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Home > Clinical Innovations > Multisite Clinical Trials in PBRN Toolkit > Communication

Frequently Asked Questions about Communications when Collaborating on a Clinical Trial with a PBRN

 

1) What are the overall goals of communication? 

Clinical Trial Development Phase

2) What is the initial step in approaching a PBRN about a new clinical trial?

3) What happens once we submit our proposal?

4) What is the next step after a proposal is approved?

 

Clinical Trial Conduct Phase

5) What does the communication process look like while the clinical trial is ongoing?

6) Who is the person responsible for promoting good communication throughout the clinical trial?

7) What are some examples of communication methods?

8) Where should clinical trial communications be stored and filed?

 

Clinical Trial Closeout Phase

9) What needs to be coordinated during the clinical trial closeout phase?

 

Dissemination Phase

10) What information needs to be communicated during the dissemination phase?

11) What are some issues to consider for authorship?

12) What are ways that the PBRN can be involved in the dissemination process?

 

 

1) What are the overall goals of communication?

Good communication will ensure that the clinical trial runs smoothly and that patient care is enhanced and not compromised.

Clinical studies conducted in collaboration with a PBRN often will have a number of diverse collaborators.

Given these many diverse collaborators, it is especially important to establish clear lines of communication. 

In order to be effective, communication should be multi-directional, allowing all of the collaborators the ability to share ideas, ask questions or voice concerns.

Good communication depends on the recognition that each collaborator brings particular skills and expertise that are important to the success of the trial.

It is important to recognize and respect the expertise that clinicians bring to each clinical trial.

Good communication is designed to keep all collaborators updated on issues such as trial progress, issues or concerns that have arisen, and changes in the clinical trial protocol. 

Below are answers to several key questions related to communication with PBRNs. However, it is important to remember that each PBRN has a unique structure and its own processes, which means there may be a great deal of variability in how communication occurs.  It is crucial to understand the processes of the particular PBRN with which you are working.

 

Clinical Trial Development Phase

2) What is the initial step in approaching a PBRN about a new clinical trial?

The first step is to contact the PBRN core team about your interest in working with the network. The appropriate contact person will vary among PBRNs.  Initial contact may be done by mail, e-mail, phone or in-person and will depend on how the particular PBRN functions.  In many cases, they will ask you to submit your clinical trial proposal according to their submission protocol. This contact can be made prior to submission of a grant proposal to a funding agency or after a grant proposal is funded. 

3) What usually happens once we submit our proposal to the PBRN core team?

The next step usually involves the PBRN core team or a PBRN governing/advisory committee reviewing your proposal and determining whether or not it is a fit for the network based on a set of guidelines that focuses on the PBRN mission.

4) What is the likely next step after a proposal is approved by the PBRN core team?

In most cases, before a clinical trial is launched or a grant proposal is written, the PBRN core team, which has established research relationships with the practices over many years, will contact PBRN member practices to identify practices that are interested in the trial and have sufficient time to complete it.  The PBRN core team will communicate with the academic research project team regarding which practices will be able to participate in the trial. (See section entitled Frequently Asked Questions about Recruiting, Engaging, and Maintaining Practices for a Clinical Trial).

Clinical Trial Conduct Phase

5) What does the communication process look like while the clinical trial is ongoing?

Once the practice/providers agree to participate, a PBRN central research project team member will convene a meeting with the practice staff (e.g., nurses, front desk) to review procedures for scheduling trial patients, identifying/reserving practice rooms for trial visits, or obtaining labs/radiology/referrals (whatever is required by the trial) to ensure that these procedures run smoothly and do not interfere with practice flow.

Communication updates to the PBRN central research project team and participating practices should occur throughout the duration of the trial.  These updates may relate to the progress of trial, enrollment numbers, and problems to be addressed by practices any issue that could affect the PBRN and its practices. 

6) Who are the people responsible for promoting good communication throughout the clinical trial?

All research project team members should promote good communication, but the PBRN Coordinator often oversees this task during the trial with the help of the Practice Liaison/Research Project Coordinator.  As mentioned in the introduction, these roles can vary significantly depending on the specific trial and PBRN. Other communication roles include:

  • Principal Investigator (PI) and academic team members: Responsible for communicating trial updates, changes, or problems to team members and funders (as appropriate).  Also responsible for communicating with consultants.
  • PBRN Director:  Responsible for reporting to the PBRN governing/advisory committee and any other entities to which the PBRN is responsible (e.g., University).  Communicates regularly with PBRN Coordinator.
  • PBRN Coordinator: Manages daily operations of the PBRN, including assignment of staff to research projects. Responsible for communicating with other PBRN core team members about the status of research projects in the PBRN. Communicates regularly with PBRN Director. The PBRN Coordinator often serves the role of PBRN Research Project Manager.
  • PBRN Research Project Manager:  Manages and organizes the PBRN-based activities of an individual research project. Responsible for communicating with other PBRN staff about the status of a trial and its implementation and progress. Serves as the PBRN central research project team contact for both participating practices and the academic research team and/or PI.
  • Practice Liaison/Research Project Coordinator: Serves as the key practice contact for the PBRN central research project team and maintains timely and ongoing communication with individuals at the practice. This role can also be filled by a Research Assistant or a Practice Facilitator. 
  • Research Assistants:  Responsible for conducting clinical trial activities and staying in close communication with the Practice Liaison/Research Project Coordinator and/or the PBRN Research Project Manager.
  • Practice Lead Physician/Clinician:  Responsible for communicating information regarding all phases of the trial with other practice providers and staff.  Works closely with the PBRN central research project team (e.g., PBRN Research Project Manager) and on-site staff involved in the research (e.g., Practice Liaison/Research Project Coordinator, Research Assistants,  Practice Facilitators).
  • Practice Manager: May communicate with the PBRN central research project team and on-site staff working on the clinical trial (e.g., Practice Facilitators) to ensure the trial runs smoothly without adversely affecting the work of the practice.
  • Practice Facilitator: Shares ideas and successes across practice teams. May perform the roles listed above for the Practice Liaison/Research Project Coordinator and the Research Assistant.

