Improving Patient Access to Cancer Clinical Trials
IMPACT is a 3-year pilot study with a comprehensive approach to improving patient enrollment, retention, minority participation and equitable access in oncology trials.
Clinical trials are the vehicle the FDA uses to bring new drugs to market safely. Patient participation is crucial to the successful completion of a trial, yet the barriers to trial participation – primarily ancillary costs – lie squarely on the shoulders of patients. Over the past 10 years, Lazarex has developed successful programs to address and remove these barriers. Currently, Lazarex stands alone in offering a complete solution to this problem and while this is a noble undertaking it is not a sustainable one.
In 2013 Lazarex and the Massachusetts General Hospital Cancer Care Equity Program joined forces to establish a pilot program focused on removing financial barriers to clinical trial participation for cancer patients and improving access to cancer clinical trials for under-served populations. Based on the success, we have greatly expanded the pilot into a nationwide effort – IMPACT – Improving Patient Access to Cancer Clinical Trials. IMPACT brings together the significant resources of industry stakeholders: academia, medicine, policy makers, industry, public health and community organizations nationwide.
The IMPACT program facilitates a coordinated effort amongst these stakeholders to create a replicable, “boots on the ground” action plan, bringing significant and sustainable change to the status quo of clinical trial recruitment, retention, minority participation, completion, and translational science – providing equitable and timely patient access to cancer discovery.
In this video Lazarex Founder Dana Dornsife explains the iMPACT initiative:
Thank You to our IMPACT Founding Sponsor
Progress – Our Efforts are Realizing Results
October 17, 2018: Two major victories for cancer patients nationwide as bills promoting equal access to cancer trials become law: Congress and the state of Pennsylvania approve language aimed at increasing access among underserved communities. The inclusion of the language follows an intensive effort by Lazarex Cancer Foundation with members of congress and Pennsylvania state officials to bring this problem forward. Read the press release here.
September 13, 2018: The American Society of Clinical Oncology (ASCO) today issued a set of recommendations for overcoming financial barriers to patient participation in cancer clinical trials. ASCO would like to thank the Lazarex Cancer Foundation for funding the ASCO Roundtable on Addressing Financial Barriers to Clinical Trials Participation in 2017, which contributed to the development of this statement. Read the ASCO policy statement, “Addressing Financial Barriers to Patient Participation in Clinical Trials.”
August 13, 2018: Massachusetts considers bill aimed at improving patient reimbursement for clinical trial expenses. Massachusetts is one of several states—including Texas, Pennsylvania and Florida—considering such legislation backed by California-based Lazerex Cancer Foundation to improve the ability of patients to enroll and remain enrolled in clinical trials. California passed a similar law in 2016. Read the full article here.
May 8 & 9, 2018: Lazarex Cancer Foundation convenes 2 days of discussions with thought leaders in oncology, public health, private industry, patient advocacy and public policy to address clinical trials and data sharing. Read the press release here.
January 25, 2018: The FDA issued revised guidance about reimbursement to clinical trial participants. The new guidance includes the following critical language and paves the way for industry funding for reimbursement of patient travel expenses:
“FDA does not consider reimbursement for travel expenses to and from the clinical trial site and associated costs such as airfare, parking, and lodging to raise issues regarding undue influence.” Read the press release here.
January 2018: We initiate IMPACT CA with institutional partners UCSF Helen Dillar Family Comprehensive Cancer Center and USC Norris Comprehensive Cancer Center.
December 2017: AMGEN signs on as the IMPACT Founding Sponsor with a $2 million grant to launch the IMPACT program.
September 2016: Governor Brown Signs into Law the California Cancer Clinical Trials Program
The new law will help increase patient enrollment, retention, and minority participation in cancer clinical trials, especially among women and under-represented communities. Read the press release here.