5 Tips for Proactively Managing Risks in Your Clinical Studies

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

A Creative Solution to Address the Biosimilar Boom

Identifying viable study sites presents a challenge in many clinical trials. Biosimilar Biosimilars Covancedevelopment 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

Immuno-Oncology Studies: Optimizing Design, Recruitment and Execution

The rise of immunotherapy has been meteoric — there are now well more than 1,000 Purple DNA Strandimmuno-oncology (IO) trials ongoing according to clinicaltrials.gov. Finding and enrolling the appropriate patients for these potentially revolutionary treatments has presented a profound challenge, one that was recently covered in the aptly titled New York Times article: A Cancer Conundrum: Too Many Drug Trials, Too Few Patients. Another piece of the puzzle is clinical trial design, which can be especially elaborate when testing combination treatments in IO. Exacerbating these issues, IO trials are an increasingly competitive race to market. There is great value assigned to reducing development times and being the first drug approved within a class or for a specific indication.

This blog article discusses the current state of immuno-oncology studies, strategies for enhancing patient recruitment, the role of companion diagnostics and solutions for dealing with the complexity of IO combination studies. Continue reading

PK/PD Modeling and Simulation – A Brief Overview and Upcoming Blog Series

The year I graduated from college was the same year an old family friend was retiring. He had spent the majority of his career designing and deploying farm equipment across the United States. When I asked for advice as I entered the workforce he told me a story.

Three months into retirement, a company in California asked him to fly out and consult with their mechanics on why a piece of equipment wasn’t working. He flew out, spent 5 minutes at the company’s site, drew an “X” in chalk on the equipment, and flew home.  They called the next day and asked what they needed to do. He directed them to the “X”. As simple as an “X” is, it represented years of experience and understanding of the intricacies of the machine and what could potentially go wrong.

He said the moral of the story was, “It’s good to know where to put the X”. Continue reading

ELISPOT Addresses the Complex Questions Arising From Vaccine and Novel Therapies

The accelerated arrival of novel vaccines and immunotherapies into the clinical space spurred the emergence of fields like personalized medicine, immuno-profiling and immuno-monitoring built around increasingly sophisticated testing platforms. Among them, immunoassays in the ELISpot (Enzyme-Linked ImmunoSpot) family are the most frequently used functional assays for single-cell analysis.

ELISPOT ChartUsing 2017 data from Trialtrove (Citeline.com), we found that ELISpot assays were used in more than 160 open clinical trials (Figure 1). The main drivers for this rising clinical usage are:

  • The increased prevalence of infectious and chronic diseases as the population ages in developed countries
  • Extensive use of immunoassays in oncology new vaccines and immunotherapies
  • Technological developments, such as test automation and rapid analysis
  • Growth in the biotechnology sector

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Meet Me in 5: Building a Long-Term Career at Covance

Our ongoing “Meet me in 5” series covers 5 people, topics or questions to illustrate how Rob Davie CovanceCovance nurtures exceptional people, provides an energized purpose and enables extraordinary potential in its employees’ careers.   

In this article, Rob Davie, vice president & general manager, global clinical development at Covance, shares his thoughts on career ownership, the benefits of our global culture and our competitive advantage.

  1. No two days are ever the same

Rob Davie didn’t originally plan to stay at Covance for 19 years and counting. He first joined Covance after working with a large pharmaceutical company and planned to eventually return to the pharma industry after gaining knowledge and experience with a global contract research organization (CRO). Continue reading

Can We Expand Companion Diagnostics Beyond Oncology?

The majority of today’s approved companion (and complementary) diagnostics (CDx) support personalized medicine efforts in oncology, a testament to researchers’ growing knowledge regarding the genetic pathways impacted in various cancers. That understanding increases our ability to convert such knowledge of biology into treatments that specifically target disease based on a tumor’s genetic makeup. This has led to significantly improved outcomes for many patients.

But can we leverage the knowledge of the biology of other disease states along with the appropriate technical progress into successful CDx expansion beyond oncology? Given that nearly 50% of all compounds in clinical development are dropped for lack of efficacy, CDx may represent a viable approach to improve this statistic and boost the efficiency of drug development efforts. Promising clinical areas where CDx may play an important role include immunology, rare and orphan diseases, and neurodegenerative diseases such as Alzheimer’s disease. Continue reading

Untangling the Mechanisms of the Diabetic Heart

Diabetes frequently accompanies heart failure (HF) and HF is observed in up to 15% of diabetic cardiomyopathypatients 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.
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5 Things to Know About the Evolving Requirements For SEND

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

Accelerating FDA Submissions with the Trial Summary Domain

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.

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