Woodruff: Clinical Research Should Be More Gender-Specific



Loading...

By Deborah Borfitz

June 16, 2008 | In virtually every medical discipline, there are unanswered questions pertaining to women’s health and well-being. Closing the gender gap in medical research may require more than simply including women in research studies, says Teresa Woodruff, executive director of the Institute for Women’s Health Research, recently launched by Northwestern University’s Feinberg School of Medicine.

“Women experience disease symptoms and respond to therapeutic treatments differently throughout their lifespan and across their monthly menstrual cycle,” says Woodruff. Hormone fluctuations and the possibility of pregnancy among pre-menopausal women have for decades been the rationale for excluding females from medical research. To this day, many researchers prefer using male animals over female animals in their laboratories simply because their hormone environment is less complicated.

 Teresa Woodruff,  Institute for Women's Health, Northwestern University 
Teresa Woodruff
Since the early 1990s, women have been represented as study subjects in higher numbers because the National Institutes of Health, as a condition of funding, now requires that researchers include women in all studies targeting diseases that impact both sexes. However, when male and female trial data gets blended, sex- and gender-specific findings are difficult to evaluate unless the trial was specifically designed to look for sexual dimorphisms, says Woodruff.

Traditionally, women’s health research has focused on issues such as pregnancy, menopause, and female-specific cancers, she adds. Only in the last five years, for example, has the medical community identified sex differences in cardiovascular disease, the leading killer of both men and women. Even far less is known about diagnosing and treating women with diseases of the brain, the musculoskeletal organs, and the immune system. Most reports on adverse drug reactions occur in women because females were not included in many of the early pharmaceutical studies.

Woodruff believes that women want to be a part of the answer. The Institute’s latest project, the Illinois Women’s Health Registry, opened three months ago and has already enrolled over 1,000 Illinois women who are willing to take part in Institutional Review Board-approved research conducted at Northwestern University. Registry participants will be matched to specific studies based on their self-reported health profiles. Woodruff says she hopes the registry “will help us identify priorities that will raise the health status of Illinois women, who now rank 33rd among the states.”

In addition to the registry, the Institute for Women’s Health Research is facilitating more women’s research by offering seed grants to young investigators and by developing an Animal Research Core that will encourage researchers to use female animal models in their studies.

“More physicians are beginning to recognize that sex and gender impact health, but they do not necessarily know the way it relates to age or genetics,” says Woodruff. “That level of sophistication doesn’t exist yet.” But “before we can get to personalized medicine, we need to understand basic sex differences.”

Woodruff predicts, “Ten years from now, the treatment of women and men will be different than it is today because of programs like the Institute for Women’s Health Research.”

________________________________

 This story first appeared in eCliniqua,one of Bio-IT World’s free e-newsletters. Subscribe here.

 

 

Click here to login and leave a comment.  

0 Comments

Add Comment

Text Only 2000 character limit

Page 1 of 1



White Papers & Special Reports

oracle20723
The Role of Analytics in Transforming Healthcare
Sponsored by Oracle

Sharing many of the data challenges and opportunities faced by Healthcare, the Life Sciences industry remains focused on delivering new, innovative therapies and solutions to patients in a cost effective, timely and safe way. With spiraling R&D costs, new methods such as adaptive trials, and never ending need for deep pharmacovigilance, the Life Sciences companies that effectively use analytics to explore, monitor and optimize their business will rapidly become the new leaders.

Oracle’s strategy—built upon Enterprise Health Analytics and Health Data Warehouse Foundation—provides a powerful, practical, and extensible approach to delivering the IT analytics infrastructure required to confront the worldwide healthcare challenge.



pegasystems
BPM-Based Case Management Approach to Optimizing Clinical Trial Efficiency
Sponsored by Pegasystems

Business Process Management (BPM) software offers liberation in the planning and management of clinical trials today. SmartBPM provides the components for automating critical clinical trial processes ranging from protocol development and patient enrollment to site management and investigator payments. Advantages are:

  • Potentially stunning return on investment at multiple levels.
  • A 500%, or better, increase in application development time by directly executing business requirements
  • Improved customer retention
  • A 50% possible reduction in training time

Discovered is opportunity to enhance relationships with investigators, subjects, and regulators while bringing momentum to a technology-impaired study startup phase. Learn more about SmartBPM in this complimentary white paper.



Cmed paper
Next-gen Cloud-based eClinical
Sponsored by Cmed Technology

New technologies are available to leverage Cloud Computing in  managing clinical trial data. This paper discusses a next generation eClinical
platform that:

  • Speeds trial set up
  • Accommodates changes with zero downtime
  • Integrates effectively with other clinical trial technology systems

It is offered with either software-as-a-service (SaaS), or turnkey infrastructure options in which the user organization operates their own cloud using their IT teams, within their data centers. Read this paper to learn and decide how best to leverage cloud computing’s many strengths for your organization’s  particular needs.



Job Openings

mskc logo
Software Engineer – Computational Biology Center

Memorial Sloan-Kettering Cancer Center seeks an Engineer to design and develop complex data analysis systems in support of cancer genomics research projects at the Computational Biology Center. Qualified candidate will have a BA, 5+ years of software development experience and expert knowledge of Java, SQL, and HTML.

Apply: www.mskcciscareers.org.  Equal opportunity and affirmative action employer.

Web Symposia
Loading...

Bio-IT World proudly presents the Bio-IT World Web Symposia Series covering a broad array of topics within the life sciences and drug development enterprise.

Leveraging BPM to Increase Efficiencies in Clinical Trial Case Management
August 3, 2010 | 1:00 – 2:30 p.m. EST
Sponsored by: Pegasystems
Program Details | Register Here 

 


Loading...

For reprints and/or copyright permission, please contact The YGS Group, 3650 West Market Street, York, PA;

(717) 505-9701 ext. 125, or via email to Ashley.Zander@theYGSgroup.com.