Skip to main content
  • login
  • contact
  • language
    • English
    • Français
    • Español
    • Português
    • Deutsch
    • 简体中文
    • 日本語
  • search
X
GEP Logo GEP Logo
  • Company
    • Leadership
    • Customers
    • Partners
    • Sustainability at GEP
    • News
    • Events
    • Culture
    • Mission & Vision
    • Awards & Recognition
  • Solutions
    • Strategy
      • Procurement Consulting  
        • Procurement Transformation
        • Digital Procurement Transformation
        • Opportunity Assessment
        • M & A Services
        • Strategic Cost Management
        • Supply Risk Management
      • Supply Chain Consulting  
        • Environmental, Social and Governance
        • Socially Responsible Sourcing
        • Supply Chain Strategy
        • Supply Chain Diagnostics
        • Inventory Optimization
        • Network Optimization
      Software
      • GEP SMART  
        • Procurement Software
        • Direct Procurement Software
        • Indirect Procurement Software
        • Digital Procurement Transformation
        • Master Data Management
        • AP Automation
        • Spend Management
        • SMART S2P Technology
      • GEP NEXXE  
        • Supply Chain Visibility and Execution
        • Supply Chain Planning
        • Supply Chain Collaboration
        • Supply Chain Control Tower
        • Should-Cost Modeling
        • Inventory and Warehouse Management
      • GEP CLICK  
      • GEP MINERVA  
      Managed Services
      • Procurement Outsourcing  
        • Source-to-Contract
          • Spend Analysis
          • Strategic Sourcing
          • Category Management
          • Supply Market Intelligence
          • Tail-Spend Management
          • Procurement Support Services
        • Procure-to-Pay
          • Cost Recovery & Invoice Auditing
          • Accounts Payable
      • Supply Chain Outsourcing  
        • Planning & Forecasting
        • Inventory Management
        • Logistics Management
        • Supply Chain Data Management
        • Supply Chain Risk Management
  • Industries
    • Automotive
    • Chemicals
    • Consumer Packaged Goods
    • Energy & Utilities
    • Financial Services
    • Government & Nonprofit
    • Industrial Manufacturing
    • Life Sciences
    • Oil & Gas
    • Retail
    • Telecommunications, Media & Technology
    • High-Tech
    • Media & Entertainment
    • Software, Social & Platforms
    • Telecom
    • Travel & Hospitality
  • Knowledge Bank
    • Digital Transformation
    • Software & Technology
    • Strategy & Planning
    • Operations
    • Procurement
    • Sustainability
    • Insights From the Top
    • COVID-19 Resource Center
    • Inflation Strategies
  • Careers
    • Join Us
    • GEP Per Se
    • Campus Connect
  • Partners
   
