Step 8.
Review & Evolve Your Registry

8.0 Overview

Review whether you’ve met your goals, make adjustments based on that assessment, determine whether you’re ready to move into the next phase of your registry and to begin to plan for the move. This iterative evaluation of your progress will help you to improve the effectiveness and relevance of your registry and provide another opportunity to engage with your stakeholders.

8.1 Revisit Registry Goals

Periodically evaluating your registry goals helps you verify that you’re achieving what you committed to―with both your registry participants and researchers. When you set up your registry, you developed a set of measurable metrics to help you monitor and evaluate the registry’s success and help you determine whether you’re accomplishing your goals. If you have not determined the components of your monitoring and evaluation approach, including developing a set of metrics, do this now.

Measure Your Success

The following questions can help you evaluate your progress in meeting your goals. Each question is followed by a sample goal and an associated metric that could help you monitor whether you are achieving the goal.

  • How many participants have joined the registry?
    • Sample goal: meet recruitment target
    • Sample metric: total number of participants
  • What is the quality of the data you have collected?
    • Sample goal: complete data set
    • Sample metric: number of fully completed registrations
  • Are participants updating their data?
    • Sample goal: high retention and active participation
    • Sample metric: number of times participants visit/update their data
  • Is your data being used?
    • Sample goal: data used for research studies
    • Sample metric: number of inquiries from researchers and number of studies in which data were used

Identify Problems and Solutions

If you are not meeting your goals, ask yourself:

  • What is working well? What isn’t?
  • What are the challenges in meeting the registry’s goals? Examples might include:
    • Not finding researchers to use the data
    • Not able to recruit participants
    • Participants not keeping their information up to date
  • What are possible solutions to these challenges?
    • Are there easy fixes or do they require longer-term implementation?
    • What resources do you need to accomplish these solutions?
    • Are these solutions feasible given your current resources?
      • If yes, revisit your timeline/calendar of events and registry plan.
      • If not, what are some ideas for how you can obtain the resources you need?

Depending on your answers to these questions, you might want to revise your goals and metrics to assess your registry’s success.

8.2 Reassess User Needs

Along with evaluating and possibly adjusting your goals, you will want to continually reassess external needs to accommodate changing industry and research priorities.

Adapt to Evolving Research Priorities

Continuing to engage with key research stakeholders is critical to the ongoing success of the registry. Stay up to date with current research interests and consider how they have changed since you first set your registry goals. Assessing changing external priorities could reveal important developments, such as:

  • Need for transition to a new technology platform
  • Changes in your funding sources
  • New or shifting stakeholders depending on the status of current research or industry focus
  • Introduction of new regulatory requirements
  • Changes in Common Data Elements (CDEs)

Continue to Engage with Registry Participants

Within an ongoing, voluntary registry, the ability to recruit and retain participants depends on the relevance of the registry. If participants feel that the registry no longer meets their needs, they will likely stop participating and your registry can lose momentum. It is critical to stay connected with participants and understand their expectations of the registry.

Surveys or other methods of collecting feedback from current and potential registry participants can be useful tools. They can expose recruitment or retention barriers and identify potential improvements to maintain your registry’s relevance to their rare disease community.

8.3 Plan for Next Steps

Look ahead and determine what’s next for your registry. You’ve fostered productive communication and received input from key stakeholders. Use the information gathered from patients, researchers, and industry to inform your next steps.

Next steps could include:

  • Forming a Scientific Advisory Board for your registry with key researchers
  • Establishing a data governance program
  • Securing funding sources to further grow the registry
  • Building your network to include other groups or organizations
  • Creating a non-profit disease advocacy organization

The scope of your registry can grow to:

  • Cover different geographical regions (e.g., national to international)
  • Address new research questions
  • Include other types of patient data (e.g., medical history, biobanks)
  • Transition to a more advanced registry platform

Use the RaDaR Tool: Registry Evaluation Checklist to determine whether the registry is ready to move to the next phase. The resources included in the Resources section of this step are also helpful.

