This section presents the guiding principles and actions codified by the IDEAS Study in response to issues expected to arise on an ongoing basis.
Current policies address:
- Enrollment Cap Policy
- The publication of scholarly information
- The use of clinical and/or image data archived during the IDEAS Study
- The guidelines for advertising by PET imaging facilities and referring physician practices
IDEAS-Study Enrollment Cap Policy
The IDEAS Study has instituted an enrollment cap for each referring physician (dementia expert) participating in the study.
The policy’s intent is to increase study generalizability by promoting diversity in dementia expert representation and patient recruitment across socio-demographic and geographic populations.
For each individual referring physician, the maximum number of patients throughout the entire study that may be enrolled is 250. The distribution of cases enrolled also will vary based on the study’s aim outlined below.
Aim 1: To assess the impact of amyloid PET on the management of patients meeting appropriate use criteria. The prospectively-recruited sample size of amyloid PET-known participants for Aim 1 is 11,050 participants (assuming a distribution of 40% dementia and 60% MCI).
Aim 2: To assess the impact of amyloid PET on hospital admissions and emergency room visits in the study cohort (amyloid PET-known) compared to matched patients not in the cohort (amyloid PET-naïve) over 12 months. The prospectively-recruited sample size of amyloid PET-known participants for Aim 2 is 18,488 participants.
The enrollment cap is distributed as follows:
160 for an individual referring physician in Aim 1 (which has an estimated national accrual total of 11,050 and includes participants for whom both a pre- and post- PET clinical assessment case report forms are completed).
90 for an individual referring physician in Aim 2 (which has a national accrual goal of an additional 7,438 patients for whom only pre-PET clinical case report forms will be collected).
The Operations Office will alert individual physicians when 140 participants have been enrolled to enable planning.
IDEAS STUDY Data Sharing and Publications Policy
Download PDF- Data Sharing and Publications Policy
Ⅰ. General Principles Regarding Clinical and Image Data Sharing
Overall Policy Goal: This policy provides information and guidelines for individuals and corporations wishing to request access to clinical or image data archived during the IDEAS study. The IDEAS Study is committed to providing investigators in academia and industry an opportunity to access data collected as part of the study for purposes that are consistent with the goals of IDEAS. This may include ancillary research studies, technology development, and educational initiatives. The following policy is drafted to provide reasonable access to data while allowing the IDEAS Study team to meet its obligation of ensuring the data will be used responsibly, and that providing access will not burden the IDEAS Study’s resources such as to impede its ability to pursue its primary research. Investigators interested in asking research questions of data collected as part of IDEAS are encouraged to do so as a collaborative effort within the IDEAS structure. This approach will engage the IDEAS Study team’s “know how” related to the data and the trial which will provide the best opportunity for a successful analysis. Requests to collaborate with the IDEAS Study should be addressed to the Research and Publications Committee (RPC).
It is appreciated that the IDEAS Study team will not be able to support all requests for collaborative analysis; and, therefore, the following policy for transfer of data to investigators for independent analysis is outlined below.
- The IDEAS Study archives the clinical and image data obtained as part of its research activity. This archive is a resource that can be used for secondary research studies, to guide further technology development, and for educational purposes. Access to CMS claims data used in the IDEAS Study is handled separately and requires permission from CMS.
- The IDEAS Study encourages such use of its clinical and image data, however, has a responsibility to ensure that their use remains ethical, purposeful and consistent with the general goals of the Study.
- Any individual or entity may submit a request for the clinical data, image data, or images linked to clinical data archived by the IDEAS Study.
- The IDEAS Study will provide requesters the raw data as it is archived in the database. However, requesters can specify subsets of data they desire using the annotated elements from the case report forms.
- In making data available to individuals and entities, the IDEAS Study is only bound by its responsibility to guard the confidentiality of study participants, sites, and participating readers. No other responsibility is assumed by IDEAS Study about the data, except as specified in other sections of this policy document.
- IDEAS Study data and images ordinarily will not be released to individuals or companies prior to the publication of the trial’s primary aim manuscripts.
- The identity (and identifiable information) of trial participants, sites and IDEAS Study investigators will not be provided.
- To the extent its resources allow, IDEAS Study aids individuals and/or entities in gaining access to its data archive, and generally requests payment for the cost of providing the requested data. It must be appreciated that the resources available to fulfill data requests are limited which may result in a prolonged timeline to satisfy requests. Limiting the requests to essential data desired may expedite data availability.
- Individuals and corporations accessing and using IDEAS Study clinical or image data assume full responsibility for any and all uses of such data. Once the data has been successfully transferred, IDEAS Study is relieved of any further responsibilities.
Ⅲ Process for Submitting Requests
- The application forms for requesting archived clinical and image data is available on the IDEAS Study Web site. Requests for access to the IDEAS Study archive should be sent to IDEAS-ResearchPub@acr.org
- In the case of independent researchers or corporations, requests should be of a research or educational nature or for purposes of technology development.
