Investigator Initiated Studies
Underlying Principles of IISs
IISs are research studies that are conceived, executed, and reported by the Investigator independent of BTG Specialty Pharmaceuticals. As such, the Investigator takes full responsibility for the design, conduct, analyses, safety, regulatory and publication activities of the study. It is the responsibility of the Investigator to comply with, all applicable laws, regulations, guidelines and industry codes governing the conduct of IISs (e.g. ICH-GCP).
Our Commitment to IIS
BTG Specialty Pharmaceuticals is committed to supporting independent research in the form of IISs that further the understanding of diseases and their treatment with the ultimate goal of helping patients. Our support of IISs provides a unique opportunity for physicians to explore areas of mutual scientific interest, and build scientific knowledge of disease management and the role that our therapies can play. BTG Specialty Pharmaceuticals can provide its pharmaceutical products and/or financial support for IISs that are approved through BTG’s review committee.
If you are a Healthcare Professional with an IIS proposal, the first step is to discuss your proposal with your local BTG Medical Liaison/Medical Advisor (ML/MA) who will provide you with a “Concept Proposal Form” for completion and submission. If you are unsure who your ML/MA is, contact us at firstname.lastname@example.org, and someone from BTG will be in touch to discuss your proposal.
The IIS process continues as follows:
|Completed Proposal Form reviewed by BTG committee|
|If conditionally approved, legal agreement negotiations are initiated; Investigator writes full protocol and submits to BTG for final approval|
|After Investigator obtains all study approvals and legal agreement is executed, BTG support commences|
Your IIS proposal will be reviewed by the BTG Specialty Pharmaceuticals review committee and will be assessed against criteria including:
- Scientific robustness, safety and ethical integrity
- Alignment with the strategy of BTG Specialty Pharmaceuticals
Investigator’s Obligation to BTG Specialty Pharmaceuticals
As the Investigator, you agree to provide BTG Specialty Pharmaceuticals a copy of selected documents (as applicable) prior to commencement of the study. These documents include:
- Ethics Committee / Institutional Review Board (IRB) and Regulatory Authority approval letter (where appropriate) for the IIS
- Copy of Ethics Committee / IRB approved protocol and consent form
- An up to date and signed copy of your CV
- Fully executed legal agreement
During the study, BTG Specialty Pharmaceuticals requires that safety and adverse events be reported to appropriate bodies as directed. As the Investigator, you must also notify BTG should there be any study document amendments, audits, patient safety concerns or issues that may significantly hinder progress, execution, or completion of the IIS as planned. Any congress abstract submissions and/or journal publications resulting from the IIS must be submitted to BTG Specialty Pharmaceuticals for review prior to submission for peer review. A final study report or publication summarising all study results must be submitted to BTG in a timely manner regardless of study outcome.
BTG’s Commitment to the Investigator
At BTG Specialty Pharmaceuticals we aim to provide you with timely feedback and a decision on whether BTG will support your IIS. Review meetings are held monthly, and once reviewed we commit to providing you with feedback as soon as possible. BTG Specialty Pharmaceuticals receives many proposals and not all are approved; each proposal is evaluated on its own merit.
If approved, a provision of support will be defined and documented in a legal agreement, which includes the roles and responsibilities of each party. Agreed financial and product support is linked with predefined milestones and will be paid when milestones are achieved.
Support of an IIS is not intended to encourage the prescription, supply, administration, recommendation, purchase or sale of any BTG Specialty Pharmaceuticals product. BTG is committed to both data and financial transparency. To ensure that BTG continues to be compliant with relevant laws and regulations, all transfers of value (i.e. payments and product provision) are tracked and reported in accordance with the relevant local regulations. We encourage all Investigators to also share and report any support provided to them when required, and to share the results of their research.
Additional Investigator Information
IISs are subject to regulatory audit or inspection. It is imperative that as an Investigator, you are aware of all the requirements that you must meet. Regardless of which country or jurisdiction you fall under, all Investigators must understand ICH-GCP or 21 CFR. Information on this guidance can be found on the ICH and FDA websites.
If you are unsure of your responsibilities as an Investigator, your ML/MA can discuss these requirements further with you.
If you have questions about the IIS programme at BTG, please contact your local ML/MA or write to us at email@example.com