Draft Policy Recommendations Self-directed Interactive Review
Category 6: Participants-Support
These policy recommendations are designed to ensure that clinical participants have the necessary support for:
1. Making an informed choice to participate in a clinical trial
2. Navigating the challenges of participation
Section 1: Participant Navigation - Training
Background:
Participant1 navigation is a relatively new concept for clinical trials. It is increasingly important in addressing the system
barriers presented by our fragmented health care system. Simply navigating the various elements of clinical trials - meeting screening and lab appointments in different places, taking time off of work, arranging child care, etc. - constitutes a significant barrier to
participation in clinical trials for underrepresented populations.
These populations include rural families, people with disabilities, the elderly, women, children, as well as various racial and
ethnic minorities. Participant navigation is wholly service-oriented, and is inherently flexible because navigators must respond as (1)
different professionals to the needs of (2) different communities who may need (3) different services with (4) different time/schedule
commitments. Ultimately, participant navigation is crucial to eliminating disparities in clinical trials because the subject may well
associate the clinical trial with the navigator (rather than with the investigator, study coordinator, project manager, etc.).
Policy Recommendation 1: Participant Navigation Training
Because high-quality participant navigation is essential to ameliorating disparities in clinical trials, the EDICT Team recommends that
institutions and providers of continuing education credits institute basic training for participant navigators.
Rationale on this policy recommendation:
The recommendation on participant navigator training addresses the emerging paraprofessional role of participant navigators
and the highly diverse backgrounds of persons entering this work. Patient navigators may be healthcare professionals, social workers,
cancer survivors or other lay persons from the community. There is a need, therefore, to institute basic training for participant
navigators to establish the core knowledge and skills they need. Participant navigation services are vital because the navigator is often
the "face" of the clinical trial to the participant. The participant navigator's presence can be critical to recruitment and especially
retention of participants from at-risk communities.
Moreover, simply expanding patient navigation services are insufficient to meet the need for several reasons. First, not all
participants in clinical trials are patients. Second, failing to draw a macro-level distinction between clinical care and clinical research
runs the risk of perpetuating the therapeutic misconception, loosely defined as the conflation of therapy with research. Avoiding the
therapeutic misconception requires treating navigation through the clinical research enterprise differently in some important senses
from navigation through the therapeutic enterprise.
Policy Maker Focus: Certifying/accrediting bodies like the Joint Commission, health professional associations, or state
paraprofessional organizations.
click here to submit your feedback on this policy recommendation
Policy Recommendation 2: Participant Navigation in Clinical Trials
Research institutions and sponsors of clinical research should:
- Ensure that entities that conduct clinical trials demonstrate that they have the capacity to deliver participant navigation services
- Encourage research protocols to include specific participant navigation plans. Such plans should include implementation
schemes that reflect collaboration and input from existing navigators and community representatives with input from patients.
Rationale behind this recommendation: same as for previous recommendation plus
The recommendation on the need to make the presence of patient navigation services an accepted standard of practice for
institutions conducting clinical trials focuses on funding and other incentives to encourage these institutions to build this capacity.
The recommendation on including navigation in the design of a specific protocol addresses the fact that participant navigation
is often an afterthought in study design and execution. Given the importance of navigation to the participant, it is advisable to include
participant navigators in the design of the specific protocol. This practice will enable navigators, along with representatives from at-
risk communities, to help the study team develop a navigation plan tailored to the needs of those communities.
Policy Maker Focus: Research institutions and sponsors of clinical research
click here to submit your feedback on this policy recommendation
Section 2: State Health Plans - Accrual and Retention Implementation
Background:
Few State Health Plans
- Address clinical research and clinical trials in general
- Encourage recruitment or retention in clinical trials of populations that bear the greatest disease burden, including underrepresented populations.
Additionally, there are numerous stakeholders with divergent views and competing priorities at the state level.
Policy Recommendation 1: State Health Plains & Disparities in Clinical Trials
State, municipal and federal policymakers work with states as they implement state health plans to increase accrual and retention in
clinical research and trials of underrepresented populations that bear the greatest disease burden.
Rationale behind this policy recommendation:
Most clinical trials do not take place in academic clinical centers. Two-thirds of phase III trials occur in community settings,
which makes state health plans an important source for policy on clinical research. Thus, there is reason to believe that disparities in
clinical trials could be reduced if state health plans focused on such disparities and recommended allocation of resources intended to
eliminate them.
Policy Maker Focus: Implementation of this recommendation would focus on federal agencies that fund clinical research and clinical
trials.
click here to submit your feedback on this policy recommendation
1 By "participant" we mean someone who participates in any clinical trial, including prevention trials.
Thank you for reviewing the EDICT draft policy recommendations, click here to return to the Interactive Review homepage.
|
