Patient Engagement: Misconceptions and Practical Tips

Published on:
February 2, 2023
Annabel de Maria

Annabel de Maria

Chief Patient Officer at Alira Health

Interview with Annabel de Maria, Chief Patient Officer of Alira Health

We believe that the relationship between healthcare companies and patients is a partnership, and a patient-centric approach at each stage of a treatment or device’s development will help companies build trust and meet patient expectations throughout the development lifecycle. To understand how companies can most efficiently and effectively work with patients and what the industry can do right now to become truly patient-centric we talked with Annabel de Maria, Chief Patient Officer at Alira Health, and patient engagement expert with 25 years of experience.

What are some misconceptions companies still have about patient engagement?

Annabel: There seem to be three important misconceptions when it comes to engaging patients.  

The first is that patient engagement is not allowed—or not needed. Some healthcare companies believe that because the regulations in biopharmaceutical and medtech are so strict, you can’t engage with patients at all. That is not true. In fact, regulatory bodies such as the FDA are clearly pointing companies toward patient engagement by releasing specific guidelines for interacting with patients. 

You do have to engage with patients compliantly—putting the right contracts in place, not promoting any type of drug—it must be a very transparent relationship. That’s the most important thing. It cannot be a commercial relationship with patients, you must work with them in  partnership. 

The second misconception is that you can simply engage patients at certain points in the process when there’s a specific need. This won’t work. Patient engagement must start at the beginning and continue throughout the product development lifecycle. Outlining patient needs, making sure they participate at the design of the clinical trials, and involving them during the regulatory and HTA process are all critical. And finally, really securing the patient journey from the eyes of the patient—not just from a literature perspective—has to be well understood by the transversal functions of the company so the right activities to support patients are put in place at the time of the launch. 

The last big misconception around patient engagement is that it’s expensive and not measurable. You should account for patient engagement in any business plan—it’s as important as physician and regulator engagement. So, there’s no added, expensive budget, it’s just part of the plan. And, if you don’t have patient engagement in place, you are going to fail at some point during the development and launch of the product. 

And in terms of return on investment, patient engagement is certainly measurable—particularly when it comes to clinical trials. According to the model described by Levitan, et al:
For a pre–phase 2 project, the cumulative impact of a patient engagement activity that avoids one protocol amendment and improves enrollment, adherence, and retention is an increase in net present value (NPV) of $62MM ($65MM for pre–phase 3) and an increase in ENPV of $35MM ($75MM for pre–phase 3).¹

Why are some companies reluctant to embrace patient engagement?

Annabel: For some companies, not knowing how to start or what processes to put in place can be a barrier. Indeed, patient engagement does require specific expertise and you really must embrace patients and the patient journey. You have to put patients at the same level of importance as all other aspects of the product lifecycle and dedicate company people and resources to working with them. And, if possible, create an internal patient council who can support the company through the complete development lifecycle of a drug. 

What are the most practical things a company can do to be more patient centric?

Annabel: First, the company needs to understand the complete patient journey—from the patient perspective. This should happen in the discovery phase. To do this, companies need to invest in market research with patients, ideally in more than one country, and different continents. This will provide a better picture of patients’ reality in different healthcare systems. Companies can use these insights to inform the clinical development plan, as well as the clinical trial design. 

Next would be to set up a patient advisory board. Companies will want to do this before entering Phase II, because here again, the advisory board’s feedback will inform the design of the trial protocol. This can help a company avoid dropout rates, secure patient visibility for the clinical trial, and reduce the number of resubmissions of the protocol to the ethical committees. 

And the third practical thing for a company to do would be to set up a patient support program to align with the launch of the new drug in market. This allows the company to support the needs of the patients while also collecting patient reported outcomes. That data can be used as Real-World Evidence and presented to payers and authorities during their annual negotiation for the drug’s price and reimbursement in each market. 

How can your organization keep patients engaged at each stage of the lifecycle? We help organizations engage with patients in a compliant manner to maximize product potential, outcomes, and experience. For more information, contact Annabel de Maria, or connect with her on LinkedIn. 


¹Levitan B, Getz K, Eisenstein EL, Goldberg M, Harker M, Hesterlee S, Patrick-Lake B, Roberts JN, DiMasi J. Assessing the Financial Value of Patient Engagement: A Quantitative Approach from CTTI’s Patient Groups and Clinical Trials Project. Ther Innov Regul Sci. 2018 Mar;52(2):220-229

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