But where’s the math?” 

 

Heywood’s company, PatientsLikeMe, collects as much data as possible from individuals who sign up to share details about their disease progression, treatments, symptoms, and struggles. Using those data, PatientsLikeMe has been able to run data experiments on various treatments, in some cases arriving at answers before a more traditional trial.

 

The question isn’t academic, Heywood said. Patients are collecting data and they are acting on it whether the industry acknowledges that or not. 10% of PatientsLikeMe members fire their physicians because they are unhappy with the level of care they are receiving, Heywood said.

 

He predicted that patients active on Facebook and Twitter will soon destroy a Phase 3 trial because the trial was not designed with their interests in mind. He called sponsors to plan for a new social contract, to engaged patients and prioritize user experience.

 

Heywood’s impression that patients are not as involved as they could be was cemented by Christine Pierre, President of the Society for Clinical Reearch Sites (SCRS). Pierre challenged sites and sponsors to remember the patients, and highlighted two lessons of communication that she hopes the industry will adopt.

 

The first was the Toyota Quality System. Any member of the assembly line can stop the development of a car if he or she notices a problem, Pierre said. Where are the safety stops in clinical trials, she asked. She challenged the industry to adopt an environment where anyone feels empowered to speak up and identify a protocol that is off-track or cumbersome for the patient, the sites, the study coordinators, or anyone else.

 

She wondered aloud where the patient voice was in trial design, and suggested that questions be raised: “Is this ok?” “Are you really going to let us do this to you?” It would be much more prudent to ask the patients, she said, than to proceed with the trial and hope to reach enrollment numbers.  

 

Hearing the Patient Voice 

 

To drive home her points, Pierre invited four patients on stage to discuss their experiences with the trial process. 

 

Chris had joined a trial on cholesterol drugs; T.J. had joined a trial on melanoma treatment; Laura has joined a breast cancer trial; and Daniel had participated in a trial for the treatment of bipolar disorder. Each patient had a slightly different experience, but their messages were consistent: they want more information, more support, and more compassion. Building trust should be a primary goal.

 

The patients said it was, “extremely important” to have their data shared with them after the trial. “After the trial is over, will you just tell me if I was on the drug or placebo?” one asked. 

 

Connection to other patients was another theme. Facebook was mentioned as one patient’s favorite source of information on his disease and treatment and trial options .

 

The informed consent process was nearly universally panned. One patient admitted to reading only about 25% of the form. One came for what he expected to be a one hour visit and left after six hours, finally signing the form with a few pages left unread. The patient in the bipolar disorder trial served as his own power of attorney. He says he read the informed consent form, but didn’t fully understand it. 

 

Instead, patients put their trust in the nurses and physicians that were explaining the process to them and signed the forms.

 

Though three of the four patients had some loose personal connection to a clinical trial or the pharmaceutical industry, they all experienced lack of support in their decision to participate in a trial. 

 

Some had family and friends that had no idea what a trial meant. Others were actively dissuaded from joining by their primary care physicians. One primary care physician said he was “disappointed” that his Stage 4 cancer patient was not content with the standard of care and wanted to try a trial.

 

All four patients actively advocated for themselves in terms of enrolling and proceeding in trials with varying levels of success. One went as far as to “bombard” the Bristol-Myers Squibb legal department with inquiries on LinkedIn until the trial was green-lighted.

 

For the sponsor, the patient said, it was an item on their to-do list. “For me, it was the difference between coaching my son’s little league team or just existing in photos.”

 

When asked how to better reach patients, the four supplied some concrete suggestions. “Clean up clinicaltrials.gov!” said T.J. emphatically. “I’m an IT guy who used to work in pharma and I found it impossible to get through.” (On his own blog, T.J. has mentioned working with CureLauncher.)

 

Chris, whose friends didn’t know anything about clinical trials before he started, recommended broader advertising campaigns. “Put an ad in the local fishing magazine,” he suggested. “That’s what my buddies read.”

 

The session ended with a standing ovation for the patients, and set the tone for a week of focus on creating better trials to bring better drugs to the patients.