The next phase of RaDaR will include step-by-step information on collecting participant medical history. Read more about future plans for the RaDaR website.

Review whether you’ve met your goals, make adjustments based on that assessment, determine whether you’re ready to move into the next phase of your registry and to begin to plan for the move. This iterative evaluation of your progress will help you to improve the effectiveness and relevance of your registry and provide another opportunity to engage with your stakeholders.

Periodically evaluating your registry goals helps you verify that you’re achieving what you committed to―with both your registry participants and researchers. When you set up your registry, you developed a set of measurable metrics to help you monitor and evaluate the registry’s success and help you determine whether you’re accomplishing your goals. If you have not determined the components of your monitoring and evaluation approach, including developing a set of metrics, do this now.

Measure Your Success

The following questions can help you evaluate your progress in meeting your goals. Each question is followed by a sample goal and an associated metric that could help you monitor whether you are achieving the goal.

  • How many participants have joined the registry?
    • Sample goal: meet recruitment target
    • Sample metric: total number of participants
  • What is the quality of the data you have collected?
    • Sample goal: complete data set
    • Sample metric: number of fully completed registrations
  • Are participants updating their data?
    • Sample goal: high retention and active participation
    • Sample metric: number of times participants visit/update their data
  • Is your data being used?
    • Sample goal: data used for research studies
    • Sample metric: number of inquiries from researchers and number of studies in which data were used

Identify Problems and Solutions

If you are not meeting your goals, ask yourself:

  • What is working well? What isn’t?
  • What are the challenges in meeting the registry’s goals? Examples might include:
    • Not finding researchers to use the data
    • Not able to recruit participants
    • Participants not keeping their information up to date
  • What are possible solutions to these challenges?
    • Are there easy fixes or do they require longer-term implementation?
    • What resources do you need to accomplish these solutions?
    • Are these solutions feasible given your current resources?
      • If yes, revisit your timeline/calendar of events and registry plan.
      • If not, what are some ideas for how you can obtain the resources you need?

Depending on your answers to these questions, you might want to revise your goals and metrics to assess your registry’s success.

Along with evaluating and possibly adjusting your goals, you will want to continually reassess external needs to accommodate changing industry and research priorities.

Adapt to Evolving Research Priorities

Continuing to engage with key research stakeholders is critical to the ongoing success of the registry. Stay up to date with current research interests and consider how they have changed since you first set your registry goals. Assessing changing external priorities could reveal important developments, such as:

  • Need for transition to a new technology platform
  • Changes in your funding sources
  • New or shifting stakeholders depending on the status of current research or industry focus
  • Introduction of new regulatory requirements
  • Changes in Common Data Elements (CDEs)

Continue to Engage with Registry Participants

Within an ongoing, voluntary registry, the ability to recruit and retain participants depends on the relevance of the registry. If participants feel that the registry no longer meets their needs, they will likely stop participating and your registry can lose momentum. It is critical to stay connected with participants and understand their expectations of the registry.

Surveys or other methods of collecting feedback from current and potential registry participants can be useful tools. They can expose recruitment or retention barriers and identify potential improvements to maintain your registry’s relevance to their rare disease community.

Look ahead and determine what’s next for your registry. You’ve fostered productive communication and received input from key stakeholders. Use the information gathered from patients, researchers, and industry to inform your next steps.

Next steps could include:

  • Forming a Scientific Advisory Board for your registry with key researchers
  • Establishing a data governance program
  • Securing funding sources to further grow the registry
  • Building your network to include other groups or organizations
  • Creating a non-profit disease advocacy organization

The scope of your registry can grow to:

  • Cover different geographical regions (e.g., national to international)
  • Address new research questions
  • Include other types of patient data (e.g., medical history, biobanks)
  • Transition to a more advanced registry platform

Use the RaDaR Tool: Registry Evaluation Checklist to determine whether the registry is ready to move to the next phase. The resources included in the Resources section of this step are also helpful.

The next phase of RaDaR will include step-by-step information on collecting participant medical history. Read more about future plans for the RaDaR website.