Tag: study design

Clinical Research: Phase 1 - Phase 4

The Importance of Site Selection and Dosing Strategies in Early-Phase Oncology Studies

Setting up an effective phase one trial for a novel investigational oncology product is rife with challenges. Every aspect from site identification to estimation and coordination of enrollment and safety review is interconnected. Nuance is important. What factors can affect, or even derail, the timeline? Who are the key influencers and experienced sites? Does a...

Clinical Research: Phase 1 - Phase 4

mHealth and Remote Clinical Trial Strategies to Include in Your next Study

What happens when patients and clinical research associates alike can’t—or won’t—go to your clinical trial sites? It’s time for a new plan. In the months since the novel coronavirus brought all normal activity to a halt, clinical trials worldwide have been forced to re-examine their strategies and reconsider their approach to data collection, data monitoring,...

Clinical Research: Phase 1 - Phase 4

A New Era in Dermatology: Study Design, Regulatory Strategies, and Patient Participation

Explore dermatology trials from the vantage point of study design, patient access, data quality, regulatory considerations, and more This webinar explores the latest changes in dermatology trials in the areas of study design, patient access, data quality, regulatory considerations, and more. Learn what’s required to understand the disease burden, patients’ treatment goals, and other critical...

Clinical Research: Phase 1 - Phase 4

Neuropathic Pain: What It Is, How It’s Diagnosed, How It’s Treated

Between 7 and 10 percent of the U.S. population suffers from some type of neuropathic pain, and a significant share of those affected require chronic pain treatment.[1] This high rate of occurrence makes our limited understanding of these afflictions, and the long search for effective treatments, all the more frustrating. Treating neuropathic pain starts with...

Study Design

Just How Big is the Placebo Problem?

The placebo response is a real psychological, physiological, and ultimately statistical phenomenon that can be a powerful therapeutic tool in the world of medicine, especially when it comes to chronic pain conditions. For a drug to be approved, its developers must be able to demonstrate that it is significantly more effective compared to a placebo....

Study Design

10 Considerations for Osteoarthritis Study Assessments

There is a great deal of variability when it comes to osteoarthritis (OA) clinical trial designs. From the type of drug being studied to the regulatory approach of the target market to the optimal route of administration, assessment selections must be carefully tailored to meet the unique needs of each individual trial. 1. Pick the...

Clinical Research: Phase 1 - Phase 4

The Placebo Problem, Part 6: Measuring the Placebo Response

This is the next installment of our look at the increasingly high placebo response that is plaguing clinical trials in analgesia and psychiatry. Check out the other posts here. Over the past few weeks, we’ve discussed the psychological, neurobiological, and genetic mechanisms responsible for the placebo response. Today, we turn to the study designs used...

Clinical Research: Phase 1 - Phase 4

Top 5 Study Design Considerations for Acute Pain Management Trials

Short-duration acute pain management trials involve a variety of complex factors that must be taken into account for successfully evaluating the safety and efficacy of a new analgesic product. These five considerations are key. 1. Choosing the Right Model There are a number of established pain models for clinical research, each with its own type, intensity,...

Clinical Research: Phase 1 - Phase 4

The Biggest Hurdles in Rare Oncology Research (And How to Overcome Them)

Translational research has the potential to help all patients, but the principles behind bench-to-bedside research hold special promise for patients with rare diseases — many of which have no standard treatments. Here’s how changes to the way rare oncology studies are performed are getting treatments to the patients who need them at a faster rate. What Makes...

Adult Drug Studies Play Important Role as Need for Pediatric Research Grows

Jennifer Strickler will describe the main differences between pediatric and adult study designs, outline the medical considerations pediatric protocols should include, and break down protocol elements specific to children and family participation.