Enrollment barriers of adolescents and young adults (AYA) on the non-chemotherapy arm of ARST1321.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19214-e19214
Author(s):  
Lisa M. Kopp ◽  
Damon R. Reed ◽  
Safia K. Ahmed ◽  
Wendy Allen-Rhoades ◽  
Viswatej Avutu ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adolescent And Young Adult ◽  
Preoperative Radiation ◽  
Cooperative Groups ◽  
Online Questionnaire ◽  
Enrollment Patterns ◽  
Medical Oncologists ◽  
Adults And Children ◽  
Barriers To Enrollment ◽  
A Site

e19214 Background: ARST1321(PAZNTIS): A Phase II/III Randomized Trial of Preoperative Chemoradiation or Preoperative Radiation Plus or Minus Pazopanib (NCT02180867) was the first National Clinical Trials Network (NCTN) study co-developed by pediatric (COG) and adult (NRG Oncology) consortia anticipating enrollment of adolescent and young adult (AYA) cancer patients. ARST1321 had two treatment cohorts, enrolling patients ≥ 2 years of age to either chemotherapy (C) (chemoradiation ± pazopanib) or non-chemotherapy (NC) (radiation ± pazopanib) arms. It was anticipated adults would contribute the majority of enrollments on the NC arm based on prior enrollment patterns. While the C arm accrued as anticipated (with high enrollment of adults and children), the NC arm had low enrollment leading to premature closure. We report on AYA accrual (defined as 15-39 years) to the NC arm and a survey aiming to identify barriers to enrolling AYA patients onto ARST1321. Methods: Our survey was emailed to 161 adult, surgical, and radiation oncologists at large sarcoma centers. A link was sent to an online questionnaire via SurveyMonkey Inc. and responses were reviewed on their platform. Results: 33 patients enrolled on the ARST1321 NC arm, of which 24% were AYA. 25% of AYA enrollments were from non-COG adult cooperative groups. This trial arm was closed in October 2017 after 3.25 years of accrual below anticipated rates. The survey response rate was 31% with a 70% completion rate. Almost half of respondents were medical oncologists with most seeing 50-200 new sarcoma cases/year at an academic institution and 30% in a pediatric environment (divided equally between radiation and surgical oncologists). 70% of respondents have a joint collaboration with their pediatric oncology team with 23% having a joint clinic. 70% of respondents’ sites opened ARST1321 and anticipated 1-5 patients would be eligible for the NC cohort. However, 42% of respondents’ sites had zero patients enrolled on that arm. The most common reasons for not opening the study and/or not enrolling patients on the NC arm included: lack of interest, disagreement with the therapy, lack of a site investigator, premature study closure, patient/family decision, competing trials, insufficient reimbursement, and regulatory delays. Conclusions: Our survey highlights multiple barriers to enrollment of AYA onto cross-NCTN consortia clinical trials spanning the age spectrum. The information obtained will help inform investigators aiming to effectively design, enroll, and conduct similar trial efforts for AYA in the future.

The Children’s Oncology Group (COG) Adolescent and Young Adult (AYA) Responsible Investigator (RI) Network: An initiative for advancing AYA cancer research in the National Clinical Trials Network (NCTN).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18016-e18016
Author(s):  
Nupur Mittal ◽  
Aniket Saha ◽  
David Robert Freyer ◽  
Michael Roth
Keyword(s):  
Clinical Trials ◽  
Medical Oncology ◽  
Adolescent And Young Adult ◽  
Institutional Leadership ◽  
Successful Model ◽  
Research Activities ◽  
Level Data ◽  
Barriers To Enrollment ◽  
Novel Model ◽  
Group Trial

