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 underserved 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:
Progress - Our Efforts are Realizing Results
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 Partner with a $2 million grant to launch the IMPACT program in California.
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.