Tag Archives: clinical trials

A listening cure: PatientsLikeMe gives patients voice in clinical trial design

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Until now, patients have had very little to do with the design of clinical trials — even though they’re key to their success. Online patient networking and research platform PatientsLikeMe, is changing all that. Last week, PLM launched a new service that lets pharmaceutical companies collaborate with patients to create clinical trials that serve their needs — amplifying the chances of success for both researchers and patients. We asked PLM’s Paul Wicks to tell us more about why this is a game-changer for medical research.

Why is this latest development so important?

The most important path to creating new medical breakthroughs is the randomized clinical trial (RCT). Hundreds, sometimes thousands, of patients volunteer to be randomized for either a new treatment, placebo or existing treatment in these large and expensive studies. This isn’t an easy process. It can be bewildering for patients to wade through incomprehensible medical jargon in order to understand what they’re signing up for. Then they have to undergo frequent testing — which includes traveling frequently to the hospital, and undergoing blood tests, brain scans, biopsies, and other procedures, some of which can be time-consuming, painful, or both. They also have to adhere to a strict set of rules while they take part.

All the while, patients don’t know if they’re on a treatment that might help or harm them, or whether they are in fact being systematically fooled by a placebo. Patients have misgivings about how they perceive the experience will be, too: 22% of cancer patients in a survey reported they thought they would be “treated like a guinea pig” in a clinical trial.

So not surprisingly, only 5% of patients take part in clinical trials. While the trials cost millions of dollars, 1 in 5 enroll no patients whatsoever, and half miss their targeted number of participants.

How has PatientsLikeMe solved this problem?

We’ve developed the first rapid, robust, representative system that lets patients have a voice in the design of study protocols. RCTs have been designed by doctors and scientists ever since the mid-20th century — when they first started being used widely – with input from regulators (like the FDA) and the business interests of pharmaceutical company sponsors, but with none from patients themselves. We share patient data from PatientsLikeMe with people designing RCTs to identify exactly the type of patients that might be eligible for a study, and get their input and feedback on every aspect of trial design.

We address everything from the language used to describe the study (e.g., “What does this word mean? Patients would probably say X instead of Y”) to the outcome measures used (e.g., “This outcome measure doesn’t really sound like something that’s important to me. Why aren’t you measuring pain?”), and aspects of the study design that are a “deal-breaker” for patients (“If I have to travel more than 20 miles to come to the study center, I’d refuse to take part”).

How will this help those who design clinical trials, and, more importantly, patients?

By listening to patients in advance, study designers can be proactive rather than reactive. They’ll more likely be able to minimize the burden on patients, and they’re far more likely to recruit enough patients to take part in their study. They’ll also glimpse the types of problems their study is likely to encounter, leaving them better prepared to shift gears or make changes if necessary.

This all seems very sensible. Why has no one ever done it before? 

A lot of people in industry are afraid of listening to patients, worried that there might be legal or regulatory barriers to speaking with them. We’ve also lacked ways to quickly gather systematic quantified and qualitative feedback from a large number of patients. That’s something patient-powered research networks like PatientsLikeMe have only recently enabled.

There have been some smaller-scale attempts to get patient input, but these have tended to be within academia, and still aren’t widely used.

What’s your ultimate goal? 

We’re trying to make it so fast, simple, and downright useful to gather this type of data that we’ll move from the status quo (almost nobody uses quantitative patient research in the design of trials) to it being the norm in the next five years.

It’s all a part of our mission to put the patient voice in the decision-making heart of healthcare — and as you can tell, I think it’s pretty exciting! This year, there will be hundreds of clinical trials that fail to meet their targets because of off-putting study protocols that place too much burden or confusion on patients. By bringing a patient focus into the system we could streamline research, increase recruitment rates, and maybe even get faster cures. Just by listening.

To find out more about Paul Wicks and PatientsLikeMe, visit the TED Blog >>>

A snapshot of recent survey results, based on 1,600 patients' views. Image: PatientsLikeMe

A snapshot of recent survey results, based on 1,600 patients’ views. Image: PatientsLikeMe