Microdose Studies Featured Articles
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South Korea: Sprinting Clinical Trial Development
11/13/2014
South Korea positions itself to be the major emerging nation in Asia for clinical trials. South Korea has precipitously burgeoned with both global and local clinical trials over the past 10 years. South Korea contributes a share of 5% to overall clinical trial registered globally in 2013. Adding further, there are 142 clinical trial sites certified by KFDA (Korean Food and Drug Administration) thus far. This places Korea second in having the highest number of clinical trial sites globally.
Korean government’s unceasing support in developing clinical and healthcare has attracted many Biopharmaceutical companies to invest in the region and the local clinical trials in Korea are surpassing the multi-national clinical trials recently. The reason for this being that the Korean Government along with the pharmaceutical companies had created new strategies to keep the R&D innovation going. Moreover Korean based pharma and biotech companies invest 65% of their total annual profit into developing innovative therapeutics in their pipeline and also the focus on developing biosimilars bolsters the increase in local clinical studies.
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Patient Reported Outcomes For Registries: Should The Treating Physician See The Data, And If So, When?
9/15/2014
The application of electronic patient reported outcome (ePRO) data collection and direct-to-patient reporting has enabled patients participating in registries to report their symptom or treatment experiences between physician visits, with minimal patient burden. These independent reporting approaches – described in Chapter 5 of the Agency for Healthcare Research and Quality’s ‘Registries for Evaluating Patient Outcomes: A User’s Guide’[i] – are often applied in real world research not only to collect data directly from the patients outside of an office visit, but also to support patient retention over long follow-up periods.
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How Do I Get My Compound Into Phase I?
4/2/2014
The primary challenge for pharmaceutical and biotechnology companies in developing their drugs is to carefully assess the relationship between efficacy and toxicity prior to entering into human clinical trials. By Dr. Scott E. Boley and Greg Ruppert