It is Time to Equip Patients Part 7:
Educating Patients: Taking Action to Refocus and Accelerate
Over the past weeks, I have discussed several barriers that make it difficult to involve patients in developing new medicines as much as everyone involved would like. My theory is that we need to do a better job educating patients. I’d love to hear your thoughts on this topic.
Some of these barriers may seem obvious and manageable on their own. However, the devil is in the details and in the overall burden of these barriers when taken together. It is complex, it is not intuitive, and it is relentless. In order to solve this conundrum, all stakeholders are going to need to work together. Unfortunately, the patients are new arrivals in the discussion and therefore face significant disadvantages, and even resistance to change the system.
Newly diagnosed patients start a long learning journey through which they cross a number of thresholds; diagnosis, current treatment options, community involvement, experimental treatment options, trial involvement, and activism. The things they must learn grow in difficulty, complexity, and depth with each step. The farther they go, the harder it is to find, let alone understand, what they need to learn. And, if they find sufficiently successful treatment at any point, they probably drop out of the journey. So, what does this mean? There are very few patients who have the will, perseverance, or even health to make this long journey successfully to the point where they are adequately prepared to make a real difference in the development of future medicines. It just takes too long!
There are two strategies that can improve this situation:
1. Refocus education efforts toward patients
2. Accelerate the learning journey so that such “qualified” patients can have a bigger impact
Refocus Efforts Toward Educating Patients
Much of the education, regulatory guidance, and advice being developed today focuses on what biopharmaceutical companies can do to try to involve patients in the process. This works on some fronts, particularly on the operational side (recruitment, retention). Unfortunately, it just tilts the balance away from the patients who want to roll up their sleeves and get to work. The companies remain in control of managing the conversation. The danger is that the companies either only make a token effort or they simply use the patients when they decide it is worthwhile.
However, if the answer to truly patient-led drug development is to get patients involved earlier and more deeply, then the focus of our efforts and investments need to shift to educating patients, their families, and other caregivers. They need to learn how they can take action that will produce the kinds of change they seek. They need to understand the language researchers use and respond to positively. They need to build the skills and confidence to confront the professionals. They need to develop and understand their own expertise. They need to learn how to manage the ups and downs of Biopharmaceutical R&D. They need to understand the various stakeholders and learn how best to manage them without compromising their own needs. They need to learn how to drive the discussion of improving the outcome of drug development. Yes, they need to learn a lot and we just haven’t invested enough in helping them learn.
In order to accomplish this, education needs to be affordable for these patients and those around them. The education also needs to be tailored to a much broader range of aptitude, backgrounds, and experience. The education needs to be simple to find and will need to be accessible to patients who may have disabilities. The education needs to meet them where they are.
Accelerate the Learning Journey
Currently, learning about drug development lags the motivation that patients have to take this journey. No one gets diagnosed and immediately asks, “Well what does it take to find, develop and gain regulatory approval for a new medicine?” That urge comes later. Thus, there is an opportunity to shorten the lag time between when a person wants to learn and when they are prepared by developing effective educational tools and providing them sooner in the journey.
In addition, some patients are faced with a short runway. Their ailment may be progressive, debilitating or even terminal. Even if their disease is manageable, they cannot escape the inevitable march of time. At some point, these patients may not be physically, mentally, or emotionally able to continue the good fight. Their motivation declines. Thus, we need to change the trajectory of their learning curve so that they have more time to exert their influence once they are fully prepared. Again, providing effective educational tools that speed up the learning curve. One way to accomplish this is to make the learning journey exciting, enticing, and fulfilling. In this way, patients will go beyond their own circumstances and seek to learn either for learning’s sake or for the sake of other patients like themselves.
There is hope
In addition to the time it takes to be fully prepared, we cannot ignore that this is multifaceted preparation. Patients need knowledge, skills, and confidence to engage fully with this system. Thus, any educational tools or system need to provide this full-thickness education. There need to be elements of study, practice, experimentation, and achievement built right into the program.
There is an example of this type of education already in existence in Europe. The European Union Patient Academy for Innovative Therapies (EUPATI) was formed in 2012 as a five-year directive of the European Innovative Medicines Initiative (IMI). EUPATI has been highly successful in bringing together experts from all corners to develop web-learning, resources, events, and tools for educating patients about the drug development process. However, this effort has been exclusively focused on the EU processes. While the scientific framework is roughly the same, the regulatory, legal, and ethical controls on drug development in the EU are much different from those in the US. Additionally, there are some cultural and political advantages for creating such a government-sponsored project in Europe.
