Study Refutes Claims on AIDS Drug Trials

Many were concerned that between the years 1985 and 1996, foster children in the NYC area were unwillingly subjected to clinical trials for H.I.V.

An investigation into the participation of New York City foster children in clinical drug trials for H.I.V. and AIDS over a nearly 20-year period has found no evidence that any children died as a result of the trials or that the foster children were selected because of their race.

Further coverage for this can be found:

Study Refutes Claims on AIDS Drug Trials New York Times
No Foster Children Died From Participation in New York HIV Drug ... Kaiser network.org
Study: NY Foster Kids Not Exploited for AIDS Research EDGE Boston

Updated Calendar of FDA Decisions and Clinical Trials

If you're in the world of Clinical Trials, you know how frustrating it can be to wait on the FDA approval or rejection of the pharmaceuticals you've worked on. Check out this post at Seeking Alpha that shows a handy way to see what decisions are slated to be made on certain drugs and clinical trials. What big decisions are you waiting on? We'd like to hear your thoughts.

University of Texas Gives $100,000 in Grants for Clinical Trials

South Texas children suffering from Leukemia may have been given $100,000 by the University of Texas to get access to clinical trials, through the University of Texas Health Center. According to mysanantonio.com, the $100,000 grant from the National Cancer Institute will provide a patient navigator at the UT Health Science Center's Regional Academic Health Center in Harlingen who will focus his or her time developing and distributing information about trials that are available to young leukemia patients.

What do you think the impact of this grant will have on the study of leukemia? Do you think other organizations will follow suit? Post your thoughts here.

Continued Growth in India's Clinical Trials

We've been frequently updating you on the rise in Clinical Trials in India, another news story on this growth has come up today that we wanted you to be aware of.

From Press Trust of India:

Clinical trials in India to test the safety and efficacy of newly invented drugs or medical devices have shown a huge growth and registered nearly a five-fold increase in the last four years, a top official said today."In 2005, around 100 clinical trials had been approved in the country by the Drugs Controller of India (DCI). In 2006, it increased to around 150 and to 240 in 2007. In the current year, around 450 have already been approved," Joint Drugs Controller of India, A B Ramteke, told reporters on the sidelines of a conference here today.

What do you make of this rise in Indian Clinical Trials? We'd love to hear your thoughts.

From CNNMONEY

The Independent Data Monitoring Committee (IDMC) constituted to oversee the conduct of the Phase III OVArian TUmor REsponse (OVATURE) Trial, yesterday recommended continuation of the study.
The OVATURE trial is a major multi-center international Phase III clinical trial of orally-administered investigational drug phenoxodiol in combination with carboplatin in women with advanced ovarian cancer resistant or refractory to platinum-based drugs, to determine its safety and effectiveness when used in combination with carboplatin.
Read more here.

AHA Meeting 2008

According to MedPage today, the American Heart Association said that lipid studies have caused a surge in discussion about clinical trial bias.

Large multinational clinical trials require a "global set of standards of conduct and behavior" to ensure that outcomes reflect objective, unbiased evidence, a prominent cardiology researcher said here.

Because pragmatic clinical trials provide the foundation for clinical practice, a global imperative exists to develop internationally recognized and accepted "rules of conduct," Robert Califf, M.D., of Duke in Durham, N.C., said during a plenary session at the American Heart Association meeting.

The first step in developing those standards should be to bolster the independence of data monitoring committees, he said.

Read more here.