Today, the American Cancer Society Cancer Action Network (ACS CAN), joined by 128 other patient advocacy groups, public health organizations and professional societies, submitted a letter responding to the request for information (RFI) issued by the U.S. Department of Health & Human Services (HHS), Office of Inspector General (OIG) regarding creating a safe harbor for sponsors of clinical trials to pay patient costs of participation in the studies. The safe harbor would make it clear that payment of such costs does not violate the Anti-Kickback Statute (AKS). The RFI comes after several years of public health organizations calling for the adoption of a new AKS safe harbor that would permit clinical trial sponsors to offset certain participation costs that prevent many from joining lifesaving research.
The comments below are excerpts from the letter and reflect continued support for the adoption of such a safe harbor by the undersigned organizations:
“Although clinical trials are […] ‘the gold standard of clinical research and provide critical evidence for new treatments,’ clinical trial sponsors struggle to enroll patients. Indeed, remarkably—and sadly— an estimated 30% of clinical trials conducted between 2011 and 2021 were suspended or terminated after failing to reach [their] enrollment target.
“Under these circumstances, it is not surprising that a 2026 study found that 89 percent of cancer patients indicated they would be more likely to enroll in a cancer clinical trial if sponsors supported them financially. Similarly, in a 2025 study, 86 percent of patients cited expenses as influencing their decision to participate in a clinical trial.
“Also not surprisingly, those living in remote or rural areas had ‘more than twice the risk of financial hardship compared to those traveling shorter distances’; and this is exacerbated by the fact that patients who have low incomes may be more likely to live in areas with less health care or clinical trial resources and thus be required to travel farther distances to a site that offers cancer clinical trials.
“Taken together, this evidence demonstrates that the financial and logistical burdens associated with clinical trial participation—particularly the added travel and cost burdens borne by rural and low-income patients—represent a substantial and well-documented barrier to enrollment, one that directly undermines the ability of clinical trials to reach their targets. Given the clear and consistent data showing that patients are significantly more likely to enroll when financial support is available, we urge that measures enabling sponsors to cover trial-related travel, lodging, and other out-of-pocket expenses are not merely beneficial but essential to improving clinical trial participation and, ultimately, advancing research for all Americans.”
Read the full letter here.
The organizations that signed onto the letter include:
American Cancer Society Cancer Action Network
1Day Sooner
Academy of Oncology Nurse & Patient Navigators
Academy of Physicians in Clinical Research
ADAP Advocacy Association
Adolescent and Young Adult Cancer Coalition
Alliance for Patient Access
Alliance for Women's Health & Prevention (AWHP)
American Association for Cancer Research (AACR)
American Association of Clinical Urology (AACU)
American Lung Association
American Society for Transplantation and Cellular Therapy
American Society of Hematology
American Society of Pediatric Hematology/Oncology
AnCan foundation
Anxiety and Depression Association of America
Association for Clinical Oncology (ASCO)
Association for the Accreditation of Human Research Protection Programs, Inc.
Association of American Cancer Institutes
Association of Black Cardiologists
Association of Northern California Oncologists
Association of Pediatric Hematology/Oncology Nurses (APHON)
Biomarker Collaborative
BlackDoctor
Brem Foundation to Defeat Breast Cancer
Cancer Active, Inc.
Cancer Support Community
Caregiver Action Network
Carolina BioOncolgy Institute & BioCytics Human Applications Lab
Cervivor, Inc.
Cheeky Charity
Children’s Brain Tumor Foundation
Coalition of Skin Diseases
Colon Cancer Coalition
Colorectal Cancer Alliance
Community Access National Network
Community Liver Alliance
Community Oncology Alliance (COA)
Connecticut Oncology Association
Crohn's & Colitis Foundation
Debbie’s Dream Foundation: Curing Stomach Cancer (DDF)
Depression and Bipolar Support Alliance (DBSA)
Derma Care Access Network
Digestive Disease National Coalition
Epilepsy Foundation of America
Esophageal Cancer Action Network (ECAN)
Exon 20 Group
Fight Colorectal Cancer
FORCE: Facing Our Risk of Cancer Empowered
Friends of Cancer Research
Gaucher Community Alliance
Gerontological Society of America
GI Cancers Alliance
Global Colon Cancer Association
GO2 for Lung Cancer
Haystack Project
Hope for Stomach Cancer
ICAN, International Cancer Advocacy Network
Illinois Medical Oncology Society (IMOS)
International Myeloma Foundation
Kidney Cancer Association
KidneyCAN
LESLIE'S WEEK a Stage 4 Breast Cancer Nonprofit
Livestrong
Living Beyond Breast Cancer
LUNGevity Foundation
Lupus and Allied Diseases Association, Inc.
Lupus Foundation of America
Lymphedema Advocacy Group
Maryland-DC Society of Clinical Oncology
Medical Oncology Association of Southern California (MOASC)
Melanoma Research Alliance
Melanoma Research Foundation
Men's Health Network
MET Crusaders
METAvivor
Multiple Myeloma Research Foundation
Myasthenia Gravis Association
National Alliance of State Prostate Cancer Coalitions
National Association of Hispanic Nurses
National Black Nurses Association
National Brain Tumor Society
National Cancer Registrars Association
National Coalition for Infant Health
National Comprehensive Cancer Network (NCCN)
National Health Council
National Hispanic Health Foundation
National Hispanic Medical Association
National Kidney Foundation
National Minority Quality Forum
National Patient Advocate Foundation
National Scleroderma Foundation
NCODA (Network for Collaborative Oncology Development and Advancement)
NRG1 Energizers
Ohio Hematology Oncology Society
Oklahoma Society of Clinical Oncology, Inc.
Oncology Nursing Society
Ovarian Cancer Research Alliance
Parkinson's Foundation
Patient Empowerment Network
PDL1 Amplifieds
Pennsylvania Prostate Cancer Coalition (PPCC)
PlusInc
Prevent Blindness
Prevent Cancer Foundation
Preventive Cardiovascular Nurses Association
Prostate Health Education Network
Rural Minds
Sharsheret | The Jewish Breast & Ovarian Cancer Community
Shercare
Society For Clinical Research Sites
Society of Utah Medical Oncologists (SUMO)
Stupid Cancer, Inc.
Susan G. Komen
The Headache and Migraine Policy Forum
The Prostate Cancer Clinical Trials Consortium
Tigerlily Foundation
Triage Cancer
Triple Negative Breast Cancer Foundation
Twisted Pink
Unite for HER
US Hereditary Angioedema Association
UsAgainstAlzheimer's
wAIHA Warriors
Women As One, Inc.
Young Survival Coalition
Your Prostate Cancer.help
ZERO Prostate Cancer