The challenge remains to develop world-class educational content, tools, and systems to prepare patients in the US to fully exert their influence on shaping medicines of the future. Since there is no organization like EUPATI in the US, it has been suggested that drug developers partner with patient advocacy organizations and interest groups. While this is certainly a necessary step, it will only lead to further fragmentation and dilution of education. In addition, in 2013, there was a call for developing a code of ethics for patient education to address this variability. This move toward consistency and quality needs to be driven by someone or some group. The field simply is not structured to do this effectively.
Pharmaceutical companies manage R&D in different ways and are very focused on the patients for which they have products or compounds in the pipeline. Much of their outreach is meant to build their own brands.
Likewise, most Patient Advocate Groups (PAGs) are disease-focused. The number of such PAGs is as high as the number of diseases. Furthermore, the size, funding, and sophistication of these groups vary greatly so that there definitely are “haves” and “have-nots.” Some Rare Disease PAGs are extremely small and cannot afford to develop their own educational programs.
Simply multiplying the number of combinations these two types of organizations yields a daunting number of variations. In order to get to the deeper education proposed here, each of these variations would incur a cost to develop. Furthermore, each could have its own spin or points of emphasis. As a patient seeking the definitive word on this topic, I would be troubled by the different stories I could find.
A more efficient, effective, and truly patient-centered approach would be to develop a common set of tools for educating patients that the PAGs could then distribute. This would ensure the design meets the needs of patients and would also cement the PAG as the “Go To” source of information. It would also facilitate the development and application of standards that could be adopted for educating patients about their disease, treatments, policies, and advocacy.
This common set of tools, like EUPATI, could have versions or add-ons for each disease or set of related diseases. The cost of building a single source or common set of core courses would be much lower and could be shared across the healthcare system, leaving only the cost of disease-specific customization to be borne by the PAG. This would put a reliable, relevant, and robust set of educational tools within reach of all PAGs, large and small. Further development, maintenance, and growth of these tools could be funded through PAG subscriptions based upon the size of a particular patient population or on a fee-for-usage basis.
Salem Oaks Consulting
Salem Oaks was formed to address this need. Our plan is to develop a suite of educational tools that help patients, their families and caregivers efficiently learn the drug development process at a number of levels. These programs will tap into 30 years of experience teaching Biopharma colleagues how to discover and develop new medicines. Our initial plan is to build five programs:
Drug Development 101
This is a basic explanation of Biopharmaceutical Research & Development (R&D). The target audience is patients and their families who have recently learned about their diagnosis and are looking for alternatives to the standard of care for any number of reasons.
Understanding Clinical Study Designs
This program digs a bit deeper into the world of clinical studies (also known as clinical trials). The program is intended for those patients who are deciding whether to enroll in an actual clinical study of an investigational agent.
This experience is being designed to help patients become good subjects. A more practical experience of the study environment and process will ensure patients are prepared and able to participate in a way that enhances the study’s effectiveness and reliability.
This includes a short, simulated experience as a drug developer. The simulation is built around the decisions that an organization must make to develop medicines. It emphasizes the multiple factors involved in each decision, the uncertainty, and the trade-offs between short-term benefits and long-term viability.
Join the Team
This hands-on program invites active advocate patients to practice working with a study team to design and execute a clinical study using Problem-Based Learning. A real protocol concept will be introduced and the team will work on the issues that arise. The participants will be coached on how they can have more impact, engage the professionals in a credible way, and take a practical, businesslike approach to their work.
In addition, Salem Oaks can provide a wide range of consulting services for patient advocates, the biopharma industry, regulators, investigators, and investors.
Kevin Freiert is the Principal of Salem Oaks Enterprises, LLC. Committed to working with patients, their advocates, biopharmaceutical companies, regulators and other stakeholders to develop educational tools that help patients bridge the gap between themselves and Biopharma R&D.
 Lowe MM, Blaser DA, Cone L, Arcona S, Ko J, Susane R, Wicks P. Increasing Patient Involvement in Drug Development. Value in Health 2016:19:869-878
 Krug S, It’s Time for a Code of Ethics in Patient Education, http://www.pharmexec.com/print/203748