Trial Design

Navigating a complex drug development landscape, sponsors must rethink their approach to risk in study design and execution.

Overcoming the illusion of knowledge in clinical research can enhance decision-making, training, and project success—helping ensure trials run smoothly and effectively.

An increase in protocol complexity is paving the way for machine learning models to optimize trial design.

The future of clinical trial design involves incorporating the patient experience into strategic asset planning.

Anticipating divestment, reallocation of investments, and retrenchment.

COVID-19 not only advanced scientific boundaries, but also transformed research methodologies and accelerated adaptive clinical trial design.

Teams must work together with technology solutions and optimize integration to unlock their full potential.

How targeted AI can improve the performance of clinical trials.

In an interview with Applied Clinical Trials Associate Editor Don Tracy, Samuel Salvaggio, Senior Trial Design Lead, One2Treat, discusses the company's main goals for attending the SCOPE Summit, including patient centric trial design.

In an interview with Applied Clinical Trials Associate Editor Don Tracy, Richard Young, chief strategy officer, CluePoints, discusses goals of the SCOPE Summit and CluePoints' evolving approach to risk detection.

Conference breakout session explores strategies for trial sites to strengthen patient relationships.

Clinical trial liaisons rather serve as experts in their therapeutic areas and as clinical trial specialists to provide a suite of strategic advantages to benefit a study.

In this video interview, Michael Andreini, president and CEO of the Multiple Myeloma Research Foundation, highlights the design of Horizon, an adaptative platform trial for the treatment of multiple myeloma.

In this video interview, Dipanwita Das, CEO & co-founder at Sorcero, highlights how artificial intelligence, real-time monitoring, and historical data can aid in optimizing 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.

In this video interview, Sujay Jadhav, CEO of Verana Health, talks external control arms and how they can increase study feasibility and inclusivity.

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.