Therapeutic Clinical Trial Enrollment Research Articles

Therapeutic clinical trial enrollment among young adults diagnosed with cancer.

6096 Background: Young adults (YA) with cancer have poor enrollment in therapeutic clinical trials. This study compares trial participation among young and older adults (OA) at a tertiary cancer care center, with a view to identifying and removing barriers. Methods: Trial enrollment data was compared between YA (age ≤39 years) and OA (age >39 years) followed at Princess Margaret Hospital (PMH), Toronto, from 2006-2008. Trials open to active accrual were: 1) therapeutic: systemic therapy, radiation, or surgery; 2) Phase I, II or III; 3) investigator initiated, industry or cooperative group. Number of trials activated and accrual data were collected through the Clinical Trial Support Unit at PMH. Number of patients with cancer were identified through the PMH Cancer Registry. Proportions of patients enrolled in clinical trials were compared between groups using a chi-square test. Results: A total of 25,958 patients (YA: 2,699; OA: 23,259) and 318 clinical trials were identified. The table reports the number of patients, trial availability and enrollment rate for the top 5 most common diagnoses for YA and OA. YA had significantly lower enrollment rates as compared to older adults (7.0% vs. 11.9%; p<0.001) including early phase trials (4.6% vs. 7.5%; p<0.001) and phase III trials (2.4 vs. 4.4%; p<0.001). Conclusions: Trial enrollment rates were significantly lower among YA patients compared to OA across the spectrum of tumor types. Further study is underway to understand differences in trial participation between YA with different primary tumours and identify barriers to enrollment among YA. Trial availability (phase I, II, III) and enrollment among the top five most common YA and OA cancers at PMH (2006-2008). Cancer site No. of patients Percent of cancer diagnoses No. of clinical trials Ratio of clinical trials: Patients No. of patients enrolled Percent enrollment Young adults Breast 338 13% 22 1:15 18 5% CNS 298 11% 11 1:27 20 7% Testicular 250 9% 0 0:250 0 0% Sarcoma 241 9% 3 1:80 1 <1% Hodgkin lymphoma 213 8% 3 1:71 15 7% Total 1,340 50% 39 1:34 54 4%† Older Adults Prostate 3,855 17% 30 1:129 494 13% Breast 3,811 16% 22 1:173 237 6% Lung 2,534 11% 37 1:68 345 14% Colorectal 1,987 9% 20 1:99 183 9% Head and neck 1,893 8% 16 1:118 85 4% Total 14,080 61% 125 1:112 1,344 10%† † p <0.001

An educational video to increase clinical trials enrollment among breast cancer patients

Only 3% of women with breast cancer participate in cancer clinical trials nationwide. The lack of awareness about clinical trials is a significant barrier towards clinical trials participation. A study was conducted at a large urban Comprehensive Cancer Center to test (1) the effectiveness of an 18-min educational video on improving attitudes toward clinical trials and trials enrollment among new breast cancer patients seen at the Karmanos Cancer Institute, and (2) to assess racial differences in attitudes regarding clinical trials. Participants were randomized to either the educational intervention prior to their first oncology clinic appointment or to standard care. A baseline and 2-week post-intervention survey to assess attitudes toward clinical trials participation was completed by participants. Of 218 subjects recruited, 196 (55% white vs. 45% African American (AA)) eligible patients were included in the analysis. A small increase in therapeutic clinical trial enrollment was observed in the intervention arm but was not statistically significant (10.4% vs. 6.1%; P = 0.277). The intervention also did not result in a clear improvement in patients' attitudes toward clinical trials at posttest. However, a lower enrollment rate for the AA women was noted after adjusting for stage (OR = 0.282, P = 0.049). Significantly more negative scores were noted in 3 out of the 5 baseline attitudinal scales for AA women. The educational video did not significantly increase enrollment in breast cancer clinical trials. The findings that AA women had significantly more negative attitudes toward clinical trials than white women may partially explain the racial disparity in enrollment. An educational video remains a simple and cost-effective way to educate patients. Future studies should focus on designing a new educational video to specifically target cultural and attitudinal barriers in the AA population to more effectively change attitudes and increase trial enrollment.

Idiopathic pulmonary fibrosis.

Idiopathic pulmonary fibrosis is a rapidly progressive illness of unknown cause characterized by sequential acute lung injury with subsequent scarring and end-stage lung disease. Treatment at present remains largely supportive, with evidence that patients' satisfaction and survival may be improved by referral to centers specializing in the evaluation of interstitial lung diseases. Although no drug therapy has clearly been demonstrated to benefit patients with idiopathic pulmonary fibrosis, a number of novel investigational agents hold promise for future study. Given the poor prognosis associated with idiopathic pulmonary fibrosis, patients should be referred to regional centers of expertise for enrollment in therapeutic clinical trials or for lung transplantation.