Clinical Treatment Act Aims to Improve Survival, Close Racial Health Care Gap

Across the United States (US), the health insurance coverage gap continues to impact millions of patients who are largely low-income or are racial minorities. After years of lobbying, Congress has passed the Clinical Treatment Act (H.R. 913), which is legislation designed to improve access to health coverage.

Currently, Medicaid, insures 1 out of 5 of Americans but does not cover the costs associated with clinical trial treatment, making it the only major payer that doesn’t guarantee coverage, including Medicare. Regular doctor’s appointments, hospital stays, lab tests, drugs to manage adverse events (AEs), and imaging are not guaranteed to be covered. While several states have their own version of the Clinical Treatment Act, the program does not exist on the national level. Twelve states currently require the coverage, however, this leaves 42.2 million people in 38 states potentially without clinical trial coverage. For many patients, cost is one of the biggest barriers to clinical trial participation, particularly for low-income patients.

For patients with a household income of $50 thousand or more, clinical trial participation is 17%, while 13% of patients with a household income between $20 thousand and $49.9 thousand participate in clinical trials, and 11% of patients with an annual household income below $20 thousand participate.¹

The Clinical Treatment Act, which takes effect in January of 2022, is a step towards closing the coverage gap, helping to improve cancer care for low-income patients and minorities.

The bill was signed into law as part of a broader coronavirus disease 2019 (COVID-19) relief bill, which was signed into law on December 27, 2020, by former President Donald Trump. It was introduced to congress by Representative Ben Ray Lujan (Democrat-New Mexico). It was initially introduced in 2019.^2,3

Oncology Clinical Trials and Survival Benefit

Clinical trials are an integral part of the drug approval process. Clinical trials can provide life-saving medication to patients at little to no cost them.

“I know that most of the drugs that we have today are a result of clinical trials... and one of the key metrics that are used in clinical trials to tell you whether a drug is successful or not is overall survival. So, most of the drugs that we have today, we have them today, because they've really helped with the overall survival of that particular cancer. I can attest that trials work. They bring drugs that help people live longer,” said Olalekan Ajayi, PharmD, MBA, director of practice transformation at Sheridan Memorial Hospital and advisory committee member at the Association of Community Cancer centers in an interview with Targeted Oncology.

Numerous prospective studies have linked clinical trial participation to improvements in overall survival (OS). A December 2012 study published in the Journal of the American College of Surgeons found that in lung, colon, and breast cancer, clinical trial participation lowered overall and cancer-specific mortality.⁴

The study, which used records from the California Cancer Registry between 2002 and 2008, analyzed 555,469 patients with stage 1 to 5 solid organ tumors. Of those participants, 0.33% were enrolled in clinical trials. The study notes that while survival may be linked to other attributes clinical trial participants have, such as being younger. Trial designs must be broadened in order to better reflect real-world cancer burden.⁴ 

A study published in 2005 in Cancer found a more direct link between survival and clinical trial participation in adolescents with sarcoma. The study analyzed the data of 38,144 young adults diagnosed with sarcoma between 1975 and 1998. The study found that the lack of survival prolongation in patients 15 to 44 with non-Kaposi Sarcoma (KS) may be due to a lack of participation in clinical trials. Investigators hypothesize that boosting clinical trial participation may help to reverse survival shortfalls.⁵

Study authors write, “For patients with KS, the highest accrual rate occurred in patients ages 35–44 years. The age‐dependent survival improvement and clinical‐trial accrual patterns were correlated directly (soft‐tissue sarcomas, P < 0.005; bone sarcomas, P < 0.05; KS, P = 0.06), regardless of whether the accrual profile demonstrated a decline or a peak (KS) during early adulthood.”⁵

An additional study published in the British Journal of Urology International found that the all-cause risk of mortality was lower for men with metastatic castration-resistant prostate cancer receiving first-line docetaxel-containing chemotherapy who participated in clinical trials than those who did not.

The study found that the median OS for men who participated in the clinical trial was 21.3 months compared to the 17.3 months for those who did not. Additionally, the vast majority, 83%, of clinical trial participants were white compared to the 67% of those who did not participate. Age and the rate of positive lymph nodes were similar between the 2 groups. Bone metastases were found in 94% of patients in the clinical trial group versus 86% of those in the control group. In all, there were no significant differences between the two groups of patients. The study included data on 247 patients, 142 of which participated in 11 different studies and 105 who did not participate in any clinical trials.⁷

Lori J. Pierce, MD, FASTRO, FASCO, the president of The American Society of Clinical Oncology, states in an interview with Targeted Oncology that in clinical trials, patients are receiving the best care possible, and in some cases, the only care possible.

