SACRAMENTO, CA--(Marketwired - Sep 29, 2016) - Earlier this week, Governor Jerry Brown signed into law the new California Cancer Clinical Trials Program to increase access to cancer clinical trials for patients, especially women and under-represented communities. This makes the State the first in the country to legally recognize the financial burdens afflicting cancer patients seeking treatment in clinical trials. The bill was sponsored by Lazarex Cancer Foundation, authored by Assemblymember Susan Bonilla, and co-authored by Assemblymember Marie Waldron.
This program is the result of a decade-long effort of Lazarex Cancer Foundation. Lazarex helps advanced stage cancer patients and the medically underserved with costs for FDA trial participation, identification of clinical trial options, community outreach and education.
"This is the first step toward creating a sustainable transformation in the 'bench-to-bedside' process for clinical trial enrollment," said Lazarex President Dana Dornsife. "We are grateful for the support of Assemblymembers Susan Bonilla and Marie Waldron, and are heartened by the response of the legislature." AB 1823 unanimously passed the full Assembly and the State Senate, 80-0. Assemblymember Susan Bonilla has spearheaded this effort since its conception by Lazarex in early 2014. The University of California and the University of Southern California also played collaborative roles in the passing of this legislation.
The new law distinguishes between inducement and reimbursement. It recognizes ancillary costs as a barrier to clinical trial participation; encourages industry support of these costs; and identifies the allowable expenses that can be reimbursed to patients.
The California Cancer Clinical Trials Program will be administered by the University of California, which will raise funds and distribute privately funded grants aimed at reducing barriers to trial participation. The funds will be used to help connect patients with appropriate clinical trials, and to cover expenses stemming from participation in those trials. It will authorize industry, public and private foundations, individuals, and other stakeholders to donate to the program directed by UC, as well as to other nonprofit corporations and public charities that specialize in the enrollment, retention, and increased participation of patients in cancer clinical trials.
"The California Cancer Clinical Trials program will transform how we connect patients with cancer trials in California and engage with industry and businesses in the oncology field," said Assemblywoman Susan Bonilla (D-Concord), the author of the bill. "Research and clinical trials are keys to treatment success, but just as important is the access and participation to those trials by a diverse population."
"I am proud to be a principal co-author of AB 1823 which creates opportunity not only for California cancer centers and patients, but will also create an environment where business and pharmaceutical companies from across the country and world will see California as the vanguard in the effort to increase accessibility and enroll patients in trials, bringing life-saving cancer drugs to market sooner," stated Assemblymember Marie Waldron ®, the original co-author of the bill.
Barriers to participation in clinical trials
An estimated 1.7 million new cases of cancer will be diagnosed and nearly 600,000 people will die from the disease in the United States this year alone. Yet only about three percent of eligible cancer patients participate in clinical trials, and only about five percent of them are from under-represented communities such as African Americans, Latinos/Hispanics, Asians and Pacific Islanders, and American Indians.
There are many reasons for this low participation, including the ancillary costs of participation in the trials. Yet diversity in clinical trials can improve their effectiveness, and can help researchers better evaluate the effects of new therapies. This can result in more robust treatments that meet the varying genetic make-up of women and men and diverse racial and ethnic groups.
About the Lazarex Cancer Foundation
Lazarex Cancer Foundation is a 501(c)(3) not-for-profit organization that is improving the outcome of cancer care for advanced stage cancer patients and the medically underserved by providing assistance with costs for FDA trial participation, identification of clinical trial options, community outreach and education. Over the last decade, Lazarex has provided direct assistance to more than 2,000 patients in over 900 nationwide trial sites, and provided advocacy, community outreach and education to more than 300,000 people. More information is available at https://www.lazarex.org.