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The Latest Developments in Osteoarthritis Imaging

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  • 20 Sep
I will be at the 2010 World Congress on Osteoarthritis in Brussels later this week. This conference, organized by the Osteoarthritis Research Society International (OARSI), runs from September 23 to September 29 and is a great opportunity to identify some of the new osteoarthritis imaging work that is going on in the field. Osteoarthritis (OA) is a common degenerative disease of the joints that is characterized by cartilage breakdown. It affects about 10% of adults in Western countries. Interestingly last year a work force put together by the FDA to further characterize OA defined it as a disease of the whole joint and not just focused on the cartilage.
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510(k) Approval Process & the Impact of Changes for Medical Devices

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  • 13 Sep

There has been a lot of discussion in the news lately about the premarket clearance process for medical devices under section 510(k) of the Federal Food and Drug Cosmetic Act. This is the approval route by which the majority of medical devices get to market by showing they are comparable to an existing marketed or approved product.

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Clinical Data Collection in Oncology Studies - Most Common Challenges

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  • 08 Sep
Creating a clinical data collection strategy for oncology studies within tight timelines can be extremely challenging. Clinical data managers often face particular issues with interpreting the complexities of the study and implementing the data flow as represented in the protocol.
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Modeling IVR Studies Ship Times

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  • 18 Aug
We often run into cases where an IVR (interactive voice response) system may not generate shipment orders for study kits every day. For example, commonly it seems they may only ship Monday through Thursday. In many cases this could be due to cold chain supplies having to be received immediately and being unable to guarantee that someone will be there to receive the shipment on a weekend. Others, however, may be for unrelated policy reasons. Standard modeling practice says to add a day to the shipping lead-time for every day that is not available for shipping (3 days in the case of the above example). Related to this concept, there is often some confusion for new users about whether the shipping lead-time for the IVR study refers to calendar days or business days.
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Top 5 Items That Have Impacted Clinical Trial Research Technology

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  • 06 Aug
Internet: From telephone-based dial-up to cable modems to DSL to FIOS to T1 lines, the speed in which we access other computers and applications has changed the world. The Internet has changed the way we communicate, shop, play games, and access information (remember phone books?). Perhaps the largest impact to clinical trial research technology (we are now able to share data instantly); the Internet allows us to clean, review and make critical decisions earlier in the process, therefore improving clinical research. Standards: I never met anyone who thought standards were a bad idea. When zip codes were introduced in 1963, mail delivery times decreased. When CDISC CDASH standards were introduced in 2008, build time for CRFs decreased. Standards have streamlined the way we setup databases, move data around, and submit data to the FDA.
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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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The Future of Clinical Trial Data Management and Technology's Growing Impact

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  • 22 May
At BioClinica's 2015 Global User Conference, I had the pleasure of leading an expert panel discussion on the future of data management. I would like to share some highlights from my perspective. Panel participants were Daun Bahr, senior director data management Orexigen; Queennette Santiago, head of data management Ultragenyx; Clara Plascencia, associate director of clinical data management Pharmacyclics; and Ann Seibel, clinical data manager BioClinica.
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Remote Monitoring in RBM Q&A

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  • 12 May

We promised to answer questions that came in following a recent BioClinica webinar. Here RBM expert, Trevor McCaw, addresses a two-part inquiry on remote monitoring.

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Risk-Based Monitoring: RBM Expert Opinion

Risk-Based Monitoring: 5 Key Questions

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  • 28 Apr

RBM experts Courtney McBean and Mireille Zerola, a member of the TransCelerate RBM work stream, address five commonly asked questions (and clear up a few misconceptions) surrounding RBM and its underlying methodology.

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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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