Considerations for Running an Effective Pediatric Clinical Trial

PedsLit_RFcombinedHR_WebSizeTreatments that are safe and effective for adults may be ineffective or even dangerous for children. But infants and children are often prescribed medications with “off-label” use, where the treatment’s safety, dosage and efficacy are based solely on adult studies. To address this issue, both drug developers and regulators are working to boost clinical trials in children and include this underserved market in their studies.

Challenges with pediatric trials

A number of factors work against studying pediatric populations. As a highly fragmented and dynamic population, children and infants undergo rapid developmental changes over time, complicating study design and interpretation.

In addition, small sample sizes and potentially low incidence rates can make it difficult to find a treatment group—as well as a suitable control group with an approved active control. Finally, ethical considerations, such as informed consent can be more complex in pediatric trials. Continue reading

Harmonizing Anatomic Pathology and Histology Services: Constructive Steps Toward Greater Precision in Global Oncology Trials

Zemanta Related Posts ThumbnailIn 2013, oncology represented the largest segment of the clinical trial market. In 2014, it is estimated to grow by 4.9%,1 reaching nearly $100 billion. The number of oncology clinical trials stands well above those in other therapeutic areas and most major biopharmaceutical companies are involved in oncology to some degree.

Yet, with such compelling numbers, why do only 6.7% of these trials lead to FDA approval from Phase 1?2 Possibly because of difficulties recruiting patients for oncology trials, but more likely due to the complexity of cancer as a disease. Continue reading

Understanding the Clinical Impact of Having a Companion Diagnostics Strategy

Understanding the Clinical Impact of Having a Companion Diagnostics Strategy

As the pace of companion diagnostic innovation continues to accelerate, the drug development industry faces several headwinds. Numerous patent ‘cliffs’ are affecting the sales of blockbuster drugs; competition is increasing for a limited clinical trial population in increasingly global trials; and health outcomes pressures from patients, payers and healthcare providers are transforming the drug development process.

Over the past 10 years, advances in analytical technologies have provided new tools to identify patients who are more likely to positively respond to a certain drug or, conversely, experience a negative reaction to the particular therapy. These tools, known as companion diagnostics, are laboratory tests for biomarkers that, once commercialized, are designed to be an accompaniment to the safe and effective use of a particular therapy. Continue reading

Central Lab Model Provides Solutions for Oncology Trials

Zemanta Related Posts ThumbnailTesting 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

ISO 15189:2012: The New Normal

Over the last decade, the U.S. Food and Drug Administration (FDA), and other global regulatory agencies, have been placing increased scrutiny on clinical data quality. It has become clear that the traditional paradigms of sample testing management will not be sufficient in the future.

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In order to avoid putting clinical trial programs at risk, the pharmaceutical industry will need to place a greater emphasis on meeting the new standards for testing data quality and documentation. The need to do so has become more pronounced with the increase in esoteric testing that has been seen in recent clinical trial programs. For example, the rise in genomics testing, immunohistochemistry (IHC) markers and flow cytometry panels has increased the volume of tests being sent out to referral laboratories. The frequency of warning letters from the U.S. FDA has also increased dramatically in the last few years. Continue reading

Experience, Insights and Results = Innovative Solutions for Oncology

The gauntlet of oncology trial planning, investigation, and final approval can be daunting. Oncology is the largest, fastest-growing, and most research-intensive therapeutic area in drug development, yet the need for new agents is urgent. Plus, cancer patients are among the hardest to recruit for clinical trials.


Innovations in personalized medicine are also creating a dynamic environment presenting increased requirements for scientific and operational expertise; access to high-performing investigator sites with the right patients; and global combinable data. Continue reading

Reducing the Variability in Multiple Myeloma Testing

IFE-PEP-2_blogMultiple myeloma is a blood cancer that typically affects those aged 70 years and older. Although considered an uncommon disease, the American Cancer Society estimates that in 2015, 26,850 new cases will be diagnosed in the United States this year. Global studies show a worldwide incidence of 86,000 cases per year.

The high five-year patient survival rate makes this type of cancer an ideal target for research and treatment studies. Pharmaceutical companies have also embraced the search for treatment of multiple myeloma, since the availability of a successful therapy would enable patients to live significantly improved and productive lives. Continue reading

Examining Tau Phosphorylation as a Potential Alzheimer’s Disease Biomarker

tauWe are always on the lookout to apply the latest research to our work and contribute additional findings to the scientific community. This month we will present a poster studying the regulation of Tau phosphorylation at the upcoming 2013 Society for Neuroscience conference in San Diego.

The interest in this research was first sparked at last year’s 2012 Alzheimer’s Association International conference in Vancouver, Canada, where we heard discussions on the effects of anesthesia on Alzheimer’s disease (AD) patients. Continue reading

The Role of the CRO in Frontloading Cardiovascular Safety

The Role of the CRO in Frontloading Cardiovascular SafetyCardiovascular safety remains a leading cause of drug attrition during preclinical and clinical development, accounting for discontinuation of approximately one third of marketed drugs.

These liabilities, which pertain to both cardiovascular- and non-cardiovascular-targeted drugs, can be identified during early development by addressing cardiovascular safety endpoints prior to the selection of a drug candidate, a process known as ‘frontloading’. Although not mandated by the key regulatory guidance for safety pharmacology (ICH S7A; US FDA, 2001), an increasing number of companies choose to conduct early non-GLP cardiovascular safety studies in support of decisions on the progression of their compounds. Continue reading

Biomarker Development for Parkinson’s Disease

Biomarker Development for Parkinson’s Disease

Parkinson’s Disease (PD) is a chronic neurodegenerative disease with no known cure, no certain cause, and no clinically available test for simple diagnosis. Research advances have been made, but there still remains a huge unmet need for diagnostic and disease progression biomarkers.

Research on this disease is focused on the changes that occur in the brain. Research has shown that the nerve cells in the brains of Parkinson’s patients have abnormal protein deposits that may disrupt normal brain function and cause Parkinsonian symptoms, such as tremor, slowness of movement, and rigidity, among others. Continue reading