NCI tackles trial enrollment

Why does it take so long to complete a clinical trial? One bottleneck that many researchers face is enrolling enough participants to make the study statistically significant. On Monday (20 July), the National Cancer Institute's Cancer Biomedical Informatics Grid -- aka caBIG -- announced plans to team up with the Susan Love Research Foundation to create a database of 1 million women interested in participating in clinical trials via the linkurl:Army of Women;http://researchers.armyofwomen.org/

Image: National Cancer Institute

Normally, patient recruitment for a single study involves multiple recruiting clinics and doctors, and in some cases take years to complete. Here, researchers could solicit volunteers through Army of Women. After an investigator has contacted prospective participants, the study would undergo the usual institutional review board (IRB) oversight and receive informed consent from each participating woman. When I signed up on the database yesterday, I was prompted to fill in my name, year of birth, email address and ethnicity, but was asked for no additional health information. I then clicked a box to receive update emails from the database containing details about upcoming clinical trials, their criteria for participation and what would be required of me as a participant. If I choose to participate, I will receive questionnaires about my health history to fill out online. I'll also receive reminders to update my health information as it changes. The aim of the project is to allow cancer researchers to "cost-effectively conduct research studies," said Ken Buetow the director of the caBIG program -- an extensive IT infrastructure designed to make data sharing and collaboration easier across cancer researchers worldwide. (Buetow wrote about the caBIG project in our linkurl:April;http://www.the-scientist.com/2008/4/1/60/1/ 2008 issue.) The service may be inexpensive, but it isn't free. Researchers are linkurl:charged a fee;http://researchers.armyofwomen.org/costtoscientists for each batch of emails they send to potential volunteers -- $1,000 for an email sent to 1,000 or more women in the database, according to the website. Specimen collection, if it is performed at Army of Women collection centers, would incur an additional fee ranging from $10 to $350 per sample, depending on the complexity of the collection procedure. Eventually, said Buetow, the cohort could be expanded to clinical drug trials, but for now, the program is designed only for epidemiological cohort studies. As of June, some 300,000 women have agreed to be contacted to participate in research and some 11,000 have already been enrolled in research investigations that requested volunteers late last year. caBIG's infrastructure will help disseminate raw data that comes out of the HOW studies, in addition to providing the security encryption to keep participants' health information private, said Buetow. The project could also help "return the research information back to the women" who participate, he said -- though he didn't specify how exactly that would occur.
**__Related stories:__***linkurl:Heading for the BIG time;http://www.the-scientist.com/article/display/54501/
[April 2009]*linkurl:caBIG in action;http://www.the-scientist.com/article/display/54511/
[April 2009]*linkurl:Preventing cancer;http://www.the-scientist.com/article/display/14134/
[22nd September 2003]