New Texas Law Removes Barrier to Clinical Trials:

 Insurance Coverage of Routine Health Services Now Required for Covered Patients Enrolled in Clinical Trials

September 1, 2009 (Austin, TX)   Effective September 1, 2009, Texas joins 27 states that  require  health benefit plans to cover routine costs for patients enrolled in clinical trials such as those for  cancer and other life threatening diseases. Routine costs are medically necessary health services, such as doctor visits, hospital stays, tests, and x-rays-- care that patients with health insurance coverage would receive as a covered benefit even if they were not in a clinical trial.  The 81st Texas Legislature passed Senate Bill 39, and Governor Perry signed the bill on June 19, 2009.

Clinical trials are an essential element in the development of new, life saving therapies for patients with cancer and other life-threatening diseases.  The success of clinical trials depends on the willingness of patients to participate.  Prior to the passage of this legislation, many Texans considering enrollment in a clinical trial may have chosen not to do so due to concerns about losing insurance coverage. 

With the passage of this new law, a significant barrier to Texans considering clinical trials as a treatment option is removed. Low participation rates in clinical trials prolong the drug development process, and can delay public access to potentially effective new treatments. Low participation rates also make it harder for researchers to answer important questions about comparing existing treatments with new treatments.   Cancer clinical trials enrollment is generally low overall, only around three percent of adults participate. Minorities, the elderly and underserved communities, especially African Americans and Latinos and those living in rural areas are particularly under-represented in clinical trials.

 Armin Weinberg, PhD, Director of  The Chronic Disease Prevention and Control Research Center  at Baylor College of  Medicine in Houston and co-founder of Intercultural Cancer Council recently completed a four-year (2005-2009) research program to address problems and solutions related to improving participation of minority and underserved patients in clinical trials. The “Eliminating Disparities in Clinical Trials (EDICT) Project” demonstrates that increasing awareness of and access to clinical trials requires a systematic approach. Patients need more and better communication to understand the risks and the benefits of trials to make informed decisions about their option to participate.  There is no silver bullet –only by promoting change and addressing barriers at the community, organizational, local, state and national levels will we see significant increases in clinical trial enrollment.”

 Tom Kowalski, CEO of the Texas Health and Bioscience Institute (THBI) and President of the Texas Life Science Foundation (TLSF), described the foundation’s plans to develop a Texas Clinical Trial Network designed to help patients learn about and enroll into trials. “Insurance coverage for routine care was a big barrier for many patients considering trials,” said Kowalski.  “Now, we need to continue work in Texas to address other patient barriers to trial participation like lack of awareness, mistrust of medical professionals, difficulty navigating the healthcare system, and geographic access.   We are developing the Texas Clinical Trial Network to provide both technology and clinical trial navigators to help increase access to and participation in trials, especially among underserved and minority patients.” 

Texas ranks first in the number of cancer clinical trials in the United States with 1,468 of 9808 open and accruing trials.  Texas follows California and New York as the state with the third largest number of clinical trials (2,013 out of 28,472 open trials) including trials for cancer and other diseases.  Continued growth of investments in research in Texas from state, federal and private sector sources – like those from the Texas Emerging Technology Fund and the Texas Cancer Prevention and Research Institute – will continue to increase the number of clinical trials opportunities for Texans. 

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 Source:

Deborah Vollmer Dahlke
Project Director, TX Clinical Trial Network
Texas Life Science Foundation
dvd@TLSFoundation.org
512.699.4493
www.TLSFoundation.org

 

Clinical Trial process

About TLSF --Texas Life Science Foundation (www.TSFoundation.org)  is a 501(c)3 nonprofit foundation focused on promoting greater understanding of Texas’ bioscience community through the exploration of new approaches to technology and research.  Its programs include the Texas Clinical Trial Network, an innovative approach designed to  expand access, accelerate enrollment and provide education and increased communication about clinical trials in Texas.

 

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