Do clinical trials need to move back to the US?

In a recent post at the Wall Street Journal Health Blog, they take a look at how most late stage human clinical trials are done outside of the United States. One reason includes the ability to better monitor the ethical treatment of patients.

According to the article:
Currently, each site in the U.S. must separately approve a study, even if it’s part of a larger trial taking place with an identical protocol at other institutions across the country or world. The National Cancer Institute has started a review process for studies it funds in an attempt to minimize the time it takes for institutions to approve and start studies.

What do you see as driving clinical trials outside of the United States?

Research Analysts Reveal Trial Sites Want more EDC and Recruitment Investment

This article in outsourcing-pharma.com discusses according to a research report conducted by clinical research industry analysts at CenterWatch, study site operators want a greater use of EDC technologies and more pharma investment in order to improve patient recruitment and efficiency in clinical trials.

The growth of trials in developing countries and in Central Europe and Eastern Europe has increased the need for improvements in EDC. Have you seen a massive shift in the pharma industry using EDC technologies?

Clinical Trials Congress 2009

Did you have a chance to make it to Philadelphia for the Clinical Trials Congress last week? If not, check out what ClinPage had to say about the event.

We get a large dose of such speakers every year at IIR’s annual Clinical Trials Congress. The 2009 event, in Philadelphia, had exactly what we had come to expect—high-level hand-wringing about the state of the industry, paired with ideas about what to do.

Cytel’s new software Increases Efficiency of AstraZeneca Clinical Trials

According to this article in outsourcing-pharma.com AstraZeneca has installed a custom version of Cytel’s East clinical trial design software in an effort to improve data handling and ensuring compliance with Clinical Data Interchange Standards Consortium (CDISC) guidelines.

These tools aid smaller clinical trials companies assess their trials at the halfway stage, potentially reducing the amount of money spent for the company. It will be interesting to see what other clinical trials companies will begin using Cytel’s new software.

Pfizer Discloses Payment Information for Clinical Trials

According to this article on outsourcing-pharma.com Pfizer will disclose payments made to principal investigators, major academic institutions and research sites involved in Phase I to IV trials that exceed $500 a year and non-monetary items such as meals that cost more than $25.

Pfizer is getting closer than any drug maker in terms of full disclosure, but if the Physician Payments Sunshine Act of 2009 is passed into law, it would require companies to disclose all payments exceeding $100 a year and would face a fine of up to $1 million if they do not comply.

Phase Forward Reports Strong Earnings

We recently posted that Covance’s revenues for their fourth quarter was up, despite the downturn economy. Today I came across this article on ClinicalTrialsToday that discusses how another clinical trials company, Phase Forward, has also reported strong earnings this past quarter. Their revenues for the 4th quarter were $48.3 million compared to $37.8 in Q4 the previous year.

Will we continue to see this trend in clinical trials companies when they report their 4th quarter earnings?

First Human Stem Cell Trials Begin

According to NewUniversity.org, UC Irvine researchers will be the first to test an embryonic stem cell treatment on humans in clinical trials. Although UCI researchers will be the first to treat humans using embryonic stem cells. This will not be the first time that humans have been treated in trials using stem cells. This is because previously neural stem cells derived from fetal brains have been used in USDA-approved trials. This is a step forward for stem cell research that had be halted by the Bush administration.

Covance Revenues are up despite the Downturn Economy

ClinicalTrialsToday.com reports that Covance, biopharmaceutical drug development services company, has released very strong 4th quarter earnings in early and late-stage development segments.

Total revenue and net revenue are up from the same period last year, even though the state of our economy has faltered in the last couple of months. Joe Herring, Covance chairman and CEO, recently mentioned in a company release that:

"reduced demand in our Early Development segment from a combination of a lower level of new project initiations and increased project delays in our toxicology and clinical pharmacology services led to a sequential decline in segment revenue and operating income."

It will be interesting to see 4th quarter earnings of other clinical trials companies and see if they had comparable results.

Oracle's Clinical database

ClinPage takes a look at what Oracle is doing to to stay prevalent in the clinical trial management software space. Patti Devereux Gaves, the senior director of product strategy at Oracle, recently stated that they're working on new endeveors to stay on the top in the field. For the whole story, read here.