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....

Against the Odds: Achieving Fast Startup in a Sickle Cell Drug Trial

Even when things go pretty well, launching a clinical trial is a game of long odds. And when the deck is stacked against you the way it was when we set out to study a drug for sickle cell disease, the difficulties can add up fast. So even we were surprised by the success of...

The Placebo Problem, Part 11: Trial-Independent Placebo Contributors

This is the eleventh 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. As we discussed last week, there are so many trial-related details that can influence the magnitude of the placebo response. But there...

5 Stages of Medical Device Development

While in many ways similar to pharmaceutical drug development, medical device development must work through some unique challenges, including: Variations in complexity — Devices may have multiple different constituent parts, including hardware, software, and medicinal components. Very different purposes — Almost all drugs are therapeutic, while devices may be therapeutic, diagnostic, monitoring, supportive, surgical, and more. Regulations regarding...

The Placebo Problem, Part 10: The Devil’s in the Details

This is the tenth installment of our look at the increasingly high placebo response that is plaguing clinical trials in analgesia and psychiatry. Catch up on the other posts in the series here. Over the last two weeks we’ve discussed several specific strategies to reduce the placebo response. One effort that is becoming increasingly popular...

3 Strategies for Treating Psoriasis

We’ve previously discussed several issues around psoriasis, including the pathogenesis of the condition and the challenges (and solutions!) of conducting psoriasis clinical trials. Today we turn toward three strategies for treating it. Although moisturizer may be an effective solution for some cases of mild psoriasis, many patients require medical intervention to ease their symptoms and...

The Placebo Problem, Part 9: Training Achieves Smaller Placebo Responses

This is the ninth installment of our look at the increasingly high placebo response that is plaguing clinical trials in analgesia and psychiatry. View the other posts in the series here. Our last post reviewed several potential strategies to reduce the placebo effect, focusing on excluding high placebo responders and alternative trial designs. Today, we’ll...

Challenges in Medication Development for Addictions

There is a significant unmet need for medications for addictions, chronic, relapsing disorders that lead to biological and behavioral changes that can have harmful medical and psychological consequences. Addictions are common, debilitating and costly disorders resulting in more than $740 billion a year in increased healthcare costs, crime, and lost productivity. Multiple medications have been...

The Placebo Problem, Part 8: Finding Another Way

This is the eighth installment of our look at the increasingly high placebo response that is plaguing clinical trials in analgesia and psychiatry. Catch up on the rest of the series here. We’re now just over halfway through our Placebo Problem series. So far, we’ve examined the details of the rising placebo response, the mechanisms...

The ABC’s of OA

Chances are you’ve either personally dealt with osteoarthritis (OA) or know someone who has. This common type of degenerative joint pain represents both a heavy disease burden and a major opportunity for drug developers. Read on to learn more about: OA’s prevalence Optimal diagnostic criteria for clinical trials Treatment options What OA research looks like...