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Going Virtual: Evolving Real World Evidence Study Design for Speed, Flexibility and Lower Cost
Using a traditional clinical-site recruitment approach is no longer the only option in observational research. With the increased adoption of electronic informed consent methods by the FDA, it is now feasible to conduct real world evidence (RWE) studies using a virtual model that eliminates entirely the need for clinical sites.
Join us to learn how to lower cost and improve the efficacy of current, site-based RWE studies as well as:
The implications of electronic informed consent by the FDA
What is required to conduct a prospective virtual RWE study
How to use electronic data for a retrospective virtual RWE study
The NIH defines precision medicine as “an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person1.” In cancer patients, we can rephrase the definition to “through detailed understanding of a cancer’s biology, providing the right drug, for the right patient, at the right time.”
In order to identify the correct drug, biomarkers are used to identify patients that can be treated with the appropriate therapy for their cancer. The FDA defines biomarkers as “a defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions2.” Great strides have been made in the discovery and validation of biomarkers in drug development. 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 →
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 →
Multiple 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 →
How can identical twins, with the same genetic makeup, experience different diseases? Scientists believe this is due to epigenetic marks or chemical tags that play a role in controlling the activities of genes. The study of the epigenetic landscape has already generated recent breakthroughs in the detection, treatment and prognosis of many diseases, including cancer.
These breakthroughs are due in part to large-scale mapping efforts of cancer genomes coupled with the rapidly dropping costs of high-throughput next-generation sequencing technologies. Identification of mutations and epigenetic analysis are the next frontier for finding reliable biomarkers and developing targeted therapies.
Next-generation sequencing platforms are particularly powerful for mutational and epigenetic studies due to their ability to quickly analyze the entire genome through multiple methods of sequencing, such as DNA, RNA, miRNA, whole genome, exome, targeted, ChIP-Seq, methylome and epigenome. As a result, researchers obtain comprehensive, clinically relevant data sets.
With these resulting data, computational biologists can mine both open source data sets along with data sets from clinical trials to narrow down options for prospective biomarkers. Continue reading →
As the biopharmaceutical industry increasingly focuses on discovering and delivering targeted, personalized medicines, we have stepped up our personalized medicine services to help sponsors conduct biomarker-driven oncology trials. The stakes are high for our clients as their drugs move through clinical development. Many of the old, well-tested strategies for developing cancer drugs are no longer relevant, and biomarkers are becoming an integral part of the story. More and more, oncology clinical trials are focused on biomarker strategies in which selecting the right patients is critical to a trial’s success. Continue reading →
When a large multinational client asked Covance to conduct a Phase III trial on a promising new colorectal cancer drug, their rigorous patient selection criteria initially caused some concern. How long would it take to identify, recruit and retain sufficient qualifying patients? After all, a recent study published by the Tufts Center found that, although 90% of clinical trials worldwide meet their patient enrollment targets, the trade off is that drug developers typically need to nearly double their original timelines to reach those targets.* Continue reading →
Last month I was interviewed by ClinicalLeader for an article about how the central laboratory approach, as opposed to the traditional, distributed model of clinical trial lab testing, is driving higher quality and efficiency in clinical drug development. The article highlighted Covance Central Laboratory Services (Covance CLS) as an example for the new model emerging – using advanced technologies and global operations to concentrate all clinical trial tests into a single, central laboratory. The article also addressed how and why the industry is beginning to adopt central laboratory services for oncology studies. Continue reading →
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 →