Study Design

Clinical Research: Phase 1 - Phase 4

Seven Things to Know About Recruiting Patients for Opioid Trials

A trial’s success depends largely on the ability to recruit and retain an adequate number of participants. Recruitment can be especially difficult in opioid clinical trials, due to a variety of factors. Here are seven things you should know about the challenges associated with recruiting patients for opioid trials: 1. Certain necessary aspects of trial...

Clinical Research: Phase 1 - Phase 4

Chronic Pain: Conducting Clinical Trials In Osteoarthritis

It’s the leading cause of disability due to pain and the most common form of arthritis, afflicting an estimated 237 million people worldwide. Osteoarthritis (OA) occurs as the cartilage on the end of bones wears down and most often affects the hands, knees, hips, and spine – though it can damage any joint in the...

Clinical Research: Phase 1 - Phase 4

The Placebo Problem, Part 6: Measuring the Placebo Response

This is the next installment of our look at the increasingly high placebo response that is plaguing clinical trials in analgesia and psychiatry. Check out the other posts here. Over the past few weeks, we’ve discussed the psychological, neurobiological, and genetic mechanisms responsible for the placebo response. Today, we turn to the study designs used...

Clinical Research: Phase 1 - Phase 4

The Use of Controlled Substances in Clinical Trials

Opioid analgesics are essential to the management of pain in many patients, but they are also associated with potential risks for abuse, overdose, and diversion, concerns which must be considered in the planning and execution of clinical trials studying these controlled substances. In this paper, we discuss the challenges of conducting clinical trials of controlled...

Clinical Research: Phase 1 - Phase 4

Choices, Choices: Which Type of Natural History Study Meets Your Needs?

When you’re looking into conducting a natural history study, you’ve got two things to consider up front: the premise that underlies all of these studies, and which of several types suits your purpose. We tackled these and other topics in our last rare disease webinar. Natural History vs. Registry Studies in Rare Disease considers a...

Clinical Research: Phase 1 - Phase 4

How Adaptive Design Clinical Trials Uphold These 3 Core Ethical Principles

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...

Clinical Research: Phase 1 - Phase 4

4 Potential Advantages of Adaptive Design

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...

Consulting

Designing Pediatric Analgesic Treatment Regimens and Assessing Their Outcomes

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...

Clinical Research: Phase 1 - Phase 4

Why Have Cancer Treatment Vaccines Fallen Short?

Vaccines were once thought to have great potential for combating some types of cancer, but reality has failed to match those expectations. To date, vaccines have failed to play a major role in the pursuit of immune response for oncology patients. There have been two notable successes — sipuleucel-T (marketed as Provenge) is approved to...

Clinical Research: Phase 1 - Phase 4

Immuno-Oncology Drug Development: Opportunities Beyond Hope

Immuno-oncology drug development is complex and requires a thorough understanding of both the immune system’s role in cancer development and the unique challenges associated with evaluating therapeutic response. Over the past decade, immuno-oncology has become one of the most promising and fastest-growing areas of cancer research and drug development. Present-day advances in immuno-oncology can be...