Appendix B - Supporting guidance for requesting a redaction to specific unpublished clinical data or including a disclaimer in a public summary document
The Department of Health and Aged Care (the department), on behalf of the Pharmaceutical Benefits Advisory Committee (PBAC), has adopted a standardised approach to requests for redacting clinical data in the Public Summary Documents (PSDs) produced for submissions considered by the PBAC. The standardised approach to redaction processes supports the PBAC’s commitment for greater transparency and consistency of information published in the PSD.
The approach has three elements:
- Process simplicity: Applicants have one (single) opportunity to request redactions of information included in a PSD, prior to its publication.
- Redaction clarity: Publication of revised standard ranges for presenting economic and financial information; and publication of all clinical evidence relied upon by the PBAC to inform its decision-making process unless a redaction exception is applied based on one or more of three criteria.
- Disclaimer requests: Applicants may request that a disclaimer be included as a footnote to specific data provided specifically for the purposes of PBAC consideration, but which does not meet the criteria for a redaction request.
These elements are outlined in the 7.4 Procedure Guidance for listing a medicine on the PBS.
This supporting guidance document provides applicants with additional guidance on how to appropriately request redaction of clinical data or inclusion of a disclaimer footnote, and information on the level of evidence required to support such requests. It does this by providing examples of ‘appropriate’ and ‘inappropriate’ requests.
This guidance document is tailored to requests relating to clinical data. This includes clinical data that are not already in the public domain from any type of clinical study, and from any type of analysis within or across or derived from these clinical studies, and any alternative estimates from sources other than clinical studies. It includes data from demographic measures as well as from outcome measures.
As outlined in the Procedure Guidance for listing a medicine on the PBS, the PBAC’s preference is for all clinical data to be published. However, the department will consider redaction requests to clinical data under the three (3) criteria, which are outlined further below.
Criteria for redaction requests:
If no results at all from a clinical study have been published
This criterion pertains to a request for redaction of unpublished clinical data from a clinical study for which no results at all will have entered the public domain at the time of publishing the PSD. The applicant must demonstrate that the publication of the information in the PSD will prevent the publication of any results from this study elsewhere, and also that there is a documented.
requirement external to the applicant that these results (with or without other results) of the clinical study are to be published once generated.
- This criterion applies to primary analysis of data directly collected from participants recruited into the identified clinical study, such as a randomised trial or a single-arm study.
- This criterion does not relate to secondary analyses across clinical studies, such as from an indirect comparison or a meta-analysis unless it can also be shown that no results from any of the clinical studies included in this secondary analysis would have entered the public domain at the time of publishing the PSD.
- This criterion does not apply in the more common circumstance of where some/any results of a clinical study have already entered the public domain (for which, see next criterion).
- This criterion can apply if the protocol of the identified clinical study has been published (for example, through ClinicalTrials.gov), so long as no results from the study have entered the public domain.
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Appropriate redaction request: The request provides evidence that the release of the specified clinical data in a PSD would prevent publication of any results from the study. It identifies the source (usually the chief investigator) of the clinical study external to the applicant. This source also provides its publication plan relating to its proposed oral or poster presentations as well as manuscript submissions to academic journals, and thus an affirmation from that source that no results from the identified clinical study will have entered the public domain by the time the PSD is scheduled to be published. If this publication plan also identifies the journal in which the primary publication is intended, and the redaction request is agreed to, then the PSD will identify this proposed journal at the place(s) where the redaction occurs. This is to help the interested reader to find the redacted information in the future. Where significant portions of data are requested for redaction under this criterion, the applicant also provides a descriptive paragraph, in lieu of the redacted data, to give context for the reader at the place(s) where the redaction occurs. Where such data are redacted, the department will finalise the descriptive paragraph to ensure the reader can understand the context. |
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Inappropriate redaction requests: The request acknowledges that preliminary results of this clinical study have been presented at a conference. However, the primary paper has not yet been published in a journal. The request states that some data from this clinical study are available on the FDA website. However, the primary paper has not yet been published in a journal. The request states that the subgroup analysis was specifically derived from the published clinical study for the Australian PBAC submission and this analysis has not been published. These three requests do not meet the essential prerequisite of this criterion; specifically that no results at all have been published from the identified clinical study. Note that, in these instances, the disclaimer described in 7.4.6 Procedure Guidance for listing a medicine on the PBS can be applied. The request is for redaction of results of comparisons across clinical studies because the specified comparative data have not been published. The request states that no results of the indirect comparison are in the public domain and disclosing the specified data may jeopardise its future publication. The request states that the existence of the meta-analysis is not in the public domain and disclosing the specified data may jeopardise its future publication. These three requests require additional justification. The applicant needs to demonstrate that no results from any and all of the clinical studies included in the indirect comparison or meta-analysis have been published, and publication of the material in the PSD would prevent the future publication of any results from any of these clinical studies. Note that, in these instances, the disclaimer described in 7.4.6 Procedure Guidance for listing a medicine on the PBS can be applied. |
If the unpublished data have been submitted for publication in an identified journal
This criterion pertains to a request for redaction of clinical data that are included in a draft manuscript that has been submitted for publication in an identified journal. The applicant must demonstrate that the publication of the information in the PSD would prevent publication in that journal.
