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How Time, Quality & Cost Metrics Affect Clinical Trials and Programs

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  • 22 Nov
There are principally three characteristics, or metrics, we can use to measure any major process: TIME. QUALITY. COST. The challenge is that these three are in competition. Nowhere is this more apparent than in the design and implementation of clinical trials and clinical programs. There are three characteristics but you can only emphasize 2! In the current environment we have seen COST become the main driver throughout the pharmaceutical and biotech industry. However, this usually works at the long-term penalty of quality and or time. A recent case in point was a small company that asked us to handle the imaging portion of the clinical trial. Everything was pared down to yield the most apparent “cost effective solution” at the outset. We are now half way through the trial and key imaging end points need to be delivered and safety evaluations are being considered. Suddenly the need for quality has come to the forefront, particularly as the data will be going to a regulatory agency. However, this shift has caused increases in scope of work that may be exceed the original budget and possibly be higher than necessary due to the amount of rework, which would have been negated if the need for quality had been more carefully considered at the start. Furthermore, time is of the essence, but due to prior decisions it has to take second place behind the quality issues.
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6 Interesting Details Discussed at CDISC Interchange 2010

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  • 12 Nov
I’m back from the 2010 CDISC Interchange in Baltimore last week. The conference was once again very informative with discussion around some really intriguing topics. Below are the items I found most interesting at this year’s conference. FDA Presentation – Last year there was some uproar when Theresa Mullin, PhD, Director of Office of Planning and Informatics, Center for Drug Evaluation and Research (CDER) and the US Food and Drug Administration, announced that the FDA planned on standardizing on the HL7 data standard and not the CDISC standards. As Dr. Mullin started to speak this year, the audience was absolutely silent with anticipation. Dr. Mullin admitted there was some confusion after their presentation last year, and she made it clear that the FDA changed their tune and totally endorsed the use of CDISC standards. Whew!
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MelaFind: assisting physicians in early melanoma detection

Melanoma Imaging Device for Early Detection & Diagnosis

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  • 26 Oct
One of my roles at BioClinica is to keep my finger on the pulse of innovative new medical imaging devices in development and to think how these could be applied to future clinical trials. An imaging device that recently caught my attention is MelaFind® from Mela Sciences (formerly Electrical-Optical Sciences). It is a hand-held multispectral digital imaging device that can be used to identify skin lesions that should be biopsied for melanoma. Not much scientific information on this melanoma imaging device is provided on the website, but the device seems to be using an Optical Coherence Tomography (OCT) type of system. I previously wrote about OCT in an early blog post that can be found here.
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The Role of Imaging Endpoints in Biosimilar Comparability

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  • 22 Oct
A biosimilar is a copy of a biologic drug, i.e. one made from living cells such as monoclonal antibodies or recombinant proteins. The term “follow-on biologics” or “biogenerics” is also used to describe the products that companies want to launch after the patent expiration of an established biologic product on the market. Typically for a generic drug approval it is sufficient to show that a chemical compound is therapeutically equivalent to the marketed version. This is relatively straightforward since chemical analysis can show the same active ingredients and a bioequivalence study can show comparable pharmacokinetics. Formal trials on clinical safety and efficacy are not required.
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Bioclinica is organized into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging & Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Molecular Marker Laboratory. Our eHealth segment comprises eClinical Solutions, Randomization & Trial Supply Management, Safety & Regulatory Solutions, and Financial Lifecycle Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

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