Patient-centric to the Core. You Asked, We Answered.

Patient-centric to the Core. You Asked, We Answered.

Posted by BBK Worldwide

BBK Q&ADuring our recent webinar,  "Patient-centric to the Core", attendees asked great, thought-provoking questions of our panelists, Christel Aprigliano (The Diabetes Collective), Claire Meunier (The Michael J. Fox Foundation), and Bonnie A. Brescia (BBK Worldwide). We answered some during the webinar, but ran out of time and couldn’t get to them all. A full summary of webinar Q&As follow; we hope it helps address some of your own questions, thoughts and concerns. If you have others, please join the conversation by posting a question in the comment section below. Also, stay tuned for an upcoming BBK eBook on this highly discussed topic.

We know that patient centricity is an important topic for so many of us – and we hope to hear from you soon!

1. Do you think patients would like to engage in two-way communications with research sites on social platforms?

Aprigliano: 

Yes, as long as you begin the process of engagement with an education outreach and ask them how you can help them learn. If you're just looking to engage patients to get them to enroll without giving them the reasons why - or how clinical trials work and the benefits of enrolling, you'll find them less responsive. You must find the social media avenue where the patients communicate, listen to the conversations, find the key influencers, and engage slowly by asking questions. Listen to the patients for unmet needs when it comes to questions and approach with a "how can we help" attitude. 

2. What are some barriers preventing companies from employing a “patient-centric” mentality when designing their studies and recruitment plans?

Aprigliano: 

  • Not including the right ePatient from the very beginning. Get a "stable" of ePatients who have different core competencies and backgrounds and keep them in the loop from the concept to completion. 
  • Hubris. Just because your company thinks the study design and recruitment plans are perfect for the patient community, if you don't accept ideas and constructive criticism from outside trusted sources, you may find yourself with five patients recruited after six months of active recruitment. 
  • Forgetting that first and foremost, the patient is a person, not a study subject. If you want patients enrolled in a study that has unreasonable requirements (including limited locations, extensive logging/testing, excessive travel and time), then don't be surprised when patients refuse to enroll or drop from the study. Patients have lives beyond their disease state and keeping that in mind may change your study design and recruitment plan. 

3. How does patient centricity save biotech/pharma sponsors and vendor CROs money in the long-term?

Aprigliano:

  • Imagine not having to spend time, money, and resources when beginning a trial, because you have engaged the patient community and understand how they think. 
  • Imagine having the assistance of those patients when you are ready to launch a new clinical trial, creating a viral information network and filling up your recruitment requirement quickly, accelerating the actual clinical trial. 
  • Imagine having ePatients give their opinions and recommendations to FDA panels about the benefit of your product. 
  • Imagine treating patients like customers in a business, wanting to keep them engaged as much as possible to prevent them from not enrolling or abandoning the study.

Why wouldn't you want to adopt a patient-centric approach when what you need are patients?

4. Can you elaborate on what trial ambassadors do?

Meunier: 

  • Trial ambassadors came about as a result of a tool that we created called Fox Trial Finder, which functions like Match.com for Parkinson’s patients and site teams working on clinical trials. We built it about three and a half years ago as an action step and it worked for the first 15,000 people who understood that trials needed people, who understood what it meant to participate in a trial, and who were just looking for that action step. Very quickly we realized that there were one million Parkinson’s patients in the U.S. alone and we had 15,000 of them -- so where were the rest? We realized that we needed to take a more proactive role in awareness building and education – and out of that there came an opportunity to tap into all the people who had already signed up for Fox Trial Finder. We were able to figure out a way to use these people to assist us to find other patients. 
     
  • Trial ambassadors do things such as go into doctors’ offices, do presentations in support groups, and recently we started to engage them with individual trials – especially large ones. We are now creating a training program which brings these ambassadors up to speed on the specifics of a particular trial, then matches them to the site teams of the trials, in order to educate physicians and patients about the need for a particular kinds of patients for specific studies. We use these especially for more difficult to recruit populations. After recently piloting this program, things are going extremely well and we find that when equipped with the information about the study, patients can generate great leads for clinical trial sites and reduce the burden of the sites to do so.

