27 posts tagged “patient voice”

It’s Clinical Trials Day, and patients are driving change

Posted May 19th, 2017 by

Today is Clinical Trials Day – celebrated to bring more attention to public health and also to recognize the contribution of the patients and healthcare professionals who make clinical research possible. At PatientsLikeMe, it’s members who are changing the way clinical trials are designed.

Bringing the patient voice to clinical trials has long been part of the PatientsLikeMe mission. Jeremy Gilbert, Vice President, PLM Health and Paul Wicks, Ph.D., Vice President, Innovation, sat down with us last year to talk about the importance of putting patients at the center of drug discovery and development. Check out their Q&A here. Recently, Paul Wicks touched on the purpose behind the latest PatientsLikeMe study on clinical trial design involving the patient perspective, and why organizations need to work on improving their trial process:

“As researchers we know that clinical trials are the best tool we have for identifying new, safe, effective treatments. Patients know this, too, and they’re motivated to take part. But what this research tells us is that actually participating in a trial is not a fun experience; about as much fun as dealing with the worst airlines, banks, or utility companies, and we all know how that can be. This is a call to action to trial designers and sponsors to step up their game and understand that while patients volunteer out of altruism, a clinical trial still has to fit into their daily life and should create as little burden as possible if we want people to enroll and see it through to the end.”

-Paul Wicks

4,718 PatientsLikeMe members took part in the survey, and below is just a snippet of what they had to say. The complete findings of this study have also recently been published – take a look!

How do patients learn about clinical trials?

59% of those who responded said they learned about a trial from their health team, while 24% said they learned via the web. For those who participated in past trials, the first person to suggest they participate was a doctor (43%) or another healthcare provider (19%), and 80% of respondents said they took part in the trial based on their own desire to.

A key takeaway from the study:

Most people are still finding out about trials through their care teams or providers, but when it comes to making a decision to take part, it’s their own desire that motivates them.

Paul Wicks weighed in saying, “We think patients are interested in participating in research in general because of altruism, that they choose to enroll in a particular trial because of its objectives, and that they stay enrolled because of their relationship with trial staff and the level of burden the study incurs on their daily lives.”

What are patients’ impressions of clinical trials?

Of those who responded, 55% were very or extremely satisfied, and 51% would tell other patients about the trial.

Jeremy Gilbert touched on the issue of patients providing feedback following a trial, “We’re starting to see another gap now, which is that companies have no way of soliciting feedback from patients as they participate in a trial, to find out what patients think of real trials. This is a surprise, because given most of us are consumers, we’re used to being able to give feedback about a product or our experience at any time.”

9% of those who answered the survey considered dropping out of their trial — side effects and worsening of overall health after the trial were the main reasons. Following the conclusion of a trial only 38% of patients recall being told about the results.

To find out more about clinical trials and how to get involved, visit the PatientsLikeMe clinical trial finder tool. Find a trial that’s right for you, search by location, phase, intervention type and more.

Thank you to all who participated and shared their experiences to help bring the patient perspective into improving clinical trials.

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“My expertise is as a person with Parkinson’s”: Member Lisa brings the patient voice to drug development

Posted April 28th, 2017 by

Member Lisa (lcs), a Team of Advisors alum who’s living with Parkinson’s disease, has found her advocacy niche: involving patients in drug development.

Parkinson's Disease patient

Lisa Cone, PatientsLikeMe member living with PD

Diagnosed with PD in 2008, Lisa served as a patient thought leader and co-author of a published journal article called “Increasing Patient Involvement in Drug Development.” She worked on the publication along with Maria Lowe, Pharm.D. – a health data and drug information clinical specialist at PatientsLikeMe – and other pharmacists and Ph.D.s.

“I hold my co-authors in the highest regard,” Lisa says. “That said, not one of them was a person with an incurable, progressive neurodegenerative disease. My expertise is as a person with Parkinson’s.”

 

Maria says that having a patient co-author was “crucial” to the publication. “We wanted to look at how drug developers were incorporating patients into drug development activities and recommend some best practices,” Maria says. “How could we possibly do this without ensuring we were representing what matters to patients?”

The value of partnering with patients

In addition to teaming up on the research paper, Lisa and Maria also both participated in a webcast on April 12 on PDUFA VI and the Patient Voice.

PDUFA stands for the Prescription Drug User Fee Act, which the U.S. first enacted in 1992 to allow the FDA to collect fees from pharmaceutical companies to help fund the FDA’s drug review and safety monitoring processes. PDUFA VI, the pending update to the legislation (up for renewal in September 2017), would require drug developers to include more of the patient perspective in the early stages and overall process of drug development. (Read more about it here.)

Maria Lowe

Maria Lowe, Pharm.D., health data and drug information clinical specialist at PatientsLikeMe

Lisa says that the FDA has been trying to drive a higher level of patient participation in the trial process and the drug approval process. New leadership and budget changes in Washington could shift or delay the FDA’s focus on patient-centeredness, but Lisa still has a message for pharmaceutical industry leaders:

“I urge you not to confuse the value of partnering with patients with the requirement to partner with patients.”

 

But she adds that low participation in trials often stems from problems in the study design from the get-go. Involving patients early and often in trial design and drug development can pay off big time, Lisa says. “The time and resources it takes to bring a single new therapy to market are significant,” she says. “Because of this investment, failure to assess the needs of patients early in the development process can mean marginal success or frankly disastrous results when taken to market.”

On becoming a patient thought leader, plus a few pointers

Lisa had professional experience in the healthcare field — before leaving the workforce, she was an executive responsible for understanding the business of and policies affecting healthcare providers.

“I do not, however, believe that these experiences are required to be an effective advocate. I believe having knowledge of your condition beyond your personal experience is the primary requirement, which is not complicated,” she says.

On PatientsLikeMe, 23,512 patients say they’re interested in advocacy. Lisa’s advice? Find a “role that most suits your gifts,” such as fundraising, lobbying or speaking. She also puts her her physical and emotional health first. “This means taking time to relax, play with my dog, visit with friends and family and getting physical activity,” she says. “I’m not always successful in this endeavor as I have a tendency to ‘over volunteer.’”

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