PM360_Trailblazer_2019   EDDIE_OZZIE_HM   PM360_Elite_2020   EDDIE_OZZIE_Winner   PM360_Trailblazer_2020   Inc_5000   PM360_Trailblazer_2021

AONN+ Joins Organizations in Letter to Congress on Passage of DIVERSE Trials Act

November 30, 2021

CRANBURY, N.J., Nov. 30, 2021 - The Academy of Oncology Nurse & Patient Navigators (AONN+) joined many organizations in writing to Congress and urging the passage of DIVERSE Trials Act, a bipartisan bill that will help ensure more patients—regardless of their race, economic means, or geographic location—have a chance to enroll in clinical trials.

Clinical drug and treatment trials are key to advancing new standards of care that can improve survival and quality of life for people with cancer. To be successful, clinical trials must enroll participants who are adequate in number and diversified in demographics.

However, some demographic groups have been underrepresented in the clinical trials process; such groups include certain racial and ethnic groups, older adults, rural residents, and those with limited incomes.

Introduced in both the House and Senate, the Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act would help increase diversity in clinical trials and make it easier for all people with cancer to participate in clinical trials by reducing their barriers to enrollment. Relevant provisions in the DIVERSE Trials Act include:

  • permits individuals to receive financial support for non-medical costs associated with their participation in clinical trials
  • allows trial sponsors to provide individuals with the technology necessary for them to participate remotely in clinical trials
  • requires the Department of Health and Human Services (HHS) to issue guidance on decentralized clinical trials to improve demographic diversity

The AONN+ Policy and Advocacy Committee has applied the navigation voice, support, and signature to the DIVERSE Trials Act. AONN+ leaders believe patient navigation is an inside track for increasing clinical trial participation as navigators have been shown to:

  • address misconceptions that start in the community concerning clinical trials
  • augment logistics of getting to a cancer center with trials
  • introduce clinical trials at an earlier stage of care to increase patient receptivity to participate
  • use cultural competence to remove barriers to trial acceptance
  • form a synergistic relationship between research staff and nurse navigators to raise trial awareness to patients

The DIVERSE Trials Act was sponsored by Sens. Robert Menendez and Tim Scott, and Reps. Raul Ruiz and Larry Buschon.

For more information on this Act, please visit

The full letter can be viewed here:

Dear Chairs Murray, Neal, and Pallone and Ranking Members Burr, Brady, and McMorris Rodgers:

The undersigned organizations represent millions of patients, health care providers, and advocates for health equity who are deeply committed to improving our science base through the adequate representation of underrepresented communities in vital medical research. We strongly support passage of the Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act (H.R. 5030/S. 2706) and urge you to prioritize this bill in your Committees to ensure it is enacted into law this year. The DIVERSE Trials Act would make it easier for all patients to participate in clinical trials while removing barriers that are known to keep certain racial and ethnic groups, older adults, rural residents, and those with limited incomes from being appropriately represented. This legislation has earned bipartisan, bicameral support, takes a practical approach that will lead to near-term improvements, and entails little cost to taxpayers.

The three provisions of the DIVERSE Trials Act will result in more efficient, inclusive, and accessible research, which will benefit the health of all Americans:

First, the legislation would permit individuals to receive financial support for the non-medical costs associated with their participation in clinical trials, by creating a statutory safe harbor for clinical trial sponsors to use in reimbursing such costs. Today, clinical trial sponsors generally supply without charge the drug or technology being investigated while insurers generally cover the other treatment costs associated with a trial. Often, however, patients must pay non-medical costs associated with participating in a clinical trial—such as transportation to a trial site, lodging in another city, meals, and additional childcare. For many people, these costs are difficult to bear and may be the difference between saying “yes” or “no” to a clinical trial that could improve their own care and the care of others suffering from the same disease. For example, a recent study showed that patients making less than $50,000 a year are 30 percent less likely to enroll in a cancer clinical trial.1 Financial barriers are a major barrier for communities underrepresented in clinical trials resulting in trials that do not adequately represent the patient populations who are intended to use the treatments being studied. By clarifying that trial sponsors can financially support patients’ non-medical costs, the DIVERSE Trials Act can change this reality for the better.