  • GEP Strategy ›
    • GEP Strategy
    • ‹ Back
      • Procurement Consulting ›
        • Procurement Consulting
        • ‹ Back
          • Procurement Transformation ›
            • Procurement Transformation
            • ‹ Back
              • Procurement Strategy
              • Org. Design & Implementation
              • Capability Building
              • Change Management
              • Governance & Performance
              • Processes & Policies
              • S2P Operations
              • Sourcing & Category Management
              • Technology
          • Digital Procurement Transformation
          • Opportunity Assessment
          • M&A Services ›
            • M&A Services
            • ‹ Back
              • M&A Clean Room
          • Strategic Cost Management ›
            • Strategic Cost Management
            • ‹ Back
              • Zero-Based Budgeting
          • Supply Chain Risk Management
      • Supply Chain Consulting ›
        • Supply Chain Consulting
        • ‹ Back
          • SUSTAINABILITY AND RESILIENCE
          • Environmental, Social and Governance
          • Socially Responsible Sourcing
          • Scope 3
          • PLAN
          • Digital Planning, S&OP, S&OE
          • Collaborative Planning
          • PROCURE
          • Source To Contract
          • Procure To Pay
          • MAKE
          • Inventory Strategy & Management
          • Operations & Manufacturing Excellence
          • DELIVER
          • Network Strategy & Optimization
          • Warehousing & Transportation Management
  • GEP Software ›
    • GEP Software
    • ‹ Back
      • GEP SMART ›
        • GEP SMART
        • ‹ Back
          • Procurement Software
          • Direct Procurement Software ›
            • Direct Procurement Software
            • ‹ Back
              • Bill of Materials Management
              • Data Analytics & Reporting
              • Inventory Management
              • Master Data Management
              • Quality Management
              • Supplier Collaboration Portal
              • Supply Chain Operations
          • Indirect Procurement Software ›
            • Indirect Procurement Software
            • ‹ Back
              • Source-to-Contract
              • Spend Analysis
              • Savings Project Management
              • Category Management
              • Contract Management
              • Savings Tracking
              • Sourcing
              • Supplier Management
              • Procure-to-Pay
              • Guided Buying
              • Procurement Portal
              • Catalog Management
              • Order Processing
              • Invoice Management
          • Digital Procurement Transformation
          • Master Data Management
          • Product Accessibility
          • AP Automation
          • Spend Management
          • SMART S2P Technology
      • GEP NEXXE ›
        • GEP NEXXE
        • ‹ Back
          • Supply Chain Visibility and Execution ›
            • Supply Chain Visibility and Execution
            • ‹ Back
              • Inventory and Warehouse Management
              • Logistics Visibility
              • Control Tower
          • Supply Chain Planning ›
            • Supply Chain Planning
            • ‹ Back
              • Supply Chain Control Tower
              • Should-Cost Modeling
              • Demand Planning
              • Supply Chain Bill of Materials
              • Supply Chain Direct Sourcing
              • Supply Planning
          • Supply Chain Collaboration ›
            • Supply Chain Collaboration
            • ‹ Back
              • Forecast Collaboration
              • Purchase Order Collaboration
              • Quality Collaboration
              • Capacity Collaboration
              • Quality Management Software
          • Supply Chain Control Tower
          • Should-Cost Modeling
          • Inventory and Warehouse Management
      • GEP CLICK
      • GEP MINERVA
      • Innovation ›
        • Innovation
        • ‹ Back
          • Emerging Technologies
          • Native to Cloud
          • Native to Mobile
          • One Unified Platform
          • Security
          • User-Centric Design
  • GEP Managed Services ›
    • GEP Managed Services
    • ‹ Back
      • Procurement Outsourcing ›
        • Procurement Outsourcing
        • ‹ Back
          • Source-to-Contract
          • Spend Analysis
          • Strategic Sourcing ›
            • Strategic Sourcing
            • ‹ Back
              • MRO
              • CAPEX
              • Logistics
              • Packaging
              • IT & Telecom
              • Energy
              • Direct Materials
          • Category Management ›
            • Category Management
            • ‹ Back
              • Contract Management
              • Supplier Performance Management
              • Savings & Compliance Tracking
          • Supply Market Intelligence
          • Tail-Spend Management
          • Procurement Support Services ›
            • Procurement Support Services
            • ‹ Back
              • eSourcing
              • Supplier Performance Management
              • Savings & Compliance Tracking
              • Sourcing Support
          • Procure-to-Pay
          • Cost Recovery & Invoice Auditing
          • Accounts Payable
      • Supply Chain Outsourcing ›
        • Supply Chain Outsourcing
        • ‹ Back
          • Planning & Forecasting
          • Inventory Management
          • Logistics Management
          • Supply Chain Data Management
          • Supply Risk Management
  • Industries ›
    • Industries
    • ‹ Back
      • Automotive
      • Chemicals
      • Consumer Packaged Goods
      • Energy & Utilities
      • Financial Services
      • Government & Nonprofit
      • Industrial Manufacturing
      • Life Sciences
      • Oil & Gas
      • Retail
      • Telecommunications, Media & Technology
      • High-Tech
      • Media & Entertainment
      • Software, Social & Platforms
      • Telecom
      • Travel & Hospitality
  • Knowledge Bank ›
    • Knowledge Bank
    • ‹ Back
      • Digital Transformation
      • Operations
      • Procurement
      • Software & Technology
      • Strategy & Planning
      • Sustainability
      • Podcasts
      • Insights from the Top
      • COVID-19 Resource Center
      • Inflation Strategies
  • Company ›
    • Company
    • ‹ Back
      • Leadership
      • Customers
      • Partners
      • Sustainability at GEP
      • News
      • Events
      • Culture ›
        • Culture
        • ‹ Back
          • GEP Core Values
          • Women@GEP
          • Diversity
          • GEP Cares
      • Mission & Vision
      • Awards & Recognition
      • Contact Us
  • Global Presence ›
    • Global Presence
    • ‹ Back
      • Americas ›
        • Americas
        • ‹ Back
          • English
          • Español
          • Portugués
      • Europe ›
        • Europe
        • ‹ Back
          • English
          • Deutsch
      • Asia-Pacific ›
        • Asia-Pacific
        • ‹ Back
          • English
          • 中文
      • Middle East ›
        • Middle East
        • ‹ Back
          • English
          • العربية
  • Contact Us
  • Careers ›
    • Careers
    • ‹ Back
      • Join Us
      • GEP Per Se
      • Campus Connect
  • Language ›
    • Language
    • ‹ Back
      • English
      • Français
      • Español
      • Deutsch
      • Português
      • 简体中文
      • 日本語
  • Rapid Response from GEP
  • BLOGS
  • Strategy
  • Technology
  • MIND
Contact Us
  •  
  •  
  •  
  •  
  •  
  •  
  •  

