From patient-centric to patient-partnered – deeper collaboration always benefits biopharma

Over the past two decades, biotech and pharmaceutical companies have made significant progress in integrating patient experience data (PED) into the development of new interventions.

This has been facilitated by increased interest from regulatory and payer/access agencies and patient advocacy groups. Now, it’s estimated that more than 90% of registrational clinical trials generate some form of PED.

The recognition of PED as a metric of therapeutic value and the growing role of this data in decision-making during intervention development and beyond is significant and represents positive progress for patient-focused intervention development.  However, PED is only one part of a patient-centred approach to drug development.

For a true patient-centric approach to intervention development, organisations should also partner with patients throughout the development life cycle – from trial design to communication strategies and support programmes.

A patient partnership approach is not easy to implement. It requires equitable collaboration where patients help drive development, which is a significant departure from the KOL-driven medicines development of previous years.

It requires that organisations understand the value of patient partnership, its challenges and the opportunity it presents.

A recently published series of essays from biopharmaceutical company executives, patient representatives and advocacy leaders, academics, regulators and patient-focused researchers offered their perspectives on where the industry is in 2025 and where it needs to go next to really be patient-centric.

Here are key takeaways from those contributions and insights into why patient partnerships are needed.

The first formal definition of patient-centricity in the biopharmaceutical industry was presented in 2017 as ‘putting the patient first in an open and sustained engagement of the patient to respectfully and compassionately achieve the best experience and outcome for that person and their family.’

This definition is still relevant today. However, exactly what patient centricity means in a practical sense in the development of interventions remains elusive.

The nature of intervention development makes it inherently challenging to truly put the patient at the ‘centre’. For instance, clinical trials must remain committed to ensuring scientific validity and regulatory compliance.

This has led to limited involvement of patients in decision-making processes. Ironically, regulatory pushes for patient centricity may have encouraged patient involvement to be more transactional than transformative.

The regulatory framework that has driven organisations to systematically consider PED has also made patient engagement activities somewhat one-sided; questions about patient experience are often driven by and aligned with organisational objectives and as a result do not represent the entire patient story.

To remedy this, patient involvement needs to be looked at from a new perspective; one that makes them an equitable partner in the process who can be involved in different and more meaningful ways.

Patients want to be involved in the co-development of interventions and their evaluation by contributing and sharing their experiences and priorities, and biopharmaceutical companies stand to benefit from this involvement.

Leveraging patient partners throughout intervention development can enhance every phase of the process by:

• Identifying unmet patient needs, priorities and preferences so interventions can be aligned where possible
• Helping design clinical programmes for human testing of interventions to improve decision-making for enrolment, intervention comparators and more
• Enhancing the design of clinical trials to create better experiences for participants and make sure endpoints generate patient-relevant data
• Using peer-to-peer networks to raise awareness of clinical trials and support recruitment
• Communicating trial results to participants, patients and medical and scientific communities
• Helping create protocols for ongoing collection of PED in routine care to further understand treatments’ impacts on patients.

To be successful, biopharmaceutical companies must prioritise patient partnerships as a core value across the organisation. However, patient partnerships in the industry face inherent challenges, namely organisational processes and budget pressures.

Several authors provided solutions for addressing these challenges:

• A standardised framework is needed to engage patients systematically in an ethical and transparent way across all stages of research, ensuring that patients are supported to participate meaningfully and sustainably
• Education and training are required both within industry and among patients to ensure productive collaboration.
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• For a pre-phase 2 project, a patient-engagement activity that avoids one protocol amendment and improves enrolment, adherence and retention can result in a net present value (NPV) increase of $62mm and an expected NPV increase of $35mm
• Patient and public involvement (PPI) interventions have been linked to a modest but meaningful increase in participant enrolment. In particular, the involvement of people with lived experience of the condition being studied has been associated with improved enrolment
• Research has found that involvement of participants in clinical trials can improve study procedures, communications of key messages and results, and the overall participant experience
• Patient-reported outcome (PRO) data can influence policy decisions, including clinical guidelines, drug approvals and product labelling.

When realigning processes for patient needs and preferences, organisations will need to consider factors like innovation and the scientific and medical frameworks in which interventions are developed.

This creates an opportunity for leaders and other stakeholders to rethink their engagement models and challenge the status quo.

Additionally, organisations don’t need to start from square one to create deeper, more meaningful engagements with patients during intervention development.

They can use existing frameworks to determine what those engagements should be and to measure them and their value.

Looking at patient engagement from a new perspective – one that moves patients from the centre of the development process and makes them an equitable partner in other areas – can lead to systemic change.

By committing to working with and listening to patients at various parts of the development process, organisations can better understand and address unmet patient needs and more fully realise their mission to improve patients’ lives.