Facing ever-increasing costs of running a clinical trial, sponsors must ensure they are properly directing their budget and resolving the areas of highest risk while maintaining patient safety and data integrity.
How can sponsors implement a robust process to allow earlier identification of emerging risks during the course of a trial? This article covers five tips for defining risk levels, categorizing risk and maintaining oversight to ensure that risks and responses are appropriately identified, documented, tracked and managed throughout the life cycle of a study. Continue reading
Identifying viable study sites presents a challenge in many clinical trials. Biosimilar development is especially challenging as the number of sponsors preparing to broaden access to today’s blockbuster biologics, by providing lower-cost biosimilar alternative, continues to grow. While this flood of research activity will make a significant improvement for patient access to breakthrough treatments, it has also created an increasingly competitive environment for finding suitable, experienced sites.
Compounding the issue, physicians are often less interested in supporting biosimilar studies, preferring to engage in clinical trials involving novel targets and compounds or those being conducted by larger academic institutions. Additionally, the level of education and training regarding the established development process for biosimilars is generally low. To overcome these hurdles, Covance has expanded its strategy to help sponsors find qualified sites and investigators willing to provide reliable clinical evidence. Continue reading
Diabetes frequently accompanies heart failure (HF) and HF is observed in up to 15% of patients with type 2 diabetes (T2D). The relationship between diabetes and the heart is, however, complex. It has long been known that diabetes is an important risk factor for coronary artery disease, resultant myocardial ischemia and infarctions leading to HF. But the direct effect of diabetes on the heart muscle is less clear.
The existence of a non-ischemic diabetic cardiomyopathy, disease of the cardiac muscle that is directly related to diabetes and not due to coronary atherosclerosis, has been a longstanding topic for debate. The recent EMPAREG-OUTCOME study in which patient assignment to the sodium-glucose co-transporter-2 (SGLT-2) inhibitor, empagliflozin, was associated with a reduction in HF hospitalizations by 35%1 (for unclear reasons) has reignited this discussion.
As our industry approaches the one year anniversary of the implementation of SEND (Standard for the Exchange of Nonclinical Data) datasets as required by the FDA for regulatory submissions, attention is shifting to the next set of requirements. From recent notices to upcoming compliance dates, we’ve compiled five key highlights for your information that will also help you proactively prepare for the changes. Continue reading
A Trial Summary (TS) domain represents an essential part of standardizing study data for electronic submissions. In July 2016, the U.S. FDA issued version 3.1 of the Study Data Technical Conformance Guide, which advised including a TS domain to identify the study start date in the submission. In clinical studies, the study start date is earliest date of informed consent from any subject enrolled in the study, whereas nonclinical studies use the study initiation (protocol finalization) date. This article reviews the importance of the study start date and makes recommendations to help ensure a successful submission for current and legacy studies.
Covance employees working to support clinical trials recognize that they are helping to move medicine forward and improve healthcare, but sometimes the impact is much closer to home.
“A client of ours was testing a new formulation of a measles, mumps, rubella and varicella (MMRV) vaccine and needed to ensure the end product was safe in pediatric populations,” explained Joshua. The Phase IV study was running smoothly but needed a Clinical Research Associate (CRA). Joshua was thrilled to take on the study and build on his experience. Continue reading
Both type 2 diabetes (T2D) and heart failure (HF) are on the rise and reaching epidemic proportions. This is no surprise as the two conditions are physiologically related. Both are associated with an aging population, dietary indiscretions and sedentary lifestyles. However, debate continues about whether or not an essential diabetic cardiomyopathy exists or if the HF frequently observed in diabetics is due to common comorbid conditions such as coronary artery disease or hypertension. In any case, the epidemiology of the two conditions runs in parallel. HF is currently the most frequent hospital discharge diagnosis provided in US patients over the age of 65 and the prevalence of T2D is about 25% in this age group.
Our ongoing “Meet me in 5” series covers 5 people, topics or questions to illustrate how Covance nurtures exceptional people, provides an energized purpose and enables extraordinary potential in its employees’ careers.
In this edition of Meet Me in 5, our leadership team shares their experiences with nurturing careers at Covance.
When disaster strikes, the safety of your en-route patient samples depends upon the contingency planning that was done in anticipation of the emergency. While many emergencies happen in an instant, immediately impacting our logistics infrastructure – earthquakes, tornados or volcanic eruptions, for example – some, such as the recent series of severe hurricanes and typhoons, have longer lead times.”
When events of this nature occur, our global logistics team is behind the scenes preparing for such events. With more than 25 full-time staff, this team monitors shipments, coordinates with couriers, and oversees all of the operations that are critical to ensuring that patient samples are received at our labs within stability. Even factoring in emergencies, transportation failures impact only about 0.1% of all specimens. Continue reading
Rheumatoid arthritis (RA) is an autoimmune disease primarily affecting the musculoskeletal system with typical symptoms including swollen and painful joints, joint
stiffness and loss of function, ultimately leading to disability if untreated. RA also has significant systemic features in many patients that appreciably impact upon their quality of life, including fatigue and depression. Prevalence varies between 0.3 – 1.0% and is more common in women and in developed countries.1
Modern RA treatment paradigms (i.e. “treat to target”) focus on achieving remission/low disease activity to minimize joint damage and disability. Biologic agents targeting key inflammatory mediators (TNF-alpha, IL-1, IL-6), key cells and activation pathways of the adaptive immune system such as B cells and T cell co-stimulation pathways, have revolutionized the treatment of RA and many other immune-mediated inflammatory diseases (IMIDs), and have rapidly been introduced into accepted treatment paradigms2,3 when earlier disease modifying anti rheumatic disease (DMARD) agents such as methotrexate (and others) are insufficient to reach these target goals. Continue reading