TOWN HALL MEETING

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EDUCATION ISSUES:

• Suggestion: NCI should produce simple public service announcements that
  explain what clinical trials are.  Helping people understand might help with enrollment.
• Can NCI help change the term from “clinical trial” to “clinical study”?  People are afraid of the word “trial.”  There are still people out there who believe they will receive a placebo and no other treatment—no wonder accruals are so low.
• How can you get into a clinical trial if the company eliminates you prior to the start because you aren’t sick enough?

Realizing that clinical trial participation is extremely low, we are happy to report that the NIH Office of Communications and Public Liaison in the Office of the NIH Director is developing a major clinical trials campaign to enhance public knowledge about clinical trials.

It would take a major overhaul of the clinical trials enterprise to change the term “clinical trials” to something else.  However, this idea has been raised before.  It is our hope that more public education will help people understand clinical trials better.

We admit it is difficult to be denied access to a clinical trial when you do not meet the specific criteria. However, to have accurate research findings in the discovery of new and effective cancer drugs, scientists require participants to meet the letter of the written clinical trial protocol.  Without these parameters in place, how could a researcher determine if the medicine or therapy worked in the targeted population?

NCI produces consumer-friendly clinical trial educational materials, available at: http://www.cancer.gov/clinicaltrials/learning.

• I have heard cervical cancer referred to as a sexually transmitted disease.  When during prevention do you feel it is appropriate to approach it as such?

The Food and Drug Administration (FDA) announced on June 6, 2006, the approval of Gardasil, the first vaccine developed to prevent cervical cancer, precancerous genital lesions, and genital warts caused by human papillomavirus (HPV) types 6, 11, 16, and 18. The vaccine is approved for use in females aged 9–26 years.  Gardasil was evaluated and approved in six months under FDA’s priority review process—intended for products with the potential to provide significant health benefits.  Early research sponsored by NCI laid the groundwork for this vaccine.

HPV is the most common sexually transmitted infection in the United States.  The Centers for Disease Control and Prevention estimates that about 6.2 million Americans become infected with genital HPV each year and that over half of all sexually active men and women become infected at some time in their lives.  On average, there are 9,710 new cases of cervical cancer and 3,700 deaths attributed to it in the United States each year. Worldwide, cervical cancer is the second most common cancer in women, with an estimated 470,000 new cases and causing 233,000 deaths each year.

For most women, the body’s own defense system will clear the virus and infected women do not develop related health problems.  However, some HPV types can cause abnormal cells on the lining of the cervix that years later can turn into cancer.  Other HPV types can cause genital warts.  The vaccine is effective against HPV types 16 and 18, which cause approximately 70 percent of cervical cancers and against HPV types 6 and 11, which cause approximately 90 percent of genital warts.

For more information, visit www.fda.gov/bbs/topics/NEWS/2006/NEW01385.html.

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