Breadcrumb

  1. HOME
  2. BLOG
  3. MIND
  4. HOW USFDAS CLINICAL TRIAL DATA TRANSPARENCY REQUIREMENT IS IMPACTING THE PHARMA SECTOR
Blog Image

How USFDA’s Clinical Trial Data Transparency Requirement Is Impacting the Pharma Sector

October 01, 2018 | Pharma and Life Sciences Blogs

Early 2018, the US Food and Drug Administration (USFDA) announced steps toward enhancing the transparency of clinical trial information. This was aimed at providing more support to further advance innovations and scientific research. The USFDA took this decision on exploring new ways to share information about product approvals which can improve patient care and better inform people about the products they prescribe or intake. To increase transparency, the USFDA is focusing on the information usually provided in the clinical study reports (CSRs).

Clinical Data Report Pilot Program

The USFDA had launched a clinical data summary pilot on March 19, 2018, where the primary agenda was to post key portions of the CSRs — the documents which sponsors create for the USFDA after each clinical study. These portions contain complete summary of the entire result, the protocols and amendments, as well as the statistical plan. The reports are redacted by the FDA to exclude confidential commercial information, trade secrets and personal privacy information. Before the data transparency move, the FDA provided drug approval action package which shared a significant amount of information from the sponsor’s application but did not have provisions to provide a complete summary of results. The incomplete information made it difficult for academic researchers, regulatory agencies and other stakeholders to gain an in-depth understanding of the studies supporting the approval.

Present Status

The pilot program started by posting summary reports of nine approved new drug applications of participating sponsors, some of which are Janssen, Johnson and Johnson, and Sanofi. Janssen Biotech volunteered as the first pilot participant for the approval of Erleada (Apalutamide, a non-steroidal anti-androgen) which will be used to treat non-metastatic, castration-resistant prostate cancer. The USFDA uploaded CSR information, FDA review along with label and other supporting documents to facilitate a deeper understanding of their approval decision. In addition to the pilot, the agency is also adding a unique identity to the materials i.e., the ClinicalTrials.gov identifier number, also called the National Clinical Trial (NCT) number. This number will make it easier to correlate the clinical listings on the website to the FDA announcements on specific drugs which can include product labeling and advisory committee meeting materials. Firms are expected to ensure that the required clinical trial data is published on clinicaltrials.gov, as delays will attract a fine of $10,000.