- This criterion only applies where the applicant has already submitted for journal publication and can provide all of the following evidence to support redaction under this criterion:
- Evidence of receipt of the submitted manuscript by the identified journal
- A copy of the submitted manuscript clearly identifying the clinical data requested to be redacted in the PSD
- Evidence that the publication of data in the PSD would prevent publication in that particular journal. Such evidence may include providing the prospective journal’s specific rules concerning pre-publication of data.
- This criterion does not apply where an applicant indicates that it intends to submit for journal publication in the future.
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Appropriate redaction request: The request provides evidence that release of the specified data would prevent the publication of that data in an identified draft manuscript submitted to a specified journal. The supporting information identifies the journal in which the manuscript has been submitted for publication, provides evidence of receipt of the submitted manuscript by that journal, provides a copy of the submitted manuscript with clinical data requested to be redacted clearly identified (for example by highlighting the relevant clinical data or providing annotations using comment boxes in the document), and provides that journal’s specific rules preventing publication in the context of pre-published data. If the redaction request is agreed to, then the PSD will identify this journal at the place(s) where the redaction occurs. This is to help the interested reader to find the redacted information in the future. The manuscript submitted to the Department will be kept confidential and will only be referred to for the purposes of confirming the specific redaction requests. The International Committee of Medical Journal Editors (ICMJE) does not consider the reporting of scientific information about a drug by a government agency to jeopardize publication plans. However, this reporting should be discussed with and agreed upon by the editor in advance where possible. Where significant portions of data are requested for redaction under this criterion, the applicant also provides a descriptive paragraph, in lieu of the redacted data, to give context for the reader at the place(s) where the redaction occurs. Where such data are redacted, the department will finalise the descriptive paragraph to ensure the reader can understand the context. |
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Inappropriate redaction request: The request advises that the investigators intend to send the specified data to a journal for publication. The request indicates that Global has advised the specified data are included in a publication plan. The request advises that Global is unable to provide the required evidence to support a redaction request under this criterion before the publication of the PSD. These requests require additional justification. The applicant needs to demonstrate that publication of the material in the PSD would prevent the publication in an identified journal. The evidence required to support this request includes evidence of receipt of the submitted article by the journal, a copy of the submitted manuscript in which the clinical data requested to be redacted in the PSD is clearly identified, and evidence that the publication of data in the PSD would prevent publication in that particular journal. This evidence should be anticipated prior to lodging a submission to PBAC. Requests that indicate that more time is required to provide the evidence will not be accepted. Note Criterion 1 may be applicable for these examples if no results at all will have entered the public domain at the time of publishing the PSD. |
If the unpublished data will breach clinical study participant confidentiality
This circumstance pertains to a request for redaction of clinical data that can be shown to potentially breach clinical study participant confidentiality.
- As the clinical data relied upon by PBAC is routinely presented as summary data, and not even de-identified individual patient data, this basis for a request for redaction has not occurred to date, and is considered extremely unlikely to occur in the future. Nevertheless, given the ethical principle of personal privacy involved, it is an important option to identify.
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Appropriate redaction request: The request relates to the results of a sub-group analysis involving extremely low patient numbers, where cross-referencing with other information from that study and or elsewhere in the public domain is likely to enable re-identification of one or more particular study participants. The request also demonstrates how this re-identification of study participants is possible from the specified information sources. Where significant portions of data are requested for redaction under this criterion, the applicant also provides a descriptive paragraph, in lieu of the redacted data, to give context for the reader at the place(s) where the redaction occurs. Where such data are redacted, the department will finalise the descriptive paragraph to ensure the reader can understand the context. |
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Inappropriate redaction request: The request is to redact the numbers of patients in each arm of a study. The request is to redact the numbers of patients in each subgroup of a study. Neither of these requests would allow re-identification of an individual study participant. |
Basis for disclaimer requests:
Where specific clinical data have been provided specifically for the purposes of PBAC consideration, but it does not meet the criteria for a redaction request, the applicant may instead request that a disclaimer be included as a footnote to that specific data in the PSD to further inform the reader.
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Appropriate footnote request: The request provides evidence that the specified clinical data were generated by the applicant beyond the pre-specified statistical plan for the clinical study, or identifies where the specified analyses were first presented in the commentary, ESC Advice or PBAC Minutes. The applicant affirms that, to the best of its knowledge at the time of making its request, the clinical data were only provided for the purposes of informing the PBAC consideration. |
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Inappropriate footnote request: The identified clinical data were generated in accordance with the pre-specified statistical plan for the clinical study, or have been submitted elsewhere. |
