Patient-centricity is the watchword in clinical research and healthcare more generally. Putting patients first not only improves the quality of their participation — which is good for clinical trial recruitment and retention — but also helps shape the design and protocol of trials.
Medical affairs teams are increasingly seen as the conduit between pharma and patients, and indeed other external stakeholders. Here, we look at the role MA teams can play to amplify the patient voice and why they are best placed to do so.
The life sciences industry has seen three main waves of patient-centricity: commercialization, R&D and enterprise-wide, according to Ryan Myers, Margaret Anderson and Casey Korba at Deloitte.
Commercial teams tend to be most prepared for patient-centricity. However, making clinical research better depends on taking more of a patient-centric approach, so more pharma companies need to improve their organizational culture in order that their entire organization understands why patients need to be at the center of pharma research.
Indeed, listening to the patient voice will better help pharma meet patients’ needs and also to improve the trust between patients and pharma, and with physicians, writes Matthias Evers, Ph.D. together with fellow McKinsey partners.
MA teams are well placed to listen to the patient voice and translate what they’ve learned into their pharma organization’s internal development. To succeed at this, however, they should focus on improving engagement with patients. The McKinsey team suggests medical affairs look to quantify patients’ unmet needs and use this data to inform trial designs.
The FDA has seen the value of including the patient voice in clinical research decisions. It regularly hosts public patient-focused drug development meetings to gain insight into particular diseases. This is in accordance with the 2012 reauthorization of the Prescription Drug User Fee Act (PDUFA), says global executive and general partner at New Ventures Funds, Harry Glorikian.
Additionally, the 2016 21st Century Cures Act and 2017 Food and Drug Administration Reauthorization Act calls for sponsors to share patient experience data when making new drug applications. MA teams need to use these laws to their advantage to motivate companies to incorporate the patient voice as often and early as possible in the trial’s process.
To understand what patients need, relationships between pharma and patients and patient advocacy groups are vital. Their experiences and priorities shape pharma’s policies and processes, explains pharmaceutical physician Karen Mullen, who is country medical director for UK and Ireland at GSK.
Medical affairs teams need to highlight the importance of the patient voice. Encouraging senior leadership to lead in this regard can be an important means of filtering this message throughout pharma organizations. “If all employees recognise the value and importance of embedding the patient voice in their work and can see that it is a priority for the company’s senior leadership team as well, they will find it easier to take a more active role in changing their own ways of working,” Mullen says.
An example of why science needs the patient voice comes from Carole Scrafton, head of FibroFlutters, a UK support group for patients with chronic and rare diseases. She says pharma is very particular about how patients should take their medicine, but this doesn’t necessarily align with patients’ lived experience. Scrafton says part of the problem is that pharma has not traditionally focused on a holistic understanding of the patient experience.
Understanding patients’ needs as well as the lived reality of treatments would help pharma make more patient-centric decisions during drug development.
Pharma’s attitudes are changing, she notes. Medical affairs teams just need to keep their organizations chartered on this new course, gaining patients’ insights wherever possible. They need to remember that the patient understands their own lived experience more than any drug developer can.
Medical affairs teams are the people that bring the patient voice into the pharma organization. They also have access to all of the relevant clinical data. “In a sense,” says Peter Janiszewski, Ph.D., associate director of medical affairs at Allergan, “the absolute truth stops with us.”
The responsibility that falls on MA teams, therefore, is significant. To fulfil their duties, they need to concentrate on their communication skills.
They need trust from patients to hear about their lived experiences of the disease. Medical affairs teams also need to translate complex scientific language and R&D data into relevant and personal narratives that resonate with patients, says Shairose Ebrahim, president and CEO at Integrated Medhealth Communication Group.
MA teams should also lead on an integrated approach that informs all external and internal stakeholders. This requires applying real-world evidence to support the value proposition, transparent messaging to patients and a commitment to building trust.
By understanding patients’ needs, pharma can build better marketing and recruitment campaigns. Including the patient voice can add authenticity to a pharma brand, writes Robin Robinson at PharmaVoice. After all, the personal stories of someone with a disease will resonate more with other patients than any hard scientific data.
The customer is not necessarily only the patient. Patient advocacy groups and patients’ physicians are also customers and MA teams need to focus their engagement on all of them, says medical affairs consultant Mary Alice Dwyer.
Focusing on the customer allows medical affairs teams to think about treatments and trial designs from the customer perspective. How do customers want to exchange information? How often? Digital processes enable MA teams to engage customers in tailored ways.
Of course, MA teams will need to know what these customers want through relationship building, but once done, a personalized strategy can be rolled out to engage these relevant customers.
Medical affairs teams perform multiple functions. They need to generate data, translate it and package it in relevant narratives. It’s patient-facing but needs to be plugged into all the various pharma departments, says Stanislav Glezer, vice president of global medical affairs for diabetes care at medical technology company BD.
These various responsibilities means MA teams are stretched to accommodate competing needs. To manage these demands, Glezer says medical affairs needs new capabilities. They should be focusing on supporting patients who are taking an active role in their own healthcare. Interaction with patients directly as well as with their healthcare providers is essential for MA teams to make better decisions.
It’s important, then, for MA teams to tap into their experience as healthcare professionals. They are knowledgeable about caring for patients. The more they can instil that mindset into their organizations, the better for all stakeholders. Part of doing this successfully requires MA teams to understand the differing definitions of value to which stakeholders might subscribe.
Patients may define value differently from payers, for example. MA teams will need to understand these different definitions and align them to a mutually beneficial outcome, explains Jill Condello at Open Health.
Medical affairs teams are uniquely placed to amplify the patient voice. Doing so will help to improve patient-centricity in trial design and ensure patients have a positive treatment experience. Listening to patients and translating their needs to pharma and external stakeholders is an area in which MA teams can add tremendous value.
Images by: fizkes/©123RF.com, pressmaster/©123RF.com, dolgachov/©123RF.com