Clinical Trials
ISSUE NO. 25 — Flexibility in Phase I Study Timing
The structure of an early-phase drug development pathway is not set in stone. In fact, certain studies that are generally considered Phase I do not have to be conducted before Phase II commences. Conversely, some studies that are typically done in Phase II can be advanced into a Phase I combined protocol to have access to key data earlier in the program. Early Phase I studies have become increasingly complex in order to gather comprehensive data related to safety and drug pharmacology. Having early access to trial results and data helps inform decisions later in the development journey, can support funding opportunities, and helps solidify the overall plan around sound data.
In Issue 25 of The Altascientist:
- Timing of early clinical pharmacology studies
- Phase I combined protocols
- Special populations
- Resource allocation
- Examples of flexible Phase I study timing
ISSUE NO. 24 — Shortening Drug Development Timelines with Asian Ethnobridging Trials
Conducting ethnobridging studies locally, during Phase I clinical trials, in the target population, can reduce drug development timelines by the number of years typically needed to complete clinical development in the target region, as compared with North America or Europe. A Phase I ethnobridging strategy allows you to recruit patients in “global” safety and efficacy trials (Phases II and III) without repeating Phase I development in that region and population.
In Issue 24 of The Altascientist:
- The importance of Asian ethnobridging in clinical research
- Bridging requirements per the ICH E5 Guidance
- Strategic program considerations per the ICH E7 Guidance
- Accelerating Asian drug development
- Language requirements for global clinical trials
- Altasciences’ expertise and experience with ethnobridging
Methodological Considerations for the Human Abuse Potential Evaluation of Emerging Drug Therapies with Psychedelic Properties
The Advantages of Liquid-Filled Capsules Over Tablets in All Phases of Drug Development
Five Facts About Psychedelics for Mental Health
As the incidence of mental health issues increases around the world, most recently exacerbated by the COVID-19 pandemic that has pushed depression to nearly triple the rate
Q&A: Setting Up Your Clinical Research for Success, With Dr. Nicole Maciolek
Tying together the phases of your drug development program are the essential research support services that help your drug candidates not only meet their milestones, but also regulator
The Impact of Social Factors on Drug Development
Drug development exists within the context of interrelated social factors that impact its norms and practices.
One Integrated Solution for Meeting Your Preclinical to Clinical Drug Development Needs
Three Key Advantages of Conducting Early-Phase Clinical Trials in North America: An Overview of the Webinar “A Hop Across the Pond”
Regulatory processes can be challenging, and potential solutions can be found in broadening your focus to include clinical sites in the U.S. and Canada for your drug development strategy. With an understanding of how regulatory agencies and market environments may differ, you will be in a better position to optimize your program. In Altasciences’ on-demand webinar, A Hop Across the Pond, Ingrid Holmes, Vice President of Global Clinical Operations, and Dr.
Current Trends in Drug Development
The drug development landscape has been evolving over the years, from an earlier emphasis on blockbuster drugs developed in-house by large pharmaceutical companies, t