In the early days of fibromyalgia drug research, trial site selection centered almost exclusively on rheumatologists and pain centers. But with more drugs on the market and still more studies underway, there has been significant expansion in the number of sites equipped to conduct this research. Up to a point, anyway. As fibromyalgia therapy matures,...
In our previous CECs blogpost, we reviewed why Clinical Endpoint Committees (CECs) are so crucial for successful trials today. But just how do sponsors establish and operate a CEC? It’s a complex process that can be broken down into these eight key steps: 1. Understand the deep level of commitment required in putting a CEC together....
Patient and parent engagement is crucial for successful pediatric drug trials. That’s why the best strategies are ones that encourage proactive involvement beginning at the early stages of protocol development through study conduct and eventual results-sharing. And that includes input. We partnered with iCAN in 2015 to ask pediatric patients, their family members, and even their friends...
At first glance, it seemed no more complex than any other global, randomized Phase 3 study. The devil turned up in the details. First challenge: overcome early patient screening failure rate of 70 percent At first, screening failure rates were discouraging at best – between 60 and 70 percent. We responded quickly, by expanding the...
Bringing a novel drug to market can be a long, perilous journey down the clinical testing pipeline, taking upwards of 10 to 15 years. Maintaining research and development productivity while navigating the ever-changing regulatory landscape, the choppy waters of today’s reimbursement environments, and the rising tide of clinical trial costs is increasingly challenging. Medicines that fail...
Also called Endpoint Adjudication Committees, Clinical Endpoint Committees (CECs) are an increasingly common component of drug development and medical device evaluation. A CEC is a centralized decision-making body for safety and efficacy endpoints. The goal of a CEC is to standardize outcomes and optimize data quality, ultimately driving study success. A CEC addresses the challenge...
Placebo response is an ever-present threat in analgesia clinical trials, and failure to sufficiently prove the efficacy of the researched compound can easily doom your promising new product. The risk can be especially pronounced when studying drugs to treat fibromyalgia. Fibromyalgia patients can be — and don’t use the term casually or critically — needy....
As researchers seek to harness the human immune system to fight cancer, they’re looking at several emerging opportunities to expand use of biomarkers. Among them: Human leukocyte antigen typing. Microbiome analysis for determining risk of inflammatory complications with immune therapeutics. Tumor mutation burden, measured via whole genome sequencing, whole exome sequencing, or comprehensive gene panel...
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...
Sponsors often face significant challenges in collecting robust, quality data that demonstrates the safety and efficacy of investigative psychiatric drugs. However, before these problems can be solved, they must be understood. Be sure to keep these four issues in mind when mapping out strategies for ensuring quality data collection in psychiatric clinical trials. 1. There...