Table 1 Overcoming barriers to community clinician-participation in clinical research through organizational support

Pre-Awareness

1. Community clinicians do not know about clinical research studies they may be eligible to participate in.

1. Conduct a multi-media outreach campaign to educate Clinicians about possible research opportunities. Identify and reach all potentially eligible Clinicians.

Awareness

1. Clinicians do not appreciate potential personal or professional benefits to clinical research. They feel research questions are not pertinent to their patients.

1. As part of an outreach campaign, craft messages that highlight benefits to Clinicians and patients, as well as the value of clinical research to the organization. When possible, provide relevant research studies with topics of interest to clinicians, with minimum exclusion criteria, or solicit clinician input on these areas and channel results to study sponsors.

2. Clinicians believe that research tasks are too difficult to successfully implement in community practice.

2. As part of an outreach campaign, identify and address barriers to research participation that are especially problematic within clinicians' systems, and effectively communicate to clinicians how these barriers will be addressed.

3. Clinicians do not believe that clinical research is valued by colleagues or patients.

3. Develop and articulate clinical research principles that value clinicians and patients and with a clear set of standards that clinicians and other research participants must adhere to.

Information-Gathering

1. Clinicians have insufficient information or ability to carefully evaluate the business, clinical, and resource implications of participating in research.

1. Provide informational and instrumental assistance pertinent to the business implications of participation. Explain how reimbursement is set for clinical research. Explain study protocol and training requirements. Review checklist for costs. Evaluate and check appropriateness of liability insurance.

2. Clinicians face considerable uncertainty about levels of reimbursement they can expect and about future additional research opportunities they can expect.

2. Develop a reimbursement schedule for research tasks clinicians can peruse to assess impact of clinical research on practice revenue. Post planned future studies on a Web-based registry to enable planning for future research engagement.

First Protocol

1. Clinicians have insufficient time or resources to register and train for a first protocol. For example, they do not know how to confirm with insurer that liability covers research-related tasks, interact with IRB, etc.

1. Provide informational and instrumental assistance from selection of the first protocol through to its successful completion. Review management and fiscal aspects of all procedures/tasks with clinicians. Explain the study reimbursement schedule including reimbursements and insurance coverage. Clarify areas of uncertainty. Provide administrative and technical support as needed. Work with clinicians to complete IRB requirements--identify and guide interactions with IRBs. Ensure that all administrative requirements are met.

2. Clinicians do not know which protocol will provide the best 'fit' with the practice and maximize likelihood of meeting recruitment goals, collecting quality data, and not disrupting patient care and administrative tasks.

2. Provide consultation on protocol selection, setting enrollment goals and study timelines, and on QA procedures.

3. Clinicians and their staff are uncertain about how to most effectively adjust workflow to accommodate research tasks.

3. Provide technology and technical support, such as a personal computer, fax machine with encryption software, and telephone computer support to help practices that do not have the technology or expertise.

Maintenance

1. Clinicians suffer repeated financial losses from research involvement.

1. Set or advocate for transparent study reimbursement schedules that fairly compensate clinicians for their time and effort. Provide consultation and audits to clinicians throughout each study as needed.

2. Clinicians fear loss of patients to specialists because of research-related referrals.

2. Establish ethical principles of research that emphasize that poaching will not be tolerated, and closely monitor all principles.

3. Clinicians do not feel that they are valued for their intellectual and clinical contributions--that they are being used for their patients.

3. Encourage a sense of research community. Recognize clinicians for their contribution and expertise. Provide a confidential venue such as a website portal to register queries/complaints/concerns about current and future protocols, continue to solicit clinician opinion about future research topics.