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

For patients with a household income of $ 50,000 or more, clinical trial participation is 17%, while 13% of patients with household incomes between $ 20,000 and $ 49,000 participate in clinical trials and 11% of patients with annual household incomes less than $ 20 A thousand participate. 1

The Clinical Treatment Act, which came into force in January 2022, is a step towards closing the care gap and contributing to improving cancer care for low-income patients and minorities.

The bill came into effect as part of a broader 2019 Coronavirus Disease Relief (COVID-19) bill that was enacted by former President Donald Trump on December 27, 2020. It was presented to Congress by MP Ben Ray Lujan (Democrat New Mexico). It was first introduced in 20192,3

Clinical studies in oncology and survival benefit

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

“I know that most of the drugs we have today are the result of clinical trials … and one of the key metrics used in clinical trials to tell whether a drug is successful or not is overall survival. Most of the drugs we have today are because they really contributed to the overall survival of this cancer. I can confirm that attempts work. They bring drugs that help people live longer, ”said Olalekan Ajayi, PharmD, MBA, director of practice transformation at Sheridan Memorial Hospital and member of the Advisory Committee of the Association of Community Cancer Centers in an interview with Targeted Oncology.

Numerous prospective studies have linked participation in clinical trials with an improvement in overall survival (OS). A study published in December 2012 in the Journal of the American College of Surgeons found that participation in clinical trials in lung, colon, and breast cancers decreased overall and cancer-specific mortality

The study, which used California cancer registry records between 2002 and 2008, analyzed 555,469 patients with stage 1 through 5 solid organ tumors. Of these participants, 0.33% took part in clinical trials. The study notes that while survival may be linked to other attributes of clinical trial participants, such as: B. To be younger. Study designs need to be expanded to better reflect the actual cancer burden

A study published in Cancer in 2005 found a more direct association between survival and clinical trial participation in adolescents with sarcoma. The study analyzed data from 38,144 young adults diagnosed with sarcoma between 1975 and 1998. The study found that the lack of survival extension in patients between 15 and 44 years of age with non-Kaposi sarcoma (KS) could be due to a lack of participation in clinical trials. The researchers believe that increased participation in clinical trials can help reverse survival deficits. 5

The study’s authors write, “In patients with KS, the highest rate of accumulation occurred in patients aged 35–44 years. The age-dependent survival improvement and the demarcation patterns of the clinical study were directly correlated (soft tissue sarcomas, P <0.005; bone sarcomas, P <0.05; KS, P = 0.06), regardless of whether the demarcation profile showed a decrease or a peak (KS) in early adulthood. ”5

An additional study published in the British Journal of Urology International found that the overall mortality risk for men with metastatic castration-resistant prostate cancer who received first-line chemotherapy containing docetaxel who participated in clinical trials was lower than for those who did didn’t do.

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

Lori J. Pierce, MD, FASTRO, FASCO, President of the American Society of Clinical Oncology, stated in an interview with Targeted Oncology that patients in clinical trials receive the best possible, and in some cases the only possible care.

“This is the best possible care patients can get. Many clinical trials compare the best standard of care with a new treatment that preliminary studies suggest is as good, if not better, than the standard of care, ”Pierce said. “It thus offers the patient the opportunity to receive the best possible care. Depending on the type of cancer, some patients may already have a relapse despite treatment. Therefore, a clinical trial is possibly the only therapy that is still available to them. “

Although participating in clinical trials increases the chances of survival and decreases mortality, many of the clinical oncology trials miss 7.6% of the population. These patients belong to minority communities that are underrepresented in the clinical trial setting.

Closing the racist health care gap

The Clinical Treatment Act also aims to strengthen the participation of minorities in clinical trials. While non-Hispanic white people make up 60.7% of the United States population, 83% of clinical trial participants are white. Black people make up 13.4% of the total population, while only 6% of clinical trial participants are blacks. A similar trend can be seen in the Hispanic or Latin American population, who make up 18.1% of the population. However, only 2.6% of clinical trial participants are Hispanic or Latino. 6

“We definitely think that the playing field will be leveled. All we do is try to level the playing field, right? We do not want to disadvantage any group and that group has been disadvantaged. So we now have a level playing field. It brings the ball back to our playing field in terms of doctors, now being able to get patients into clinical trials, ”said Pierce.

Despite similar breast cancer rates, black and African American women are more likely to die from the disease, according to the National Cancer Institute. In addition, black and African American men are twice as likely to die from prostate cancer as white men.

“It’s going to have an impact, and I definitely hope the impact is huge. Well if you look at the number of people in the country who are enrolled … 1 in 5 patients are Medicaid patients. So that’s about 70 million Americans … Now, if you look at the racial distribution of these patients, we see that over 50% of these patients are non-white. So they are either a combination of Black, Hispanic, or other races. By doing this alone, we hope that we will be much more effective by including these patients in clinical trials, ”Ajayi said.

Ajayi said the COVID-19 pandemic has further highlighted racial differences in health care.

“One thing that COVID has really shown us is huge differences in race and in terms of health care and health outcomes. This is one of the things that I think is critical to tackling this battle against racial disparity in admitting patients to clinical trials, ”Ajayi said.

Better protocols for clinical trials

The FDA has put a stronger focus on promoting diversity in clinical trials in recent years and issued official guidelines on the matter in late 2020. The guidelines were boosted by the COVID-19 pandemic. 6

According to the FDA, when a drug is being developed, it is important that the population it is being studied in reflects the population who will be using it. In addition to racial and ethnic minorities, the FDA encourages greater efforts to include pregnant women, children, and older adults

“Laws like this encourage access to clinical trials, so specialists will have access to more clinical trials. [Many] Cost is an obstacle for these patients. So if routine care costs are covered, you’ll see more clinical trial participants, Ajayi said. “Second, we will see better study admissions because we will see more study enrollments. In oncology, patient emergence for clinical trials is always a challenge, so laws like this will help with clinical trials, which means we will have many more successful trials. “

REFERENCE:

1.Medicaid participants must have access to clinical trials. ASCO. Accessed May 13, 2021. https://bit.ly/3ybRKCo.

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

3..HR 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 Participating in Cancer Studies Improve Survival? J. Am Surg Coll. 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 provides guidance on improving diversity in clinical trials and promoting inclusivity in medical product development. FDA. November 11, 2020. Accessed May 13, 2021. https://bit.ly/3brEH5Q.

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

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

source https://dailyhealthynews.ca/clinical-treatment-act-aims-to-improve-survival-close-racial-health-care-gap/