CARE is The Center for the Advancement of Research. It oversees the Investigator-Sponsored Research (ISR) Program, which consolidates and tracks the evaluation, funding, and follow-up of investigator-sponsored research proposals that are supported by Boston Scientific. For you, this program makes proposal submissions easier and the process more accessible. For Boston Scientific, the program ensures studies are progressing and makes the results more visible.
A sponsor-investigator is a single individual or facility that is responsible for fulfilling the obligations of both a sponsor and an investigator. The sponsor's role is not related to financial support, which is provided by a funding agency. Following is a brief overview of the roles and responsibilities in the ISR Program:
| Funding Agency | CARE through the ISR Program | Provides financial support for the study according to a defined Research Contract, which outlines milestones and specific deliverables |
| Sponsor | Physician | Oversees the conduct of the study, including document management, data management, data analysis, publication, FDA reporting, etc. |
| Investigator | Physician | Conducts the day-to-day research according to a defined protocol and per specified procedures |
The program supports unsolicited, investigator-sponsored trials. This means that as the sponsor, you are entirely responsible for protocol design, statistical analysis, study registration, IRB approval, reporting of adverse events, and other sponsor responsibilities. You will need a working knowledge of study design and management as well as federal regulations for conducting research and good clinical practice (GCP) guidelines. You will also need to ensure you have the resources available to conduct the trial (eg, personnel, equipment, time). For more information, visit www.fda.gov
Submit your idea through the CARE website: www.guidantcare.com. You can set up a user account to manage submissions, track the review process, document milestone completion and payment, and submit publications.
The ISR Committee reviews studies on a periodic basis to evaluate them for scientific merit, novelty, strategic alignment, and other criteria. If a study is of interest, it passes to the funding review phase in which the top studies are offered contract opportunities.
The ISR Committee is a multi-functional team consisting of experts in science, clinical applications, regulatory, and law. Additional individuals may participate in proposal evaluation as needed.
For a full protocol evaluation and funding review, the ISR Committee must receive:
A full protocol consists of:
Yes. An optional process exists in which a study idea can be submitted to the ISR Committee for review. To submit a study idea, only the following are required:
With this information, the ISR Committee will determine whether or not Boston Scientific would like to support the exploration proposed by the study idea. If so, the additional information required for a proposal submission will be necessary before funding can be considered. Please note: expression of interest is NOT an automatic approval.
The ISR Committee meets monthly to evaluate proposals for scientific validity, regulatory risk, and strategic alignment. On a quarterly basis, the highest priority studies are evaluated for funding. You can expect communication from the committee along the entire process. Additionally, decisions are posted on the CARE website (www.guidantcare.com) and can be accessed through users' individual accounts. If your study has been selected for funding, you will be immediately notified so research contracts can be agreed upon and executed in a timely manner.
No. As part of the requirements for product promotion, investigator-sponsored trials must be "unsolicited." Boston Scientific is allowed to post generalized areas of interest, but cannot participate in study concept generation or protocol development. Once the protocol is developed, the committee may ask questions to clarify the design or may offer general advice if the proposal needs more structure. However, you must maintain your role as the author and owner of the project.
In most cases, unless otherwise specified, you or your facility will own the data. In that case, patient/study data received by CARE that are related to your study will be destroyed. If your research agreement indicates that Boston Scientific will own or have access to data, methods and types of disclosure will be specified therein.
No. Boston Scientific cannot manage the study nor participate in data collection or analysis.
No, under no circumstances will Boston Scientific delay or halt publication of results. To protect intellectual property, you will be asked to submit a draft prior to submission to a third party so Boston Scientific can request reasonable redrafting if propriety information is revealed.
Should your study fall behind such that additional time, additional funding, or protocol changes become necessary, you will be asked to describe what has caused the change and what you believe can be done to get the project back on track. The ISR committee will review the proposed changes and work with you to make a decision on remedial action. Because study progress is documented in the research contract, an amendment is generally required.
The ISR Committee will consider the "big picture" in evaluating proposals and will look into any past and current projects and their status. Past performance will be considered. However, the Committee recognizes that a study might be closed or delayed for reasons beyond your control. Depending on the reason(s), the ISR Committee may decline to fund future projects, withhold a funding decision until outstanding issues are resolved, or determine that past closure or delay is not indicative of future study performance.
As a condition of publication, the International Committee of Medical Journal Editors (ICMJE) requires study registration prior to enrolling the first subject(s). The party who is responsible for conducting the trial (either sponsor or principal investigator) must register the study. As that individual, it is your responsibility to get your study registered. To learn about trial registration, visit the NIH protocol registration information website: http://prsinfo.clinicaltrials.gov/.
As part of good clinical practice (GCP) and as study sponsors, you should report AEs to the center IRB where the AE occurred and to Boston Scientific's Technical Services at 1-800-CARDIAC. To learn about reporting to IRBs, refer to the documented processes for the particular IRB(s). Guidance from the FDA regarding AE reporting is available at www.fda.gov.
The FDA defines specific responsibilities for physicians, investigators, and sponsors. You must understand the requirements for all of these roles. Information on these requirements is available online in the FDA guidance on good clinical practice (GCP) and CFR 21 among other available documentation. Visit www.fda.gov.
The ISR committee has developed a "toolkit" that is provided to all recipients of ISR Program funding. The toolkit provides contacts, to-do lists, instructions, process explanations, additional resources available, reminders, and other relevant information as a reminder and quick reference guide. This material is designed to enable you to meet FDA and Boston Scientific requirements, complete your study successfully, and have a good experience conducting research with Boston Scientific's support; however, it is not a replacement for more extensive programs that may be available. The committee expects that you will already have an understanding of good clinical practice (GCP) and sponsor requirements.
To access these documents online, visit:
Good Clinical Practice:
http://www.fda.gov/ohrms/dockets/ac/04/briefing/4028B1_08_GFI-ICH%20E6.pdf
Code of Federal Regulations 21:
http://www.fda.gov/cdrh/aboutcfr.html