The IIT/IIS program serves as a conduit between Neurocrine and external investigators to expand research.
Neurocrine may provide support for IIT/IISs that have the potential to advance scientific knowledge and improve patient care and clinical outcomes.
This program is open to all qualified researchers who are interested in conducting their own trials. Neurocrine may provide support for an IIT/IIS through a grant of funding and/or with the supply of Neurocrine product.
The grant requester is responsible for the design, implementation, and conduct of the IIT/IIS including compliance with all relevant institutional and regulatory requirements.
The following are examples of topics of interest as they pertain to Neurocrine's clinical programs:
Characterize benefits of valbenazine in patients with Tardive Dyskinesia (TD)
Explore new methods of symptom screening and differential diagnosis
Explore which variables may predict outcomes in TD patients
Expand scientific understanding of the biological effects of valbenazine
Explore use of valbenazine in new indications
Explore the use of opicapone in motor and/or non-motor symptoms throughout the course of Parkinson's disease (PD), especially early, in multiple PD subtypes, and various patient populations
Explore the use of opicapone with different formulations of carbidopa/levodopa
Technology-assisted and/or telemedicine-based assessments of measures of motor function of PD patients
Assessments and treatments of quality of life and activities of daily living of PD patients, and caregiver burden
Neurocrine may choose to provide support for studies sponsored by outside investigators or institutions (Sponsors) that advance medical and scientific knowledge and are of interest to Neurocrine, referred to as Investigator Initiated Trials or Studies (IIT/IIS). These studies can generate important information about Neurocrine products as well as valuable medical and scientific information that can lead to improvements in clinical care, the development of new treatments, and better delivery of healthcare to patients. Neurocrine may provide support for an IIT/IIS through a grant of funding, product, or both.
If an investigator or institution desires funding and/or free product for research to be initiated, conducted, and sponsored, a complete IIT/IIS grant request must be submitted through the IIT/IIS portal. (See below.) Your proposal may take 4 to 6 weeks for review, but please feel free to contact us at firstname.lastname@example.org with any questions.
- An IIT/IIS grant request must be submitted through the IIT/IIS portal by filling out the simplified form on this website and attaching CV(s) (required) for the investigator(s) along with any documents that may help with the initial concept review of the submission (eg, study synopsis, protocol, or a detailed project summary)
- The final study protocol is not required during this initial submission but is required before final grant approval
- You have the option of making your initial submission as comprehensive or simplified as you'd like, while providing enough information for the initial review (at a minimum, filling out the attached application for consideration)
Click here for a sample study synopsis document.
- The Neurocrine IIT/IIS Scientific Review Committee will review each submission based on medical and scientific merit, consistency with Neurocrine scientific strategy, study feasibility, reasonableness of the study budget, and sponsor's qualifications
- Depending on the completeness of the information provided with the initial submission, there may be additional information requested before a final funding decision is made, including a clarification on submitted details, request for detailed study synopsis, final budget, and milestones
Decision and Contracting
- Once the initial submission is reviewed, a representative from the Neurocrine IIT/IIS Scientific Review Committee will be in contact with the submitter for additional information as requested by the committee and required for a final decision, with the final decision by the committee, and/or to initiate next steps
- A final decision to proceed with the study is contingent upon the parties executing a mutually agreed upon written contract
- If the proposal is approved, contracting will be initiated
- Payments and/or provision of investigational drugs are made at agreed upon milestones in a written contract executed by all parties involved in the study as work is completed, with final payment upon completion of the study and submission of the final deliverables