Advancing Clinical Knowledge Through Research
At BioDelivery Sciences International (BDSI), our aim is to help physicians better understand the clinical impact and benefits of buprenorphine through research.
We are committed to supporting research to help advance the understanding and treatment options for chronic pain. Part of this commitment involves supporting investigator-sponsored research (ISR) that will further the understanding of our products.
The Investigator-Sponsored Research Program
BDSI defines ISRs as, “studies with scientific merit developed and sponsored by an independent investigator known as a sponsor-investigator. An ISR may be a clinical study conducted without the participation of BDSI, for which the ISR sponsor-investigator requests BSDI to provide either funding, drug product, or both.”
Through our ISR program, a clinical researcher known as the sponsor-investigator can submit his/her own study proposals for consideration involving treatments for chronic pain. We encourage and support these sponsor-investigators to explore potentially beneficial treatment options.
What are the areas of research?
ISR proposals will enhance the medical and scientific knowledge of pharmacotherapy in patients with chronic pain through the
- Process and clinical impact of transitioning patients to alternative therapy options
- Clinical impact of buprenorphine’s mechanism of action, efficacy, and safety
- Pharmacoeconomic impact of buprenorphine
Who can conduct research?
The ISR program is open to all who are interested in conducting their own research
- Private practices
- Community health centers
- Cooperative groups
- Physician networks
- Academic medical centers and universities
What are the standards of research?
The sponsor-investigator must be able to demonstrate evidence of high ethical and scientific standards, must be qualified to and capable of conducting the proposed study in compliance with Good Clinical Practice (GCP), applicable federal and local legal requirements, and must not be the subject of any legal restrictions or sanctions.
What is the sponsor-investigator responsible for?
The ISR study is conducted independent of BDSI and the sponsor-investigator assumes full responsibility for all aspects of the investigation including:
- Trial design
- Ensuring appropriate institutional and regulatory submissions
- Ensuring compliance with government regulations
- Study conduct, including responsibility for ensuring appropriate medical safeguards, medical monitoring, and medical supervision
- Analysis and interpretation of the results
- Communication of the results (eg, publications)
Does BDSI provide support?
The BDSI ISR program consists of a committee of medical and scientific staff who meet regularly to review our company’s ISR study proposals. Support for the ISR program is awarded based on scientific merit, patient safety, unmet medical need, availability of funds, feasibility of the proposal, and alignment with BDSI’s areas of interest. Submission of a proposal does not imply or guarantee approval. All proposals will be reviewed based on research merit criteria. Financial and/or product support is contingent upon full execution by both parties of the research agreement.
BDSI may provide support for these programs in the form of funding and/or study materials. Funding is dependent upon various factors, including:
- Published areas of interest
- Availability of funds
- Merit of the proposal
- Duration of the proposed study
- Fair market value
All protocols and study activities must comply with, and be conducted pursuant to, GCP guidelines and applicable statutes and regulations.
How to Apply
BDSI welcomes unsolicited proposals from qualified sponsor-investigators in our areas of interest. Well-written, scientifically sound studies that enhance the understanding of our medicines, improve patient care, and spark new ideas for disease-related research will be considered. If you are a sponsor-investigator, you can initiate the application process by completing a Proposal Intake Form of the proposed research and submitting it to the BDSI email address ISR@bdsi.com. Submission of a proposal does not imply or guarantee approval.
After you apply
Concept submissions will be reviewed collectively by the BDSI ISR Review Committee. The sponsor-investigator will be informed about the outcome, and should BDSI be interested in the concept submission, the sponsor-investigator will be contacted and invited to submit further details and a final protocol on the ISR in order to be considered for full approval.
All funding requests will be assessed to ensure that they do not exceed local fair market value. Funding requests for expenses not associated with the conduct of the study are strictly prohibited.
Tracking and monitoring ISRs
BDSI will monitor the ISR sponsor-investigator’s compliance and adherence to their contractual obligations related to the disclosure of findings, agreed upon milestones, and safety reporting. In addition, milestones will be part of the contract which would include publication of the results.