Upskilling Community Cancer Centers: A Training Pilot Hints at Promising Ways to Boost Oncology Clinical Research

Abstract

Purpose

This pilot project was designed to determine whether a targeted educational initiative could build clinical research capacity at community cancer centers, enhance research-readiness, and foster greater racial and ethnic inclusion in oncology clinical trials. (36 words)

Methods

In Phase 1 of this project, a cancer center survey (n=334) set out to identify barriers to study implementation. Focus groups (n=23) were convened to consider educational needs of site staff.

Phase 2 involved engaging with self-identified research-naïve and/or low trial capacity programs with diverse catchment areas. Training was delivered via a hybrid model of self-study and virtual live instruction. Nineteen participants from 10 sites participated in Part 1 (Self-study of Key Resources and Guidance) and 16 participants from 9 sites participated in the instructor-led training (Parts 2 and 3). (90 words)

Results

In Phase 1, 83% of cancer center survey respondents said their program conducted clinical research. Challenges identified included patient recruitment (40%), limited staffing (36%) and lack of training in research administration and conduct (25%). Respondents desired information on clinical research opportunities (65%), connection to study sponsors (49%) and clinical research coordinator training (41%). Focus groups expressed interest in foundational training in research and clinical trials; education on standing up trials tailored to program size; and recruiting diverse patients.

In Phase 2, a participant survey found that learners believed the program to have improved their knowledge and confidence. (97 words)

Conclusion

This initiative indicates that training could enhance research-readiness, providing a blueprint for training research-naïve oncology staff in the community setting. If multiplied at scale, this approach could increase patient access to clinical trials and accelerate study completion. (37 words)

Introduction: Need for access to oncology trials at the community level

Cancer is the second-leading cause of death in the United States overall and the leading cause among people younger than 85 years.¹ Oncology clinical trials account for some 41% of all clinical trials, with 2,162 trial starts in 2024, a slight increase on 2023 and a rise of 58% over the last decade; most oncology trials focus on rare cancers, which accounted for 74% of 2024 oncology trial starts.² Yet, only 2-8% of adults with cancer participate in clinical trials, despite most study participants having favorable experiences.^3,4 Oncology studies historically have included low participation and a lack of ethnic and racial diversity.⁵ Analyses of cancer studies indicate that only 4%-6% of trial participants are Black and 3%-6% are Hispanic, despite representing 15% and 13% of cancer patients, respectively.⁶

While ongoing changes at the US Food and Drug Administration (FDA) may call into question future initiatives, in June 2024, FDA published draft guidance recommending that sponsors submit Diversity Action Plans for each trial intended to support FDA approval.^7,8 The FDA Oncology Center of Excellence (OCE) led the development of this guidance.⁹

Many diverse patients receive care at community cancer centers, which offer an alternative location to the hospital setting.^10,11 Some 85% of patients with cancer are diagnosed and treated in community settings.¹² One study found that cancer trial enrollment among oncology patients totaled 21.6% at National Cancer Institute-designated comprehensive cancer centers, 5.4% at academic (non–NCI-designated) comprehensive cancer programs, 5.7% at integrated network cancer programs, and 4.1% at community programs.¹³ Numbers of community oncology research sites—which can support participant enrollment in clinical trials—remain unchanged despite increasing clinical trial activity.¹⁴ There is an urgent need for greater community engagement to improve diversity of enrollment and access to treatment, enabling patients to benefit from clinical research as a care option (CRAACO).

There are various approaches to improving oncology study enrollment. One model is the integrated research organization (IRO), where a single entity manages all aspects of a clinical trial across a national network of community practices. An example is SiteBridge, which prepares physicians to conduct clinical research by providing a package that includes staff, training, and technology.¹⁵ In addition, Javarra has a centralized clinical trials management system designed to introduce efficiencies with a model that flexes to meet partner needs by working with existing systems and EHRs.¹⁶

Another potential solution is to train healthcare staff at community clinics to implement oncology clinical trials, potentially adding research-ready sites in regionally, racially, and ethnically diverse areas.

Upskilling community cancer centers for ‘research-readiness’

Community cancer clinical trials are studies that take place in community settings, helping to improve access to cancer care for diverse populations. Broader community engagement can decrease disparities in cancer treatment for underserved groups and potentially improve care and health outcomes for all cancer patients.¹⁷ Community outreach is an increasing priority.^18,19,20 Partnerships with community bodies can help mitigate historical inequities and build trust.²¹ Remaining challenges include historical mistrust, institutional barriers and resource constraints; these can be addressed through institutional commitment, dedicated funding and flexible engagement.²²

A pilot project puts a potential solution into action

As a response to the lack of clinical research sites for the growing number of oncology clinical trials, the Association of Cancer Care Centers (ACCC) and the Association of Clinical Research Professionals (ACRP) collaborated to expand access to clinical trials as follows:

• Phase 1: ACCC worked to understand how cancer programs engage in clinical research. A survey was carried out to identify barriers to study implementation, with focus groups convened to consider educational needs of site staff.
• Phase 2: This set out to build research capacity by engaging with research naïve and/or low trial capacity programs with diverse catchment areas. Oncology clinical research training was provided in partnership with ACRP. A survey was carried out to evaluate participants’ perspectives of the training.

