Cato Research Regulatory Scientist Amber Barnes, PhD, RAC will be speaking on “Informed Consent Content and Process Requirements” at the August 2, 2010 meeting of the NC East Chapter of the Society of Clinical Research Associates (SoCRA).
Dr. Barnes’ presentation will focus on the elements of the informed consent document, and the components of the process. Industry specific scenarios will be presented to reinforce important concepts, for example: evaluating and documenting capacity to consent, voluntariness, HIPAA authorization, withdrawal of consent, and more. Discussions will also include reported poor regulatory performance regarding informed consent, and successful solutions for practices that increase the protection of human subjects in clinical research.
Venue: Cato Research
4364 S. Alston Avenue
Durham NC 27713
For more information visit: North Carolina (East) SoCRA Chapter News
Image via Wikipedia
We bleed from similar veins.
– Tupac Shakur
Lovenox is not, I repeat, not a biologic therapeutic. It is derived from a biological source (pig intestines, yum), but it is not protein-based. However, the FDA’s approval of a generic form has a rather interesting bearing on the future of biosimilars.
But first, the basics: Lovenox (enoxaparin sodium for injection) is an anti-coagulant that has a variety of uses including as a method of preventing serious clotting conditions like deep vein thrombosis (DVT). It is made from heparin, which is a complex arrangement of sugars. Lovenox was developed by sanofi-aventis; the approved generic was developed by Momenta Pharmaceutical and Novartis. (Two other companies were in the race to get a generic Lovenox approved: Teva and Amphastar)
Ok, so what does this approval of a generic sugar-based drug have to do with biosimilars? While it is not protein-based, it is an extremely complicated molecule to make and refine. More importantly, these complications are similar to the kinds of complications that arise when attempting to reproduce a protein (eg, a biologic drug product). Before this, many believed that if a generic Lovenox was ever approved, it would be a bellwether for FDA approvals of biosimilars. Continue reading →
This is a guest post by John Johnson, Ph.D. John is a Senior Biostatistician and the Associate Director, Statistics at Cato Research.
Clinical trial protocol amendments occur for good reasons. An unanticipated safety issue may arise, new information about the disease or treatment may suggest alterations, or recruitment and enrollment may not go as planned.
One aspect of protocol amendments that often gets overlooked is the statistical analysis. This is because it is not always obvious that an alteration to one non-statistical section of the protocol can have an impact on the statistics.
Take, for instance, the relaxing of inclusion/exclusion criteria to speed enrollment. This usually has the effect of enlarging the target patient population, which in turn can make the uncertainty in the estimate of the treatment effect larger. This has the effect of lowering the power of the study, unless the sample size is increased.
Statistical methods are being developed to account for this possibility now. However, these methods often require more complex programming and require more care (i.e. time and money) to assure correctness.
These hidden costs, along with others, should be kept in mind when first developing a protocol, and later when protocol amendments are being considered.
Related articles:
Yesterday, Cato Research hosted a webinar titled, “Nonclinical Drug Development – A Successful Path Forward.” Senior Toxicologist Sharon Daily, Ph.D. gave a very informative presentation that was followed by some great questions from the audience.
As promised, the slides from Sharon’s presentation are now available for download here(PDF file).
Stay tuned for details on our next free webinar, scheduled for Thursday, 26 August 2010.
Privacy is not something that I’m merely entitled to; it’s an absolute prerequisite.
– Marlon Brando
On July 8th, the Department of Health and Human Services (HHS) announced that it was proposing changes to Health Insurance Portability and Accountability Act’s (HIPAA’s) privacy rules. These changes flow from the HITECH Act of 2009 which expanded the protections governed by HIPAA.
The changes include:
- Expanding individuals’ rights to access their information and to restrict certain types of disclosures of protected health information to health plans
- Requiring business associates of HIPAA-covered entities to be under most of the same rules as the covered entities
- Setting new limitations on the use and disclosure of protected health information for marketing and fundraising
- Prohibiting the sale of protected health information without patient authorization
Not enough, you say? The HHS added that:
“HHS also looking more closely at entities that are not covered by HIPAA rules to understand better how they handle personal health information and to determine whether additional privacy and security protections are needed for these entities [emphasis added].”
I don’t know about you, but the people I know tend to fall into three buckets: 1) People that only divulge health information when strictly required and/or under duress, 2) People that speak fairly openly but only in general terms, and 3) People that feel the need to discuss specifics about all of their health issues with anyone within a 10-foot blast radius. These proposed changes will be welcome news to the first two buckets at least.
Oh, and here’s a useful resource from HHS if you’re interested in the full scope of rules and laws about protected information and security: A Summary of Selected Federal Laws and Regulations Addressing Confidentiality, Privacy and Security.
