Following a National Cancer Institute (NCI) and American Society of Clinical Oncology (ASCO) co-sponsored symposium, the research team compiled a summary of best practices and strategies for future research aimed at advancing cancer trials more rapidly. These recommendations were published in the Journal of Oncology Practice. 

Reference: Denicoll, AM, et al. J Oncol Pract (2013) Vol 9, No. 6, Pg 267-276. http://jop.ascopubs.org/content/9/6/267.full

Excerpted from the JOP article:

Patient- and Community-Centered Recommendations

 
Best practices

  1. Consider the patient point of view, including potential barriers, when reviewing and implementing trials. Patient advocates should be part of this effort.

  2. Identify and address reasons why eligible patients decline trial participation, for example, via screening logs and focus groups.

  3. Simplify informed consent documents and enhance personal communication during the informed consent process, including clarifying possible financial liability the patient may incur by participating in the trial.

  4. Educate patients and the community, including community providers, about clinical trials, using culturally appropriate material.

  5. Involve advocates and/or advocacy organizations in education about trials and in trial promotion.

  6. Engage racial/ethnic minority and other underserved communities to help develop strategies to increase access to clinical trials.

  7. Involve community leaders in the design and implementation of trials that are important to them, to ensure buy-in and cultural sensitivity.

  8. Use principles of community-based participatory research that involve engaging the community in the research development process when appropriate.

  9. Explore the use of social media, patient registries, and electronic databases to enhance recruitment to prevention, quality-of-life, survivorship, and rare-cancer studies.

  10. Provide access to peer mentors (other patients who have participated in a clinical trial) and patient navigators for those patients identified as in need of additional support.

  11. Include multilingual staff and medical interpreters as members of the research team.
Future research
    Patient decision making

  • Develop and test interventions tailored to the needs of different patients' demographics and communication preferences. Such interventions may include communication strategies and use of decision aids. Future research must address the multiple factors that influence patient decision making.

  • Evaluate the impact of patient navigators, advocates, and recruitment specialists on accrual.
    Racial/ethnic minority and underserved populations

  • Develop and test culturally sensitive educational tools/interventions. Strategies should seek to overcome patient-based factors among various minority and underserved communities, including attitudinal and logistical factors.

  • Identify and evaluate key site infrastructure components (eg, focused patient navigators and multilingual staff) of successful minority clinical trials programs and evaluate their implementation at other sites. Build this evaluation into an established trial design. Study and learn from successful initiatives in therapeutic and prevention trials among the Cooperative Groups, Minority-Based CCOPs, and other research programs.
    Community involvement

  • Conduct studies of educational interventions that evaluate not only improved patient understanding, but also changes in enrollment rates.

  • Evaluate the ability of Community Advisory Boards and/or community-based participatory research to improve community perceptions of and participation in clinical trials.

  • Identify factors that facilitate physician referral and community provider participation in clinical research.

 

 

Physician/Provider-Centered Recommendations

 
Best practices

  1. Develop evidence-based training initiatives to improve provider communication when discussing a trial with a patient. Physician leaders should educate colleagues about such initiatives and serve as mentors in training new researchers and staff.

  2. Provide incentives for clinicians to participate in research. Incentives may include protected time, administrative support, training, and participation in professional meetings.

  3. Disseminate availability of local trials to primary care providers and other referring providers through the mechanisms most widely used in that community, using culturally appropriate material.

  4. Recruit investigators from minority/underserved communities.

  5. Provide ongoing feedback to referring physicians while their patients are on a trial.

  6. Adopt elements of recruitment planning and work with research teams to ensure commitment to such plans. Elements could include screening, enrollment, and retention rates; identification of sources for accrual; contingency strategies for slow accrual; and evaluation of those strategies.

  7. Use information technology, such as registries and electronic health records, to identify potentially eligible patients more efficiently and reduce chart-review time.

  8. Publish on strategies that led to successful accrual to trials. Methodologically rigorous studies of accrual interventions are needed in the literature.
Future research
    Physician/provider communication

  • Study physician and research team communication with prospective trial participants and identify the most successful and efficient methods for improving patient understanding of trials, accrual, and satisfaction with care. This could involve comparing the ways in which high- versus low-accruing physicians and/or research teams communicate with their patients.

  • Test the effectiveness of training physicians and research teams in these communication methods and evaluate for improvements in patient understanding of trials, accrual, and satisfaction with care.

  • Identify the optimal timing to offer and discuss clinical trials with patients, including timing relative to initial diagnosis and presentation of treatment options.
    Recruitment planning and evaluation by investigators

  • Determine which recruitment strategies are most helpful for specific types of studies.

  • Embed accrual studies in appropriate Cooperative Group trials to generate evidence-based strategies for recruitment (ie, prospective testing of recruitment interventions).

  • Identify meaningful metrics for evaluating recruitment strategies and the impact of correction plans, in real time, on improving accrual.

  • Assess the impact on accrual of using documented, comprehensive recruitment plans.

  • Test the use of screening logs as a recruitment evaluation tool.

  • Evaluate the utility of patient registries, databases, and electronic tools for increasing accrual, such as those offered through NIH's Clinical and Translation Science Awards ResearchMatch176,177 and NCI's AccrualNet,172,173 which may have potential benefit for busy sites.

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Site-centered recommendations:  

Best practices

  1. Promote accrual through leadership best practices and organizational development. This may include establishing a “culture of commitment” to clinical trials from the highest levels at a site as part of standard of care, including multidisciplinary teams that prioritize clinical trials.

  2. Implement site and clinical trialist performance standards that qualify clinical investigators based in part on their accrual performance.

  3. Use available site data, including screening logs, to verify that patient populations are available for trials the site is considering, and to identify patient populations at the local level who lack available trials.

  4. Promote leadership/ownership of investigator-initiated trials.

  5. Use formal quality improvement techniques to increase the efficiency of opening and conducting trials.

  6. Use a clinical trials management system as a tool to track the various aspects of managing protocols and empower a Steering Committee or core team to utilize it to evaluate site progress.

  7. Close trials that fail to accrue at a reasonable pace, with allowances for variable rates for less common tumor types or more rare disease settings.

  8. Use the NCI's Central IRB (CIRB) for NCI Cooperative Group trials to shorten IRB turnaround times and reduce workload of local IRBs, particularly with the new CIRB Independent Model.
Future research
    Site leadership, organization, and operations

  • Study both successfully accruing and poorly accruing sites for lessons learned regarding their organizational and leadership strategies, as well as their infrastructure, staffing, and trials portfolio. Test new organizational models and evaluate their impact on accrual. Models are especially needed for private-practice trials unsupported by an academic institution.

  • Identify, implement, and then evaluate leadership models effective in other fields, such as commercial enterprise, that may also be applicable to improving accrual to clinical trials. Consider engaging anthropologists, sociologists, and operations engineers in developing these leadership models.