- Before indicating in a grant proposal that clinical and/or image data archived by IDEAS Study will be used to conduct the proposed research, an investigator should submit a request and obtain written approval from IDEAS Study prior to submitting the grant proposal. IDEAS Study treats such requests as it does any other, as detailed below.
IV Clinical/Image Data Requests Review and Approval Process
- The Research and Publications Committee (RPC), which reviews and decides upon requests for archived clinical and/or image data sets on a regular basis, is composed of the following members:
- The Chair, who is the lead statistician of IDEAS Study.
- Two other members of the IDEAS study team, including the Study Chair.
- A representative appointed by CMS.
- A representative of each of the participating manufacturers.
- A senior researcher in Alzheimer’s dementia, selected from the research community at large.
- The roles and responsibilities of the Data Access Committee related to data distributed under the data sharing policy include the following:
- The scientific merit of the proposal
- Whether the scope of the data request is consonant with the scope of the scientific project for which the data will be used
- Whether the requesting party has sufficient resources to carry out the project
- Whether the request overlaps or conflicts with primary or secondary IDEAS Study aims.
- The practical feasibility of fulfilling the request
The criteria, which may change from time to time, are widely promoted via the IDEAS Study Web site.
V Requestor’s Responsibilities Regarding to Data Use
- Access to IDEAS Study archived clinical and image data is provided within the parameters described below.
- The specific purpose for the data use must be agreed to by the individual requesting the material and IDEAS Study at the time that the request is approved.
- The data set may be used only for that purpose and only by the requesting party.
- The data may not be passed on to or shared with a third party unless first agreed to by IDEAS Study.
- The data may be used only for the time period specified in the IDEAS Study request approval.
- In the case of corporations, IDEAS Study must be informed of situations in which clinical/image data sets are passed on to collaborating corporations and the intent in sharing the material.
- Those granted access to the IDEAS Study archive are required to sign a statement indicating their agreement with all policies prior to being allowed access to IDEAS Study clinical or image data.
- Manuscripts must be submitted to the IDEAS Study RPC at least one month prior to journal submission for review to ensure representations related to IDEAS Study are accurate. Feedback to investigators is non-binding; however, investigators publishing manuscripts that appear to misinterpret IDEAS Study data risk the submission of commentary or a letter to the editor by IDEAS Study.
- Any publication based on IDEAS Study data/images must cite IDEAS Study as the source of data.
- Copies of published manuscripts must be submitted to IDEAS Study headquarters at the time of publication.
- The Biostatistics Center’s and IDEAS Study team’s participation must be acknowledged in a manner appropriate to the nature and extent of its contributions, including authorship when warranted.
IDEAS Study Advertising Policy
Download PDF- Advertising Policy
The IDEAS Study seeks broad participation by providers who will ensure dissemination of this opportunity across all populations and thereby ensure the generalizability of the results achieved from the study. To achieve this objective, it is understood that referring physician practices and PET imaging facilities may wish to employ marketing materials that will help educate the community they serve, promote awareness of the IDEAS Study and their participation in the Study, and stimulate potential subjects to seek a qualified IDEAS Study provider for potential enrollment in the Study.
Given the complexity of the study design, the degree of interaction between referring physician and PET imaging facility, and the various different business models employed by participating sites, the IDEAS Study team has established a policy on the use of marketing materials. This policy is intended to ensure that all marketing/advertising contains accurate information and that such material is consistent with principles of human subject protection.
- All marketing materials to be used by IDEAS Study participating sites must be approved by the IDEAS Study.
- Pre-approved marketing materials will be provided in the IDEAS Study Toolkit on the IDEAS Study website, and may be used without further review by IDEAS Study. These materials are also pre-approved by Schulman IRB. Sites operating under a local IRB must still submit the pre-approved marketing materials provided in the Toolkit to their local IRB for review and approval.
- Marketing materials developed by sites should be submitted to IDEAS-Study@acr.org. An IDEAS Study subcommittee will review proposed marketing materials for accuracy, consistent with the Study protocol and protocol requirements, and consistent with Study operating principles. Results of reviews will be provided to the requesting site as promptly as possible, and generally within 30 days.
- Site-developed material should be submitted by the facility as follows:
- PET Facility: PET Facilities must submit marketing materials to IDEAS-Study@acr.org. Approval or edits will be provided to the facility for implementation.
- Dementia Specialist Practice/Schulman IRB: Submit marketing materialss to IDEAS-Study @acr.org. Approval or edits will be provided and forwarded to Schulman by IDEAS Study. Schulman approval and/or edits will be incorporated by IDEAS Study and a final approved version will be provided to the Dementia Expert for use.
- Dementia Specialist Practice/Site Local IRB: Submit marketing materials to IDEAS-Study @acr.org. Approval or edits will be provided to the submitter to provide to the local IRB. Should the IRB require changes to the version approved by the IDEAS Study then the IRB approved revision must be submitted to IDEAS Study for final review and approval.
- Failure by sites to comply with this policy or requirements specified by the IDEAS Study may result in termination of the participating site or facility as detailed in the IDEAS Study Participating Site Agreement or the PET Facility Memorandum of Understanding, respectively