Study Design

Clinical Research: Phase 1 - Phase 4

Driving Product Development And Finding The Fast Track In Early-Phase Oncology Programs

Your company has received funding for a first-in-man trial of a novel oncology compound. The circumstances are typical: limited budget, uncomfortable timeline, a scarcity of skilled clinical trial professionals, and limited knowledge of regulatory hurdles to form a robust clinical strategy. And you recognize that the success of the drug — and possibly the company...

Clinical Research: Phase 1 - Phase 4

Where Expertise Meets Nuance: Conducting PTSD Clinical Trials

The invisible wounds caused by post-traumatic stress disorder can dramatically affect mental health and diminish quality of life. According to the Sidran Institute, a nonprofit organization serving people who have experienced or witnessed traumatic events, PTSD is associated with an extremely high rate of medical and mental health service use. Patients may incur the highest per-capita cost...

Clinical Research: Phase 1 - Phase 4

Boosting Immuno-Oncology’s Effectiveness Against Cancer

Immuno-oncology continues to be an exciting frontier in the fight against cancer. Researchers continue to develop drugs that allow the body to weaponize its own immune system against the growth of new tumors. Most uses of immunotherapies have been limited to cancers, like those in the lungs or pancreas, that produce a strong immune response. In his article...

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....

Clinical Research: Phase 1 - Phase 4

CAR T-cell Therapies: Safety Considerations and Toxicity Management

Immuno-gene therapeutics are transforming the therapeutic landscape of hematological malignancies. The recent approvals of two chimeric antigen receptor (CAR) T-cell therapies—tisagenlecleucel (marketed as Kymriah™) and axicabtagene ciloleucel (marketed as Yescarta™)—mark the beginning of the next revolution in cancer treatment. However, along with demonstrated efficacy in hematologic malignancies, CAR T-cells have the capacity to elicit serious...

Consulting

Analgesia eBook: The Placebo Problem

TABLE OF CONTENTS SECTION ONE: PLACEBO PROBLEM OVERVIEW CHAPTER 1: INTRODUCTION CHAPTER 2: RISING RESPONSE CHAPTER 3: A BRIEF HISTORY OF THE PLACEBO SECTION TWO: UNDERLYING MECHANISMS CHAPTER 4: PSYCHOLOGICAL UNDERPINNINGS CHAPTER 5: NEUROBIOLOGICAL MECHANISMS CHAPTER 6: THE PLACEBOME SECTION THREE: MEASURING THE PLACEBO EFFECT CHAPTER 7: PLACEBO RESEARCH STUDY DESIGNS CHAPTER 8: DRUG-PLACEBO INTERACTIONS...

Clinical Research: Phase 1 - Phase 4

Immuno-Gene Therapeutics in Hematological Cancers: How Science Drives Study Strategy

This webinar will review the current state of technology in gene therapeutics and examine trends in immuno-oncology and gene therapy for hematological malignancies. Topics will include: Ingredients for successful study planning and delivery Operationalizing studies to achieve conclusive data outcomes Data-driven approach to choosing the right sites in the right countries Key drivers to retaining...

Clinical Research: Phase 1 - Phase 4

Considerations When Operationalizing Trials for Osteoarthritis of the Knee

Treating the chronic pain experienced by patients with osteoarthritis is among the most enduring challenges in analgesic drug development. Operationalizing trials for osteoarthritis of the knee requires careful consideration of study design, strategies for mitigating placebo response, and site selection.

Consulting

6 Reasons Why Early Oncology Drug Trials Fail (And How to Avoid Them)

Unfortunately, not all oncology trials succeed. In fact, the phase success and likelihood of approval (LOA) rates for oncology are the lowest across major therapeutic areas. Although there are many reasons for these relatively poor success rates, issues determining dose, schedule, and regimen in early phase trials are among the most prominent. Why and Where...

Study Design

AD Trials: Is your protocol asking the right questions?

Most trials for potential Alzheimer disease (AD) treatments fail—and the reason may be poor protocol design. After all, typical AD studies are double-blind placebo-controlled parallel group clinical trials with a dual outcome, including a cognitive measure and a global impression of aptitude for the activities of daily living—a trial design originally developed to study cholinesterase...