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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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With Good Clinical Trial Technology, Why Is Data Still Double Entered?

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  • 09 Jun

That's just the first in a long series of persistent questions in the clinical trial industry. Why don't we have one consolidated place to see all information regarding a specific region, site, or patient? How come every clinical trial seems to use different terminology and disparate applications (resulting in a new learning curve and low user adoption)? Why can't we get ad-hoc reports in a format that is actually useful, covering a timeframe we actually care about?

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The Use of Imaging Technologies to Improve the Flavor of Lamb

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  • 03 Jun
A few weeks ago while attending the International Osteoporosis Foundation (IOF) World Congress in Florence, I had some of the best lamb I have ever tasted at a recommended restaurant. So good, in fact, that the local chefs ate there as well at the end of their evening. It turned out the restauranteur owned a sheep farm.
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Case report form CRF

Have CDISC Standards Changed the Way We Collect Data

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  • 01 Jun
CDISC Standards have drastically changed the way we collect data. How many times have we heard that the adoption of standards is a long, slow process? I'm here to tell you - I have seen the result of all of this talk about standards, and it looks like that ocean blue oasis is just peeking over the horizon. Remember all those comments on paper case report forms? In 1989, I worked on a clinical study where all the patients were HIV positive and had Pneumocystis Carinii Pneumonia (PCP). The data was vast and messy for every patient. There were pages of concomitant medications, adverse events and labs. The medical history alone was a nightmare to data enter - make that - double data enter nightmare since it was a paper-based study.
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ASCO Preview Medical Imaging in Cancer Clinical Trials

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  • 26 May

The American Society of Clinical Oncology (ASCO) 2010 annual meeting starts next week in Chicago. On Tuesday, June 8 there is a joint session between ASCO and the Radiological Society of North America (RSNA) on "Imaging Informatics and Optimizing Imaging in Cancer Diagnosis."

 

American Society of Clinical Oncology ASCO

 

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Top Image: Retinal Nerve Fiber Layer Analysis. Bottom Image: Macular Thickness Analysis

OCT Novel Imaging Technology Providing A Window into the Body

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  • 20 May
One emerging medical imaging technology that I have been following with interest is Optical Coherence Tomography (OCT). OCT is best described as ultrasound using light. As described by Huang et al. in a 1991 Science paper, OCT generates cross-sectional tissue images by measuring reflections from a light source. Changes in the coherence or wave structure of the reflected light, coupled with the time-delay in reflecting it, allow information on location to be generated. In this respect OCT is similar to ultrasound pulse-echo imaging. What makes OCT exciting as a diagnostic and drug development tool is that image resolution is only limited by the coherence of the light source. High resolution can, therefore, be obtained from a pinpoint light source. Add in frequency domain mapping and the ability to measure thousands of data points rapidly and you can obtain a detailed image in a matter of seconds.
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FRAX iPhone app screen shot – can be used in clinical trials

FRAX iPhone app Tool to Access Fracture Risk in Clinical Trials

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  • 19 May
The iPhone continues to make inroads into all aspects of our lives, and medical imaging and clinical trials have not escaped. Doctot (Doc tools of the trade), an Irish company run by medical and software professionals, recently launched an iPhone app (priced at $5.99 in the US), which makes the WHO Fracture Risk Assessment Tool (FRAX) readily accessible to doctors.
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Data Champions in Risk-Based Monitoring

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  • 20 Apr

Data Champions in Risk-Based Monitoring

The centuries-old saying, "knowledge is power" coined by Francis Bacon in 1597, is fitting in our risk-based monitoring (RBM) conversations today. In research − trial data is power. This is becoming even more apparent as our data is being used in new ways to inform monitoring and study management decisions to run better trials.

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New Approaches for Measuring Muscle Fatty Infiltration

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  • 17 Apr

Clinical Trial FIT-ness: New Approaches for Measuring Fat

The presence of fatty infiltration in muscles of the lower extremities (thigh and calf) serves as a proxy for impaired muscle function and metabolic status, often seen with musculoskeletal diseases like osteoarthritis (OA), Sarcopenia, Duchenne Muscular Dystrophy, Pompe disease and Polymyositis/Dermatomyositis. Most clinical research for musculoskeletal diseases relies on non-invasive imaging methodologies for assessing changes in inter-muscular adipose tissue (inter-MAT), intra-muscular adipose tissue (intra-MAT) and muscle in the lower extremities.

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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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