5. Can you explain what it is to “de-risk” Parkinson’s?

Meunier: 

We talk about de-risking the field of Parkinson’s disease (PD) to encourage the industry to continue to invest in new therapies and to make PD a field that is attractive to work in. I think of this as lowering the barriers to entry (or the barriers of staying) for a given group to do work in PD. We do this in a lot of ways, but some examples are: sponsoring a $65m biomarker validation study to confirm markers of PD progression for the field, creating animal models and assays that are affordable and easily accessed, and hosting and publicizing a database of patients who are well characterized and who are available for trial participation in any PD IRB approved trial (Fox Finder).

6. What happens if several sponsors go to the Fox Foundation at the same time to target the same patient population through Fox Trial Finder? How does Fox Foundation handle that? 

Meunier:

The goal of that tool is to tee up all of the opportunities that match to someone’s profile (includes age, duration of diagnosis, medications, and symptoms, as well as zip code which really targets the people who are nearest the trial sites). So if two trials are seeking the same group of people in the same geographies, those people would match to both trials. Fox Trial Finder is about serving up all of the options for someone to participate and then letting the volunteer choose which ones to pursue.

7. What are 3 to 4 concrete steps / actions I can employ to help my organization be more patient-centric as we plan our trials? I am with an orphan biopharm / rare disease organization.

Aprigliano:

  • There should be someone in your company devoted to physician/patient engagement, focusing on building relationships with the physicians and their patients.  
  • There should be extensive research in determining what those physicians need for educational resources to help the patients understand the benefits of the trial. 
  • The information regarding the trial should be easily available and accessible to the patient population throughout the trial online with multiple ways to connect with the organization. Patient centered outcomes are becoming increasingly required in FDA consideration for drug approval.

Meunier: 

  • Engage early with the patient groups in your disease area. When you are ready to go to market may be too late to start the conversation.
  • Partnering with them doesn’t always have to involve money. Money is definitely something needed for advocacy organizations, but thought partnership and learning on both sides can be just as valuable.
  • Don’t rely on the patient group to come up with all of the ideas on how to partner; both sides should be looking at what other disease groups are doing with partners and thinking creatively about programs that bolster the work of the patient group and support the goals of the company simultaneously.

8. What is EUPATI?

Brescia:

EUPATI is the European Patients’ Academy on Therapeutic Innovation. Funded by the Innovative Medicines Initiative, the consortium project provides scientifically reliable, objective, and comprehensive information to patients on medicines research and development. Its mission is to increase the capacities and capabilities of well-informed patients and patient organizations to be effective advocates and advisors in medicines research, e.g. in clinical trials, with regulatory authorities and in ethics committees. EUPATI also offers patients and the public basic information, training and education around health issues. 

9. Can you elaborate on the difference between patient-centric and patient-friendly?

Brescia:

In my view, patient centricity is a philosophical commitment to understand what matters to patients as a group – such as those with a specific condition – as well as being attentive to each patient’s experience of his or her disease and within a clinical trial. Patient-centric programs value the patients’ perspectives on what is being studied, what outcomes matter most in terms of daily living, or to what extent a patient would go to improve or expand treatment options. Patient centricity is including patients in study design, outreach, message development, site orientation and training. And, as Christel brought home during the webinar, being patient-centric means caring intensely about every study participant in your research site, at every visit, and through every procedure.

Being patient-friendly is much easier to execute as it is more about enrollment and retention tactics – using language that matches patients’ preferences, reimbursing travel costs in a timely manner, respecting patient’s time by being on time, extending office hours, and the like. 

These two constructs are not mutually exclusive. Yet, in today’s clinical research environment, being patient-friendly is a minimum requirement. Companies that pursue true patient centricity are gaining a long-term advantage over those who wait.

Are You Patient-Centric eBook

Topics: Webinars, Patient Centricity