Patient advocate engagement in early stage development (part 2)

By: Sharon Dion

This is the second in a two-part series about involving patients and advocacy groups in clinical trials. The first blog entry, can be found here: Patient advocate engagement in early stage development.

Since 2010, MK&A and The Brooks Group have produced a syndicated market research report for the pharmaceutical industry to provide competitive benchmarking and strategic insights into advocacy relations. Known as Successfully Targeting Advocacy Relations (STAR) , the report is updated in the spring and fall of each year with a combination of questions that are consistent year-to-year and topics that are unique. Over 100 patient and professional organizations from a number of therapeutic areas are surveyed for each report.

In the spring of 2014, one of our special topics was to explore patient group involvement with industry in early research and development. The feedback is eye-opening and provides a road map for pharmaceutical companies to more deeply involve patient groups at all stages of early product development.

Interest in Engagement on R&D

To start, we asked organizations what their level of interest would be in engaging with a pharmaceutical company on early research and development efforts.

  • A whopping 69% of organizations surveyed had a high level of interest in engaging with pharmaceutical companies on early research and development efforts.
  • There was some variation between therapeutic areas, with hematology and immunology groups most interested and HIV/AIDS and respiratory groups least interested.

Combined, nine out of every ten groups surveyed had high or moderate level of interest in engaging with pharmaceutical companies. These are passionate patient advocates who are looking at making an impact in the treatment and quality of life of those they represent. This is an excellent opportunity for pharmaceutical companies to harness that passion and knowledge.

Best Ways to Engage Advocates
Advocates were asked their opinion on how patient groups could assist pharmaceutical companies in early research and development efforts. Although there were a wide-range of answers, there were three that stood out:

  • Assist with clinical trial recruitment and awareness efforts
  • Provide input on patient reported outcomes and quality of life issues
  • Provide advice on clinical trial protocols

In all three of these areas, interests of patient groups and pharmaceutical companies overlap. Companies are always looking to spread the word to a broad array of potential clinical trial enrollees and in many advocate groups, providing up-to-date, accurate information about clinical trials is a key function. Although more pharmaceutical companies are starting to engage patient advocates to gather information about the patient view on patient reported outcomes, quality of life issues and appropriate/acceptable clinical trial protocols, it is still not the norm. Taking these actions and seeking out patient advocates prior to commencing, or even designing, a clinical trial will assist in developing and executing clinical trials that are more acceptable to patients and the patient group alike and may even lead to findings that are more directly applicable to patients.

Challenges to Engagement
We were also interested in finding out what patient groups saw as the challenges, both real and perceived, in working with pharmaceutical companies in their early development efforts. Although there were again a number of different answers, the top three were:

  • Restrictions placed on the relationship by the company’s legal and regulatory departments
  • Lack of communication/awareness in what companies are doing in early stage development
  • Lack of understanding within a company of the benefits of incorporating the patient voice in early stage drug development discussions

All three of these challenges are surmountable with education. Every company has policies (some external and some internal) that it must follow, ensuring advocates (and company representatives) know what those are at the beginning of the relationship is essential. Identifying appropriate patient advocates, appointing a single point of contact and ensuring at least a quarterly update, alleviates communication concerns around clinical trial opportunities, whether they be recruiting, ready to launch or in design.

Lastly, in many companies, the advocacy function resides outside of the research and development organization. The internal team who has the relationship with the patient groups should broker and manage the connections with the clinical development team. MK&A has decades of experience in helping companies and patient advocates connect and work through all these challenges to ensure a mutually beneficial relationship.

These are high level findings, amalgamated across therapeutic areas from the STAR report. The full STAR report contains deep information in a number of therapeutic areas and offers insight and rankings of companies. We would be pleased to walk you through the whole report and show you how the robust information can help both pharmaceutical companies and patient advocates achieve their goals.

About the Author:

Sharon Dion

Sharon Dion is vice-president at MK&A.  She can be reached at +1 212 620 2774 or

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