LD Connect Data Access and Publication Policy

Overview

PatientCrossroads, Lipodystrophy United, Bristol-Myers Squibb and AstraZeneca, in partnership with leading international Lipodystrophy (LD) researchers have developed the LD Connect Patient Registry. The purpose of LD Connect is to generate sufficient data to better characterize the lipodystrophy patient community.

An objective of the LD Connect Patient Registry is to disseminate the results of the collected data to the scientific community. These results will include registry outcomes, secondary analyses, and ancillary studies. Access to the de-identified registry data is available to participants in the registry, non-participant members, industry, and federal agencies.

Data Access & Publications Committee

The LD Connect Data Access and Publications Committee (referred to as “the Committee” throughout this policy), comprised of members of the LD Connect Registry Governance Board, will oversee access and use of the registry data. The purpose of this committee is to establish the criteria for access, to avoid conflict with and/or duplication of other publications and presentations and to protect the interests and privacy of the participants. The Committee will review requests to collect additional data and to recruit participants into studies. The Committee will facilitate and monitor publications and presentations to ensure the timely dissemination of registry results and will propose policy guidelines for authorship of publications, update the guidelines as necessary, and assure compliance with the publication policies. The Committee will maintain representation from advocacy, research institutions, government, industry and international stakeholders.
The Data Access and Publications Committee is comprised of the following members of the Governance Board:

  • David Araujo-Vilar, MD, PhD (Universidade de Santiago de Compostela)
  • Kyle Brown (PatientCrossroads)
  • Rebecca Brown, MD, M.H.Sc, (National Institute of Diabetes and Digestive and Kidney Diseases NIH)
  • Andrea Dunaif, MD (Northwestern University, Feinberg School of Medicine)
  • Abhimanyu Garg, MD (University of Texas Southwestern Medical Center)
  • Taisia Isupov, PharmD (AstraZeneca)
  • Elif Oral, MD (University of Michigan)
  • Vanessa Rangel Miller, MS, MBA (PatientCrossroads)
  • David Savage, PhD (University of Cambridge)
  • Andra Stratton (Lipodystrophy United)

Review Criteria

Complete proposals and requests will be reviewed for scientific merit and potential to contribute to the primary or secondary research goals of the registry project. In addition, the amount of resources necessary to fulfill the request, source of request for data, and intended use of requested information will be taken into consideration. The Committee will also seek to avoid duplication of research efforts and/or publications.

Refer to the item list presented for each proposal/request type.

Review Process

Registry data may be utilized following a standard process of a research request, to further study this patient population, as outlined below.

  1. Research proposals will undergo a rapid initial review by two members of the Data Access and Publication Committee.
  2. The initial reviewers’ recommendations and the received proposal will be reviewed by the entire Data Access and Publications Committee. A majority of Committee members to vote in favor of a proposal is necessary for approval of a request.
  3. Approved data requests will be prioritized. The anticipated time from submission to notification will be consistent with the frequency of the Committee meetings, approximately four weeks.
  4. The status of the review and feedback will be supplied to the requestor, including anticipated time-lines for approved request completion. Queries regarding the proposal and the approval decision from the Committee will be communicated to the requestor by the LD Registry Coordinator via email.
  5. If a requestor plans to publish or present data, then the publication and/or presentation draft(s) must be reviewed by the Committee and AZ/BMS. Details regarding publications are outlined below.

When a question arises regarding data requests that might compromise proprietary corporate information, the advice of the Committee in collaboration AZ/BMS, will be sought prior to the final decision granting access.

Special Circumstances

These policies are intended to serve as a guide to all interested parties on the routine access and use of registry data. It is recognized that every circumstance that might arise cannot be anticipated. Any requests for consideration of special circumstances or exceptions to the stated policies must be presented to the Committee, which will render judgment. Disputes or appeals resulting from the decisions of the Committee will be presented to PatientCrossroads, which will have final judgment on data access and use in each case.

Services Available

LD Connect Professional Portal: Access to Registry Data

LD Connect brings the experiences and data reported by those living with Lipodystrophy to you.

The Professional Portal is a central resource to better understand the health characteristics and needs of those living with Lipodystrophy. LD Connect makes the de-identified data collected by the registry available to any qualified researcher, advocacy organization or other qualified requestor interested in the lipodystrophy community. The qualifications of the requestor will be reviewed by the Data Access and Publication Committee prior to granting access to the de-identified data.

Approved registered users will use a unique username and password to view the current registry data on the Registry Data section of the website.

