Intellectual property rights balance the incentive for innovative thought and creative expression with the greatest pubic access to the writings and discoveries that result. The form and function of the intellectual property determine the manner and duration that it may be protected. A well-crafted clinical trial agreement protects the intellectual property rights of the parties engaged in the research.
At a recent industry conference, representatives of a clinical trial site disclosed to a panel of expert mentors that their site had been attacked by ransomware. Ransomware is a type of malware that encrypts a computer’s data, rendering it useless. The ransomware sender offers the decryption key for a price. This column looks at how ransomware attacks happen, what sites can do to prevent attacks, and what to do if you are attacked (or think you are being attacked).
Anyone who works on a particular publication long enough can certainly fall into some comfortable routines that make the birth pangs of each issue easier to bear. For example, using the October issue of ACRP’s journal as a bit of breathing space in between themed issues, giving the editors a chance to “clear the pipeline” of miscellaneous articles that had come in out of the blue.
What is the difference between biomarker and pharmacogenomic (PGx) research? How is this research conducted and what value does it have for patient care? These are just some of the questions that institutional review board and independent ethics committee (IRB/IEC) members may ask themselves when encountering PGx or biomarker research in a clinical protocol. This article summarizes findings from an Industry Pharmacogenomics Working Group survey of IRB/IEC members on related topics.
As clinical trials go global and companies continue to outsource critical functions, technology becomes more important in optimizing stakeholder communications and data management processes throughout the drug development lifecycle.
