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What does Patient Centricity mean for Clinical Research Sites?

Patient Centricity is a huge buzzword in pharma, but what does it mean? This article explains the term from concept to practice for clinical research sites.

7/18/2018 | By Caroline Diep | Edited by Alec Pettifer |

Best Practices

A Brief Definition

"Patient centricity" is Pharma's buzzword, first officially defined by AstraZeneca through a publication in BMJ Innovations. In 2017, the company used interviews, questionnaires, literature reviews, and workshops to gather insight from key stakeholders, patients, and caregivers. From these efforts, a single definition for patient centricity was created for biopharmaceutical companies to adopt and can be found below:

"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."

From this research, patients self-identified 5 points they needed in their interactions with pharmaceutical companies:

  1. Inclusiveness
  2. Sharing goals that are patient and family-centered
  3. Empowering patients to take control of their own health
  4. Working in a way that shows respect, compassion, and openness
  5. Working in partnership
Patient Centricity Concept

Patient Centricity, from Concept to Practice

Despite this initial headway, it's been difficult for pharma sponsors to meet the demands of increasingly informed and empowered patients. AstraZeneca's Guy Yeoman has commented, "I liken the process of transforming the industry towards patient-centricity to turning an oil tanker - we've only moved a couple of degrees." For Big Pharma, there are three main issues blocking change.

  1. A lack of tangible guidance on how to approach patient-centricity.
  2. No way to quantify the benefits of subject centric initiatives.
  3. No way to measure return on engagement.

While sponsors seem slow to adopt patient-centric cultures, the FDA has shown their investment. Signed in December 2016, the 21st Century Cures Act was passed to help accelerate the development of medical products with the goal of bringing new treatments to the public with greater speed and efficiency. Upholding the Cures Act, from 2012 to 2017 the FDA held 24 disease-specific patient-focused drug development (PFFD) meetings. Patient advocates, researchers, drug developers, and others were brought together to systematically capture patients' experiences, needs, and priorities and incorporate them into the drug development process. A more specific outline of the goals for these PFFD meetings can be found here. With the FDA's efforts, a patient-centric culture change may be coming to clinical research, impacting research sites and CROs.

Private Investigator

The Value of Patient Centricity to Clinical Research Sites

Research sites may have to adapt to a patient-centric pharma industry looming in the future. However, compared to sponsors, clinical research sites really do have a better shot at creating a patient-centered experience. After all, sites are the ones who engage directly with subjects. For them, patient-centric initiatives can be incredibly valuable and actionable. For instance, increasing patient engagement can:

However, the problem is still the same. What does that look like for sites? What are the benefits?

Here are a few ideas for what sites can do to be more patient-centered in clinical trials:

What Sites Can Do Benefits
Asking about patient pain points Especially for studies on rare diseases, a lack of information on the patient experience can be frustrating. By asking participants about their everyday needs, you can have a better understanding of what treatments would ease unaddressed pain points.
Asking how patients make their decisions about trial participation Learning about how patients decide which studies to take on can help with recruitment efforts. Maybe travel assistance is a big factor. Are you doing it? Are your patients spending a lot of time online? Are you doing social media marketing?
Asking for input about eligibility criteria You can have a better sense of whether eligibility criteria are too restrictive.
Ask patients about their schedules You might be able to avoid too many out-of-visit window appointments and under-enrollment. CRIO's scheduling feature will keep you on track so that you know what's going on and when!
Listening about how to better the patient experience during a trial Interacting in a friendly manner and engaging with patients at a site can lead to reducing dropout rates in a study.
Review the patient-centric approaches used by other companies For example, Alec Pettifer tweeted out a new model for patient engagement here! You can attend upcoming conferences for conversations and talks by thought leaders.
Patient Caregiver Relationship

Understanding what patients and caregivers need is valuable, so that, overall, treatments will better target people's medical needs. Share this post on Twitter and Facebook, and subscribe to our blog for curated content like this!

Author: Caroline Diep is the Marketing Intern at Clinical Research IO. She is currently a rising Senior at Harvard College studying Sociology.

Thanks to Alec Pettifer for reviewing and editing this blog post!

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