eyeforpharma Philadelphia Conference VIRTUAL

Apr 14, 2020 - Apr 17, 2020, Philadelphia

FREE TO ATTEND: The world’s greatest gathering of pharma’s value-designers with 6000+ pharma decision-makers from marketing, patient engagement, advocacy, clinical, medical affairs, market access, RWE and IT,

Pharma’s new ally: The caregiver

Pharma has only just started thinking about how engaging with caregivers could unlock a range of valuable insights

While pharma and the wider healthcare sector are making patients more central to their innovation efforts these days, little consideration is given to caregivers.


The role of the unpaid caregiver is one they would do well to consider more. Caregivers comprise an enormous, and largely untapped, reservoir of information and wisdom about the individuals they provide care for, says Schiffon Wong, Executive Director, Global Evidence & Value Development at EMD Serono. 


“There is a significant opportunity when it comes to caregiver input into medical product evaluation. Understanding this can further our own ambitions to develop new products and improve patient outcomes.”




Wong is involved with Embracing Carers, a global initiative founded by Merck KGaA, Darmstadt, Germany and led by its biopharma business EMD Serono in the U.S. and Canada, in collaboration with leading carer organisations to increase awareness, discussion and action about the often-overlooked needs of carers.


A source of insights

Such initiatives will grow in importance. As populations in the developed world age and as healthcare delivery systems fragment and grow more complex, carers will become ever more important allies in improving outcomes.


The day-to-day experience of carers has huge potential to deliver valuable insights, says Grace Whiting, President and CEO of the National Alliance for Caregiving (NAC). “It is important for people who are designing drugs and devices to understand how they are used in the real world from the way someone takes their medicine to how devices impact the effectiveness of it.”


Understanding the role of the caregiver can help provide pharma with a multitude of valuable insights and pathways to innovation, says Wong. “The benefits of enhancing our engagement with caregivers are multi directional and span the health ecosystem.” 


Their potential contributions can help improve trial recruitment, retention and engagement and exist along the entire process from discovery, pre-trial, trial and post-approval: 


Discovery & Pre-Clinical Phase: Caregivers can help build a holistic understanding of the natural history of a condition and can weigh in with their own impressions of research priorities, as well as articulating those as reporters, surrogates, or proxies for their care recipients. Their perspective can be used to continually refine the target product profile and design product features, including dosing and mode of administration. Caregivers can be valuable partners in crafting development tools like trial endpoints, PROs, and ObsROs.


Phase 1-3: They can participate in clinical trials as observer, reporter, surrogate, and/or proxy for the care recipient, or for their independent perception of benefit-risk tradeoffs. Where individuals rely on a family caregiver to enable their participation in a clinical trial, obtaining caregiver input on protocol design, informed consent content and processes, and recruitment and retention strategies will improve acceptability, enrolment, and retention. 


In clinical trial simulations their contribution can be great in post-clinic visit care or follow-up. Caregivers also can serve on data safety monitoring boards, assess communications with potential and enrolled clinical trial participants (and caregivers), and help to make sense of trial data.


Regulatory Review: Caregivers can provide support in key regulatory meetings, articulate the unmet medical needs of patients, validate the desirability of benefits experienced by clinical trial participants and evaluate the tolerability of tradeoffs of potential or experienced side effects, adverse events, or other harms, based on their observations and interaction with patients and other caregivers. Caregivers may also be valuable to include in focus groups or other market research conducted to assess packaging and patient-facing materials being developed for a commercial launch.


Post-Approval: They can provide insights for products that are approved with post-marketing study requirements or where a label change or new indication is being considered. They can also collaborate on evidence collection and other surveillance activities. Their viewpoints will have great importance for some conditions in developing and supporting market access strategies and health technology assessments (HTA), especially where there is a home care delivery component.


But pharma has much to do before it can realise these benefits.


More work needs to be done in the industry as a whole to better understand the role and experiences of caregivers, says Whiting. Caregivers have differing roles, which may evolve over time, with different kinds of patients, in different disease settings and at different stages of a disease’s trajectory.


For example, a caregiver’s role may evolve over time from being one of observer/reporter to being a surrogate and back again as a condition progresses. Treatment periods vary, patients can be elderly or young and have differing mental and physical capabilities. Caregivers ability to absorb and process information, sometimes profuse and complex, is a further consideration.


The nature of their relationships with the patient can also have very different implications for caregivers’ ability to contribute. For example, parents are very effective reporters of pain in their young children but adolescents can accurately report on their pain themselves.


Assessing which care givers can help contribute to medical product development, which of those might need training and other forms of support to help build their confidence and skills and which may already have too heavy a burden of responsibilities to contribute is a yet another consideration. The need to balance the patient’s privacy with the caregiver’s ability to contribute is another.


An innovation opportunity

A much more detailed understanding of such dynamics would be of great value to pharma but the work is only beginning, says Whiting. “Data is being collected but we don’t understand it very well. That is where innovators can set themselves apart.”


Pharma also needs to adapt its own internal processes if it is to engage effectively with caregivers, says Wong. “Pharma needs to take a step back and look at our disease or compound strategies and ask: what are the opportunities to engage carers? 


“It requires strategic change management. We need to be elevating the right mindset and getting the education right internally. We need the right processes and infrastructure that allow us to embed this in the organisation, and to establish some new norms.”


That does not mean appointing someone in the organisation as a specific owner of the caregiver engagement function, however. “Ideally everyone should be caregiver champions,” says Wong. “I would not advocate for pharma to make this a dedicated function because there is risk of having siloed thinking as a result. While the care partner is distinct, they are part of that network around the patient.


“And it is by working with the wider healthcare network, including advocacy groups and healthcare policy makers to combine good policy with solid science and data-led insights into the role of carers, that the best opportunities to innovate will see the best results,” says Whiting. “The new possibilities for incorporating the caregiving perspective are still emerging but they will require this ‘all aboard’ approach, adds Wong.


Measuring engagement

The thinking is still developing about ways in which pharma could track how it engages with carers to best effect, says Wong, but an existing template that could help shape this thinking is the seven Patient Engagement Quality Criteria:


1. Shared purpose

2. Respect and accessibility

3. Representativeness of stakeholders

4. Roles and responsibilities

5. Capacity and capability for engagement

6. Transparency in communication and documentation

7. Continuity and sustainability


Another relatively simple but valuable way to measure progress would be at the strategic level of a clinical development plan, adds Wong. “Are you making space to think about the role of the care partner in strategy documentation? That is a good entry point and it will provide a good indication of where you are going over time.”




Many pharma organisations are a long way away from getting to such detailed considerations, however. In many cases there is a job to be done simply to impress upon colleagues the potential benefits of engaging with caregivers, says Whiting.


“People recognise that the caregiver exists but the understanding that the caregiver is a separate human being from the person who needs care isn’t always clear, nor is there a realisation that the caregiver’s voice is additive. That it can work in harmony with the patient voice is a relatively new idea that is still emerging.”


eyeforpharma Philadelphia Conference VIRTUAL

Apr 14, 2020 - Apr 17, 2020, Philadelphia

FREE TO ATTEND: The world’s greatest gathering of pharma’s value-designers with 6000+ pharma decision-makers from marketing, patient engagement, advocacy, clinical, medical affairs, market access, RWE and IT,