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Development of Lay Summaries

Sharing the Astellas Experience

Marta Nabielec

Astellas Pharma Global Development

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How did we start?

Company’s commitment to post for public access lay summaries for Astellas sponsored studies*

• For marketed products only

• Posted side-by-side with CSR summary results

* Not submitted to regulatory databases

Development of instructional template

• Agreement obtained from internal stakeholders and leadership team

• Feedback from patient advocacy group on pilot lay summaries selected from different therapeutic areas

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How did we start?

Prepare your organization for the requirements of lay summaries

• Communicate with your key stakeholders and keep them in the loop on news and updates

• Ensure the leaders in your organization are on board with the new requirements

• Reach out to functional groups who are your key contributors by hosting “road shows” or similar events to raise the awareness; involve them from the very beginning

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How did we start?Develop lay summary process flow

• Identify and train dedicated writing resources

For consistency and continuity of knowledge it was important for us to identify dedicated writing resources.

• Identify a Lead Person for writing oversight

An individual who works with writers directly, ensures consistency across therapeutic areas and adherence to template and company standards

• Select document review team

Only key contributors from the project team were included in the review. It was critical to involve project leads who helped resolve conflicting comments.

• Ensure everyone on the team has access and understands the template requirements

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Key Points to ConsiderInvest in pre-work to minimize the rework during the drafting process

• Standardize your template as much as possible

• Ensure the key leaders in your organization understand the concept and requirements for reporting study results to laypersons

• Agree with your key leaders on:

- Definitions of commonly used research terms (e.g., open-label, blinded study, description of randomization)

- Layperson definition of drug indication

- Use of layperson dictionary of terms

• Know who your “Decision Maker” is for resolution of conflicting comments

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Our Current Approach

Lay summary component headings from Annex V were modified for the purpose of our template.

“Homegrown” template created before EU consultation document became available.

Where possible, results presented in tabular format and same standard phrases used to describe results across lay summaries

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Challenges

Defining medical condition and terminology in simple language understandable to a layperson

• No simple and easy way to define medical terms in lay language

• If not defined with a 1st lay summary this can present a big challenge for the writer

Simplifying study description

• Avoiding complex medical terms while giving the lay audience an adequate description of the study and study objectives

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ChallengesDescribing inclusion/exclusion criteria in a lay language

• Describing the technical criteria in such a way that the description is appropriate for a layperson

• Reducing the list of criteria to the key ones important to a layperson

• Ensuring the same key criteria are used across lay summaries, if applicable

Reporting results of efficacy endpoints

• Converting statistical results to a lay language; how much numerical information to provide?

• Rephrasing the technical description of endpoints from study protocol to everyday English understandable to a layperson

• Concern that the lay description can be perceived as promotional

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Challenges

Standard approach to presenting adverse reactions

• Differences in presentation of adverse events or age breakdown between study reports; this is especially challenging for legacy and “acquired” reports

• Tables cannot be simply copied across documents: headings may need to be modified when copied from a technical summary document and some additional explanation may be required

• Translating MedDRA terms into lay language while maintaining consistency across summaries

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ChallengesProviding information about investigational product

• Depending on the development stage the list of drug identifiers including internal compound name and trade names can be very lengthy

• Providing trade names for every comparator can even add more complexity

Providing sponsor’s information

• Is it sufficient to provide sponsor’s name and address?

• What exact contact information should be provided so it is actually useful to patients and general public?

• Change in sponsor’s name (e.g., mergers or acquisitions)

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Challenges

Including a reference to the technical results summary

• Technical results summary may be available on more than one website; for retrospective posting we have referred the readers to the Astellas homepage.

• Ensuring no inconsistencies are found between the lay summaries and technical results summary

Statement about additional future trials

• Including a standard statement may work for most studies but not all; slight modifications based on the program status might be required

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Challenges

Readability check performed on every lay summary

• Study title alone or even sponsor’s information can significantly lower readability score- may consider checking the document excluding these parts

• Readability score alone may not always be the best indicator of the text complexity - ensuring a clear flow of the information in the lay summary is as much important as the final score

Additional checks are performed to confirm lay summaries meet disclosure requirements

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What Other Experiences Can We Share?Resources

• Finding the right resources can be a difficult task. Writing a lay summary is a quite different task and requires different skills set.

• Assigning a dedicated resource found to be an optimal solution vs CSR writer

Consistency between already published trial results and lay summary

• Accurate reflection of the study results in lay language without introducing promotional language

• Reporting efficacy results with adequate explanation understandable to a layperson

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What Other Experiences Can We Share?

Achieving an acceptable readability score accounting for study complexity and therapeutic area; how to find the perfect balance?

• Short and clear sentences broken up into paragraphs

• Use of everyday English

• Scientific terms defined and abbreviated later in the text

• Document flow and logical order of presentation: defining endpoints before the results are presented later in the document

Aiming for acceptable scores, however differences in readability scores are inevitable.

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Challenges foreseen in future

Translation of lay summaries to multiple languages

Timeline for submission of lay summary

Reporting results from long-term studies with a primary data cut-off