The pilot project was supported by a grant from Genentech, a member of the Roche group.

The Association of Cancer Care Centers (ACCC) provides education and advocacy for the cancer care community, comprising a network of more than 45,000 multidisciplinary professionals from over 1,700 provider organizations nationwide.²³

Methods

Phase 1: Aimed at understanding barriers and solutions

As Phase 1 of these efforts to expand access to clinical trials, ACCC and Genentech collaborated in 2022 to conduct a research study focused on:

• Understanding how cancer programs engage in cancer clinical research
• Gathering insights into common barriers and solutions related to clinical trial implementation and patient recruitment
• Understanding the needs of programs that do not currently offer clinical trials
• Identifying tools and resources to support cancer programs.

A cancer center survey (n=334) was carried out to identify barriers to study implementation, with focus groups (n=23) convened to consider educational and mentorship needs of site staff. During Phase 1, ACRP collaborated with ACCC to build the project structure, and also developed an ACRP Oncology Educational Module, which was produced by convening a group of ACRP volunteer oncology subject matter experts. The oncology training module was developed to supplement ACRP’s core educational program for Clinical Research Coordinators (CRCs), specifically the Association’s CRC Competency Foundations training.

Phase 2: Engaging with research-naïve community clinics or low-capacity trial sites

Phase 2 involved engaging with self-identified research naïve and/or low trial capacity programs with diverse catchment areas. The goal was to start building research capacity at those cancer centers by:

• Sharing of clinical trial resources from ACCC’s Community Oncology Research Institute (ACORI)
• Providing a targeted, oncology-specific clinical trials training program in partnership with ACRP. This included:
  • Free access to theACRP Clinical Research Foundations course with an Introduction to Oncology Clinical Trial Nuances
  • Participation in a collaborative online learning environment for peer-to-peer engagement and capacity building
  • Access to ACCC clinical trial tools, including a site self-assessment, implicit bias training, and clinical trials glossary
  • Peer-to-peer networking opportunities within the live education sessions
• An opportunity for guided mentorship through site feasibility assessment with Genentech

Criteria for sites to be included in Phase 2 were: self-identified as research naïve or low trial capacity; geographically, ethnically, or financially diverse catchment areas; organizational support for growing trial capacity; and availability to participate in an eight-week training course.

The program training consisted of two core components that were delivered via a hybrid model of self-study and virtually led live instructor training (Sidebar 1). The self-study portions of the program were primarily focused on materials that prepared participants for the instructor-led sessions. A total of 19 participants from 10 sites participated in Part 1 (Self-study of Key Resources and Guidance), and 16 participants from 9 sites participated in the live instructor-led training (Parts 2 and 3). The two educational components wereACRP’s existing CRC Core Competency Foundations and ACRP’s new Supplemental CRC Oncology eLearning. Overall, ACRPs clinical research training courses align with the Joint Task Force on Clinical Trial Competency framework to inform a competency-based training approach.

An overview and outline of the curriculum for the training are shown in Figures 1 and 2.

Results

Phase 1: Major challenges were patient recruitment, staffing and lack of training

Of the cancer center survey’s 334 respondents, 83% indicated that their program currently conducts clinical research. The most common challenges identified were patient recruitment (40%), limited staffing (36%), and lack of training in research administration and conduct (25%). The main resources desired by the respondents were communication about clinical research opportunities (65%), connection to clinical trial sponsors (49%), clinical research coordinator training (41%), and grant-writing skills/training to support and build research programs.

The focus groups (n=23) identified several topics as being of particular interest: foundations in research and clinical trials; education on standing up trials tailored to the size of the program; and recruiting and enrolling diverse patients.

From a training perspective, 19 participants from 10 sites participated in Part 1 (Self-study of Key Resources andGuidance), and 16 participants from nine sites participated in the live instructor-led training (Parts 2 and 3). The training was delivered by two of this paper’s authors, Beth Bieze and Katie Marceau.

Phase 2: Oncology clinical research education delivered to nine sites, 16 participants

Phase 2, aimed at building research capacity at research-naïve and/or low trial capacity programs, enrolled nine sites with 16 participants for the learning program. Site characteristics were as shown in Figures 3, 4, 5, and 6. Phase 2 of the oncology clinical research education project was completed in February 2025. This phase focused on identifying the participating ACCC community cancer programs and participants, implementing the training as a pilot to help advance foundational knowledge, and measuring the success of the program. In cases where there were fewer participants in live sessions, this was due to personal emergencies and professional capacity to continue.

