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
Overcoming Design Challenges
ICH E14 REGULATORY GUIDANCE 2005 AND 2015
It has been one year since the International Conference on Harmonisation (ICH) updated its 2005 cardiac safety guidelines. The 2015 update allows for specific QT interval analysis based upon concentration effect modeling up to supratherapeutic during Phase I as a reasonable substitute for a Thorough-QT (TQT) dedicated trial. These Phase I data along with preclinical results are submitted to the FDA prior to Phase III as a waiver request from a separate TQT study. This is good news! A dedicated TQT study involving time-wise comparisons of baseline corrected data is an expensive and lengthy endeavor. It typically takes place after proof of concept but before Phase III. Collection of QT information during an existing Phase I study costs substantially less and can provide go/no-go decisions much earlier. Continue reading
Whether large or small, vaccine studies differ from standard drug development in many ways. Sarah Slette, Sr. Study Manager, Vaccines & Novel Immunotherapeutics at Covance, explains the unique challenges her team faces and their solutions to rapidly deliver customized vaccine kits to sponsors’ sites across the globe.
For many technology companies entering the mobile health space, meeting US Food and Drug Administration (FDA) requirements may be unfamiliar territory. The guidelines can appear convoluted and contradictory at first glance, and some devices and/or applications (apps) fall into regulatory grey areas.
To make progress in this rapidly changing field, companies need to find a way to work within the regulations while encouraging creative development. Consulting with experts and the FDA, considering key design issues, taking precautionary quality measures and assessing global requirements will increase the chances that a company can bring a safe and successful mobile health device and/or app to market.
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
What to Expect When Submitting Your First SEND Dataset to the FDA
With the December 17, 2016* requirement for the FDA Standard for the Exchange of Nonclinical Data (SEND*) fast-approaching, our Covance SEND action team prepared a dataset for test submission to the FDA. This helped us to better understand the FDA’s SEND submission requirements, build experience and confirm our readiness to help clients submit their SEND datasets.
During this process, we uncovered a couple of significant learnings:
- Allow for adequate time to prepare and submit to the FDA
- The process to deliver our first test submission took more than two months from kickoff to FDA notification
- It’s important to start early to understand the preparation time needed for submissions
- For test submissions only, the dataset must be submitted on a physical CD and sent to the FDA via postal mail
- This came as a surprise to us, since SEND is a streamlined electronic format of the data
- (Note: In a real submission, the SEND datasets will appear in a specific location labeled “tabulations” in the submission folder structure as described in section 7 of the FDA CDER/CBER Study Data Technical Conformance Guide).
(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
To drive change, medicine requires hard data to supply evidence of clinical benefit. However, the studies we rely on to make decisions about a drug’s efficacy are often statistically underpowered – that is, therapeutic trials may fail to show the benefit of agents or devices when a benefit does, in fact, exist. This is due to limited data from smallpatient populations or too much variability in the data.
We performed analyses of studies of anticoagulation in electrical cardioversion to examine this problem more clearly. We also show how proactive data pooling could help to mitigate limitations in statistical power. Continue reading