7) What are some examples of communication methods?

Below are some of the commonly used methods of communication and ideas for situations in which a particular method might be preferable.  It is important to remember that there are varying levels of comfort with different modes of communication, and the PBRN central research project team will be critical in finding a method that is both effective and acceptable.

  • In-person meetings between research project teams and practice sites
    • Ideal forum for the PI and the PBRN central research project team to make an initial presentation of the clinical trial and for presenting trial updates
    • Ideal forum for providing training (e.g., new clinical interventions, trial procedures such as consenting)
  • Tele- or videoconferences
    • Can be used instead of in-person meetings if there are distance and/or financial limitations
    • Can be used to provide updates and to report back trial findings.
  • Clinical trial website and/or the PBRN website
    • Ideal as a reference for trial information
    • Ideal forum for providing continual updates on the trial
  • E-mail or Listserv messages
    • Often used to communicate updates, answer questions, or provide tips to participating providers/staff
    • May also be used for practice participants to share ideas with each other (e.g., related to recruitment, best practices for implementing practice change)
  • Newsletters 
    • Ideal for providing periodic updates to a wider audience, including trial participants
  • Social media such as Facebook and Twitter
    • Useful for giving brief updates or providing links to trial-related resources

8) Where should clinical trial communications be stored and filed?

Appropriate trial-related communications (e.g., meeting minutes, newsletters) can be stored on a secure server or website so that the PBRN central research project team and participating practices can retrieve communications when needed without having to save trial-related documents on their own computers.

Clinical Trial Closeout Phase

9) What needs to be coordinated during the clinical trial closeout phase?

Notify the PBRN central research project team and participating practices of clinical trial closure.

All practices should receive a thank you note, letter, and/or certificate of participation as recognition of participation in a trial or other important related activity (e.g., site visit).

Dissemination Phase

10) How do we include the PBRN in disseminating the results of the clinical trial?

PBRNs strive to report their important results in peer-reviewed publications and presentations.  Publications that align with the PBRN mission are important to advance the PBRN and its reputation.

The involvement of the PBRN central research project team in the implementation of the clinical trial meets criteria for co-authorship and they should be involved in reviewing and editing the draft manuscript and providing final approval of the paper prior to submission.  Sometimes key PBRN clinicians will play an important role in the clinical trial implementation and advising the academic research project team these clinicians should be offered co-authorship if appropriate.

In addition to the PBRN central research project team members, it is ideal for PBRNs to engage one or more PBRN governing/advisory committee representatives during study execution and data analysis to gather feedback from a different perspective (non-research clinician or community representative). This will help in interpreting results.

Participating practices and individual providers or practice staff should be listed in the Acknowledgements or Appendix for their contributions to the trial, if they are not authors.

PBRN research project team members (e.g., Research Project Coordinators, Practice Facilitators) should also be listed in the Acknowledgements or Appendix for their contributions to the trial, if they are not authors.

Include the PBRN central research project team and practices in opportunities to participate or lead secondary manuscripts or presentations.

Ensure a PBRN governing/advisory committeerepresentative and a member of the PBRN leadership reviewseach manuscript tooensure alignmenttwith the PBRN mission and, if appropriate, PBRN publication guidelines..

Create aCreate a practice-friendly version of the trial results for the Practice Lead Physicians/Clinicians and/or others present to the practices.

11) How do we include the practices and patients in the dissemination phase?

It is important to keep the participating practices and patients in the loop by providing information on trial results and publications through letters, e-mail, results summaries, or newsletters.  

It is optimal if PBRN clinicians and staff who participated in the clinical trial present the trial results at meetings alongside academic research investigators. This increases the visibility of the PBRN with outside audiences.

12) What information needs to be communicated during the dissemination phase?

The academic research team should collaborate with the PBRN central research project team on opportunities for publication and conference presentations. Many PBRNs have publication policies and procedures that should be followed.

Clinical trial results should be presented to the PBRN central research project team and participating practices prior to publication to give feedback or insights. Often, these "observations from the field" help to explain what worked (or didn't work) and can be used for informing the discussion or findings.  

The optimal way to present results is in-person; however, if that is not feasible, a written report and copies of any published manuscripts should be provided to the practices.

The PBRN central research project team and participating practices should be asked about how to refer to the practices in any publications, posters, or presentations (e.g., by name or anonymously). Permission may be required by the PBRN and/or its practices for inclusion of names in printed materials.

The PBRN central research project team and participating practices should also be informed if results will be presented at a conference or meeting.

Both participating practices and patients should receive trial results (practice example, patient example) from the academic research project team, keeping in mind the need for universal health literacy in any trial-related communications.

 

 

 

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