For the training, Part 1 (self-study) took place between October 7 and October 24, 2024; Part 2 lasted one month (October to November 2024); and Part 3 took place in January 2025. Details of participant numbers are shown in Sidebar 2.

Learner-participant survey findings: Overall positive learning experience and increased confidence

Of the 16 ACCC learner-participants from ACCC centers, nine responded to a follow-up survey comprising 26 questions (Sidebar 3). Overall results showed a positive learning experience, with self-reported confidence in clinical research knowledge gain for oncology clinical trials. Roles represented were 3 CRCs, 2 clinical research nurses, an oncology research coordinator, a cancer center administrator, an Investigational Drug Service (IDS) pharmacist, and an oncology social worker. Respondents had between 2 and 40 years of experience. Seven had worked on a clinical trial, 2 had not. All respondents said they would be part of the decision-making process if a trial was being considered at their clinic. For most survey respondents (7 or 64%), this was their first experience with ACRP, with only two being members of ACRP.

Roles and numbers of individuals who took part in the learner-participant survey are shown in Figure 7.

According to the survey, the training successfully enhanced participants’ knowledge of oncology clinical trials. The majority of respondents strongly or somewhat agreed with the following statements:

• This training enhanced my knowledge of oncology trials (7 strongly agreed, 1 somewhat agreed, 1 somewhat disagreed)
• I have a clearer understanding of the roles and responsibilities of principal investigators (PIs) and clinical research coordinators (CRCs) in oncology studies (5 strongly agreed, 2 somewhat agreed, 2 neither agreed nor disagreed)
• I feel that I could participate in/lead an oncology trial, but may need additional support (3 strongly agreed, 4 somewhat agreed, 1 neither agreed nor disagreed, and 1 somewhat disagreed)
• I will encourage my site to actively seek opportunities to participate in oncology trials (7 strongly agreed, 2 somewhat agreed)
• I liked the mixed format of self-study and live training (5 strongly agreed, 3 somewhat agreed, 1 neither agreed nor disagreed)
• I would recommend this training program to others (6 strongly agreed, 3 somewhat agreed)
• I would be interested in additional training leading to certification (5 strongly agreed, 3 somewhat agreed, 1 somewhat disagreed)

There was less consensus on the statement that “I was able to focus on the training while still achieving my day-to-day work responsibilities,” with around one-half strongly (1) or somewhat disagreeing (3), and another half strongly (1) or somewhat agreeing (3). One neither agreed nor disagreed.

Training found to be easy to follow

All respondents strongly or somewhat agreed that the training was easy to follow (6 strongly agreed, 3 somewhat agreed), the trainer made the session engaging (6 strongly agreed, 3 somewhat agreed), and the resources provided by the teacher after each session were helpful (6 strongly agreed, 3 somewhat agreed). All strongly agreed (9) that the trainer was a subject-matter expert.

High level of satisfaction with study resources

Most respondents strongly (5) or somewhat agreed (3) that the self-study resources were helpful in preparing for the training sessions (1 somewhat disagreed); that they had the time to complete the self-study before the training sessions (6 strongly agreed, 1 somewhat agreed, 1 neither agreed nor disagreed, and 1 strongly disagreed); and that the self-study resources were easy to access (6 strongly agreed, 2 somewhat agreed, 1 somewhat disagreed).

Next steps proposed: Future updates and more detailed courses with certification

In answer to the open question of ‘what would you like to see as a next step in this pilot project,’ respondents said they would like training that includes updates on clinical trial policies and FDA regulations, mock trial or mock audit formats, a greater focus on oncology, and more detailed courses leading to certification.

In response to the open question of ‘how can we support your professional development,’ learner-participants said they would like to receive updates about clinical trials, including quarterly updates on regulations, frequent FDA audit findings, and incorporating artificial intelligence (AI). They were interested in additional free courses, and in courses for Investigational Drug Service (IDS) pharmacists and social workers, and in having access to other ACRP trainings. The fact that the trainer has offered to be available in future to the Learner-Participants was mentioned as a benefit for their professional development. All but one respondent (8 total) said they would attend more clinical research conferences if a stipend were available to cover expenses.

Learner-participant interviews: Improved knowledge, scheduling challenges reported

ACRP conducted interviews with four learner-participants to secure direct feedback about their experience in the program. Overall, the participants reported that they emerged from the training with greater knowledge yet also reported several challenges with the operations and administration of the program. Answers to open-ended questions included:

• “The oncology training program was excellent, and I learned a lot.”
• “Having work to do alone was good, the hard part was the rigid schedule.”
• “The training seemed more suitable for new CRCs with no experience of studies.”
• “My main goal was to understand the most important regulatory parts of oncology clinical trials.”
• “Having a recording of the presentations would have been helpful if I missed a session.”
• “I was able to carve out time for the training; if I had to see a patient, I would drop off briefly and come back.”

