What is the value of a patient-centric approach if that approach doesn’t include the patients themselves? While many life sciences companies have worked to encompass considerations that may be important to patients such as survival rates, quality of life, and ability to perform activities of daily living, they don’t always capture the real-life experiences of patients and what is actually most important to them.

As patients have become more informed about their conditions and have greater access to scientific information, they want a more prominent voice in all aspects of a medication’s lifecycle—from development to commercialization and beyond. They want a relationship with life sciences companies that is less transactional and more transformational. They want a patient inclusive approach.

So, how many life sciences companies are actually making an effort to include patients in things like drug development strategies, clinical trial protocols, patient engagement communication, etc.? More specifically, what role is Medical Affairs playing in working with patients to create educational materials that would make sense to fellow patients?

Why Focus on Medical Affairs?

Traditionally, the role of Medical Affairs is to generate scientifically accurate content for disease state education or on-labeling messages to healthcare providers (HCPs). But Maarten Beekman, MD, who spent over 33 years in corporate pharma before moving to the next chapter in his life to help medical leaders and companies to increase the impact of the Medical Affairs function, says, “Medical Affairs are best placed to be the ‘voice of the patient’ and should take the lead to develop a governance model on patient engagement in close collaboration with the Compliance function. The risk of not including patients in all of what we do is getting bigger than the risk of including patients.”

To find out how actively Medical Affairs departments are incorporating patients in what they do, PM360 partnered with Cactus Life Sciences on a survey of Medical Affairs professionals within life sciences companies. Furthermore, Cactus Life Sciences leveraged these findings at a recent training session where they received more feedback and insights into the minds of Medical Affairs professionals and their current work with patients.

“It was amazing to see the energy in the room and the true passion that the Medical Affairs colleagues had about wanting to do more with patients, and their frustration with not being able to,” says Laura Perry, VP of Marketing and Insights, Cactus Life Sciences. According to Perry, the three biggest insights that came of the workshop were:

  1. During the workshop, 25% of participants polled strongly agreed and 75% agreed that their organization should do more than they are currently doing to contribute to patient-centric initiatives.
  2. The majority of the participants reported that they are not actively involved in or do not provide support for a project that includes the simultaneous co-creation of education materials by both patients and clinicians, but would like to in the future.
  3. Compliance was seen as one of the major hurdles in becoming a truly patient-centric company. Observationally, this is truer for the small and mid-size pharma and biotech companies than for larger pharma companies.

What Even Is Patient Centricity?

Of course, it is important to first understand how Medical Affairs professionals define “patient centricity” as the term may mean different things to different organizations. The breakdown of how our respondents choose to define this term is:

  • 68%: Placing the patient’s well-being at the core of all initiatives
  • 48%: A shift from disease-centered to a patient-centered strategy and from product-led to a patient-led development process
  • 32%: Adding patients in the scientific process, including patient-centered end points in study development
  • 32%: Ensuring health equity and inclusion, including access to a drug at all socio-economic levels
  • 29%: Key development and performance indicators, including renumeration structures are adapted to put patient-first initiatives as priority
  • 23%: Clear communication about medicines risk-benefits and drug development in patient-friendly language
  • 19%: Patient preference information is included into the regulatory risk-benefit assessment
  • 6%: Including patient authors, peer-reviewers, guest editors, and contributors to journals for clinical trial publications

Leigh Boehmer, PharmD, BCOP, Chief Medical Officer, Association of Community Cancer Centers (ACCC) and one of the workshop leaders/presenters, found it particularly interesting that 32% believe patient centricity should involve adding patients in the scientific process. In another question, when asked how well their companies have actually engaged patients in the research and development (R&D) process 33% said fairly or poorly and 26% didn’t know or weren’t sure—that’s nearly 60% of respondents. That presents a clear disconnect according to Dr. Boehmer as only 29% said they are doing an excellent or very good job in this area.

“I believe patient-centricity requires active engagement of patients and/or the patient advocacy community in the design and conduct of medical education, clinical trials, etc.,” Dr. Boehmer explains. “We must place value on the integration of patients’ needs and lived experiences by inviting them to the table during all stages of creation and curation. What’s more, we need to approach them not just in the throes of disease but also in the reporting of pertinent results to at-risk populations, and when addressing screening/early-detection resources/activities, and other times before and after a diagnosis or healthcare crisis. Only then, do I believe, will we truly begin to build trust and effectively communicate; especially within historically marginalized and minoritized communities.”

But right now, that is not something our Medical Affairs respondents do very often. The majority (54%) say that they never or almost never invite patients to co-develop some kind of project, material, or other activity (Figure 1).

The Barriers Preventing Patient Centricity

What’s preventing those working in Medical Affairs from involving patients more in what they do? The most common barriers mentioned by our respondents for why patients aren’t invited to be a part of the R&D process are: determining which patients to engage with (40%); concerns about regulations governing engagement with patients (33%); lack of trust from patients (30%); patients’ knowledge of the research process/science (27%); patients’ lack of objectivity and unrealistic expectations (27%); and lack of knowledge about how to engage with patients (20%). Other respondents noted that they lack resources, either the time (17%) or money (13%)—and 10% say they don’t have enough prioritization from their peers or leadership to invite patients to partake in the R&D process.