e18016 Background: The COG has previously developed a successful model in which institutional RIs are identified to champion site-level research activities and trial enrollment. In response to low participation of AYAs in COG clinical trials, the COG AYA RI Network was developed. Methods: In January 2018, the COG AYA Committee solicited nominations of AYA RIs by site Principal Investigators. The AYA RI role is focused on the following site-level activities: 1. Working with the local IRB to prioritize AYA relevant studies; 2. Developing systems for screening AYAs for enrollment; 3. Serving as a liaison with medical oncology; 4. Educating staff on disparities in AYA outcomes. Increased site-level interaction with adult NCTN groups is a goal of this initiative. Results: The network was launched in February 2018. Subsequently, 144 RIs (physicians, research staff, psychologists, administrators) from 118 demographically and geographically diverse sites have joined the initiative. To date, there have been 9 interactive webinars, with 18 presenters from diverse institutions, each attended by 60-90 RIs. Two symposia on addressing barriers to enrollment were held at COG meetings. Shared site-level barriers and facilitators to enrollment have been identified. The most common recommendations for improving AYA accrual are: 1. Increase the number and diversity of AYA trials; 2. Increase collaboration between pediatric and medical oncology; 3. Increase support and resources from institutional leadership; and 4. Overcome logistical constraints to accruing AYAs to COG trials. Recently, the COG AYA RI Network joined with the SWOG AYA Committee to identify site-level dyads involving an AYA RI representing each group. Conclusions: To our knowledge, the COG AYA RI network is a novel model for enhancing AYA-focused cooperative group research at the site level, including enrollment on clinical trials. Next steps include conducting a formal survey to gather site-level data and establishing metrics to assess impact of this initiative, as well as continuing to work closely with SWOG to improve cross-group trial enrollment of AYAs.

A closer look at some National Clinical Trials Network sites and their recruitment ability.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18055-e18055
Author(s):  
Frank Makosiej ◽  
Montessa Lizaso
Keyword(s):  
Clinical Trials ◽  
The United States ◽  
Recruitment Rate ◽  
Tumor Type ◽  
Cooperative Groups ◽  
Enrollment Rate ◽  
Alliance Network ◽  
Large Numbers ◽  
Cancer Trials ◽  
A Site

e18055 Background: Targeted therapies have prompted clinical trials centers to screen large numbers of patients of a particular tumor type and to test further to identify those with molecular targets that meet the criteria of the study protocol. In March of 2014, the NCI converted Cooperative Groups into National Cancer Trials Network (NCTN) to better address the scientific needs and challenges these more innovative treatments introduce. The Alliance for Clinical Trials in Oncology is one of the five US Oncology Network groups, and Lead Academic Participating Sites (LAPS) are academic institutions recognized to be able to enroll high numbers of patients onto NCTN trials. Some LAPS sites were recognized to overlap into the Alliance Network as well. An analysis of their recruitment rates and comparison to non-LAPS or non-Alliance sites were reviewed. Methods: Between the years of 2011 to 2016, Covance Xcellerate captured over 2,688 unique Investigators participating in cancer trials in the United States. Seven hundred, seventy-four, cancer trials were involved. Nine hundred, forty-eight unique sites were identified. Results: On a site view, those institutions that were part of the Alliance Network enrolled patients at a median rate of 0.24 pts/site/mo, while LAPS sites recruited at a faster median enrollment rate of 0.33 pts/site/mo. Sites that overlapped within both networks enrolled at a rate of 0.30 pts/site/mo, and sites that were not members of either the Alliance or LAPS network enrolled at a rate of 0.23 pts/site/mo. When analysis of recruitment rate was narrowed further to look at individual investigators that were members of these networks or not, investigators representing from both Alliance and LAPS, their median enrollment rate was slightly higher at 0.33 pts/site/mo when compared to those investigators that were only members of LAPS network. Also, those sites that part of Alliance and LAPS recruited the most patients into studies. Conclusions: Sites that are members of networks such as the Alliance or LAPS, can recruit more patients into a clinical trial at a faster rate than sites that were not participants of the Alliance or LAPS.

scholarly journals Barriers to Enrollment of Elderly Adults in Early-Phase Cancer Clinical Trials

2008 ◽  
Vol 4 (4) ◽  
pp. 162-168 ◽  
Author(s):  
Michele Basche ◽  
Anna E. Barón ◽  
S. Gail Eckhardt ◽  
Lodovico Balducci ◽  
Martha Persky ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Early Phase ◽  
Age Groups ◽  
Experimental Treatment ◽  
Cancer Center ◽  
Cancer Clinical Trials ◽  
Sources Of Information ◽  
Barriers To Participation ◽  
University Center ◽  
Barriers To Enrollment