Custom and Raw Data Reports

To accelerate the understanding of lipodystrophy and scientific investigations, the LD Connect Registry strives to make the data useful and available to the greater community. Data from the registry can be used to:

  • Recognize the health characteristics of those living with lipodystrophy
  • Identify medical needs among those living with lipodystrophy
  • Study site feasibility and planning for clinical trials and research studies
  • Assist with recruitment for study opportunities
  • Understand the relationships between patients and their healthcare providers

Interested users may request a .CSV (Excel) format of the de-identified patient data for the purposes of scientific investigation and more detailed analytical study. This raw data report provides the de-identified patient-entered data with longitudinal responses, if requested. Reports can also be customized to target subsets of participants who meet specified criteria.

The requestor must be qualified and capable of conducting the research in compliance with applicable legal and regulatory requirements. Local laws, rules, and regulations on personal data privacy (including the collection and use of personal data) must be respected. The requestor is responsible for obtaining all regulatory and ethics approvals/authorizations, where applicable.

How to Request Data Reports

The Data Access and Publications Committee will review requests for data reports. Preference will be given to non-profit organizations and programs which openly share data and findings. To request a data report, please provide the following information to the LD Connect registry coordinator (coordinator@ldconnect.org):

  • Name of Principal Investigator/Co-Investigators/Requestor(s)
  • Name of the institution, organization, or company
  • Title, role or occupation
  • Current Dated Curriculum Vitae (or other statement of qualifications)
  • Email address
  • Contact phone number
  • Project title
  • Project description (not to exceed 1 page). This should be in the form of an extended abstract, including purpose, specific aims, background, methods/analysis, and source of funding.
  • Type of data requested: Raw data export or Custom data export
  • If a custom data export is requested, please include the criteria for inclusion. Refer to the Registry Data section for the list of data elements collected by the registry.

If the data will be used for a publication or presentation, please also provide:

  • Time frame for completion of the project.
  • List, in order of priority, the scientific journal(s) to which the completed manuscript might be submitted.
  • List the meeting name and year if an abstract will be prepared for possible presentation.
  • Refer to the publication policy section for guidance on use of registry data in publications.

Any material to be published using the LD Connect Registry data must be approved by the Committee. Users are requested to submit a summary of the data analysis within one year of receipt of the data report(s). Refer to Review Criteria and Review Process for further information. The approval process for publications is independent of the approval process for the data request. Prior to the release of any registry data, an approval notification will need to be obtained from the LD Coordinator prior to generating a publication.

Patient Notices and Recruitment

Need to find participants for a lipodystrophy study or clinical trial?

LD Connect can be used to disseminate recruitment notices to registry participants or target populations with the characteristics needed for recruitment of specific studies. LD Connect is deeply committed to issues of privacy and identity, and will take every available measure to ensure the security of the personal information of participants. Only studies approved by an Institutional Review Board or human subject ethics committee will be sent to LD Connect participants.

How does it work?

The LD Connect coordinator will send study recruitment notices to participants by email and will post study notices on the LD Connect registry website. The registry will not supply identifying information to a designated study coordinator – Participants will be referred to the study coordinator for more information and to be consented into the study.

Interested investigators are encouraged to contact the LD Connect registry coordinator by email (coordinator@ldconnect.org) to discuss using the registry to notify participants of study opportunities.

The Data Access and Publications Committee will review requests to recruit participants. Preference will be given to non-profit organizations and programs which openly share data and findings. To initiate a request, please provide the following information to the LD Connect registry coordinator (coordinator@ldconnect.org):

  • Name of Principal Investigator/Co-Investigators/Requestor(s)
  • Name of the institution, organization, or company(s)
  • Title, role or occupation
  • Current Dated Curriculum Vitae (or other statement of qualifications)
  • Email address
  • Contact phone number
  • Project title
  • Anticipated dates of recruitment
  • Brief project description (Lay Language protocol Summary)
  • Institutional Review Board/Independent Ethics Committee or Ethical Review Board Approval Letter
  • Inclusion/exclusion criteria (Refer to the Registry Data section for the list of data elements collected by the registry.)
  • Study recruitment letter

Upon approval, study investigators/sponsors will be contacted by the registry coordinator to establish dates for distribution of notices. Study investigators/sponsors should be aware that any communication to participants or information on the website will include language to the effect that LD Connect does not endorse specific studies, and provides recruitment notices as a service to the community. Participants are encouraged to discuss all study opportunities with their medical care providers.

Investigator/Industry Sponsor Responsibilities for Patient Notices and Recruitment

The registry can pre-screen participants as likely candidates, however, investigators/industry sponsors responsible for the study will determine the prospective participants’ full eligibility, and are responsible for addressing and answering participant concerns and questions about the study opportunity.

Study investigator/sponsors are requested to share any relevant study recruitment updates, study termination information or study results with LD Connect, who may in turn share designated information with patients and professional registrants.

