Guidance for Researchers Developing and Conducting Clinical Trials in Practice-based Research Networks (PBRNs)

Including a PBRN core team member on the academic research project team to facilitate recruitment of practices to a trial is important.

A simple 1-page information sheet about the trial is extremely helpful for the recruitment process and for informing participating practices about the trial details, how it will impact the practice, and what value it provides to the practice.

Using different forums (eg, PBRN meetings, E-mail, newsletters) to advertise the trial is best.

To improve chances of successful recruitment, target practices in which there is already an interest in the trial's topic and provide incentives (eg, continuing medical education, financial incentives, quality improvement).

Considering practical factors such as size of practice, scope of practice, and resources available is necessary when determining appropriate practices to approach.

Involving primary care practices in the design of the trial and engaging them in an ongoing advisory or participatory role will improve buy-in.

For each trial, try to minimize the work required by the practice and design the intervention to cause as little disruption as possible to clinical care.

Providing adequate funding to the practices and reducing their burden of regulatory requirements is crucial.

For a successful trial, key practice clinicians and staff need adequate training at the start of and as needed throughout the trial.

Τo maintain trusting relationships, keep PBRN personnel involved in all steps that involve the practices.

Maintaining ongoing communication between the PBRN research project manager and a key contact at each participating practice is helpful.

At the completion of the trial, make sure to recognize the accomplishments and contributions of the participating practices.

Keep the trial fun and interesting.

Although the budget process may vary among PBRNs, the most important aspect of budget development is to include the PBRN core team in the process to ensure that the budget is appropriate and realistic.

Deciding who will hold the primary budget and who will serve as subcontractors may depend on whether the PBRN and/or the principal investigator are affiliated with an academic institution or a nonprofit organization.

Ideal timing for a rough draft of the budget is no later than 6 weeks before a grant due date and a final budget, including subcontracts, no later than 3 weeks before the due date.

Nonprofit PBRNs may provide budgeting advantages to a grant, such as lower indirect cost rates or efficient strategies for paying incentives and honoraria to patients and practices.

It is important that a trial budget includes costs that are particular to working in a PBRN (eg, practice honoraria, PBRN infrastructure costs, site visits).

Linking practice payments to milestones is a good way to structure a budget.

When budget cuts or changes are required, it is important that both the academic research project team and the PBRN core team make these decisions together.

It is critical that the academic research project team meets its obligations to both the PBRN and the practices participating in the trial to maintain willing practice partners for future trials.

PBRN and practice representatives are essential members of the research project team, and involving them in all aspects of a clinical trial is important.

The PBRN central research project team members offer critical feedback and advice on how best to work with the member practices.

PBRN research project personnel vary depending on the particular PBRN and the specific clinical trial.

Responsibilities for PBRN research project personnel also differ for each trial, so clarifying who is responsible for which activities before the trial starts is important.

For most studies, a PBRN research project manager works closely with the academic research project team during all phases of trial implementation.

In some studies an on-site practice liaison/research project coordinator helps to facilitate implementation of the trial within a practice.

For a trial to run smoothly, creating a manual of protocol procedures that clearly outlines all trial procedures and provides simple, clear presentations of the work and workflow in the practice setting is imperative. Storing this manual in a secure manner that is accessible to all research team members is critical (see Table 5).

Developing a data-sharing agreement that addresses issues such as data ownership before the commencement of a trial is important. The data-sharing agreement should address how patient confidentiality will be maintained, including what information will be de-identified and how this will be accomplished.

Each trial should also use a regulatory binder to manage important documents. This binder contains the most recent version of the protocol, informed consent document, IRB approval letters, training documents of study personnel, a site personnel delegation log, and other study correspondence.

Ensuring quality requires detailed documentation of trial progress and maintenance of organized trial files.

A clinical trial quality management plan can help to make sure that all issues that affect trial quality are being appropriately addressed. Regular review of this plan is important.

Regular communication between the academic research project team, the PBRN on-site research project team, and the participating practices is key to keeping all team members engaged in the trial.

Offering opportunities for training and professional development is another strategy for keeping PBRN on-site research project team members engaged.

Understanding all the steps necessary for closing out a trial and clarifying who will be responsible for which steps is important.

Given the number of collaborators involved with most studies involving PBRNs, establishing clear lines of communication to ensure that a trial runs smoothly is important.

Engaging the PBRN core team and/or PBRN central research project team in communications with the practices at all phases of the trial is crucial.

All research project team members should promote good communication, but the PBRN coordinator often oversees this task with the help of the practice liaison/research project coordinator.

Communication should be ongoing and updates should occur frequently.

Effective communication should be multidirectional, recognizing and respecting the expertise that all collaborators bring to a trial.

There are several different methods of communication (eg, in person, E-mail, phone conferences), and they should be tailored to the preferences of the collaborators.

In-person meetings are ideal for the initial presentation of the trial, practice training, and periodic trial updates. Video or web-based conferences can be used in place of in-person meetings if there are distance and/or financial limitations.

Websites associated with the trial or the PBRN provide good venues for trial information and for providing continual trial updates. Secure, password-protected web pages on these sites or proprietary software programs can provide centralized project document and communications storage and retrieval.

E-mail, newsletters, and social media are useful methods for providing periodic trial updates, answering questions, or providing tips to participating providers/staff.

Engaging PBRNs in publication and presentation opportunities when appropriate and acknowledging the contribution of the PBRN and the PBRN research project team members who are not authors in publications and presentations are important.