Data Standards Featured Articles
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Clinical Trial Complexity, Diversity, And Right To Try Continue To Impact Pharma
2/16/2016
If it’s the first quarter of a new year, chances are that Michael Martorelli and his research team at Fairmount Partners has been hard at work preparing their annual questions issue of the Pharmaceutical Outsourcing Monitor. With the latest issue addressing 16 questions addressing pharma and biopharma companies for 2016, he once again does not disappoint readers.
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Using The Cost Of Adverse Events To Determine Drug Safety
2/3/2016
There are limitations to the drug approval system we currently have in place that is based on clinical trials. Data disclosures are often deemed inadequate, regulatory review and approval can be a lengthy process, and many would argue there is a bias in the industry and academia against publishing negative results.
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Patient-Reported Outcomes: Engaging Patients As Partners For Better Pharmacovigilance Practices
1/29/2016
Today, there is greater awareness surrounding the benefit and risk of pharmaceutical products, amongst health care professionals (HCPs) and consumers alike. Safety and efficacy data from clinical trials are no longer sufficient and there is a demand for more evidence including effectiveness of treatments as well as comparative effectiveness, relative to other therapies.
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Using Real-World Data For Clinical Research: Challenges And Opportunities
1/21/2016
Across the country, there is growing awareness of challenges facing the clinical research enterprise. Among these challenges are the expense and logistical complexities of performing clinical trials, much of which is created by the need for elaborate, stand-alone data collection systems that are distinct from the systems used for normal clinical care.
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MDR-TB Study Requires A New Approach To Trials
1/19/2016
Otsuka Pharmaceutical has been an industry leader in TB drug development for over 30 years. The company is currently focused on MDR (multidrug-resistant)-TB, which refers to a form of the disease that is resistant to at least the two main first-line drugs available on the market.
In a recent clinical trial, many of the sites lacked proper personnel, training, and equipment. Learn how the company overcame these challenges to make the trial a success.
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Risk-Based Monitoring: Understand It Before You Implement It
12/1/2015
Duncan Hall, CEO Triumph Research Intelligence (TRI) and Triumph Consultancy Services, is dedicated to helping CROs and pharma firms align their core business processes with the latest technologies. Obviously a lot of his time is currently spent helping clients navigate the difficulties of implementing a proper RBM (risk-based monitoring) plan. Installing the technology is not difficult, but making sure the solution you select properly aligns with your needs can be a challenge.
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Can Electronic Health Records Bring Down Drug Prices?
11/2/2015
Protocol development is a difficult task, even with the experts we have in pharma companies and clinics. One way of measuring the quality of those protocols is looking at the number of protocol amendments pharma companies generate. These are generally due to a protocol being too complex, or the criteria being too strict. Generally, the end result is not enough patients enrolled in the study on time. One solution to that problem might be the reuse of electronic health records (EHRs).
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Survey Says: Technology Use In Clinical Trials Continues To Grow
10/16/2015
How pervasive is the adoption of new technologies in clinical trials? DrugDev recently surveyed 572 clinical trial investigators from 11 countries to try and answer that very question. Their results are good news for technology vendors, clinical personnel hoping for greater efficiencies provided by emerging technologies, and sponsors hoping to cut the time and cost of trials.
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Clinical Insights: “RBM Is The Biggest Game Changer Since EDC”
9/4/2015
Will risk-based monitoring be the hottest trend to hit clinical trials in years? Mike McKay, Associate Director of Operational Excellence for Shire Pharmaceuticals thinks it will be. “I believe RBM will be the biggest game changer to hit clinical operations since EDC (electronic data capture),” he says. It’s potential to increase quality and lower the time and cost of conducting clinical trials has only just begun to be explored. Think about it, why should we employ a traditional one size fits all monitoring approach when we know that there are good sites and bad sites and that only a small fraction of the total data is changed via source data verification? Resources should be focused on improving the data quality at the problem sites and we now have RBM platforms that are built to identify issues early so we can nip problems in the bud and correct bad habits.”
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IN CASE YOU MISSED IT: Clinical Leader Top 3 Articles For August 2015
8/28/2015
August 2015 was an active month on Clinical Leader. The top three articles for the month covered a range of topics, including new EU regulation on harmonization, lessons learned from an initial venture into Risk-Based Monitoring, and a piece on using Source Document Verification as a quality control measure in clinical trials. If you missed any of them, please take a moment to see what everyone was excited about.