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Performance Metrics Dashboard

Operational Metrics in Clinical Trials, Part 2

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  • 04 Aug
Metrics defined by the Metrics Champion Consortium (MCC), a group of experts in clinical research, define how to measure the performance of our clinical trials and makes it easy to see where we are, and where we need to be in our study. Since the metrics are the same for all clinical studies, we are comparing apples to apples. We can see the number of subjects enrolled, completed, the number of open queries and entered pages. We can see the data by study, by site, or pool site data from multiple studies. Since we are using defined metrics, we know that the definition for ‘average time from CRF submission to verification’ is: Sum (CRF Verified Date - CRF Expected Date) / (Number of CRFs). The definitions remain consistent across different clinical studies and programs.
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Ongoing Development of Imaging Biomarker Standards in Clinical Trials

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  • 29 Jul
One of the areas that I am active in is the ongoing development of standards for the qualification of imaging biomarkers. When the Prescription Drug User Fee Act (PDUFA) was renewed in 2007, the FDA agreed to develop by the end of 2011 a guidance document on “Imaging Standards for Endpoints in Clinical Trials.” Work on this is ongoing. At the recent FDA/RSNA/SNM meeting held on April 13-14, 2010 at the NIH, which I attended, Janet Woodcock M.D., Director of the Center for Drug Evaluation and Research (CDER) gave an update on the FDA’s perspective. A copy of her presentation can be downloaded here.
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PET Neurochemical Classification

The Use of Biomarkers and PET in Early Alzheimer’s Disease Diagnosis

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  • 27 Jul
Alzheimer’s disease (AD) is the most common form of dementia and is incurable, degenerative and irreversible. It affects around 4.5 million people in the United States, a number that is expected to exceed 12 million by 2050. Neuropsychological tests, such as the mini-mental state examination (MMSE), are commonly used to diagnose patients. However, cognitive impairment may be due to another disease, not Alzheimer’s. There remains an unmet need to be able to differentiate between different forms of dementia.
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Operational Metrics in Clinical Trials, Part 1

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  • 22 Jul
If you can not measure it, you can not improve it. –Lord Kelvin The Metrics Champion Consortium (MCC) develops metrics that allow trial sponsors and CROs to share a common set of clinical trial performance metrics across studies. This not-for-profit group is solving a very complex problem in a very elegant, straightforward way. They gather industry experts to identify and define a common set of clinical trial metrics that can be used in all studies. See a recent Metrics Champion Consortium press release here.
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DCE-MRI Biomarkers Technology and Development

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  • 19 Jul
Following on from my recent post on Optical Coherence Tomography, another interesting medical imaging technology that I am actively involved with is Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI). DCE-MRI is an imaging technique that combines the magnetic field and radio frequency imaging of MRI with the injection into a vein of a standard MRI contrast media that makes organs, tumors and blood vessels easier to see. Essentially DCE-MRI provides the tracking of low molecular weight contrast agents through blood vessels, in particular the vasculature of tumors. By analyzing the pharmacokinetics of the contrast agent into a specific tumor, it is possible to measure alterations in vascular permeability, blood flow and extracellular volumes. This is of interest in the development of cancer drugs that inhibit new blood vessel formation (anti-angiogenesis) or disrupt existing blood vessels (vascular disrupting agents) for example. O’Connor et al in the British Journal of Cancer provides a good review of DCE-MRI imaging biomarkers in oncology clinical trials.
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Imaging Biomarkers in Oncology Clinical Trials

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  • 15 Jul

Following on in my series of blog posts about imaging biomarkers and the recent BioClinica symposium, I wanted to share some insights provided by Ali Guermazi, MD (a consultant to BioClinica, who was also a co-author on the Cheson Criteria) from Boston University School of Medicine who spoke on “Imaging Biomarkers in Oncology from RECIST to beyond.”

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Imaging Biomarkers in Clinical Trials

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  • 06 Jul
Imaging biomarkers are currently a “hot topic” in pharmaceutical circles. This was brought into focus at a recent symposium in Princeton and repeated in Amsterdam on “Current and Innovative Imaging Biomarkers in Neurology and Oncology Drug Development.”At this symposium, BioClinica brought together several leading experts and key opinion leaders to present on emerging imaging biomarker trends. Cornelis van Kuijk (Professor and Chair Department of Radiology, Vrije Universiteit Medical Center, Amsterdam) provided an informative introduction to imaging biomarkers in clinical trials. He started off his presentation by saying: “Imaging biomarkers should reflect disease activity and are used to study natural course of disease and to study interventions for treatment such as medication.”
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Best Practices for Applying Electronic Signatures When Using EDC

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  • 01 Jul

Electronic Signature Application Questions

There is quite a bit of information by the FDA and others about what it means to apply an electronic signature.

