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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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Food and Drug Administration (FDA)

Why hasn't the FDA more actively promoted CDISC standards

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  • 18 May
It has always been a mystery to me why the FDA hasn't more enthusiastically embraced and offered incentives for NDA submissions to conform to the CDISC standards (A bit of this mystery was lifted for me at the CDISC INTRAchange in March). The INTRAchange is a meeting of the core CDISC participants and Dr. Theresa Mullin, Director of Planning and Informatics at FDA/CDER, spoke about the data review process at the FDA. The FDA uses their Janus software as a repository to store the data, but they allow the reviewers to use different end-user tools to generate their views or develop their own code for analysis purposes.
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Eyjafjallajökull volcano in Iceland – Has this volcano affected your clinical trial?

Multinational Clinical Trials vs Mother Nature

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  • 17 May

We all know someone who has been impacted recently by the ash from the Eyjafjallajökull volcano in Iceland.

Source[01]: Wikipedia, photographer: Henrik Thornburn

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Integrating Clinical Trial Data to Bring Products to Market Faster

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  • 14 May
All clinical trial data is digital. We have to submit it to the FDA in a digital manner but it currently gets there in a disparate manner with many systems involved. What is needed to bring products to market faster is what is now known as a "clinical ecosystem." This was something I wrote about before this great term was coined. The concept is that new product development can take place faster through the ongoing integration of electronic data within a clinical ecosystem.
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3 Reasons to Share Data from Unsuccessful Clinical Trials

3 Reasons to Share Data from Unsuccessful Clinical Trials

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  • 25 Nov

A recent proposal by the U.S. Department of Health and Human Services (HHS) could expand the amount of clinical trial data that drug companies must share with the public. Under the proposal, clinical trial sponsors would be required to report findings for drugs and devices that fail to reach approval.
 

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eSource: Are You On-Trend with Other Sponsors?

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  • 12 Nov

eSource is a topic that has everyone talking and it continues to dominate the conversation at industry gatherings, including the annual SCDM conference held earlier this fall. From what I heard there − and continue to hear – sponsors' experience with eSource runs the full gamut.

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Risk-Based Monitoring Versus Intelligent Monitoring

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  • 31 Oct

Why Intelligent Monitoring is Even Smarter

When I speak on the topic of risk-based monitoring (RBM) at industry events, someone invariably comes up afterward to say how nice it is we finally stopped talking about risk-based monitoring!

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eSource: Still in the Shallow End of the Pool?

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  • 23 Oct

Dipping a toe in the water is always easier than jumping right into something new.

I am reminded of this old axiom as I look back at the recent SCDM conference and see it holds true for eSource.

Testing different eSource modalities within a controlled environment is one way to get acclimated and explore the use of eSource in your clinical trials while building experience – all in a low-risk way. Beginning with data that's directly entered as eSource is a whole lot easier and safer than attempting to hit it 100 percent from the high dive on the first try.

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