March 7th 2024
The six steps to designing a successful diversity action plan for a clinical trial protocol.
January 12th 2024
Study examines how many registered clinical trials with published protocols are also publishing their results.
December 6th 2023
Study findings elevate the need to optimize protocol amendment experience.
October 10th 2023
While steady progress has been made in recent years, CROs and sponsors still have decisions to make on which solutions are best for them.
August 23rd 2023
It is unrealistic to include infinite adaptations in an IRT system, thus identifying the optimal level of adaptations requires examination of the study’s characteristics and planning phase considerations.
Implementing Digital Biomarkers in Clinical Trials: Early Success and Best Practices
Webinar Date/Time: Tue, Mar 26, 2024 11:00 AM EDT
How to Operationalize Your DCT or Hybrid Trial: Best Practices for Emerging Biopharma
Webinar Date/Time: Tue, Sep 19, 2023 11:00 AM EDT
Rethinking Oncology Trial Strategy: New Approaches for an Evolving Landscape
Webinar Date/Time: Thursday, September 7th, 2023 at 10am EDT | 7am PDT | 3pm BST | 4pm CEST
Rethinking ECOG Scores to Improve Patient Access and Clinical Trials Eligibility
Recent study results highlight need for new metrics in ECOG scoring to mitigate variability.
Q&A with Antonella Santuccione Chadha, MD, chief medical officer, Altoida, and pro bono CEO of the Women’s Brain Project
In this Q&A, Santuccione Chadha speaks on the lack of sex- and gender-based analysis in clinical trial results.
How Reverse-Engineering Clinical Trials to Leverage the AI-based-Digital Twin Solution Solves for Many Current Issues
These devices can help researchers identify data points that are not immediately available to researchers.
Ancillaries are simple, right? Think again.
Webinar Date/Time: Wednesday, March 29, 2023 at 11am ET |10 am CT | 8am PT
Apply Design Analytics to Pressure Test Protocols
Webinar Date/Time: Wednesday, March 22nd, 2023 at 11am EDT | 8am PDT | 3pm GMT | 4pm CET
SCOPE 2023: Beat AML Master Trial Successes
Len Rosenberg, head of clinical operations at Beat AML, discusses the outcome of his company's study, which was four years in the making.
How to Supercharge Real World Evidence Generation in Phase IV Trials
Webinar Date/Time: Thu, Mar 16, 2023 11:00 AM EDT
Enabling Patient Data Ownership With Self-Sovereign Identity
Buy-in from industry stakeholders pivotal to ensure bright future for the decentralized approach.
Top Considerations for IRT Audit Data Management
Webinar Date/Time: Tue, Feb 21, 2023 11:00 AM EST
Methods to Recruit Healthcare Providers for Virtual Advisory Boards in Drug Development
Tufts CSDD study addresses barriers in recruitment.
How Life Sciences Companies Can Strengthen Regulatory Submissions With External Control Arms
Data from past clinical trials has provided researchers with a good starting point to create more ECAs.
How COVID is Forcing a Reckoning in Respiratory Clinical Trials
Pandemic has brought new sense of awareness to respiratory diseases and clinops.
NLP Analyzes the Past to Inform the Future of Clinical Trial Design
Natural language processing can help simplify protocols of the past, as evidenced by a recent Novartis initiative.
Quantifying Protocol Deviation Experience by Clinical Phase
Study uncovers pre-pandemic deviation levels.
Just How ‘Real’ is Real-World Data?
Addressing sources of tension on differentiating types of data.
With Project Optimus, Success Favors the Prepared
Oncology drug developers must start asking questions in preparation of FDA’s dose optimization initiative.
Using Machine Learning to Predict Placebo Response and Increase Clinical Trial Success
A look at the prevalence of placebo response in clinical trials and how advanced solutions can mitigate the risk it poses to drug development.
Considering Patient Burden in Oncology
Implementing new strategies with the use of patient-reported outcomes.
Amplifying Patient Voices in Protocol Design
Insights from studies on advisory boards and participation burden.
Utilizing DHTs for Clinical Trial Endpoints
Increased use of remote assets will showcase new endpoints derived from digital health technologies.
How to Address—and Overcome—Operational Challenges in Master Protocol Studies
Trials that address multiple questions simultaneously using a master protocol can be operationally complicated. These complexities can be managed, even in studies used to support a marketing application.
Recent Data Shows Positive Attitudes for Decentralized Trials in Rare Disease Patients
87% of people surveyed said they had no concerns about a decentralized approach to clinical trials.
An Adaptive-Block Randomization Method when Stratifying by Investigator in Small-to Medium-Sized Studies
A novel adaptive-block method of randomization to maximize the efficiency of overall treatment group balance, while maintaining balance at investigational centers in smaller sized studies, is proposed.
Addressing the Needs of Clinical Trial Sites in a Post-COVID-19 World
Recognizing pre-pandemic pain points, such as patient engagement and protocol development, could lead to post-pandemic trial success.
COVID Advances Clinical Trial Transparency
Sponsors are beginning to make their study protocols public as pressure for a COVID-19 vaccine rises.
What Clinical Trial Assessments Can Be Done Virtually?
While not all clinical trial assessments can be done virtually, there are many that can be adapted for virtual use.
Key Points to Success in Decentralized Alzheimer’s Diagnostic Clinical Trial
This article highlights how C2N Diagnostics and Firma Clinical Research teamed up to create a successful Alzheimer's diagnostic clinical trial while allowing participants to remain in their homes.