Purpose: To describe patient/family and logistical barriers to participation in university-based, early-phase cancer clinical trials for adults age ≥ 65 years, and to identify influences on their decisions to participate. Participants and Methods: In-person surveys were administered to subjects age ≥ 65 years with advanced tumors who had received prior chemotherapy. Subjects were recruited from private medical oncology practices collaborating with the University of Colorado and Moffitt Cancer Center research networks. Results: Three hundred individuals (51% age 65 to 74 and 49% age 75 or older) responded. Overall, 60% reported one or more barriers to participation in an early-phase trial; logistical barriers such as driving or time demands (34%) or reluctance to be treated at a university center (21%) were most common. Seniors age 75 or older were more reluctant to be treated at a university center (27% v 14%; P = .005), or concerned about loss of continuity with their primary oncologist (24% v 15%, P = .05). Older seniors were also significantly more reluctant than younger seniors to consider treatments with substantial nausea, vomiting, or fatigue. Older and younger seniors differed little in their preferred sources of information; both age groups emphasized the importance of the primary oncologist (100%), a nurse who provides experimental treatment (93%), other patients (83%) or acquaintances who had received experimental treatment (83%). Conclusion: Potential strategies to overcome barriers to enrollment of seniors into early-phase trials include providing more information about trials to community oncologists and prospective enrollees and assisting these individuals in navigating logistical barriers to enrollment.

Abstract 3769: Barriers to Obtaining Informed Consent in Acute Stroke Clinical Trials

Stroke ◽  
2012 ◽  
Vol 43 (suppl_1) ◽  
Author(s):  
Sacha R Masuca ◽  
Devsmita S Das ◽  
Deji Delano ◽  
Malcom Irani ◽  
Renga Pandurengan ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Acute Stroke ◽  
Single Center ◽  
Severe Stroke ◽  
Single Center Study ◽  
Investigational Therapies ◽  
Clinical Trial Enrollment ◽  
Barriers To Enrollment ◽  
Clinical Research Trials

Background Identification of barriers to enrollment in acute stroke clinical trials may identify ways to improve enrollment and expedite completion of clinical research trials. In this exploratory analysis we sought to evaluate the differences in presenting characteristics between patients who are able to provide informed consent (IC) compared with those who were enrolled by the legal authorized representative (LAR). Methods From our single center, prospectively collected registry, we identified consecutive patients with acute ischemic stroke (AIS) who presented to our emergency department and were enrolled into acute (<8hrs from symptom onset) prospective clinical treatment trials. Data collected included arrival time, thrombolysis time, IC time, source of IC (LAR or patient), aphasia or neglect and method of arrival. For analysis, the patients who were consented by a LAR were compared with patients who provided their own IC. Results From 2003 - 2011, we identified 124 patients who met inclusion criteria. There were no differences in age, sex, presentation or door to needle times (Table 1). Patients who were able to provide IC presented with less severe stroke (p<0.0001). Aphasia and neglect were significantly more common when a LAR provided IC (p<0.0001). LAR consent required a significantly longer amount of time (90 vs. 71 min., p=0.04). Conclusions In our single center study, we found that patients with milder stroke are able to provide IC and the presence of aphasia or neglect can hinder enrollment in the absence of a LAR. In addition, when patients are able to provide IC, they do so almost on average 20 minutes faster than the LAR. Additional evaluation is necessary to determine the reasons for delay. Since good outcomes with investigational therapies for AIS treatment are likely to be time dependent, further efforts should target improvement of the IC process to minimize delay in clinical trial enrollment.

Evaluation of Activation of a NCI National Clinical Trials Network (NCTN) Study S1826 for Hodgkin Lymphoma (HL) at Children's Oncology Group (COG) Institutions

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 20-20
Author(s):  
Sharon M. Castellino ◽  
Angela Punnett ◽  
Susan K Parsons ◽  
Nicholas P. DeGroote ◽  
Sally Muehle ◽  
...  
Keyword(s):  
Pediatric Oncology ◽  
Research Funding ◽  
Design Research ◽  
Medical Oncology ◽  
Adolescent And Young Adult ◽  
Novel Agents ◽  
Successful Implementation ◽  
Institutional Infrastructure ◽  
Medical Oncologists ◽  
Tumor Boards

