This is Part Two of our series on the increasingly high placebo response that is plaguing clinical trials in analgesia and psychiatry. Read the other parts here. Analgesic and psychiatric drug development is facing an enormous problem: rising placebo responses in randomized controlled trials (RCTs) threaten the ability of pharmaceutical companies to successfully identify novel...
In 1978 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issued the Belmont Report, which has since become a pivotal document in medical research ethics. This report pointed to three unifying ethical principles that must be followed in clinical research: respect for persons, beneficence, and justice, which are considered fundamental for...
For hundreds of years, the medical community has known that the mere act of receiving treatment, even if it’s just a sugar pill, can improve a patient’s symptoms. Therefore, in order to ensure that the effects of an experimental treatment are real, most randomized controlled trials (RCTs) include a placebo arm. Placebos are most often...
Acne is a common chronic inflammatory skin condition with a complex pathophysiology involving multiple factors. Effective types of treatment involve both prescription and over-the-counter remedies that may be topical or systemic. While many popular therapies have been available for decades, today’s patients and physicians have more options for acne management. Additionally, new research and novel...
Adaptive design is a type of clinical trial methodology that incorporates prospectively planned opportunities for modification of one or more aspects of a study’s design or its hypotheses based on interim analysis of study data. Explicitly planning these pre-specified changes helps to maintain scientific integrity while also introducing greater flexibility in the clinical research environment. The major...
When it comes to pediatric analgesic clinical trials, protocols cannot be simply “cut and paste” from adult trials. Likewise, extrapolation of efficacy and risks from adult studies is not always reliable due to developmental and physiological differences. Researchers engaged in pediatric trial design must consider the specific physiology, pharmacology, and normal daily activities for each group being...
Article 50 was triggered on March 29, 2017, and officially started the two-year negotiation period before the U.K. exits the European Union. The uncertainty of Brexit has left researchers and others in the clinical trials industry nervous about their future. Many of the largest changes for researchers in the U.K. depend on what happens during the next...
The journey to treating fibromyalgia has taken a sometimes circuitous path. After a burst of activity about a decade ago, the pursuit of new therapies took a years-long pause before reigniting in recent years. In the past five years, we’ve performed 16 fibromyalgia clinical trials (more than any other CRO), and here are some reflections...
Acne — specifically acne vulgaris — is the most common skin disorder in the United States, affecting up to 50 million Americans each year. While many cases are restricted to mild manifestations during one’s teenage years, acne is a highly visible condition that can have a major impact on a patient’s quality of life. It’s a disorder with the potential...
One of the first steps in the development process is to create the target product profile (TPP) that defines the projected marketed product label. The TPP helps rule out any pharmacodynamic effects that are no more beneficial than current therapeutic treatments. Developing a TPP is also an opportunity to evaluate intellectual property and ensure that the product has an...