Impact on the Pharmaceutical Industry

This move impacts the pharmaceutical industry significantly. Now the pharma companies are expected to submit enriched data sets and hence there will be issues regarding data management. Each company has its own trade secrets and procedures, and therefore, they will have to scrutinize the information which will be available to the public post submission. Due to such development on data transparency, there might be a slowdown in the drug development process. Pharmaceutical companies that utilize “alteration” of existing drug as a life cycle management strategy, for e.g., using an anti-allergen and tweaking it to create an anti-asthma drug, will be impacted. By releasing the required level of information to academics and researchers, the business strategy of “evergreening” of a drug” will be under pressure. Also, the development pipeline of a company can be hampered if competitors start using the information for inventing a new process of the same drug.

Conclusion

Such transparency requirements help in better understanding the trial and the result. The data published under the “results” section was previously lacking the details required to satisfy stakeholders and sponsors. Now, with the release of result synopses and application of simple language in the “summary” of trial data, they can comprehend the development process and outcomes of trials much better. Patients will now receive a more detailed perspective of their clinical trial processes and hence can make better informed decisions. The populace that once had to depend on inaccuracies published via secondary resources can now access scientific and trustworthy information.

 

Add Comment +

FEATURED POST

...
Supply Chain Strategy Blogs

How to Effectively Monitor Scope 3 Emission Reporting From Your Supply Chain

...
Supply Chain Software Blogs

From Cost to Resiliency: How Supply Chain Priorities Have Changed

    BLOG CATEGORIES

  • Marketing Blogs
  • Professional Services Blogs
  • Pharma and Life Sciences Blogs
  • IT & Telecom Blogs
  • Logistics Blogs
  • Chemicals Blogs
  • Energy & Utilities Blogs
  • Market Intelligence Blogs
  • Oil and Gas Blogs
  • MRO Blogs
  • Supply Chain Blogs
  • Facilities Management Blogs
  • Human Resource Blogs
  • Procurement Process and Excellence Blogs
  • Agro Blogs
  • Direct Materials Blogs
  • CAPEX Blogs
  • Packaging Blogs
  • Automotives Blogs
  • Healthcare Blogs
  • Corporate Travel Blogs
  • Metals & Minerals Blogs
  • Technology Blogs
  • Awards and Events Blogs
  • Category Management Blogs

TAGS

sustainability
Procurement Software
supply chain strategy
Inflation
Russia-Ukraine War

By checking the box below, you consent to GEP using your personal information to send you thought leadership content – such as white papers, research reports, case studies – and other communications. GEP representatives may contact you to provide additional information or answer questions.

If at any point in time you decide to withdraw your consent, you may unsubscribe by emailing your request to us at privacy@gep.com.

Please refer to the GEP Privacy Statement to understand how we manage and protect your personal information.

Terms of Use | Privacy Statement

Contact Us

Ask Us

Send us your question(s)

