How Advocacy Groups and KOLs Influence Enrollment, Execution, and Adoption.

Country by country, region by region, around the world, there are marked differences in every aspect of drug development and commercialization. How do patients interact with physicians—and with trials and what is their receptiveness to participate in clinical trials? Where do prescribing physicians learn about new therapeutic options? Whose voice do patients trust? And what evidence or data will regulatory bodies require from sponsors to approve these therapies? Your ability to successfully navigate these questions is of critical importance to the success of your product, and getting clear, reliable answers early in the process can smooth your entire drug development path.

Two key relationships can pave the way: Patient advocacy organizations (PAOs) and key opinion leaders (KOLs). In this post we will discuss what each group offers and how to maximize these relationship.

 

Patient Advocacy Organizations Lend Credibility—and Create Community Champions

Both patients and healthcare professionals rely on advocacy organizations to stay up to date on new research, new therapies, and other developments within a certain disease state. A strong connection to an PAO can increase both interest and trust in your product as well as building a strong foundation for the familiarity with your product among potential prescribers. When choosing a potential partner (s), consider what you hope to gain, so you can determine the best match.

PAOs and pharmaceutical companies share a common mission: to improve patient’s lives. Patient organizations are committed to finding better treatments, enhancing healthcare access, and advocating for individuals with various medical conditions. Patient advocacy organizations are invaluable in amplifying the voices of patients and their caregivers, as well as educating their community about current clinical trials and approved therapies. And importantly, patient advocacy organizations are the trusted voice of the community they represent.

  • Size and scope: Larger organizations often cover a multitude of indications, for instance multiple types of cancer or heart disease; small organizations may be very targeted, perhaps focused on a rare disease or dedicated to a specific mission, such as helping patients in a certain country access adaptive equipment. Some smaller organisation may be part of a larger umbrella organization, and therefore less nimble than they first appear. Check for fit before pursuing a partnership.
  • Geography: Related to size and scope, large organizations may also work across regions, even spanning the globe, whereas some smaller organizations operate hyper-locally. Both options offer distinct advantages.
  • Engagement tactics: In the United States, giving an educational grant to an organization can help spark the development of a relationship. In Europe, such a grant is illegal; you need to reimburse an advocacy organizations at fair market value for clearly defined work such as review of the protocol by their scientific advisory board or patient advisory board. Attendance at a patient or research conference is another potential option for engagement. PAO seeks the highest level of ethical conduct in engagement with pharmaceutical companies. The goal of engaging with pharmaceutical companies is to help enable the development of therapies while maintaining autonomy as a patient advocacy orgnisation. All interactions between the PAO, industry, and the disease community should be transparent; should enable trust, accountability, and shared learning; and ultimately should work most efficiently and effectively toward advancing meaningful treatments for patients.

While parsing through the many possible partners may feel daunting, the rewards can be dramatic. You gain access to a target patient population, easing clinical trial enrollment and laying the foundation for commercialization. You build credibility and a group of advocates for your product, which can be invaluable later when you face regulatory bodies. And engagement with an advocacy organization may even lead to suitable investigators and KOLs.

KOLs Are Allies with Unparalleled Insights

Many of the larger, more sophisticated advocacy organizations have developed or are affiliated with Centers of Excellence that provide specialized, multidisciplinary care for the indication being studied. While it is tempting to simply research physicians publishing in your indication, that often only uncovers the top two or three KOLs—who are likely to be overcommitted. Instead, by casting a wider net, you can discover a host of physicians who are already treating the patients you are targeting, and who have connections with other physicians or potential investigators in a certain country. Here is where having a CRO that has contacts in various countries that can reach out in the native language to identify potential KOLs can be critical.  Having identified your KOLs, foster engagement by involving them in your protocols and processes.

  • Reviewing your endpoints: While your study’s primary endpoint will be driven by regulatory demands and science, secondary and exploratory endpoints should be of value to the disease community. A KOL can provide critical input.
  • Shaping your clinical development plan: A KOL can explain how they would implement your study—and what barriers a certain study design might pose for their patients or even their institution. If they have previous analogous study experience, they can also help you avoid missteps they may have witnessed.
  • Illuminating regional differences: A KOL can help you understand the ways the treatment landscape shifts from country to country. For instance, in the United States, choice of hospital for an individual patient is highly dependent on insurance; in Eastern Europe, a specific indication may only be treated at a handful of hospitals. It will be useful to know the lay of the land prior to initiating clinical studies.

There are many ways to engage KOLs in your study, with varying levels of time commitment. They can serve on steering committees, scientific advisory boards, safety review committees, independent data monitoring committees, or adjudication boards. They can help present to potential sites and at conferences; they can participate in the authorship of papers. Each of these options helps raise their profile and yours.

Consider recruiting KOLs both in the regions where you plan to run trials, and also where you hope to gain regulatory approval. Already well versed in your study, a KOL who is on your team can provide an enthusiastic signature on a regulatory submission—and may even be present to show support at review meetings. Together with advocacy organizations, these trusted voices can shape your trial’s trajectory—from enrollment and execution to approval and commercialisations.

 

Looking to strengthen your next trial with the strategic relationships?

Connect with Ergomed to discover how our global network of experts and advocates can accelerate your development journey and enhance clinical and commercial outcomes.

 

Supporting Trials with Confidence

As trials continue to grow in complexity, placing dedicated resources at the site level is no longer a luxury—it’s a necessity. Site-centric service models, including the use of embedded site managers, offer a proven way to de-risk studies, support clinical teams, and deliver a better experience for patients.

In oncology studies, where the margin for error is slim and patient experience is critical, this model helps ensure not only compliance and data quality but also compassion and consistency.

Looking to strengthen your oncology or rare disease trial with tailored, site-centric support? Contact Ergomed to learn how our experienced teams help streamline operations, enhance site relationships, and ensure every study milestone is met with confidence.