Background: HL is an adolescent and young adult (AYA) cancer that lacks uniform approaches across medical and pediatric oncology. Differences include risk classification, chemotherapy backbone and use of radiation therapy. Heterogeneity in institutional programs and resources for AYAs adds to the gap in understanding why outcomes for AYA HL differ. In order to expedite equitable access to novel agents for AYA patients by medical and pediatric oncology providers, a NCTN facilitated trial for advanced stage HL was launched. The SWOG-led S1826 trial (NCT03907488), open to patients &gt; 12 years of age, was activated in July 2019. We assessed barriers and facilitators to trial activation at COG institutions for this first in-kind approach. Methods: A web-based survey was distributed through the COG communications office to institutional principal investigators (PIs) of 216 institutions in North America. To achieve optimal response rates, the survey was distributed in four waves over a 6-week period. Branching logic differentiated questions for institutions that had opened or planned to open the trial vs. those who did not. Topics included institutional characteristics, joint partnership with medical oncologists to activate AYA trials, and specific barriers for opening this trial. Descriptive statistics were calculated using SAS v.7.1. Results: The response rate was 73% with 158 unique responses among 216 COG institutions queried. Among responding institutions 24% were freestanding children's hospitals; 18% were NCI-designated cancer centers. 55% of respondents indicated a known affiliation with another NCTN cooperative group other than COG. 31% indicated prior experience in participating in a non-COG led NCTN trial for other diseases. 42% of institutions reported a central trials infrastructure for joint pediatric and medical oncology trials. 44% indicated use of the central IRB mechanism, and 4% used a provincial IRB. While 40% had an established AYA oncology program, 30% reported regular lymphoma tumor boards with medical oncology; 8% indicated the ability to see AYA lymphoma patients in a joint pediatric and medical oncology clinic. The trial is open at 79/158 (50%) COG institutions to date and an additional 56 indicated future intent to open the trial. Among 135 COG institutions with open or intent-to-open status, 73% of institutional principal investigator (PI) were pediatric oncologists, 24% were medical oncologists and 4% were joint PIs. PI determination was based on: enrolling as a COG-only site (57%); institutional policy (5%); a discussion among investigators (23%); or other factors (14%). These were categorized as: more resources or anticipated patients in medical oncology (n=4); the trial being opened in medical oncology before pediatrics (n=11); being open in pediatrics before medical oncology (n=2); no interface for joint studies (n=1). Among the 14% of respondents who indicated the trial would not be opened, a competing trial was the reason in 35%. Other reasons included: lack of awareness of the trial, concerns about study design or chemotherapy backbone, lack of easily accessible protocol documents, anticipated lack of accrual, concerns around funding support, challenges with regulatory support, data management, or institutional process for medical and pediatric joint trials. Respondents' recommendations for facilitating activation of AYA intergroup studies include needs for: increased resources and funding; guidance on communication and navigation with medical oncologists for managing joint trials; institutional infrastructure for AYA trials; clearer rationale for a change in the chemotherapy backbone relative to prior COG studies; accessibility and consistency of protocol study naming conventions and protocol documents (i.e. therapy roadmap) on the COG electronic site. Conclusions: Successful implementation of AYA trials is germane to early access to novel agents for younger adolescents. Overall, COG institutions indicate a high level of endorsement for a NCTN AYA trial for HL with 85% indicating activation completed or planned. This survey suggests that AYA trials can be implemented successfully in a network but require education, early communication between pediatric and medical oncologists, and flexible infrastructure for all group participants. (Funding: U10CA180886, U10CA180888, and UG1CA233230) Disclosures Parsons: Seattle Genetics: Consultancy. Herrera:Bristol Myers Squibb: Consultancy, Other: Travel, Accomodations, Expenses, Research Funding; Merck: Consultancy, Research Funding; Genentech, Inc./F. Hoffmann-La Roche Ltd: Consultancy, Research Funding; Gilead Sciences: Consultancy, Research Funding; Seattle Genetics: Consultancy, Research Funding; Immune Design: Research Funding; AstraZeneca: Research Funding; Karyopharm: Consultancy; Pharmacyclics: Research Funding. Friedberg:Acerta Pharma - A member of the AstraZeneca Group, Bayer HealthCare Pharmaceuticals.: Other; Astellas: Consultancy; Kite Pharmaceuticals: Research Funding; Bayer: Consultancy; Seattle Genetics: Research Funding; Roche: Other: Travel expenses; Portola Pharmaceuticals: Consultancy.

scholarly journals Effect of Medical Oncologists' Attitudes on Accrual to Clinical Trials in a Community Setting

2013 ◽  
Vol 9 (6) ◽  
pp. e275-e283 ◽  
Author(s):  
Carol P. Somkin ◽  
Lynn Ackerson ◽  
Gail Husson ◽  
Vicky Gomez ◽  
Tatjana Kolevska ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Delivery System ◽  
Community Setting ◽  
Health Delivery ◽  
Medical Oncologists ◽  
Integrated Health ◽  
Health Delivery System