  • Authors of manuscripts accepted for publication are requested to notify LD Connect within 2 months of acceptance.
  • Study investigators/sponsors are requested to provide an annual update regarding study recruitment or closure.

Refer to Review Criteria and Review Process for further information.

Collect New Data

To accelerate the pursuit of scientific investigation and understanding of lipodystrophy, the LD Connect registry can be used by investigators to collaborate and collect new data through supplementary surveys presented to LD Connect members. Interested investigators are encouraged to contact the LD Connect registry coordinator by email (coordinator@ldconnect.org) prior to submitting a proposal to collect new data. Collected data may be subject to the Publication Guidelines. The Committee reserves the right to charge to compensate for the effort required to implement new surveys. Collected data will be excluded from data exports for up to 2 years or the time of publication of the data, whichever occurs first.

The Data Access and Publications Committee will review requests for collaboration and new data collection. When possible, preference will be given to non-profit organizations and programs which openly share data and findings. The following information should be sent by email to the LD Connect registry coordinator (coordinator@ldconnect.org) to submit a proposal:

  • Name of Principal Investigator/Co-Investigators/Requestor(s)
  • Name of the institution, organization, or company
  • Title, role or occupation
  • Current Dated Curriculum Vitae (or other statement of qualifications)
  • Email address
  • Contact phone number
  • Project title
  • Project description (not to exceed six (6) pages, including references and tables). This should be in the form of an extended abstract, including purpose, specific aims, background, methods/analysis, source of funding, and dissemination plan, as appropriate.
  • Survey questions, written in accordance with PatientCrossroads Question Development Guide
  • Target population
  • Time frame for completion of the project.
  • Institutional Review Board/Independent Ethics Committee or Ethical Review Board Approval Letter
  • Other information as requested

Any material to be published using the LD Connect Registry data must be approved by the Committee. Publications of new data will be reviewed per the Publication Guidelines. Refer to Review Criteria and Review Process for further information. The approval process for publications is independent of the approval process for the data request.

Publication Guidelines

There will be varying needs for data access and publication rights, and the needs of each interested party must be accommodated. The following policies for data access and publication rights have been created after consideration of the needs and also the contributions of each interested group.

“Publication” means any public disclosures of any information relating to the LD Connect Registry or Registry Data, and shall include, without limitation, any article, manuscript, data, text, diagrams, posters, charts, slides or pictures related to the investigative findings. If identified by AstraZeneca/Bristol-Myers Squibb (AZ/BMS), all Confidential Information belonging to AZ/BMS that may be contained in any Publication shall be deleted.

If data are supplied for a publication, the requestor will be expected to produce a manuscript of publishable quality within six months.

Manuscripts must be completed and submitted within a reasonable period of time according to the following the writing directive: If, after a period of six months following completion of data analysis, the draft is not substantially complete, the Committee reserves the right to make other arrangements to ensure timely publication. If a satisfactory manuscript is not produced within the allotted time frame, the Committee may rescind the data. An extension may be granted when deemed necessary. New data collected through the registry in partnership with external investigators will be granted an extension as appropriate.

Criteria for Authorship

All individuals who have made substantial intellectual, scientific and practical contributions to the registry and the publication should, where possible, be credited as authors; all individuals credited as authors should deserve that designation.

Criteria for authorship of a publication should be based on:

  • substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data; and
  • drafting the scientific publication, or revising it critically for important intellectual content; and
  • final approval of the version to be published.

All authors of publications generated from LD Connect data must meet all three criteria above. The identification of authors must be complete prior to the drafting of a publication. Other individuals who assist in the analysis or drafting of a publication must be acknowledged in the publication, according to their level and type of contribution.

Authors must agree to take responsibility for the integrity and accuracy of the data within the publication, and have full confidence in the integrity and accuracy of the work of all co-author(s).

In addition to the terms for receiving custom or raw data reports, the following limitations apply for publications of registry data:

