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New Patient Group Gets Muted Response—So Far
It’s probably fair to say that the European Patients’ Academy on Therapeutic Innovation (EUPATI) has made a rather slow start since its launch on February 1. There doesn’t seem to have been a huge blaze of publicity or a massive wave enthusiasm for the new group, which has so far amassed a mere 13 followers on Facebook.
So what’s EUPATI about, and should we be interested in it? According to its website, over the next five years this patient-led academy will develop educational material, training courses, and a public Internet library to educate patient representatives and the lay public about all processes involved in medicines development. Topics will include personalized and predictive medicine, design and conduct of clinical trials, drug safety and risk/benefit assessment, pharmaco-economics, and patient involvement in drug development. Read More
FDA Study Data Standards and Common Sense
An interesting new publication showed up recently on the FDA CDER Data Standards Program web page titled CDER Study Data Standard Research and Development. In this posting, CDER seems to finally put in writing what industry has been clamoring for—a stated position on the use of data standards to represent clinical study data. The document begins with a solid statement of support for using CDISC standards now and in the future, but things drift a bit south from there, as they attempt to also explain an R&D effort to explore the use of HL7 version 3 XML as “a promising solution for the exchange of study data.”
While I applaud CDER’s support for CDISC and have great admiration for the many accomplishments of HL7, I can’t help but question the odd, apparently single-minded devotion to HL7 XML. Though everyone acknowledges the limitations of the quarter-century old SAS v5 Transport (XPT) format, there are many other alternatives available for replacing it; indeed, FDA may be the only reason that SAS transport is used at all these days. Read More
Posted in IT Tagged CDISC, FDA, FDA CDER Data Standards Program, HL7, HL7 V3 XML, IT, R&D, SAS Transport, Wayne Kubick 2 Comments
EU Questions Electromagnetic Radiation Limits
It is fashionable in many healthcare circles to denigrate the European Union for adopting a high-handed and inflexible approach to many of the complex issues that health policy is fated to cover. It is still more fashionable—indeed almost mandatory—to castigate the European Parliament, the EU’s self-styled representative of the people, for adopting an unrealistically cautious attitude to health regulation. January has offered a compelling instance that such prejudices are certainly not always justified. Read More
Posted in Regulatory Tagged electromagnetic radiation, European Parliament, European Union, MRI, Peter Liese, Peter O'Donnell Leave a comment
Government Funded Research, Is it That Different?
In December 2011, the President’s Bioethics Commission released its “Moral Science: Protecting Participants in Human Subjects Research.” The report was ordered by President Obama following an October 2010 revelation that the US Public Health Service supported unethical research in Guatemala from 1946 to 1948 that involved intentionally exposing thousands of Guatemalans to sexually transmitted diseases without their consent.
The Bioethics Commission was then tasked to oversee a thorough fact-finding investigation into the specifics of the studies, as well as assure that current rules for research participants protect people from harm or unethical treatment, domestically as well as internationally. Read More
Posted in Uncategorized Tagged Bioethics Commission, government funded research, Lisa Henderson, NIH, President Obama Leave a comment
Quicker Review for Generics and Biosimilars on the Horizon
The FDA’s review process for new drugs is slow. That is not news. But if a new agreement between the agency and the industry is approved by Congress things might get a little quicker. Read More
Posted in CRO/Sponsor, Regulatory Tagged biosimiliars, FDA, generics, Tim Denman, user fees Leave a comment
Calculating the Cost of R&D: Defending Tufts Research
Estimates of what it takes to deliver a compound to market are more than an academic exercise — such data has an increasingly important on-the-ground impact on industry revenues, because if you cannot justify your costs how do you expect to prevail on price? Fundamental to the debate on the “productivity lag” in drug R&D is the assertion that the cost to bring a new compound to market is high—and going higher. Critics of the industry are concentrating their (f)ire on this issue, contending that average cost estimates are excessive and tend to distort the increasingly important calculation of “value” for payers and policy-makers in pricing new medicines. The divide even extends to industry itself, as evidenced by GSK CEO Andrew Witty’s recent assertion that a better consensus is needed to measure drug development costs, based on the principles of “frugal science.” Read More
Are Black Box Warnings Enough? Should FDA Do More?
According to a recent report from Medco Health Solutions (download here http://medco.mediaroom.com/), one in five insured Americans has taken at least one psychotropic medication in the past year. Overall, Americans have increased their intake of psychiatric medications by 22 percent (from 2001 to 2010), with women 45 and older showing the highest use of these drugs. For their part, men aged 20 to 44 increased their use by 43 percent.
Although the increased use of these drugs may seem to indicate an increase in effectiveness, antipsychotics may be more damaging than beneficial. The FDA noted in 2007 that some anti-anxiety medications such as benzodiazepines actually worsened depression. This caused the FDA to issue additional safety labeling information recommending that patients be under strict monitoring for the first few weeks of treatment. Read More
Posted in Regulatory Tagged antipsychotics, Black Box Warnings, David Muzina, FDA, Kayda Norman, Medco, psychotropic medications, Regulatory Leave a comment
Your Help Needed on Survey
This survey https://www.surveymonkey.com/s/96RD6CH will close on Friday, so this is your chance to share your views on Clinical Trial Agreements.
It is widely known that the site agreement negotiations of Clinical Trial Agreements are a delaying factor in clinical trial start-ups. Applied Clinical Trials and Salvius Legal BV are collaborating on a survey https://www.surveymonkey.com/s/96RD6CH to obtain insight in the way CROs and sponsors manage their site agreement negotiations, what the actual delays are and where the true bottlenecks in the process can be found. Read More
CV Assessments Set to Increase
Last week, I spoke at the 6th Cardiovascular Risk Assessment Summit and provided an overview of CV safety, challenges facing sponsors, and current trends. Read More »