Clinical Trials: Women Needed

As a career lab rat since 1999, I found out a lot about the world of clinical trials. Much is underregulated. There is ineffectiveness because there is incentive for researchers to carry out studies quickly and cheaply. Women are discriminated against in phaze-1 clinical trials for "good" reasons but forbidding women from participating in research so as not to take chances with unborn fetuses does more harm than good, and I have heard this from researchers whom have no way of changing the system. Males between 18 and 45 years of age are the most used demographic for drug trials and the majority whom are chosen for phaze-1 trials are often incentivized only by money for their participation. Research sites often take in men whom are homeless, under-educated, unemployed and whom are former ex-cons and whom find a way to deceptively enroll in paid research in spite of having substance-abuse histories. It is not an easily addressable issue. When it comes to research to put a drug on the market, rapid enrollment of clinical trial volunteers is important. The recruitment of volunteers by research sites is such that many research sites avoid making strict exclusion criteria for participation in research.Most people would not volunteer for little or no pay. Certain medical research can pay several thousand dollars for a few weeks of living in dorm and being medicated. Social conditions, sometimes also living conditions in research sites are often deplorable. Research volunteers in dormatories do not have the same specified legal protections against sexual harassment or workplace bullying that government volunteers or salaried employees would have more of a defined, legal right to. Government needs to get more involved in regulating research sites particularly Contract Research Organizations. Or, departments such as the Food and Drug Administation, Office of Human Research Protections, Association for the Accreditation of Human Research Protection Programs (etc) should be assigned to regulate and oversee far more than the dosage of medications in clinical trials.

http://en.wikipedia.org/wiki/Workplace_bullying

http://www.healthyworkplacebill.org/

http://www.time.com/time/nation/article/0,8599,2005358,00.html

http://www.eapdlaw.com/files/News/9ef81354-3bc2-48de-990c-0238d212ff65/Presentation/NewsAttachment/99f197f3-90d5-46d1-a3a4-0a761c044dc7/Client%20Update_Volunteer%20Workers%20May%20Bring%20Suit%20for%20Sexual%20Harassment%20May05.pdf

http://www.nytimes.com/2011/05/14/opinion/14tolentino.html

http://www.asaecenter.org/Resources/ANowDetail.cfm?ItemNumber=29755

http://www.gshnj.org/_media/forms/volunteerpolicy.pdf

http://webcache.googleusercontent.com/search?q=cache:y1sIn_3Mtz8J:www.humanrightscommission.vic.gov.au/index.php%3Foption%3Dcom_k2%26view%3Ditem%26layout%3Ditem%26id%3D1128%26Itemid%3D574+volunteer+vs+volunteer+sexual+harassment&cd=7&hl=en&ct=clnk&gl=us&source=www.google.com

L.M. of NY 5:33PM July 05, 2011

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Bhnfbwer of IL 2:20PM July 14, 2009

Thanks for the comments. Stephen, with regards to your question, I didn't find a lot of academic references to this, but Ana María García did an award-winning documentary La Operación (1982) on this topic. Here's a lnk to an interview with her.

http://www.ejumpcut.org/archive/onlinessays/JC29folder/AnaMariaGarciaInt.html

Deborah Kotz of DC 3:50PM April 03, 2008

Two thoughts. First, women need a permanent advocate within the federal health agencies to ensure that women are appropriately studied and that their unique health needs receive the careful, focused attention they deserve. There's an effort underway now to do this:

http://www.womenshealthresearch.org/site/PageServer?pagename=policy_main

Second, women need resources to help them understand what participating in medical research entails and what the benefits are to them and others. There's a public education campaign called "Some Things Only a Woman Can Do," which has resources for women, including specialized materials for older women, African Americans, and Hispanics (in Spanish): http://www.womancando.org/

Richard Schmitz of DC 1:00PM April 03, 2008