• Clario accelerates your clinical trial from initiation to implementation. LEARN MORE →

Your using an unsupported browser. Please update to a modern browser for a better experience.
Skip to content
Clario Clario
  • Solutions
    • eCOA Clinical Trials
      • eCOA Clinical Trials
      • eCOA Live
      • eCOA Multimedia
      • eCOA Rater and Participant Training
      • eCOA Rescue Studies
      • Suicidal Ideation
    • Artificial Intelligence (AI)

      Discover Clario's AI solutions, where innovation meets expertise. Since 2018, we have revolutionized clinical trial endpoint analyses with more than 30 AI-enabled solutions across 600+ active trials, enhancing data quality and patient privacy while expediting data collection processes.

      Go to page
    • Cardiac Safety
      • Cardiac Safety
      • Arrhythmia Analysis
      • Blood Pressure Services
      • ECG — On-site to DCT and Phase I-IV
      • Phase I/TQT Cardiac Assessment
      • Regulatory Consultation and Statistical Analysis Expertise
    • Medical Imaging
      • Medical Imaging
      • Medical Imaging science team
      • Image Redact AI
      • Image Repository
      • Imaging Platform
      • Image Workflow
      • Modalities
      • SMART Submit
    • Precision Motion for Clinical Trials
      • Precision Motion for Clinical Trials
      • Precision Motion: Scientific Consulting Services
      • Precision Motion: Scientific Publications
    • Respiratory Solutions
      • Respiratory Solutions
      • Site-Based Spirometry (FEV1, FVC, PEF, etc.)
      • Home & Hybrid DCT Spirometry​
      • Cough and Lung Sounds
      • Diffusing Capacity (DLCO)
    • Trial Enablement
      • Trial Enablement
      • Clinical Adjudication
      • Eligibility Solution
      • Reporting & Analytics
      • Source Document Manager
    • Decentralized Trials

      All the precision endpoint technology and services your virtual or hybrid trial needs to deliver more certain outcomes.

      Go to page
  • Therapeutic Areas
    • Cardiovascular & Metabolic
    • Dermatology
    • Gastroenterology
    • Hepatology
    • Infectious Diseases
    • Musculoskeletal
    • Neuroscience
    • Oncology Clinical Trials
    • Ophthalmology
    • Respiratory Solutions
  • Resources
    • Articles
    • Case Studies
    • Downloads
    • Events
    • External Publications
    • Webinars
  • About
    • The Clario Story
    • Careers
    • Corporate & Social Responsibility
    • Leadership
    • Legal & Privacy
    • Newsroom
    • Scientific Expertise
    • Security Governance
    • Strategic Partnerships
    • Values & Culture
  • Support
    • Customer Support
    • In-Country Cardiac Safety Support
  • Solutions
    • eCOA Clinical Trials
      • eCOA Clinical Trials
      • eCOA Live
      • eCOA Multimedia
      • eCOA Rater and Participant Training
      • eCOA Rescue Studies
      • Suicidal Ideation
    • Artificial Intelligence (AI)
    • Cardiac Safety
      • Cardiac Safety
      • Arrhythmia Analysis
      • Blood Pressure Services
      • ECG — On-site to DCT and Phase I-IV
      • Phase I/TQT Cardiac Assessment
      • Regulatory Consultation and Statistical Analysis Expertise
    • Medical Imaging
      • Medical Imaging
      • Medical Imaging science team
      • Image Redact AI
      • Image Repository
      • Imaging Platform
      • Image Workflow
      • Modalities
      • SMART Submit
    • Precision Motion for Clinical Trials
      • Precision Motion for Clinical Trials
      • Precision Motion: Scientific Consulting Services
      • Precision Motion: Scientific Publications
    • Respiratory Solutions
      • Respiratory Solutions
      • Site-Based Spirometry (FEV1, FVC, PEF, etc.)
      • Home & Hybrid DCT Spirometry​
      • Cough and Lung Sounds
      • Diffusing Capacity (DLCO)
    • Trial Enablement
      • Trial Enablement
      • Clinical Adjudication
      • Eligibility Solution
      • Reporting & Analytics
      • Source Document Manager
    • Decentralized Trials
      • Decentralized Trials
  • Therapeutic Areas
    • Cardiovascular & Metabolic
    • Dermatology
    • Gastroenterology
    • Hepatology
    • Infectious Diseases
    • Musculoskeletal
    • Neuroscience
    • Oncology Clinical Trials
    • Ophthalmology
    • Respiratory Solutions
  • Resources
    • Articles
    • Case Studies
    • Downloads
    • Events
    • External Publications
    • Webinars
  • About
    • The Clario Story
    • Corporate & Social Responsibility
    • Leadership
    • Legal & Privacy
    • Scientific Expertise
    • Security Governance
    • Strategic Partnerships
    • Values & Culture
  • Support
    • Customer Support
    • In-Country Cardiac Safety Support
  • Careers
    • Life at Clario
  • Newsroom
  • Login
  • Contact sales
    • Log in
    • Contact sales
  1. Home Resources Downloads Regulatory guidance for PRO strategy in oncology trials

Regulatory guidance for PRO strategy in oncology trials

August 12, 2022

Oncology drug approvals are now based on more than just survival and tumor response. Regulators expect Sponsors to incorporate the patient voice and collect more symptomatic data to understand a drug’s full impact on patients’ functioning, wellbeing and quality of life. Failure to do so may lead to:

  • Missing important patient symptoms and experiences
  • Denial of getting patient-reported data on your drug label

Ultimately it may make it harder to differentiate your drug in a highly competitive market.

In our new guide, Kelly Dumais, Principal Scientific Advisor and Jowita Marszewska, Scientific Advisor at Clario eCOA, set out in more detail how these regulatory developments impact PRO Strategy.

Fill out for brochure access

Latest Downloads

See all
Poster

Neurostatus-eEDSS results in high consistency of Expanded Disability Status Scale assessments: Experience from 13 clinical trials

Download icon Download icon
Download
Datasheet

Centralized DLCO services

Download icon Download icon
Download
Brochure

Clario Precision Motion: scientific consulting services

Download icon Download icon
Download
Brochure

Opal V2C® System Precision Motion

Download icon Download icon
Download
Clario logo
    • Solutions
    • Therapeutic Areas
    • About
    • Resources
    • Careers
    • Newsroom
  • Get in touch

    • Contact
    • Support
    • Customer portal

Follow us

Twitter LinkedIn Glassdoor
×

Contact sales

If you are looking for a partner to help you generate the richest clinical evidence with the right clinical trial technology, please fill in the form below.


Not what you're looking for?

Please visit our Contact Page for customer support, office locations, or media contacts.

Thanks for your form. Our team will be in touch very soon.

  • © 2023 Clario

    • Legal and Privacy Terms
    • Security Governance
    • Cookie Policy
    • Impressum

Please enter your business email before proceeding to xTalks to complete registration.

×