Infectious diseases contribute to approximately 25% of global mortality and present critical healthcare challenges, especially in under-resourced countries. Recent research and development breakthroughs may help transform this situation. The industry is now leveraging novel analytical and bioinformatics technologies to better understand the biology and response to viral and bacteriological infections, and thereby develop more rapid and effective strategies for evaluating new therapeutic agents in clinical trials.
1. Applying lessons learned
Hepatitis C virus (HCV) therapeutics, frequently described as a breakthrough area in drug development, because it highlights the result of combining the biological understanding of disease and prioritizing appropriate resources to speed drug development. The first curative therapeutic regimens containing direct-acting agents for this important cause of liver disease were approved in 2011. Since then, seven additional regimens have received FDA approval with several more promising treatments currently in late stage clinical trials. Continue reading
Companion diagnostics are evolving quickly as novel technologies emerge and new drug targets appear. Dr. Mark Roberts, Director of Diagnostics Development, recently shared his thoughts on the industry trends ahead of the World CDx Boston 2015.
How much progress has been made in the area of companion diagnostics? Continue reading
Testing drives drug development. From laboratory tests on patient specimens comes almost all of the clinical data needed for a new drug application. How and where those specimens are collected, transported, stored, and analyzed impacts the quality and usefulness of the data they produce. In the past, most tests were processed by local, academic, and specialized testing laboratories and coordinated by each investigator. However, centralized testing is becoming an accelerated trend – one that uses advanced technology and global operations to concentrate oncology clinical trial tests in a single, central laboratory.
The core value of a central lab is consistency. When local laboratories perform testing, their results will be different and results vary over the course of the trial. Central laboratory testing, on the other hand, offers ‘combinable data.’ The end product is that a result from a central laboratory is similar regardless of the global location where it originated from and the lab location where it is tested. At all of Covance’s central laboratories — in Indianapolis, Geneva, Singapore, Shanghai, and Tokyo — we generate data from the same analytical method platform, SOPs, equipment, reagents, and standards, eliminating variables that affect tests results. Continue reading
Day in and day out, you hold us to a high standard in managing your clinical trials’ logistics needs. The infrastructure that enables us to deliver greater than 99% sample receipt within stability works so smoothly that you rarely need to give it a second thought. But what happens when a natural disaster wipes out roads and bridges, shuts down airports, and even causes referral labs to shut down, stranding samples in transit?
Cancer is a disease that affects all of us; we all know someone with cancer, or have been diagnosed ourselves. Total cancer deaths worldwide in 2008 were approximately 7.6 million – approximately 13% of all deaths worldwide according to the World Health Organization. Therefore, intuitively, one would think that finding cancer patients to participate in clinical trials would not be an issue. However, that’s not the case.
Given the sheer numbers of those afflicted with cancer, we tend to lose sight of the actual prevalence of the disease at a given time in a community. When spread out over a lifetime, cancer is not as common as we assume. So, when posed with the question of where to find cancer patients for clinical trials, intuitive answers will most likely fail. However, statistics can help shed light on the patient recruitment dilemma. Continue reading