Let’s do a quick word association exercise. What is the first word that comes to mind when you read each of the terms below?
Chances are your responses were somehow affected by your level of familiarity with medicines development.
Patients are the most important stakeholders in the development of new therapies. Thus, one might conclude that patients must be involved in the process of developing these therapies. While there are some excellent examples of patient involvement improving both the execution and the focus of clinical trials, it is far from the norm. Why?
There seems to be consensus from all the stakeholders that patient involvement would enhance the development of new medicines and devices. There also seems to be consensus that this promise is not being realized. Why?
The purpose of this series is to identify and characterize some of the barriers to effective collaboration between patients and the innovative pharmaceutical industry.
Understanding the Problem
There are several factors that make it difficult to achieve the type of deep patient involvement in the drug development process and the shaping of the future of medicine. In this series, we will explore five of these barriers and look for common elements that may provide a course of action.
- Patients Don’t Speak the Language of Drug Development
- Professional Experts Can Be Intimidating
- Patients and Researchers See the Journey Differently
- Many Stakeholders, Many Stakes
- Biopharma May Be Missing What is Most Important to Patients
This installment will focus on the challenges the very language of medicines development presents.
Patients Don’t Speak the Language of Drug Development
The language used to describe the development of new medicines is quite dense with medical terminology, regulatory requirements, and industry jargon. Making matters worse is the propensity for the experts in drug development to create a shorthand of acronyms and labels to describe very complex topics. The words used can have multiple meanings and when the layperson, the lay-patient, is suddenly submerged in this new language, they can find it very difficult and confusing. It also can be quite scary.
This is not surprising when the traditional players and decision-makers in biopharmaceutical R&D have been very well-educated scientists and physicians. It also is not unique to medicine development. In 2009, The Alan Alda Center for Communicating Science was established to empower scientists and health professionals to communicate complex topics in clear, vivid, and engaging ways; leading to improved understanding by the public, media, patients, elected officials, and others outside of their own discipline. The work of the Alda Center has demonstrated that scientists are not very good at talking to fellow scientists, let alone the common patient. Clearly, there is a need for these professionals to adapt their language to the audience they are seeking to work with.
Communication is a two-way street. Patients who learn the lingo would be better equipped to understand, contribute to, and shape the conversations about emerging therapies. In addition, they would gain confidence in critical thinking when reading the news and scientific papers.
Unfortunately, there is not a coherent system for helping patients learn about the field of medicine development. There certainly are efforts, but these are fragmented and not always easy to find.
- The publicly available courses typically used to train new pharmaceutical researchers are too expensive for most patients to afford.
- Many patient-focused educational efforts sponsored by biopharmaceutical companies are intended to convince patients and volunteers to participate in their clinical studies as subjects.
- Sometimes these programs are very narrowly focused on a particular disease or even product.
The bottom line is that most currently available educational resources do not provide the depth and breadth of understanding required to be an active player in the design, execution, and interpretation of clinical studies. And none of these programs help the patients understand the full scope of medicine discovery and development. Thus, patients who want to be involved at this more instrumental level, come to the table at a serious disadvantage.
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. A foundation for this learning journey is the language of researchers.
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. If the answer to truly having 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 those patients, their families, and other caregivers. These key stakeholders need to learn how they can take action that will produce the kinds of change they seek. But first, they need to understand the language researchers use and respond to positively.
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.
One model for doing this is to provide these educational opportunities through the Patient Advocate Groups that serve them. The ideal would be to develop a common independent curriculum that teaches the basic language and process of medicines development that applies to all therapeutic areas. This core could then be modified and supplemented to surface the disease-specific considerations. It could also be tailored for scientific literacy levels. Such a model would both leverage the scale of the Patient Advocate Groups and encourage more consistent terminology. The more Patient Advocate Groups that get involved, the more cost efficient the development of the materials overall. This model would also provide a much larger and broader audience who could provide feedback and encourage ongoing improvement of the program. It’s time we get started!
 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