In a large integrated health delivery system with an active clinical trials program, oncologists' participation in clinical trials was quite variable. Oncologist values, beliefs, and awareness of clinical trials play an important role in accrual.

scholarly journals 4500 Providing a System for Practical Monitoring Training for Clinical Trials within Academic Institutions

2020 ◽  
Vol 4 (s1) ◽  
pp. 114-115
Author(s):  
Advaita Chandramohan ◽  
Sukhmani Kaur ◽  
Eunjoo Pacifici
Keyword(s):  
Clinical Trials ◽  
Academic Institutions ◽  
Educational Module ◽  
Consent Forms ◽  
Study Protocols ◽  
Clinical Research Coordinators ◽  
Monitoring Visit ◽  
Source Data Verification ◽  
A Site ◽  
Monitoring Report

OBJECTIVES/GOALS: The goal was to understand the effectiveness of a novel clinical trial educational module and a corresponding initiative designed and disseminated by the Southern California Clinical and Translational Science Institute (SC-CTSI) to increase the quality of clinical trials conducted in academia. METHODS/STUDY POPULATION: The CRCs (Clinical Research Coordinators) for the initiative are asked to complete the online training. Possible study protocols are picked to be monitored by the CRCs. The monitor is instructed to study the protocol extensively and prepare for their monitoring visit. The trained monitor from the initiative then reaches out to the CRC of the study that is to be monitored and carries out the monitoring visit. Afterwards, the monitor sends initiative personnel the monitoring report, which is evaluated to see if the monitor checked everything they should have during the visit. The PI of the study is contacted with highlights from the monitoring report and improvements that they can make. RESULTS/ANTICIPATED RESULTS: The first study monitored was a site of a large NIH-sponsored study where the consent forms were signed electronically. It was found that the monitor could not access the consent forms. Therefore, the monitor could not do source data verification. The PI of the study said that they would be raising this issue with the NIH. During the monitoring visit of the second study chosen for the initiative, patient binders were specifically examined for informed consent and source documentation completeness. The charts of patients were also reviewed. The only deviation found was a missing signature in the Investigator Site File. For the last two studies, data will be reported. DISCUSSION/SIGNIFICANCE OF IMPACT: Monitors were not only able to monitor efficiently, but also able to point out deficiencies in the monitoring practices of large studies. This model could be expanded to other academic institutions to establish quality management systems to ensure data integrity and subject protection.

scholarly journals Improving recruitment and retention of adolescents and young adults with cancer in randomized controlled clinical trials

2019 ◽  
Vol 0 (0) ◽  
Author(s):  
Sharron L. Docherty ◽  
Stacey Crane ◽  
Joan E. Haase ◽  
Sheri L. Robb
Keyword(s):  
Clinical Trials ◽  
Young Adults ◽  
Randomized Clinical Trials ◽  
Adolescents And Young Adults ◽  
Adolescent And Young Adult ◽  
Recruitment And Retention ◽  
Randomized Controlled Clinical Trials ◽  
Pros And Cons ◽  
Adult Resilience ◽  
Psychosocial Programs

Abstract Participation of adolescents and young adults (AYAs) with cancer in randomized clinical trials (RCTs) is necessary to advance treatments and psychosocial programs. Exploring AYAs experiences in an RCT will inform strategies to support recruitment and retention. A qualitative design was used to study the experiences of 13 AYAs in the Stories and Music for Adolescent and Young Adult Resilience during Transplant I (SMART I) trial. Key themes included: Weighing the Pros and Cons; Randomization Preferences; Completing Measures; and Worthwhile Experience. The experiences of AYAs during RCTs can bring insights that inform the design and management of AYA trials. Strategies include improving assent/consent processes, design of electronic interfaces and encouraging researcher flexibility.

scholarly journals How Outcomes Are Defined in Clinical Trials of Mechanically Ventilated Adults and Children

2014 ◽  
Vol 189 (8) ◽  
pp. 886-893 ◽  
Author(s):  
Bronagh Blackwood ◽  
Mike Clarke ◽  
Danny F. McAuley ◽  
Peter J. McGuigan ◽  
John C. Marshall ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Mechanically Ventilated ◽  
Adults And Children
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