Trial Design

Investigators find that most exclusion criteria in critical care randomized clinical trials are justifiable, but 60% include at least one poorly justified exclusion, most commonly affecting pregnant or lactating individuals.

Phase III HELIOS-B trial found that Amvuttra (vutrisiran) also preserved functional capacity and quality of life in patients with transthyretin amyloidosis with cardiomyopathy.

Semaglutide 7.2 mg significantly outperformed semaglutide 2.4 mg and placebo with a 20.7% average reduction in weight and a comparable safety and tolerability profile, further establishing its efficacy in obesity treatment.

Webinar Date/Time: Wed, Jan 22, 2025 11:00 AM EST

Publicly funded non-inferiority trials have grown in popularity with high levels of non-inferiority margin reporting; however, a recent analysis notes a need for improved design and reporting practices to ensure clinical relevance and reliability.

To meet the growing demands of clinical research, sponsors must prioritize comprehensive support models, such as clinical site ambassadors and patient journey coordinators, who can address operational challenges and improve site relationships, patient satisfaction, and overall trial efficiency.

The FDA's guidance is part of a broader effort to modernize clinical trials, improve efficiency, reduce participant burden, and expand access, particularly for underrepresented populations and those in geographically or economically constrained areas.

With universal adoption of health literacy best practices slow going over the years, advocates are redefining the term to encompass much more of what health-related communication requires beyond simply words.

Understanding how the dynamics between the two play hand in hand in influencing patient recruitment and retention.

What learning science has taught us about the drivers and predictors of change—and applying those to clinical research practice.

Webinar Date/Time: Thursday, November 21st, 2024 at 11am EST | 8am PST | 4pm GMT | 5pm CET

Overcoming this bias—which affects everything from trial design to data collection—is a critical obligation of clinical research stakeholders.

Webinar Date/Time: Tuesday, January 21st, 2025 at 11am EST | 8am PST | 4pm GMT | 5pm CET

Webinar Date/Time: Wed, Oct 30, 2024 11:00 AM EDT

Session reveals how organizations can implement DCTs into their clinical trial planning and execution processes.

Multi-region clinical trials can provide for varied results, but may not paint a full picture for a specific population.

An overview of the advantages of implementing AI into clinical development and the obstacles that prevent its widespread adoption.

Gathering hard evidence on the benefits and risks of DCT solutions.

The key approaches today in unlocking the door to study inclusivity. Hint: they all prioritize participants.

Webinar Date/Time: Wed, Sep 25, 2024 11:00 AM EDT

Webinar Date/Time: Wednesday, September 25th, 2024 at 10am EDT | 7am PDT | 3pm BST | 4pm CEST

Results from the joint Phase III clinical trial of the vaccine also demonstrated results comparable to the companies’ licensed COVID-19 vaccine.

Tracking efforts to advance the mission and concept of "clinical research as a care option."

Q&A with Joachim Lövin explores the challenges and lessons learned in boosting the flexibility of conducting decentralized clinical trials post-COVID.

Results demonstrated prolonged progression free survival of two patients in Acclaim-1 study and partial remission from maintenance therapy in Acclaim-3 study.

Webinar Date/Time: Tuesday, August 27, 2024 at 11:00 AM EDT | 8:00 AM PDT | 4:00 PM BST | 5:00 PM CEST

Clinical trial for BI 3034701 is expected to evaluate the safety, tolerability, and pharmacokinetics in healthy men and overweight or obese individuals aged 18-55 years old.

Reportedly, data from the Vivacity-MG3 trial marks the first time an FcRn blocker demonstrated superiority over placebo in treated generalized myasthenia gravis (gMG).

A three-part framework for a more comprehensive conceptual model of patient experience data can provide a more rounded understanding of patient experiences in clinical trials and beyond.

Webinar Date/Time: Wed, Jul 17, 2024 1:00 PM EDT