Second, the DIVERSE Trials Act would allow trial sponsors to provide individuals with the technology necessary for them to participate remotely in clinical trials. Clinical trials almost always require participants to report their condition, symptoms, side effects, or other data on a regular basis and/or to have certain health indicators monitored by web-enabled technology. Some trials of new treatments consist entirely or substantially of such monitoring and so lend themselves to more comfortable and efficient remote participation. For this to work, however, participants must have access to technologies, such as portable computers, tablets, and software applications. This legislation would take the common-sense step of allowing sponsors to provide such technology to participants in a clinical trial. The benefits of this provision include eliminating a financial barrier to participation in clinical trials that are increasingly incorporating web-enabled technology and fostering the conduct of trials that utilize remote participation and include larger cohorts of underrepresented groups.

Finally, the legislation would require the Department of Health and Human Services (HHS) to issue guidance on decentralized clinical trials. While the COVID-19 pandemic accelerated the need for clinical trials in which patients could participate at or close to home, researchers have long endeavored to make clinical trials more convenient for participants. The decentralized approach could open the door to clinical trials for a much broader array of participants, such as those who live hours from a trial site or do not have the ability to make repeated visits to the trial site due to work or caregiving schedules. A significant hinderance to the conduct of decentralized trials has been the absence of clear guidance on the design, conduct, oversight, and other requirements of this research approach. Issuing guidance on the conduct of decentralized clinical trials is an urgent priority for patients, advocates, and health care researchers alike.

We stand at the cusp of a health care revolution—as breakthroughs in genetics, immunotherapy, systems biology, precision medicine, and other specialties lead to more effective treatments and even potential cures for many of the most intractable diseases. Clinical trials are the means by which such breakthroughs are shown to be effective and safe. Making clinical trials more efficient, inclusive, and accessible—as the DIVERSE Trials Act would do—means bringing the growing benefits of medicine and science closer to every American.

Please prioritize the DIVERSE Trials Act (H.R. 5030/ S. 2706) this year to ensure more patients—regardless of their race, ethnicity, economic means, or geographic location—have a chance to enroll in clinical trials.



The Honorable Robert Menendez

The Honorable Tim Scott

The Honorable Raul Ruiz

The Honorable Larry Bucshon


  1. Unger, J. M., Gralow, J. R., Albain, K. S., Ramsey, S. D., & Hershman, D. L. (2016). Patient Income Level and Cancer Clinical Trial Participation: A Prospective Survey Study. JAMA Oncology, 2(1), 137–139.


About the Academy of Oncology Nurse & Patient Navigators, Inc: The Academy of Oncology Nurse & Patient Navigators, Inc (AONN+), is the largest national specialty organization dedicated to improving patient care and quality of life by defining, enhancing, and promoting the role of oncology nurse and patient navigators. The organization, which has more than 8900 members, was founded in 2009 to provide a network for all professionals involved and interested in patient navigation and survivorship care services in order to better manage the complexities of the cancer treatment process.

About the Journal of Oncology Navigation & Survivorship: The Journal of Oncology Navigation & Survivorship ( is the official publication of AONN+. JONS seeks to strengthen the role of nurse and patient navigators in cancer care by serving as a platform for these professionals to disseminate original research findings, exchange best practices, and find support for their growing community.

About CONQUER: the patient voice magazine: CONQUER: the patient voice magazine ( is the AONN+ premier forum for patients with cancer. CONQUER magazine features articles written by and for patients with cancer, survivors, nurse navigators, and other oncology team members. This magazine addresses the issues that patients, their family members, and caregivers face every day in an easy-to-read format. Issues include interviews with patients with cancer, information on access to care, and articles on lifestyle topics such as nutrition, stress management, personal finance, and legal and employer issues.

About The Lynx Group: The Lynx Group (TLG) is a premier medical communications and education company acutely focused on oncology and rare disease states. TLG specializes in market access to and with advanced practice providers, patients, and their caregivers. With more than 100 years of combined senior leadership experience, TLG continually creates award-winning medical education and cultivates strong relationships within proprietary brands serving patients and their caregivers, physicians, payers, nurses, pharmacists, navigators, and practice managers.

TLG has broad and deep experience in crafting custom, award-winning solutions for life science and biotech companies. Currently, TLG partners with more than 50 of the top pharma and biotech companies globally. TLG proudly serves as co-founder and association management company of the Academy of Oncology Nurse & Patient Navigators (AONN+) and the Association for Value-Based Cancer Care (AVBCC).

Last modified: November 24, 2021
 1249 South River Road, Suite 202A, Cranbury, NJ 08512
© The Lynx Group, LLC. All Rights Reserved.