To improve your experience on Lilly TrialGuide, please use the latest version of Chrome, Firefox, Safari, or Internet Explorer, with JavaScript enabled.
This website is not optimized for your browser, as configured.
Collaboration

Patient-Focused Drug Development: A Systematic Approach

Patient Focused Drug Development A Systematic Approach Feature Image

If you’ve been following us for a while, you may have noticed that our blog and Twitter content often points out that clinical research involves a partnership among many groups of people: sponsor companies (such as Lilly), study coordinators and principal investigators at clinical research sites, ethical review boards, and, of course, patients. The image we created on Lilly TrialGuide to illustrate the relationship among these various groups is meant to subtly show that the patient is at the center of clinical research. Who is involved in clinical trials

While health care providers may be experts on the clinical aspects of a given medical condition, patients are experts on what it is like to live with their condition. When we are developing a potential new treatment in a specific disease, we need to understand several key points:

  • What does it mean to the patient to have this disease or condition?
  • What do patients experience with this disease or condition?
  • What would a successful treatment look like from the patient’s perspective?

Patients have a unique viewpoint that can provide insights on the outcomes that matter most to them.

  • Severity and frequency of symptoms
  • Impact on daily function and daily life

PROAdapted Bullets 17Apr2019-01

This approach is aligned with upcoming guidance from the U.S. FDA on Patient-Focused Drug Development, or PFDD. PFDD is a systematic approach to help ensure that patients’ experiences, perspectives, needs, and priorities are captured and meaningfully incorporated into the development and evaluation of medical products, at all stages along the way.

For example, we often use patient questionnaires in our clinical research studies to collect information from the patient’s perspective. These patient questionnaires are one form of patient-reported outcomes, or PROs. A PRO is defined as “any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else." Understanding the patient’s viewpoint through measures like PROs can be just as important as data we collect through things like laboratory samples (such as blood, urine, stool, or tissue) and imaging results (such as CT, MRI, or PET scans).

Patients are experts on what it is like to live with their condition, and we are making it a priority to listen to them. Drug development is at its best when we include the patient perspective throughout the process.

Tags: PROs,

Recent Articles

COVID-19ResearchTypes FeatureImage1 19May2020

Types of Clinical Research for COVID-19

Leigh Anne Naas Headshot
Leigh Anne Naas
June 3rd, 20206 minute read

As the world works to quickly learn about COVID-19, a mix of research studies is underway. This guide explains the different types of COVID-19 studies and what researchers hope to learn from them.

InnovationInClinicalTrials TweetChatBlog 14May2020-01

Tweet Chat: Uncovering Innovation in Clinical Trials

Leigh Anne Naas Headshot
Leigh Anne Naas
May 27th, 20203 minute read

On International Clinical Trials Day, we hosted a tweet chat to generate conversation on #ClinicalTrialInnovation. If you didn’t have a chance to attend, we’ve broken down the key takeaways here.

AStoryofResearchVolunteers FeatureImage 6May2020-01

Meet Four Research Volunteers

Leigh Anne Naas Headshot
Leigh Anne Naas
May 13th, 20201 minute read

Over 2 million brave people take part in clinical trials every year, testing new treatments that may make life better. Meet four of those people.

A De-centralized Response Featured Image

Clinical Trials: A De-Centralized Response

BlogAuthor Don2 3Dec2019
Don Harder
May 4th, 20203 minute read

The quick adoption and scaling of decentralized trials will be one of the positive outcomes of having to look at the world of clinical trials in a different way. Learn more about the shift.

CISCRP Feature Image 2

2019 Perceptions and Insights Study: Part 2

Kevin Hudziak Photo
Kevin Hudziak
April 7th, 20203 minute read

In the second installment of our two-part infographic series, we focus on the use of technology in clinical research and how it may pave the way to decentralized clinical trials.