  • It is anticipated that LD Connect will work collaboratively with the Committee (or their designees) in pursuing investigations and preparing publications and presentations of registry data. Where possible, collaboration and co-authorship of publications by investigators from LD Connect and the Committee will be the goal, reflecting the collaborative nature of the overall project.
  • Priorities in selecting journals/forums for publications submission will be given to peer-reviewed journals as well as presentations and publications of abstracts at national and international scientific meetings.
  • Any proposed publications resulting from research from registry data will be submitted to the Committee with at least 30 business days prior to the date of submission for review. Any disagreements about the use of the data will be resolved by a good faith effort by all parties. Publications will be reviewed to ensure the appropriate use of the data in accordance with the policies provided by LD Connect , and that the use of data is consistent with the initial data request submitted to LD Connect. In cases where inappropriate use of data has occurred, LD Connect, the Committee, and/or the Industry Sponsor(s) may deny the use of data.
  • AZ/BMS reserve the right to review publications/presentations prior to submission for publication/presentation for the purposes of protecting its intellectual property rights and deleting AZ/BMS confidential information. If there is concern from the Committee regarding the intellectual property rights of another industry sponsor, then this concern will be escalated PatientCrossroads, which will have final judgment in each case. The LD Connect Coordinator will be responsible for forwarding all publications to AZ/BMS for review.
  • For peer-reviewed publications, or as needed for other requests, this initial review and proposal will be forwarded to the entire Committee for final approval or rejection.
  • LD Connect and participating researchers should be acknowledged in all publications and presentations of registry data. The Industry Sponsor(s) should also be acknowledged in all publications. In any such publication, an author shall include a statement that its study is based in whole or part on data provided by LD Connect, a program graciously sponsored by AZ/BMS.
  • All financial relationships between AstraZeneca/Bristol-Myers Squibb (or future Industry Sponsors) and any external author(s) of a supported publication must also be disclosed, including relationships unrelated to the publication itself.

The primary author should keep the LD Connect Data Access and Publications Committee appraised of all events following submission (i.e., acceptance). The citation for an accepted publication should be sent to LD Connect and distributed to the Committee via email by the LD Coordinator (coordinator@ldconnect.org). A pdf copy of the full Publication will be requested if publically available.

The Committee will maintain an up-to-date repository of research requests, related approvals, bibliography, and repository of all publications pertaining to the registry. Lead authors are responsible to provide LD Connect with all final publications.

AstraZeneca/Bristol-Myers Squibb (AZ/BMS)

Initial funding of LD Connect has been generously provided by AstraZeneca/Bristol-Myers Squibb (AZ/BMS).

AZ/BMS may request access to de-identified registry data for scientific investigation or designate independent investigators to pursue research questions subject to the rules, as outlined in the Agreement signed between PatientCrossroads and BMS. If available, AZ/BMS may also request customized reports of their own product(s) and their use in a different format or content from a standard report, which may include comparative data from the larger database. Prioritization will be given to data reports related to safety and/or regulatory requests. The data regarding specific AZ/BMS products will be protected for AZ/BMS use only and any reference in publications will be general in nature.

Each data request must be submitted in writing and will be presented to the Data Access and Publications Committee. The Committee will review the request to ensure that the data requested does not include proprietary corporate information from future Industry Sponsors (if applicable) and to ensure that the privacy of registry participants is not compromised. If there are no conflicts identified in relation to the criterion above, then the request will be approved.

Per contractual obligations, AZ/BMS will receive:

  • Annual report of registry data or semi-customizable report template
  • Six (6) customized queries per year of registry data as requested by AZ/BMS (Additional queries will be available with additional cost)
  • Preparation of registry data for publications, manuscripts or presentations may be available for individual projects by request
  • Registry reports will be prioritized upon request for regulatory and patient safety considerations

The Committee will be notified of any publications, manuscripts or presentations generated from the data received.

Future Industry Sponsorship

Additional sponsorship of LD Connect by companies with an interest in Lipodystrophy are available. All industry sponsors will be provided with routine quarterly registry data reports.

Future industry sponsors may request access to the database for scientific investigation or designate independent investigators to pursue research questions as outlined in the agreement between the industry sponsor and PatientCrossroads. If available, industry sponsors may also request special reports of their own product(s) and their use in a different format or content from a standard report, which may include comparative data from the larger database. The data regarding specific industry sponsors’ products will be protected for their use only and any reference in publications will be general in nature. Each data request must be submitted in writing and presented to the Committee or its designee.

The Committee will review requests by industry sponsors for special reports or access. When a question arises regarding data requests that might compromise proprietary corporate information, the advice of PatientCrossroads will be sought prior to the final decision granting access.

Restrictions on Use of Data by Requestors

Product-specific results may be used for marketing, publications, and other purposes if data are presented unmodified from registry reports and publications. The Committee must grant permission if data are modified or put into another context for external dissemination.

Requestors have permission to use the registry name, LD Connect. The Committee and PatientCrossroads retain the right to deny the use of the registry name. Requestors cannot sell or share the data with another institution, organization, or company without prior written consent from the Committee.

Revisions to the LD Connect Data Access and Publication Policy

The Lipodystrophy Connect Data Access and Publication Policy will be reviewed by the Committee on an as-needed basis. Any revisions to this policy will need to be reviewed and approved by PatientCrossroads, AstraZeneca and/or Bristol-Myers Squibb prior to implementation to ensure compliance with contractual obligations.


Final Version 1.0 / 11Apr2014