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...
Patients in fibromyalgia clinical trials are an interesting bunch. On one hand, you’ll seldom find a more accommodating and cooperative group of people. For years the condition was so poorly understood that many patients were treated dismissively by physicians who didn’t recognize fibromyalgia as a genuine affliction. And even today, the disease’s many symptoms continue...
Both understanding the role of patient advocacy groups in building better clinical trials and improving the research process mean first taking a look at the history of orphan drug development in the United States and Europe. An “orphan drug” is a drug that treats a condition that fewer than 200,000 people have. Because rare diseases...
Wearable medical devices are yielding increasingly important insights into health. Rosalind Picard, Sc.D., professor of Media Arts and Sciences at MIT, discussed the applications of one such device, wearable wrist sensors that measure electrical changes in the skin, in an informative plenary lecture we attended at the American Pain Society’s 36th annual meeting in Pittsburgh,...