• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trial Listings
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Market Research
    • Benchmark Reports
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Clinical Trial Listings
  • Advertise
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Newsletters » Research Practitioner

Research Practitioner Subscribe

May 31, 2023

View Archived Issues

Download Current Issue:

  • Research-Practioner-May-June-23.pdf
Endpoint Adjudication

Research Teams Navigate Increasing Endpoint Adjudication Processes

Endpoint adjudication — a standardized process for ensuring that assessments of the safety and efficacy of the investigational product are consistent, objective and unbiased — add new stakeholders, procedures and unique considerations to a traditional trial as well as increased attention from regulators and sponsors. Read More
failing-to-plan-planning-to-fail.png

Failure to Develop a Solid Research Plan Is a Plan for Trial Failure

Any successful clinical trial begins with a solid research plan that lays out the research project, its importance and how it will be conducted. It can include everything from big-picture objectives and methodologies to details about equipment and personnel requirements, but if the plan is incomplete, unclear or inaccurate it can result in delays, budget overruns, protocol deviations or errors that render data useless. Read More

EMA Seeks Public Comment on New Trial Data Transparency Rules

The European Medicines Agency (EMA) is seeking public comment on its transparency rules and protection of personal and commercially confidential data submitted to its clinical trials database. Read More

EMA Seeks Industry Feedback on Single-Arm Trial Guidance

The European Medicines Agency (EMA) is seeking industry’s thoughts on a new draft guidance on general considerations and challenges for single-arm trials that serve as the key source of efficacy data. Read More

Q&A Guidance Gives Additional Risk-Based Monitoring Advice for Sponsors

Following up on 2013 guidance, the FDA has issued a new question-and-answer guidance with additional recommendations for trial monitoring approaches, monitoring plan content and follow-up/communication of issues caught through risk-based monitoring. Read More

COA-Based Endpoints Covered in FDA Patient-Focused Drug Development Guidance

The FDA has published the fourth and final guidance in its patient-focused drug development series, offering stakeholders recommendations for incorporating clinical outcome assessments (COA) into trial endpoints. Read More

FDA Releases Guidance on FDA, OHRP Reviews of IRB-Ineligible Pediatric Research

The FDA has issued draft guidance outlining the process for FDA/Office for Human Research Protections (OHRP) reviews of pediatric trials that are ineligible for IRB review and approval. Read More

FDA Guidance Advises RCTs for Oncology Drugs Seeking Accelerated Approval

Sponsors of new oncology drugs and biologics that aim to apply for Accelerated Approval (AA) should use a randomized controlled trial (RCT) design rather than a single-arm trial in most cases, the FDA advises in new draft guidance. Read More

UK Proposes Sweeping Changes to Rules Governing Clinical Trials

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has proposed major reforms to its clinical trial regulations, including a 30-day maximum for reviewing new trial applications and a 10-day maximum for granting a decision after receiving requested follow-up information. Read More

Upcoming Events

  • 06Jun

    Gene & Cell Therapy Regulation: Comparability and Other New Developments

  • 07Jun

    Developing World-Class SOPs: Optimizing Quality and Compliance

  • 08Jun

    Implementing ICH E8 R1 Recommendations Increases Site and Participant Relationship Scoring Measures

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • MAGI East 2023

    MAGI East 2023 Preview: Janssen Reports on Environmental Impact of Trials

  • Complexity-360x240.png

    Phase 3 Trials Significantly Rising in Complexity, Says CSDD

  • Quality Level Scale

    Build Quality into Trials Like You’d Build a House, Says FDA’s BIMO Director

  • DE&I

    Trust-Building, Community Connection Still Essential to DE&I Efforts, Experts Say

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell or Share My Data

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing