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Study Design

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. Osteoarthritis, sometimes called degenerative joint disease or degenerative arthritis, occurs when the protective cartilage on...

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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...

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Consulting

5 Operational Considerations for Rare Disease Trials

From researchers to sponsors to patients to advocacy groups to clinicians, rare disease research is full of passionate, driven, and determined people. As the greatest asset to the field, all people involved must be utilized to their greatest potential for a study to be successful. That’s why significant attention must be paid to the operational challenges within...

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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...

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Study Design

6 Early Phase Dose-Finding Trial Designs for Oncology Therapeutics

Phase I and II trials may have different overall goals (i.e., demonstrating safety vs. efficacy), but the two both struggle with a major challenge in oncology study design: finding the right dose. Luckily, decades of data and innovations have given researchers the tools necessary to plan a successful dose-finding trial. Read on for a look...

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Consulting

Six Dosing and Safety Considerations in the Era of Emerging Therapies

Sponsors of emerging hematologic therapies – including gene transfer and gene editing, adoptive cellular, and antibody-drug conjugates – face a unique set of challenges in conducting early-phase, dose-finding studies. Key considerations for developing early-phase trials that can more accurately define the recommended dose and identify adverse events for emerging therapies include: Using dose-finding trial designs...

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Consulting

The Placebo Problem, Part 13: The Pediatric Placebo Response

This is the thirteenth installment of our look at the increasingly high placebo response that is plaguing clinical trials in analgesia and psychiatry. Read the rest of the posts in the series here. Until now, our Placebo Problem series has focused exclusively on the placebo response in adults. Today we turn to another population: kids....

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Clinical Research: Phase 1 - Phase 4

Clinical Leader – Maximizing Immuno-Oncology Clinical Trial Success

Immuno-oncology is a unique approach to cancer treatment that leverages the body’s immune system to help fight cancer. In recent years, immune checkpoint inhibitors have changed the landscape of immunotherapy, and emerging therapies such as chimeric antigen receptor T-cells (CAR-T), dendritic cell vaccines and bi-specific T-cell engager (BiTE) antibodies are pushing the envelope even further....

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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...

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Patient and Stakeholder Engagement

3 of the Hardest Obstacles We Face in Alzheimer’s Clinical Drug Trials

For the estimated 30 million people worldwide who have Alzheimer’s disease, progress toward understanding and treating this most prevalent form of dementia is frustratingly slow. The few approved drugs address only the condition’s symptoms, though scores of drugs to prevent onset or alter the disease’s course are now under study. From high screen failure rates...

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