Some Front Row Perspectives on Patient Centricity

Paul Ivsin — Mon, 04 Aug 2014 09:17:03 +0000

Précis:

"And that is quite likely the biggest barrier to advocates of patient centered clinical trials today: not that they will be resisted, but that their message will be co-opted and their efforts shunted into high-visibility but low-impact initiatives".

That quote is from my last post, where I expressed some concern about the current surge of interest in patient centricity.

It seemed wise to field test this question, so I put it to two people who recently leapt headlong into this exact area: co-founders of organizations designed to bring greater patient engagement to clinical trials:

Abbe Steel, CEO of HealthiVibe, which is focused on bringing greater patient input into the earliest stages of trial design through focus groups and patient surveys
Casey Quinlan, co-founder of Patients for Clinical Research, which aims to be a force in patient education and engagement for clinical trials

Neither agreed that current efforts are entirely symbolic (not surprising, of course ... that’s why I asked them in the first place). However, neither was willing to give a particularly ringing endorsement of the current appetite for structural change within pharma. Both only expressed the most cautious of optimism: Abbe admitted, “I’m not so sure I would say they have made ‘substantial’ changes”, but noted that she had “seen pockets of success… from social media to patient advisory boards to using patient survey data to map out the patient journey to support a host of initiatives from clinical trial recruitment programs to patient adherence and support programs.”

Similarly, Casey expressed frustration with a “complete failure of the industry to figure out how to listen to patients”, but still felt “there are some lights appearing on the horizon”. For example, she pointed out Lilly’s recent initiatives to develop an API, along with more human-understandable language, for its trial listings.

The regulatory perspective may need to change first: “I see people-commonly-called-patients as the key drivers here, IF regulatory bodies will start listening to us.” To make them listen, it may be necessary to have “patients to storm the barricades”.

Both were also in agreement about when patient engagement should begin in the R&D cycle: Day 1. As Casey put it: “To paraphrase Leonard Kish on the HL7Standards blog, patients can be the blockbuster drug discovery partners of the 21st century.” Along the same lines, Abbe suggested: “Patient engagement can start as soon as a company knows they want to be in a particular therapeutic area ... from phase I through patent cliff”.

One interesting area of divergence was whether pharma could truly be the first mover in patient centricity, since all of its operations are so acutely focused on regulators. Casey – perhaps not surprisingly for a person who has spent years as a patient advocate across many different facets of healthcare – sees the regulatory barriers as too large for pharma to unilaterally overcome. “In pharma, collecting patient feedback is made problematic by regulatory issues,” she noted. And, therefore, the regulatory perspective may need to change first: “I see people-commonly-called-patients as the key drivers here, IF regulatory bodies will start listening to us.” To make them listen, it may be necessary to have “patients to storm the barricades”.

At this point, we are clearly scratching the surface of patient centricity in trials – unfortunately, scratching the surface may be either the first step in knocking the wall down, or the first step in applying a glossy new coat of paint to the same old wall.

For my own part, I am still highly uncertain about the industry’s true ability to change on this issue.On the other hand, Abbe appears to see room for pharma to act on its own. “Pharma can absolutely be patient centric. In many cases, it isn’t the IRBs/ECs or FDA/EMA getting in the way of patient-directed initiatives, it is pharma’s own legal/regulatory/privacy/compliance groups.”

At this point, we are clearly scratching the surface of patient centricity in trials – unfortunately, scratching the surface may be either the first step in knocking the wall down, or the first step in applying a glossy new coat of paint to the same old wall.

Additionally, I do think that, for better or for worse, the current regulator-centric development system isn’t going to change much. Pharma will look to FDA and EMA, and if their patient-focused efforts prove to be symbolic, it will be extremely unlikely that individual companies will not stay in line.

So as I head into the Patient-Centered Clinical Trials conference in Boston, I will be listening closely for answers to these questions:

How actionable are our intentions? Are they associated with actual budgets, people, and deliverables?
Are we getting specific regarding the actual impact of patient perspectives, or are we still locked into cheerful “summarizing for consideration” non-statements?
How are we measuring the impact of this work? Are there concrete benchmarks, or are we simply positioning ourselves to declare victory later no matter what happens?

However, it is always refreshing to engage with dedicated and energized advocates like Abbe and Casey. If substantial change towards patient centricity does happen, it will be due in no small part to them and the small but growing army of e-Patients among us.

Paul Ivsin is VP, Consulting Director at CAHG Clinical Trials. A renowned expert on study enrollment strategies and patient engagement, he writes on clinical trial issues at Placebo Lead-In and Placebo Control. We’re happy to say that Paul will be joining us at the Conference in Boston on September 4-5.

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Inciting Patient Engagement and Action: Is MY cancer different?

Ellen Hoenig Carlson — Wed, 05 Oct 2011 19:43:07 +0000

Précis:

We are intrigued by the launch of Is My Cancer Different? and its potential impact on both patients and the business.

Is My Cancer Different? is an unbranded educational website that promotes a movement of sharing, with the intent of prompting patient dialog with their oncologist. The simple -but compelling- question is designed to raise awareness that each person’s cancer is different and to get patients to ask their oncologist to see if their cancer might respond to a more individualized cancer treatment.

The site supports Clarient, a GE Health Company’s new molecular test that may help doctors identify which treatment can best target a person’s particular breast cancer. Interestingly, Clarient chose to share the official website launch during the 2011 Social Health Summit #SXSH that we attended, along with many other pharma/healthcare social media enthusiasts, ePatients, and Patient Opinion Leaders (POLs). [Be sure to read Shwen Gwee's recap: The 6 P's of Healthcare]

During the conference, Is MY cancer different? received twitter support; following the conference, ePatient’s wrote blogs. Here are a few examples of the word of mouth generated over the last few weeks:

Blogs: Cancer Hawk , Diabetes in Spain, Chronic Babe, Where We Go Now, Aaron Outward, Stem Cell Transplant, Social Media Club

This campaign reflects many of the points we raised in our complementary eBook: 2011 Brand Champion Health Check.

Are you working to deliver more personalized treatment, content and experiences? [pg. 8]
Given smaller targets, how can you leverage existing social networks and dialog to online or virtual communities, to extend messaging to low incidence patient groups in a cost effective way? To create buzz? To enable 'peer-to-peer' healthcare? [pgs. 8-9]
Are you speaking with a voice that reveals humanity—in a conversational tone, with personality, empathy and true emotions? Are your choice of words simple, using the language of your patients and caregivers? [pg. 10]
Are you doing your part to stimulate patient learning and involvement; to encourage patients to be their own best advocates and health team partners? [ pg. 10]
How can your brand help to encourage greater trust and dialog between doctors and their patients and families, to help improve patient outcomes? [pg. 15]

Brand Champion Health Check: Is Your Brand In Shape To Win?

View more presentations from Ellen Hoenig Carlson - Advance MarketWoRx

Is My Cancer Different? is a great example of brand champion leadership. They have committed to a challenge of 1 million shares in 1 million minutes. What do you think? Will they make it?

Feel free to join the movement and help spread the simple question that can make a huge difference in the fight against cancer. Follow @ismycancerdiff on twitter and/or facebook.

You can also learn more about the ePatient movement at epatients.net and join The Society of Participatory Medicine.

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patient-centered

Some Front Row Perspectives on Patient Centricity

Inciting Patient Engagement and Action: Is MY cancer different?

Brand Champion Health Check: Is Your Brand In Shape To Win?