To do so successfully, the pharmaceutical sector will need to earn patients’ trust, something that it has not always had — or actively prioritized — in the past.
“In the past, a stigma surrounded pharma among the general public,” says Priya Patel, MSc, principal real-world evidence consultant at OPEN Health. “Naturally, there will always be patients who do not fully appreciate the purpose and intentions of the pharmaceutical industry in developing new treatments and ensuring they’re accessible to the patients who need them. There may also be patients who are influenced by negative media stories and believe that the industry does not have patients’ best interests at heart.
This can create reluctance to participate in research on behalf of pharmaceutical companies. This is where education is key. We need to show patients the importance of doing the research and how it will benefit them. Similarly, in the digital age, patients are becoming a lot more aware of issues surrounding data privacy and consequently are more protective of their information, so they are less quick to sign off on the use of their personal data. Dealing with this, again, comes back to education. Our patient resources and consent forms must be very clear on how we intend to use data. We must reassure the patient that they are in control of their data, and that, if they want to withdraw at any time, they can.”
At the same time, regulatory pathways are changing. Agencies including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have signaled a greater willingness to access real-world data (RWD) and real-world evidence (RWE) in decision-making processes. Regulators are also pressing stakeholders to include PROs in both clinical trials and post-marketing studies, and they are encouraging the adoption of more patient-centric measures within health technology assessments (HTAs).
This creates a need for change within healthcare and the life sciences. Stakeholders must promote health literacy and education among patient populations and the general public while working to ensure that they are communicating in language that is suited for its audiences. They must develop new models for ensuring that patient voices are heard throughout the research process, going beyond merely surveying prospective participants at a project’s start to encompass co-creation (including patients among a study’s named authors).
To do so successfully, the pharmaceutical sector will need to earn patients’ trust, something that it has not always had — or actively prioritized — in the past.
“In the past, a stigma surrounded pharma among the general public,” says Priya Patel, MSc, principal real-world evidence consultant at OPEN Health. “Naturally, there will always be patients who do not fully appreciate the purpose and intentions of the pharmaceutical industry in developing new treatments and ensuring they’re accessible to the patients who need them. There may also be patients who are influenced by negative media stories and believe that the industry does not have patients’ best interests at heart.
This can create reluctance to participate in research on behalf of pharmaceutical companies. This is where education is key. We need to show patients the importance of doing the research and how it will benefit them. Similarly, in the digital age, patients are becoming a lot more aware of issues surrounding data privacy and consequently are more protective of their information, so they are less quick to sign off on the use of their personal data. Dealing with this, again, comes back to education. Our patient resources and consent forms must be very clear on how we intend to use data. We must reassure the patient that they are in control of their data, and that, if they want to withdraw at any time, they can.”
At the same time, regulatory pathways are changing. Agencies including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have signaled a greater willingness to access real-world data (RWD) and real-world evidence (RWE) in decision-making processes. Regulators are also pressing stakeholders to include PROs in both clinical trials and post-marketing studies, and they are encouraging the adoption of more patient-centric measures within health technology assessments (HTAs).
This creates a need for change within healthcare and the life sciences. Stakeholders must promote health literacy and education among patient populations and the general public while working to ensure that they are communicating in language that is suited for its audiences. They must develop new models for ensuring that patient voices are heard throughout the research process, going beyond merely surveying prospective participants at a project’s start to encompass co-creation (including patients among a study’s named authors).
"The COVID-19 pandemic really highlighted the importance of communicating medical information from a position of compassion and understanding."
LARA GROVES, PHD PRINCIPAL REAL-WORLD EVIDENCE CONSULTANT, OPEN HEALTH
They must actively strive to empower patients to be full participants in research and health communications to ensure that their needs are kept front and center at all times.
“The COVID-19 pandemic really highlighted the importance of communicating medical information from a position of compassion and understanding,” says Lara Groves, PhD, a principal real-world evidence consultant at OPEN Health. “It also taught us how critical it is to have access to information that’s both accurate and up-to-date. Research needs to learn these lessons. It must be equitable, inclusive, and accessible for all patients.”
Making HEOR accessible to patients is a broad-ranging topic spanning multiple disciplines and capabilities. Accordingly, we interviewed numerous people from across our organization, inviting them to share their knowledge, experiences, and thoughts for the future. They are experts in patient engagement and writing, health psychology, data dissemination, health
literacy, communications and, of course, HEOR methodologies and processes. To serve as a framework for our thinking and guidance, we developed the concept of the four domains of patient participation in the HEOR process.
These domains correspond to four areas where collaboration with patient communities will drive better outcomes, both for the research and ultimately for the patients we strive to serve. These stages span the entirety of the project lifecycle, from its conception to the communication of results. Alongside the spectrum of patient participation, we hope these domains will help our industry colleagues achieve deeper and more lasting partnerships with the patient community. In so doing, they will create virtuous circles where engagement will speed up research processes and improve communications, which, in turn, will accelerate access, advance patient outcomes, and increase trust in the pharmaceutical industry.
They must actively strive to empower patients to be full participants in research and health communications to ensure that their needs are kept front and center at all times.
“The COVID-19 pandemic really highlighted the importance of communicating medical information from a position of compassion and understanding,” says Lara Groves, PhD, a principal real-world evidence consultant at OPEN Health. “It also taught us how critical it is to have access to information that’s both accurate and up-to-date. Research needs to learn these lessons. It must be equitable, inclusive, and accessible for all patients.”
Making HEOR accessible to patients is a broad-ranging topic spanning multiple disciplines and capabilities. Accordingly, we interviewed numerous people from across our organization, inviting them to share their knowledge, experiences, and thoughts for the future. They are experts in patient engagement and writing, health psychology, data dissemination, health literacy, communications and, of course, HEOR methodologies and processes. To serve as a framework for our thinking and guidance, we developed the concept of the four domains of patient participation in the HEOR process.
These domains correspond to four areas where collaboration with patient communities will drive better outcomes, both for the research and ultimately for the patients we strive to serve. These stages span the entirety of the project lifecycle, from its conception to the communication of results. Alongside the spectrum of patient participation, we hope these domains will help our industry colleagues achieve deeper and more lasting partnerships with the patient community. In so doing, they will create virtuous circles where engagement will speed up research processes and improve communications, which, in turn, will accelerate access, advance patient outcomes, and increase trust in the pharmaceutical industry.