CpHI Europe: Pharma companies fail to engage patients early in drug development  

The pharma industry is now incorporating more patients’ perspectives in the development process of their products, but there is still room for improvement, said Michal Davidescu, Health Access Specialist, Pfizer, in a keynote address at the ongoing CpHI Europe meeting.

On the second day of the meeting, discussions highlighted the need for pharma companies to engage patients even before conducting clinical trials, in order to achieve a truly patient-centric approach to product development.

During her talk, Davidescu highlighted that a patient-centric approach is defined by the involvement of patients across all drug development stages, from drug discovery and design, preclinical development, clinical development to marketing application, commercialisation, and Phase IV trial data. “For a cohesive patient centric program, patient preferences should be considered early and be continually assessed throughout different milestone activities of the drug development lifecycle,” she added. According to her, in order to have the greatest potential outcomes and impact there is a clear need to involve patients prior to assessment and even development of a product.

Pharma is failing to engage patients in three essential stages of the drug development process—Target Product Profile, (TPP) Quality Target Product Profile (QTPP), and Target Product Label (TPL), said Davidescu. Currently, the majority of patients are only included in the clinical trial stage, where mostly age, sex and patients history is taken into account for enrolment, however, a patient’s lifestyle, needs, and dosing schedules are still not considered.

During the session, Davidescu emphasised that patient feedback, experiences and perspectives need to be integrated before a product is assessed in clinical trials to provide a better understanding of the disease’s impact on daily life and to improve trial enrollment, design and selection of meaningful endpoints or even to make changes in drug formulation.

Steps to improve patient-centric approaches

In order to have a more patient-centric approach, Davidescu suggested the implementation of regular monthly surveys as well as frequent discussion groups and focus groups with patient advocacy groups, hospital staff and caregivers to receive insights and feedback on the patient journey. She concluded that the correct mindset towards adopting patient-centricity is there but “we still have a long, long way to go”.

Adopting a patient-centric approach can not only reduce the probability of complicated late-stage changes but also support patient adherence and lower product discontinuation rates. Artificial intelligence (AI) and digitalisation are useful tools that can be utilised to improve patient centricity according to Davidescu.

The use of wearables, mobile apps and sensors as another important aspect of the patient journey that can also improve patient adherence and enhance patient experience, said Mithun Ratnakumar, director Technology Strategy & Governance, Gerresheimer, in another talk. Digital tools and AI are an opportunity to collect and analyse data as well as provide real time feedback to the patient, Ratnakumar noted.

“Offering personalised features and contents to the patient so that there is a personalized user experience…bridges the gap between the understanding and adherence,” and reduces patient burden, Ratnakumar. Such a holistic approach to implementing remote monitoring and drug delivery solutions in a patient journey, do in fact work, he noted. Ratnakumar presented findings from the University of Pittsburgh Medical Center, which showed that the remote patient monitoring solution they implement could reduce hospital readmission by 76%.

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