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
Clinical trials are becoming increasingly complex and competitive, so attracting the best investigator sites to participate in a trial is a crucial step in meeting patient enrollment targets.
Delaying approval by even one day can cost hundreds of thousands of dollars or more, depending on the drug. This means that timely trial implementation, including patient enrollment, may add significant value.
Meeting patient enrollment milestones in cooperation with investigators has traditionally been viewed as the responsibility of the contract research organization (CRO). Now, important new data show that a sponsor’s choice of a central lab impacts the willingness of investigators to work with a sponsor on clinical trials. Continue reading
The complexity of clinical trials continues to rise. New biomarkers for safety and efficacy continue to emerge, and new types of information – such as genomic profiles – have become critical to submissions for drug approval. Against this dynamic backdrop the central challenge facing trial sponsors remains the same: the need to bring together diverse data sets, draw meaningful insights from them and act quickly to maximize return on investment.
Covance and Global Specimen Solutions, Inc. (GSS) have announced a five-year strategic alliance that gives Covance clients access to a comprehensive and integrated solution that includes GlobalCODE®, snapTRACKTM and GSS wraparound services. This will enable near real-time data cleaning across clinical trial data sources which allow interventions to be made during the clinical trial, impacting overall trial execution and data validity. This also allows cross-protocol, cross-program analytics which provide context for data results, assuring robust clinical trial design and operational excellence. Continue reading
With its measurable impact on patient survival, there’s no denying that immunotherapy is already causing momentum in ways that cancer is treated. Drug researchers and developers are identifying new candidates in their growing pipelines and exploring combinations of immunotherapies, while regulatory agencies are providing expedited review and approval of these therapies for new indications at an unprecedented rate.
With checkpoint inhibitors from ipilimumab (Yervoy®) to nivolumab (Opdivo®) to pembrolizumab (Keytruda®) to the most recently approved atezolizumab (TecentriqTM), each breakthrough has provided new insights on how the immune system can be activated and manipulated to fight a variety of cancers. Continue reading
As any drug developer knows, clinical trials generate a lot of raw and electronic data from multiple sources. Yet tracking progress and reviewing results from each separate database can be cumbersome in traditional environments. This “rear-view” mirror approach to monitoring doesn’t support preventative planning to mitigate future risks and can account for 20-30% of a trial’s costs.
Recognizing the opportunity increase efficiency and deliver information faster, Covance created Xcellerate® Monitoring, a platform that integrates clinical trial data to help sponsors proactively decrease the inherent risks associated with clinical trials.
At a recent clinical seminar in China, Dimitris Agrafiotis, PhD, Vice President, Chief Data Officer discussed how Xcellerate Monitoring tracks quality, patient safety and protocol compliance in clinical trials. Continue reading
Demonstrating the efficacy, safety and differential benefit of a new drug relies on collecting and analyzing enormous amounts of data generated in a clinical trial. Yet this process of extracting knowledge from data is often the source of many inefficiencies.
We recently spoke with Dimitris Agrafiotis, PhD, Vice President and Chief Data Officer at Covance to hear his thoughts on how informatics has affected drug development and will continue to transform the pharmaceutical industry.
Q: Why is informatics important in a global context?
More and more major businesses and industries are being run on software and delivered as online services―from movies to agriculture to national defense. Many of the winners of this new economy are Silicon Valley-style technology companies that are invading and overturning established industry structures. Continue reading
(This is part 3 of a 3-part series on Inflammatory Disorders Studies. View part 1 here.View the complete series in our Inflammation eBook.)
Patient-reported outcomes, compliance and retention are key components of success.
Recent research contends some underlying immune system response mechanisms are common to inflammation-related diseases, such as asthma, COPD, psoriasis, rheumatoid arthritis, lupus and inflammatory bowel disease. These diseases are referred to as Immune-Mediated Inflammatory Disorders (IMIDs). There is a significant shift in the approach to managing traditional inflammatory diseases from organ-based symptom relief to tackling common underlying pathways of immune dysregulation which offers the hope of disease modification. Continue reading
(This is part 2 of a 3-part series on Inflammatory Disorders Studies. View part 1 here.View the complete series in our Inflammation eBook.)
Ensure your ROI and keep inflammation clinical trials on track.
The good news: The surge in the number and size of industry-sponsored trials in inflammation presents opportunity. The not-so-good news: The surge also presents challenge. Clinical trials for Immune-Mediated Inflammatory Disorders (IMIDs) present certain pressures for even the most committed investigators and sites: IMID trials frequently have longer than usual duration and enrollment can be highly competitive. Additionally, patients whose disease is well-managed by the new treatments available may not be motivated to try something different. Continue reading
(This is part 1 of a 3-part series on Inflammatory Disorders Studies. View part 2 here.View the complete series in our Inflammation eBook.)
Placebo response rates can obscure treatment effects, putting effective drugs at risk
One of the confounding factors in clinical studies that can contribute to difficulty in discriminating an active treatment effect versus placebo is subject eligibility creep when subjects (e.g. with milder forms of disease severity at baseline) may get enrolled inappropriately by sites when struggling to meet recruitment targets and timelines. Baselines are skewed and misrepresented since subjects initially may be assessed as suffering from the more severe disease grades required to meet inclusion criteria. Continue reading
Change is in the Air
There’s reason for new hope in the ongoing battle against cancer. From standing-room-only presentations of provocative data at cancer conferences, to landmark publications and new drugs approvals, the signs are multiple and clear. Harnessing the immune system as an anti-cancer therapy–a strategy that has yet to fully deliver on its promise– is now the most exciting area of oncology drug development.
Immune Surveillance: an Invisible Malignancy Sentinel
The first chapter in the story of cancer immunotherapy is a tale that provides perspective on how evolving scientific insight serves as a backdrop to the interplay between human hopes and the sometimes capricious nature of medical advances. But that story is well beyond the scope of the next 800 or so words. However, we can take advantage of hindsight to consider some of the key lessons learned. Continue reading