Tag: placebo response

Clinical Research: Phase 1 - Phase 4

The Placebo Problem in Pain Research: Keeping Up With the ‘Mrs. Joneses’

We were conducting a trial for a painful diabetic neuropathy (PDN) drug and were investigating why one site had an especially high placebo response rate. Then one of our representatives, waiting in the site’s lobby to meet with the principal investigator, pinpointed the likely reason when a patient walked in the door. “Mrs. Jones,” the...

Clinical Research: Phase 1 - Phase 4

Operational Challenges of Neuroscience Clinical Trials, Part 2: High Placebo Responses   

Neuroscience clinical trials, especially those for psychiatry and analgesia indications, have always had to deal with the challenge of high placebo response. Most troubling is that the placebo response rate seems to be on the rise, at least in the U.S.   Bigger placebo responses make it harder to show that an experimental treatment is...

Premier Voices #4: The Placebo Problem Part 2 With Michael Kuss

Measuring, interpreting, and mitigating placebo response is a persistent and growing challenge in analgesia clinical trials. In the conclusion of our Premier Voices podcast series on the placebo problem, Paul Mirek, Marketing Manager, and Michael Kuss, BS, Vice President, Analgesia Product Development, examine experimental trial designs, inclusion and exclusion criteria, and other approaches to managing the...

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....

Consulting

The Placebo Problem, Part 15: Ethical Considerations

This is the fifteenth and final 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 our Placebo Problem series draws to a close, we conclude by taking a brief look at three ethical issues...

Consulting

The Placebo Problem, Part 14: A Brief History of the Placebo

This is the fourteenth 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. The term “placebo” first took hold in an unlikely place: funerals. Placebo, Latin for “I shall please” first came into use in...

Clinical Research: Phase 1 - Phase 4

The Placebo Problem, Part 12: The Nocebo Response

This is the twelfth 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 posts in the series here. After focusing exclusively on the placebo effect in this series, today we’re going to take a quick detour, turning to...

Clinical Research: Phase 1 - Phase 4

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...

Clinical Research: Phase 1 - Phase 4

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...

Clinical Research: Phase 1 - Phase 4

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...