Here are the questions around electronic signatures that I hear most often:

  • Should the electronic signature be applied to all pages in the electronic CRF?
  • Should the electronic signature be applied to Adverse Events, and Study Completion as typically done on paper? 
  • Should electronically transmitted laboratory data be electronically signed?
  • What happens if pages are electronically signed and the data changes? 
  • What if a page is electronically signed, then a query is added to the page?
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Quantitative Imaging Biomarkers Alliance

Improving the Use of Imaging Biomarkers in Clinical Trials

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  • 30 Jun
One of the areas I spend time on is attending working groups and scientific meetings designed to improve the use of quantitative imaging biomarkers in clinical trials. One such group is the Quantitative Imaging Biomarkers Alliance (QIBA) that is organized by the Radiological Society of North America (RSNA). Established in 2008, QIBA includes representatives from pharmaceutical companies, imaging equipment manufacturers, government agencies, professional societies and clinical trial centers.
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Technology for Clinical Trial Supply Planning

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  • 25 Jun
The 2010 Optimizer User Conference recently ended and I am happy to report a surge in discussion around technology for clinical trial supply planning. I think this speaks well to the growth of the Optimizer product and greater acceptance of the application of more sophisticated tools to the clinical supply planning process in general. There were a number of roundtable discussions and open training sessions, which were as valuable for me as I believe they were for the attendees.
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The Future Development of Imaging Biomarkers

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  • 22 Jun
An imaging biomarker is a quantifiable anatomic, physiologic or metabolic parameter derived from an image that is an indicator of a particular disease. Furthermore a biomarker is a parameter which can be used at an indicator of the progression of a disease or medical condition or the effect of treatment. A number of public-private partnerships are working together to develop novel imaging biomarkers. One of these is the Alzheimer's Disease Neuroimaging Initiative (ADNI). A few years ago the ADNI started a clinical trial (ADN1-1) that involved 57 sites with 200 normal subjects followed for three years, 400 subjects with mild cognitive impairment (MCI) followed for 2 years and 200 subjects with Alzheimer's disease (AD) followed for 2 years. Participants receive clinical exams, cognitive tests with some also having FDG-PET and PiB-PET. The aim was to gather longitudinal data over time and link early cognitive, imaging and biomarker changes to later clinical decline.
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How Will the Stimulus Package Affect Clinical Research?

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  • 10 Jun

To borrow from Oprah, here is what I know for sure:

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The Four Pillars of Intelligent Monitoring

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  • 24 Mar

Risk-Based Monitoring (RBM) Evidence Mounting In the recent paper from industry consortium TransCelerate BioPharma, Inc., Evaluating Source Data Verification as a Quality Control Measure in Clinical Trials (available here) issued in November 2014, RBM gains further support as evidence from actual clinical trials is presented corroborating earlier findings cited by the US FDA and EMA.

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Practical Risk Based Monitoring Methodologies

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  • 17 Mar

eClinical Greetings from Barcelona!
Jonathan Andrus
After a few crimps in the travel plans thanks to another winter storm hitting the US, everyone arrived safe and sound in sunny Barcelona for our second Annual European User Conference. It was two days of quality time with our customers and partners (recapped here in a news release).

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CTMS Microsoft SharePoint Integration Key to CROs

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  • 12 Mar

CTMS: Microsoft SharePoint Integration
When surrounded by such beauty and energy in Barcelona, who wants to sleep? Having just returned from BioClinica's European User Conference there last week, I admit I'm still reacclimatizing to the UK as I write this.

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Site Monitoring Reinvented Part 2

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  • 02 Mar

Regulatory authorities require clinical trial progress to be monitored. The site visit report, known as the Monitor Visit Report (MVR), is where sponsors provide evidence that all regulated activities have been completed along with documentation of the outcome. These reports are open to regulatory inspection at any time during a study, as well as after, and even post product approval.

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