It’s not hard to find people who don’t like the US Food and Drug Administration (FDA), the government agency that, among other things, regulates medical therapies. In fact, if you type “do people like the FDA?” into an internet search engine you’ll quickly find out that for a lot of people the answer is “no”.

But the Agency is trying to change and deserves credit for taking seriously many of the criticisms that have been levelled at it over the years and trying to address them.

Patient Engagement

The latest example is the news that the FDA has set a date for the first-ever meeting of its first-ever Patient Engagement Advisory Committee (PEAC). On its website, the FDA says the PEAC will be focused on patient-related issues:

“The PEAC is a forum for the voice of patients. It will advise on complex issues involving medical devices and their impact on patients. Its goal is to better understand and integrate patient perspectives into FDA oversight, improve communication about benefits, risks, and clinical outcomes, and identify new approaches, unforeseen risks, barriers, and unintended consequences linked to medical device use.”

In the past, the FDA created forums where patients could describe how a disease affects their daily lives and share views on treatment options. But many saw those efforts as little more than window dressing—venues for venting, not vehicles for real change.

The FDA also includes patient representatives in advisory committee meetings. However, the PEAC is its first committee dedicated solely to patients and their needs. All nine core members have direct experience as patients, patient advocates, or caregivers—a very encouraging sign.

We tip our CAP to the FDA

At CIRM, we support anything that ensures patients not only have a seat at the table but that their voices are heard and taken seriously. That’s why for every clinical trial we fund—and even some pre‑clinical projects—we create a Clinical Advisory Panel, or CAP (we do love our acronyms).

Each CAP has three to five members. That includes at least one Patient Representative, one External Advisor, and one CIRM Science Officer. The CAP’s job is to guide the Project Team and offer recommendations throughout the trial.

The Patient Representative ensures the patient perspective shapes the trial’s design. They keep the trial centered on patient needs. Patients often raise questions or concerns researchers may overlook. They also help improve patient recruitment and retention. We believe trials designed with patients in mind are far more likely to succeed.

When announcing the PEAC, the FDA said:

“Patients are at the heart of what we do. It makes sense to establish an advisory committee built just for them.”

I completely agree.

My only regret is that they didn’t call it the Patient Engagement Advisory Committee for Health. Then the acronym would have been PEACH—and this certainly is a peach of an idea, one worth supporting.

Related Links:

• CIRM CAP Kickoff to New Clinical Trials
• Unfolding Collaboration: New EurostemCell video
• Thirteen organizations issue joint patient advisory statement