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

The CenterWatch Monthly Subscribe

May 3, 2022

View Archived Issues

Download Current Issue:

  • May 2022 (Vol. 29, Issue 05)
Calculator - Estimate

Sponsors Overestimate Cancer Trial Budgets, Underestimate for Other Trials

A troubling trend is being seen in clinical research: sponsors frequently overestimate their oncology trial budgets while underestimating budgets in other areas, creating challenges for sites trying to prepare for and manage trials. Read More
Adapt

Sites May Need to Adapt for Coming Years as Sponsors, CROs Shift Focus to Fewer Sites

Sponsors and CROs are shifting away from the traditional wide-net approach and focusing more on investing in fewer numbers of sites. Should this trend pick up speed as some project, sites may need to adapt best practices, embrace sponsor-driven changes and keenly address their shortcomings to remain competitive. Read More

FDA Recommends Sponsors Submit Plans for Achieving Trial Diversity

A new draft guidance from the FDA calls on sponsors to submit detailed plans for achieving racial/ethnic diversity in their trials as part of their investigational new drug (IND) or investigational device exemption (IDE) applications. Read More

EMA Guidance Defines Commercially Confidential Information for Redaction

A new draft guidance from the European Medicines Agency (EMA) defines requirements for redacting commercially confidential information (CCI) in trial data and documents filed to the Clinical Trials Information System (CTIS). Read More

CDER Director Discusses Priorities for Fiscal 2023

Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni outlined the center’s budget priorities in fiscal year 2023 in a webinar hosted by the Alliance for a Stronger FDA. Read More

Pediatric Extrapolation OK to Evaluate Safety, ICH Draft Guideline Says

Data from adult trials of a particular drug can be used to evaluate the safety of the drug in a pediatric population, according to a draft guideline released for public comment by the International Council on Harmonization (ICH) and the European Medicines Agency (EMA). Read More

Peter Marks Envisions New Development Model for Gene Therapies

To expand the field of gene therapy, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), believes that the current clinical development framework is in need of rethinking in terms of trial design, endpoints, communication and other areas. Read More

FDA Adopts Revised ICH Guideline on Quality in Clinical Trial Design

An international guideline focused on building quality into clinical trials is now official FDA guidance. The agency has published the International Council for Harmonization’s (ICH) E8(R1) — General Considerations for Clinical Studies as a final guidance, signaling its support for the “quality by design” concept. Read More

FDA Officials Look to Set the Record Straight on Definition of ‘Digital Biomarker’

In an effort to address differing definitions of the term “digital biomarker” and improve discussions on drug and device development, FDA officials have penned an article meant to clear up misconceptions and spur alignment toward the agency-endorsed definition. Read More

EMA Advises Using COVID-19 Approaches to Support Ukrainian Clinical Trials

The European Medicines Agency (EMA) has called on sponsors conducting trials in Ukraine to address disruptions related to the current conflict by applying strategies used to address the pandemic where and when they can. Read More

Study Lead Opportunities

New Study Lead Opportunities from Anixa Biosciences, Jazz Pharmaceuticals and Visus Therapeutics. Read More

FDA Actions

New FDA Actions from Blue Earth Therapeutics, Novartis and STAAR Surgical. Read More

Upcoming Events

  • 28Jun

    Effective Root Cause Analysis and CAPA Investigations for the Life Sciences

  • 16Oct

    WCG MAGI's Clinical Research Hybrid Conference - 2022 West

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

  • Protocol-360x240.png

    Avoid Deviations by Making Protocol Review a Team Effort

  • SelectionProcess-360x240.png

    Give Us a Voice: Sites Clamor for a Say on Vendor Selection

  • Convince-360x240.png

    Use Data and Details to Convince Site Leadership to Add Staff

  • AsktheExpertsBadge-360x240.png

    Ask the Experts: Listing Trial Staff and Others on the Statement of Investigator

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 My Personal Information

Footer Logo

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

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing