Technology Advances in Feasibility, Recruitment and Retention

Jan 8, 2016

Biopharmaceuticals are intensely focused on efficiency and time to market; however, the nature of clinical trials continues to present obstacles to attaining these goals. Today’s trials are still far too costly, and study cycle times remain too long to achieve a recoverable time to market. In response, many biopharmaceuticals are focused on reducing study cycle time by pinpointing the right countries, sites and patients. Paul Evans and Xavier Flinois at Parexel share their thoughts with the public on technology advances in feasibility, recruitment and retention. ...

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Rare Diseases: Ethical Considerations in the Clinical Development

Jan 8, 2016

The drugs used to treat rare diseases are called “orphan drugs”. There are limited numbers of patients available for enrolment in clinical trials, so it is difficult to ascertain the safety and effectiveness of the product being tested for use. It is important that the risk/ benefit ratio is carefully weighed, and that trials be designed to systematically observe patients and attempt to collect adequate data to demonstrate effectiveness, as well as to determine the optimal dosage. Balamuralidhara V. and his colleagues at JSS College of Pharmacy focus on rare diseases and their ethical considerations in clinical development. ...

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Proactive Pharmacovigilance- A New Model for the 21st Century

Oct 23, 2013

The discipline of pharmacovigilance (PV) largely originated in reaction to public health disasters caused by medications. Sidney Kahn at Sciformix Corporation looks into the approaches for detecting significant, previously unrecognized hazards of medications after their introduction into clinical use, and how this has been principally based on collecting anecdotal reports of suspected adverse drug reactions. ...

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Cardiovascular Therapeutics Watch Column

Oct 17, 2013

Rick Turner at Quintiles provides an overview of how one of the hottest areas in the treatment of hypertension concerns drug-resistant hypertension. Drug-resistant hypertension is commonly defined as blood pressure (BP) levels above a specified target despite a patient’s adherence to at least three optimally-dosed antihypertensive medications of different classes, including a diuretic. In addition to these requirements, Turner and O’Brien have recently argued that a patient should be on such a regimen for a minimum of three months before the classification is made. The methodology by which BP measurements are made also needs to be given careful consideration in ...

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