National Cancer Institute: Restructuring to Support the Clinical Trials of the Future

Good, Marjorie J.; Castro, Kathleen; Denicoff, Andrea; Finnigan, Shanda; Parreco, Linda K.; Germain, Diane St.

doi:10.1016/j.soncn.2020.151003

Cited by 5 publications

(3 citation statements)

References 48 publications

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“…Speci cally, for organizations that fall under the non-industry category, we identi ed patient organizations, academic organizations (universities, medical institutions, research networks, etc. ), and governmental agencies such as the National Cancer Institute and its designated cancer centers [39], which are leaders in cancer research in the United States [40][41][42], as separate categories. Below are the ve sponsorship categories for each study in the dataset: 1.…”

Section: Sponsorship Categories and Classi Cation Criteriamentioning

confidence: 99%

“…The analysis of collaboration between PO-GOV focused on the NCI-a liated organizations because most PO-GOV collaborative studies included the NCI and/or NCI-designated comprehensive cancer centers (hereafter NCI-CCC), which are 51 leading cancer research centers in the United States (as of December 2022) [40][41][42]. The top 20 NCI-CCCs that had sponsored/co-sponsored more than 100 clinical trials were selected for further analysis.…”

Section: Collaborative Trends Of Posmentioning

confidence: 99%

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Trends in collaboration with patient organizations on cancer-related clinical trials: Collaborative relationship with existing stakeholders and the characteristics of their co-sponsored studies in the United States

Lee

Sengoku

2022

Preprint

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Background In recent years, the importance of patient centricity in drug development has been recognized, affecting the stakeholders conducting clinical trials. In this context, end users, patients and patient organizations are becoming increasingly involved in the development process to address their unmet medical needs. However, there is a lack of research on environmental trends in which patient organizations collaborate with incumbent stakeholders in drug development. This study aimed to understand the current status of clinical trials regarding patient organization involvement as sponsors and collaboration with different types of sponsors in cancer-related clinical trials. This cross-sectional study also examined the characteristics of clinical trials involving patient organizations as new stakeholders by analyzing the environmental factors that promote collaboration with existing stakeholders. Methods A total of 14,830 interventional clinical trials registered on ClinicalTrials.gov between January 1, 2010, and December 31, 2020, were categorized and analyzed by target cancer types and five different sponsor types: 1. patient organization co-sponsored (PO-co), 2. academia (ACD), 3. governmental (GOV), and 4. industry co-sponsored (IND-co) and 5. industry only (IND). Results PO-Co studies accounted for 2% (289 of 14,830) of the total studies, ACD 5%, IND-Co 21%, GOV and IND 36%. When the 289 PO-Co studies were analyzed by cancer type and eligible study population, we found that the proportion of pediatric studies was significantly higher for PO-Co studies (30% (88 of 289)) than for total studies (9% (1,378 of 14,830); P < .001), and we also found that collaboration with PO was more common for certain cancer types compared with the total study. Regarding collaboration with POs, more than half of the PO-GOV collaborative studies were conducted at the Nation cancer center comprehensive cancer centers, and even particular investigators actively engaged in collaboration with POs. Conclusions A cross-sectional analysis of cancer-related clinical trials revealed that the involvement of patient organizations as sponsors in clinical trials did not increase significantly over time. However, some organizations have become actively engaged in certain cancers and pediatric populations that are less prioritized by incumbent sponsors. We also found that governmental sponsors and selected principal investigators played an important role in collaborating with patient organizations. These findings provide a basis for understanding the current status of patient organizations and for considering further contributions.

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Section: Sponsorship Categories and Classi Cation Criteriamentioning

confidence: 99%

Section: Collaborative Trends Of Posmentioning

confidence: 99%

Trends in collaboration with patient organizations on cancer-related clinical trials: Collaborative relationship with existing stakeholders and the characteristics of their co-sponsored studies in the United States

Lee

Sengoku

2022

Preprint

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“…The US Food and Drug Administration recommends that PROs be collected electronically using cloud-based data capture platforms ( 3 ). Based on this recommendation, the Medidata Patient Cloud ePRO app (hereafter referred to as “ePRO app”) has been adopted by the National Cancer Institute (NCI)-supported National Clinical Trials Network (NCTN) ( 4 ). The ePRO app can be used to collect survey data directly from patients.…”

mentioning

confidence: 99%

Patient-targeted education (ePRO-E) to increase ePRO intent within an Alliance clinical trial (A221805-SI1)

Smith,

Cho,

Hillman

et al. 2024

JNCI Cancer Spectrum

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Background The Patient Cloud ePRO app was adopted by the National Cancer Institute National Clinical Trials Network (NCTN) to facilitate capturing electronic patient-reported (ePRO) outcome data, but use has been low. The study objectives were to test whether a patient-targeted ePRO educational resource (ePRO-E) would increase ePRO intent (number of users) and improve data quality (high quality: ≥80% of the required surveys submitted) within an ongoing NCTN study. Methods The ePRO-E intervention, a patient-targeted educational resource (written material and 6-minute animated YouTube video), was designed to address ePRO barriers. ePRO intent and data quality were compared between two groups (N = 69): a historical control group and a prospectively recruited intervention group exposed to ePRO-E. Covariates included technology attitudes, age, sex, education, socioeconomic status, and comorbidity. Results Intervention group ePRO intent (78.8%) was significantly higher than historical control group intent (47.1%) (p = .03). Patients choosing ePRO vs paper surveys had more positive/higher technology attitudes scores (p = .03). The odds of choosing ePRO were 4.7 times higher (95% CI; 1.2–17.8) (p = .02) among intervention group patients and 5.2 times higher (95% CI; 1.3-21.6) (p = .02) among patients with high technology attitudes scores, after controlling for covariates. However, the 80% submission rate (percentage submitting ≥ 80% of required surveys) in the ePRO group (30.6%) was significantly lower than in the paper group (57.9%) (p = .05). Conclusions ePRO-E exposure increased ePRO intent. High technology attitudes scores were associated with ePRO selection. Since the ePRO survey submission rate was low, additional strategies are needed to promote high quality data submission.

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Parents’ Insights into Pediatric Oncology Phase I Clinical Trials: Experiences from Their Child's Participation

Crane

Croop

Lee

et al. 2021

Seminars in Oncology Nursing

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National Cancer Institute: Restructuring to Support the Clinical Trials of the Future

Cited by 5 publications

References 48 publications

Trends in collaboration with patient organizations on cancer-related clinical trials: Collaborative relationship with existing stakeholders and the characteristics of their co-sponsored studies in the United States

Trends in collaboration with patient organizations on cancer-related clinical trials: Collaborative relationship with existing stakeholders and the characteristics of their co-sponsored studies in the United States

Patient-targeted education (ePRO-E) to increase ePRO intent within an Alliance clinical trial (A221805-SI1)

Parents’ Insights into Pediatric Oncology Phase I Clinical Trials: Experiences from Their Child's Participation

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