RFP

Request for a business proposal

Feedback

Share your thoughts, comments and suggestions

Demo

Schedule a live demo of our software

Discover
STRATEGY
Strategy
  •   Procurement Consulting
  •   Digital Procurement Transformation
  •   Strategic Cost Management
  •   Opportunity Assessment
  •   Supply Chain Risk Management
  •   Supply Chain Consulting
  •   Supply Chain Strategy
  •   Supply Chain Diagnostics
  •   Inventory Optimization
  •   Procurement Transformation
  •   Sustainability and ESG Consulting
SOFTWARE
Software
  •   Procurement Software
  •   Supply Chain Software
  •   Source-to-Contract
  •   Procure-to-Pay
  •   Supply Chain Planning
  •   Supply Chain Collaboration
  •   Supply Chain Visibility & Execution
  •   Supply Chain Control Tower
  •   Should-Cost Modeling
  •   Inventory & Warehouse Management Software
  •   Source-To-Pay Software
MANAGED SERVICES
Managed Services
  •   Procurement Outsourcing
  •   Strategic Sourcing
  •   Tail-Spend Management
  •   Category Management
  •   Procurement Support Services
  •   Supply Chain Outsourcing
  •   Supply Chain Planning & Forecasting
  •   Inventory Management
  •   Logistics Management
COMPANY
Company
  •   About Us
  •   Leadership
  •   Customers
  •   Sustainability at GEP
  •   Careers
  •   News
  •   Awards
  •   Partners
  •   Contact Us

Fresh Insights, Now on Your Phone

  • Dowmload On The App Store Button
Stay Connected
  •  
  •  
  •  
  •  

Latest Tweets

  • How can companies ensure optimal #MRO spend management, value maximization and risk mitigation in 2023? #GEP sugges… https://t.co/AWkvSs094s

  • Join #GEP experts to learn about key trends, risks and tips to improve bottom lines in #ITAndTelecom, #Marketing,… https://t.co/ESwGywl5WU

  • Join #GEP experts to learn about key trends, risks and tips to improve bottom lines in #RealEstate,… https://t.co/X96tMimU9E

  • The #ElectricVehicle revolution, with lower total cost of ownership, is coming to #manufacturers and global… https://t.co/xWhtPA4EZq

  • Fun at work! Our Technology interns enjoyed a game of cricket, while the TSO CIT Launchpad campus new joiners got t… https://t.co/TrYYM3rfrv

  • Join #GEP experts to learn about key trends, risks and tips to improve bottom lines in #ProfessionalServices,… https://t.co/5veQICcMOe

  • #GEP's Ramachander Raja details ways that #CIOs need to create #sustainable IT, in @TechTarget. https://t.co/ANLfkeJGnq

  • A warm welcome to our new joiners who’ve been a part of the Tech Launchpad Program 2023. Best wishes for a rewardin… https://t.co/xhBfYYhEbu

  • We’re glad to welcome our new class of Technology interns who’ve joined through the GEP Internship Program 2023. He… https://t.co/jwJcZT1a6s

  • How can organizations track and report #ESG metrics accurately? #GEP shares a six-point framework to help leaders d… https://t.co/AdrBBSruH6

  • With #CAPEX continuing to be a top priority for #CFOs, how can companies mitigate #SupplyChain #inflation risks? So… https://t.co/4cSw24jmcq

  • The GEP African Ancestry Network is observing #BlackHistoryMonth with an information series, focused on how the Bla… https://t.co/MXdyHe6kI8

  • What effective real estate practices can financial firms adopt to reduce carbon emissions and succeed at #ESG trans… https://t.co/xx7Zrh5yrs

  • We are delighted to announce @SubhashMakhija1, #GEP #CEO and Co-Founder, as the newest member of the CNBC CEO Counc… https://t.co/MNJXch4Vte

  • #Procurement leaders must develop a spend category management plan to power them through 2023 and beyond. #GEP’s Ry… https://t.co/5JxFw1UbsY

  • How can #automotive companies get the EV transition right? Electric vehicles may be the right option, but it’s not… https://t.co/WmGNCK6sFw

  • Conquering 2023 Supply Chain Setback - 31 Jan 2023 https://t.co/wg0MdRATfh

  • On the occasion of Republic Day in India, GEP Hyderabad held an art competition and GEPpers showed their creativity… https://t.co/NSHrXILbiv

  • We're proud to announce the extension of our #procurement services agreement with @Macys's Inc. to help drive… https://t.co/Hgn4uaGbW0

© Copyright GEP 2023. All rights reserved. Terms of Use | Privacy Statement | Cookie Policy |   | Quality Policy | GEP Logo