Key learnings

Lessons learned included the fact that many sites are looking for resources to clinical trial build capacity. However, some programs were unable to participate due to lack of staff or lack of availability. Many sites self-identified as research naïve but carried robust portfolios and expressed a desire to expand. This may be due to lack of benchmarking of non-NCI comprehensive cancer center sites. In this pilot, there was low representation from mid-western-states, and low Native American/Asian representation in catchment areas. Useful steps would be to expand the community engagement/participation by building local workforce bridge programs between local community colleges and healthcare clinics/sites; establish a journey of professional development for the local clinic/sites through access to on-demand training that would lead to accredited clinical research workforce certification; and set up an online mentorship lifeline platform for supporting newly established clinic-sites.

Challenges faced during this project included:

• A significantly longer timeline for identifying suitable ACCC sites than anticipated. Some sites that were not already conducting clinical research were not able or willing to participate in the training due to training length or personnel availability. In addition, certain sites that were conducting clinical trials said they could not spare the time of their site professionals to participate.
• The community partners requiring shortening of the training sessions due to trainee day-to-day workloads. ‘Live’ parts of the course were reduced from 4 to 2-2.5 hours per week over 6 weeks.
• Trainees having varied levels of knowledge of clinical trials, rather than all being study naïve.

Training-related learnings to build upon and scale for future models include the need to:

• Assess learner-participants’ level of knowledge prior to implementing training so that this can be adapted to the cohort’s level of expertise and to address knowledge gaps
• Ensure protected time for the learner-participants
• Assess the need for a refresher course for Learner-Participants
• For a training program that combines foundational clinical research training with therapeutic-area training, it is important to ensure that the therapeutic area training is sufficiently robust
• Involve the courseware trainers in the program design to promote a deep understanding of the program for all involved from the start

On the communications front, it will be important to explore how best to let other sponsors and CROs know that these sites are ready to conduct a trial. One approach might be to create an ACRP-Trained Community Healthcare Center Register.

Study limitations include the small numbers of clinical research professionals and sites that participated in this pilot, and the fact that the full CRC curriculum was not used (instead, the focus was on oncology).

Conclusion

Overall, the pilot project indicates that training could successfully enhance research-readiness among community cancer centers. The program provides a blueprint for training of research-naïve oncology staff in the community setting. If multiplied at scale this approach could significantly enhance the number of oncology clinical trial sites across the U.S. trained to conduct clinical research, helping boost enrollment and diversity of patient populations. This would increase patient access to clinical trials and could shorten the timeframe for study completion. The training may make more sites feel empowered to participate in clinical trials and may encourage more individuals to enter clinical research.

Planned next steps for this project include a continued educational partnership between ACRP and ACCC, trial sponsor site feasibility mentorship by Genentech, and exploration of new opportunities to train research-naïve programs and low-trial capacity sites to expand access to clinical trials for underserved and underrepresented communities.

Building clinical research capacity at community cancer centers would be an important step forward in advancing new therapies and improving patient outcomes. By establishing an appropriate infrastructure, nurturing collaborations, reaching out to the community, and promoting continuous learning, sites can enhance their research capabilities and contribute to the global fight against cancer.

Authors

Kara Bastarache, CAE, Senior Manager, Association of Clinical Research Professionals (ACRP)

Ruma Bhagat, MD, MPH, Senior Director, Health Equity & Population Science (HE&PS), Genentech

Beth Bieze, MA, CCRA, ACRP-PM, FACRP, Clinical Quality Management Director, ProTrials

Kimberly Demirhan, MBA, BSN, RN, Assistant Director, Provider Education, Association of Cancer Care Centers (ACCC)

Mona Gilliam, MSN, APRN-BC, CNS, Senior Medical Science Director, Medical Society External, Genentech

Susan P. Landis, BA, Chief Executive Officer, Association of Clinical Research Professionals

Katie Marceau, RN, MS-NL, OCN, CCRP, Executive Director- Clinical Trial Site Solutions, TrialNAV

Nicole Richie, PhD, Vice President & Global Head Health Equity & Population Science (HE&PS), Portfolio & People Leader, Genentech

Latha Shivakumar, PhD, Senior Director, Clinical Education and Research, Association of Cancer Care Centers

Marian Valia, Chief Learning Officer, Association of Clinical Research Professionals

Acknowledgements

ACRP and ACCC appreciate the commitment from Genentech, a member of the Roche Group, which supported this initiative with an educational grant.

The authors thank Jill Dawson, PhD for writing support.

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