“As a former clinician, my view is that keeping the patient’s needs (no matter our opinion on them) at the epicenter of all decisions is the cornerstone of good practice,” says Hosie Bhathena, Senior Vice President Scientific Services, Cactus Life Sciences. “If we are to move to a truly patient-centric approach in medical affairs, it’s important for us to acknowledge that we need to get better at learning how to communicate with and educate patients. While it’s somewhat surprising to see more than 50% of respondents suggest patients’ lack of awareness of research, science, objectivity, etc., bars them from engaging with this most critical group, it is heartening to see 20% of respondents saying they need to learn more about how to engage with patients successfully. Hopefully, it is this sort of thinking that will drive future Medical Affairs initiatives.”

In terms of what’s stopping more patient-centric initiatives from happening within Medical Affairs beyond just R&D, the majority of respondents (57%) cite their department’s historical precedent to only ask for clinicians’ input (Figure 2). Another significant barrier according to just under half of respondents (47%) is simply a lack of standard operating procedures for how to best engage with patients and/or caregivers.

“The barriers most commonly chosen by respondents all point back to a lack of guidelines about how to engage with patients, whether that be whom to engage with and/or how to interact in a meaningful way, within federal or other regulations,” notes Lily Chu, MD, MSHS, Vice President of the International Association for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis and also one the workshop leaders/presenters. “Some groups have published articles that might be helpful. One example is Bloom et al.’s 2018 article ‘The Rules of Engagement,’  which provides a checklist pharmaceutical companies can use to evaluate which patient groups to collaborate with on clinical trials. Another example is the U.S. FDA’s 2019 document targeting industry professionals, ‘Patient engagement in the design and conduct of medical device clinical trials.’

Despite facing these barriers, the vast majority of the respondents (84%) feel that their organization has effective community outreach and sustainable engagement strategies/programs that are tailored to meet the needs of patients. Eighty-seven percent also believe their organization has strategies in place to demonstrate trustworthiness to the patient/caregiver community. But as Dr. Boehmer points out, 30% of respondents said a lack of trust from patients was a significant barrier when trying to engage patients as advisors during R&D, so there is a bit of a divide between an organization’s perceived trust from patients and how much trust patients are actually willing to give the company.

Meanwhile, Dr. Beekman was also surprised to see such a high number of respondents believe they are delivering programs and support that meet patients’ needs and earn their trust, but as he says, “the question is of course if patients were included in these strategies…I am not so sure!”

Incorporating Patients into Medical Affairs

However, our respondents are currently involving patients directly in a few different types of communication activities (Figure 3). The majority are seeking patient input on disease state education (60%) and patient education post launch (52%), while 44% are also involving patients in the creation of plain language summaries. But Dr. Beekman believes that Medical Affairs can do more, including much earlier in the process considering only 8% said they involve patients in clinical trial summary results.

“Having patients involved from the start of the development program will ensure the patient perspective is continuously there,” Dr. Beekman explains. “First of all, do we really understand the key pain points in the patient journey? And if so, what can we do to reduce these pain points, e.g., ensure the right patient outcomes are defined in a clinical study protocol, develop patient tools beyond the actual medicines, etc.”

He also says it is important to identify the right patients to work with, especially when it comes to more common diseases.

“How do you define the ‘heart failure’ or the ‘COPD’ patient? The best model is probably to organize ‘patient panels’ of five to seven heart failure or COPD patients to try to get a good socio-demographic mix,” Dr. Beekman advises.

To further ensure Medical Affairs departments are better suited to meet patients’ desire for more transformational engagement, Dr. Chu says two ingredients are essential: commitment to incorporating patient input in good faith and clear communication.

“Before engagement, professionals could prepare by noting which issues or questions would benefit the most from patients’ views and then assuring those areas are discussed during meetings,” Dr. Chu explains. “After engagement, conveying to patients how their input reinforced or changed the project at hand can help patients feel listened to and empowered.”

Dr. Chu also notes that a failure to incorporate patients into the process can prove detrimental to a product’s success. “In 2011, a trial by the British government failed to meet its goals, because it didn’t incorporate patient or caregiver input early, appropriately, or enough,” she says. “It sparked a patient rebellion that led to international press coverage, a court case, and eventual withdrawal of the treatment.”

Caregivers are another group that should not be ignored. Shama Buch, Vice President Scientific Services, Cactus Life Sciences, has had to care for several family members who have since passed away. In a blog post, “Why Healthcare Providers MUST Care About the Caregiver,”  she wrote: “In this day and age, we should not have to wonder if each new symptom that your loved one shows on their journey has been studied and explained…but the challenge is not the absence of information, rather how the information is accessible for an exhausted, emotionally wrung out primary caregiver. What I miss is the simple instructions I need, to look after my loved one as a daughter, as a sister, as a caregiver. I miss the clarity of information that only comes when someone has been through what you have and can guide you. I miss another caregiver writing about even treatment options from the perspective of a patient not a physician…Hence the intensity and urgency of need for patient- and caregiver-focused communication.”

That is what a patient/caregiver inclusive approach can mean to the people life sciences companies are trying to reach who are actually dealing with the diseases their products treat. It is why patient centricity is no longer—and may never have been—enough.

“In order to truly realize transformational engagement, long-standing partnerships with patients, patient advocacy groups, and community leaders and groups must be prioritized and achieved,” Dr. Boehmer says. “To this end, I would suggest that all those working within the healthcare ecosystem complete recurring education/training and evaluation to demonstrate and maintain cross-cultural competencies, mitigation of biases, and equitable, inclusive communication.”


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