“This is the best possible care that patients can receive. In many clinical trials, you're comparing the best standard treatment to a new treatment that preliminary studies suggest, is as good if not better than the standard treatment,” said Pierce. “And so, it gives the patient the opportunity to receive the best possible care. And for some patients, depending upon their type of cancer, they may have already recurred, despite being treated. And so, a clinical trial might be the only therapy that's still available to them.”

Although improvements in survival up increased and mortality is decreased with clinical trial participation, many of the oncology clinical trials leave out 7.6% of the population. These patients below to minority communities that are underrepresented in the clinical trial setting.

Closing the Racial Health Care Gap

The Clinical Treatment Act is also aiming to boost minority participation in clinical trials. While non-Hispanic white people make up 60.7% of the United States population, 83% of participants in clinical trials are white. Black people make up 13.4% of the overall population, while only 6% of clinical trial participants are Black. A similar trend is seen in the Hispanic or Latino population, which makes up 18.1% of the populace. However, only 2.6% of participants in clinical trials are Hispanic or Latino.⁶

“We certainly think it levels the playing field. Everything we do is to try to level the playing field, right? We don't want to disadvantage one group, and this group was disadvantaged. So, we now have a level playing field. It puts the ball back in our court in terms of physicians to now be able…to bring patients on clinical trials,” said Pierce.

According to the National Cancer Institute, despite having similar rates of breast cancer, Black and African American women are more likely to die from the disease. Additionally, Black and African American men are twice as likely as white men to die of prostate cancer.

“It will have an impact, and I certainly hope that that impact is huge. Now, when you look at the number of people in the nation who are enrolled … 1 in 5 patients are Medicaid patients. So that's about 70 million Americans… Now out of these patients, when you look at the distribution of race, we find out that over 50% are not White. So, they're either combination of Black, Hispanic, or other races. By mere virtue of that, we're hoping that we're going to see a lot more impact in getting these patients enrolled in clinical trials,” said Ajayi.

According to Ajayi, the COVID-19 pandemic has further highlighted the racial health care disparity.

“One thing that COVID has really shown us is a lot of disparity in race, and when it comes to healthcare, and health outcomes. This is one of the things that I think is crucial in fighting this battle against racial disparities in enrolling patients for clinical trials,” said Ajayi. 

Better Clinical Trial Protocols

The FDA has placed more of a focus on advancing diversity in clinical trials in the past few years, offering official guidance on the topic in late 2020. The guidelines were spurred on by the COVID-19 pandemic.6

When a drug is being developed, it’s important that the population it is being studied in reflects the population that will use it, according to the FDA. In addition to racial and ethnic minorities, the FDA encourages more of an effort to include pregnant women, children, and older adults.6

“Laws like this promote clinical trial access and will, as a result, specialists will have access to more clinical trials. [Many] times cost is a barrier for these patients, so, by having routine care costs covered, you’re going to see more enrollment in clinical trials, said Ajayi. “Secondly, because we're seeing more enrollment in trials, we're going to see better trial approvals. In oncology occurring patients for clinical trials is always a challenge, so having laws like this will help with clinical trials means that we're going to have a lot of more successful trials.”

_REFERENCE:

_{1.Medicaid Enrollees Need Clinical Trial Access. ASCO. Accessed May 13, 2021. https://bit.ly/3ybRKCo.}

_{2..The Clinical Treatment Act. Association of American Cancer Institute. Accessed May 13, 2021. https://bit.ly/2QjcXZX.}

_{3..H.R. 913 (116): Clinical Treatment Act. Gov Tracker. Accessed May 13, 2021 https://bit.ly/3bqlj9F.}

_{4.Chow C, Habermann E, Abraham A, et al. Does Enrollment in Cancer Trials Improve Survival? J. Am. Coll. Surg, 216; 4: 2013, https://doi.org/10.1016/j.jamcollsurg.2012.12.036.}

_{5. Bleyer A, Montello M, Budd T, National survival trends of young adults with sarcoma. Cancer, 103: 1891-1897. https://doi.org/10.1002/cncr.20995}

_{6.FDA offers guidance to enhance diversity in clinical trials, encourage inclusivity in medical product development. FDA. November 11, 2020. Accessed May 13, 2021. https://bit.ly/3brEH5Q.}

_{7. Goyal J, Nuhn P, Huang P, et al. The effect of clinical trial participation versus non-participation on overall survival in men receiving first-line docetaxel-containing chemotherapy for metastatic castration-resistant prostate cancer. Br. J. Urol. 110;11b:2021.}

_{https://doi.org/10.1111/j.1464-410X.2012.11286.x.}