By:

Hannah Kerfoot 

When attending conferences and conventions in the pharmaceutical industry in the past few years, you might have noticed, as we at Pharmora have, a shift in priorities. Patient-focus has been at the forefront in many industry discussions, and regulatory agencies have been active in reinforcing the idea that the patient should be at the centre of the industry. 

But what is patient centricity?
Patient centricity has been defined 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” (Yeoman et al., 2017). This could mean ensuring that patients are consulted before trials are conducted, during trials, and that their voices are heard throughout the product life cycle.  

What are the important principles in patient centricity?
Industry members have been focusing on certain strategies to try and centre patients in the product life cycle. Some of these strategies are education, information, collaboration, access, and transparency.  

Education and access to information are great ways to get patients involved; when a patient is better informed, their feedback and opinions will be more helpful and useful.  

Collaborations allow processes to quicken and sometimes offer confidence to patients that companies will hold each other accountable. This goes hand-in-hand with transparency; when the industry is more open with patients, there is more opportunity for trust. 

Pharmora has been monitoring the regulatory situation and noticed that there is a global trend towards a patient-centric approach.  

Summaries of various governing bodies’ efforts towards patient-centricity: 

The MHRA have been working on their “Patient Involvement Strategy 2021-25”, now in its final year before any updates or revisions. We have put together a blog to talk about this more, find it here.

The EMA have begun to switch communications of post-marketing submissions to their IRIS platform, with the idea of not only making processes more streamlined but also allowing for greater transparency. Read more about this change in our blog on the subject here.  

The FDA released their “FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making” in 2024. This consists of 4 Guidance topics:  

  • Collecting Comprehensive and Representative Input 
  • Methods to Identify What is Important to Patients  
  • Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments 
  • Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making.  

To support this, the FDA also have Patient-Focused Drug Development Program Staff.  

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) published their “Patient-Focused Drug Development (PFDD)” reflection paper in November 2020, and re-reviewed it based on public consultation in 2021. An ICH reflection paper serves the purpose of introducing topics they will discuss in the future, and the objectives in the reflection paper are added to the ICH Association Multi-Annual Stategic plan.  

Since then, there have been many discussions about the impact patient-focus could have on the industry. We at Pharmora agree; patient-centricity should be at the centre of the pharmaceutical industry’s minds. After all, patients are who we make medicine for! 

References:  

Defining patient centricity with patients for patients and caregivers: a collaborative endeavour – PMC 

FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making | FDA