Patient-reported outcome (PRO) instruments are used to gather data directly from patient self-reports. Their use in clinical trials is increasingly common. As clinical trials continue to cross borders, an instrument developed in one language or culture must be adapted or translated for use in another language or culture. When a PRO instrument is translated into another language the possibility of cultural errors and understandability issues increase; potentially impacting the study data.
Archive for the ‘Medical Devices’ Category
When Clinical Trials Cross Borders – Adapting Patient-Reported Outcome Instruments
Monday, May 3rd, 2010
Healthcare Reform and the Life Sciences Industry
Friday, April 9th, 2010The recently approved healthcare reform legislation will extend coverage to 32 million uninsured Americans, change practices for coverage limitations or denials for people with existing medical conditions, and enable the self-employed to purchase insurance through state-based exchanges. As one would expect, money to cover healthcare reform needs to come from somewhere. In addition to going after medical insurance fraud, several taxes are included in the legislation (many in the life sciences industry) to help pay the bills, including:
– Drug manufacturers would pay $16 billion between 2011 and 2019.
– Health insurers would pay $47 billion over the same period.
– Medical device manufacturers would pay a 2.9 percent excise tax on the sale of any of their wares, beginning Jan. 1, 2013. Earlier drafts of the bill called for the additional fees for medical device makers to go into affect this year, but the final bill delayed that until 2013.