User account menu Search Menu Home Healthcare Professionals Investigator-Initiated Trials / Studies Investigator-Initiated Trials / Studies As part of our commitment to delivering innovative therapies to patients worldwide, Novartis believes in the need to support ethical independent clinical research conducted by qualified third-party investigators. The value of the scientific research produced by these investigators is key to complementing Novartis-sponsored research by helping to ensure we better understand the benefit/risk profile of our therapies, as well as enabling us to explore new opportunities addressing unmet medical needs. The proposed clinical research must offer meaningful scientific and/or clinical objectives supported by valid study designs in which the privacy rights, safety and welfare of patients is of paramount importance. Novartis defines IITs as “studies with scientific and medical merit developed and sponsored by an independent investigator or academic sponsor. An IIT may be a clinical or non-clinical study conducted without the participation of Novartis, for which the IIT sponsor requests Novartis to provide either funding, drug product or both.” Novartis global investigator-initiated trial guidelines (PDF 0.3 MB) IIT guidance document (PDF 0.6 MB) Strategic areas of interest We welcome unsolicited research proposals from qualified investigators in our strategic areas of interest which we list below. Well-thought through studies that enhance our delivery of innovative therapies to more patients worldwide, enhance patient care, and align with our strategic areas of interest will be considered. If you have questions on any steps of the process or wish to discuss your study concept, please feel free reach out to your local Novartis contact (e.g. MSL, Medical Advisor) for support. COVID-19: We are interested in COVID-19 vaccination studies in combination with Novartis products. Cardiovascular, Renal & Metabolism Inclisiran (Leqvio®) Iptacopan (LNP023) Sacubitril/Valsartan (Entresto) Immunology, Hepatology and Dermatology Canakinumab (Ilaris) Secukinumab (Cosentyx) Neuroscience Ofatumumab (Kesimpta) and siponimod (Mayzent) - Multiple sclerosis (MS) Oncology alpelisib (Piqray) Asciminib (ABL001): Capmatinib (Tabrecta®) dabrafenib (Tafinlar) + trametinib (Mekinist) Jakavi [177Lu] Lu-DOTA-TATE (Lutathera®) [177Lu] Lu-PSMA-617 ribociclib (Kisqali) sabatolimab (MBG453) tisagenlecleucel (Kymriah) Ophthalmology Brolucizumab (Beovu) Lifitegrast (Xiidra®) and ECF843 SAF312 Voretigene neparvovec (Luxturna®) Respiratory Enerzair Breezhaler (QVM149; indacaterol acetate, glycopyrronium bromide and mometasone furoate [IND/GLY/MF]) Omalizumab (Xolair) How do I submit an IIT request? IIT requests are submitted via the Novartis Grants, External Studies and Managed Access System or GEMS portal. Please submit your concept by clicking here. Guidance on using the GEMS portal is available here: Novartis GEMS portal external user guide (PDF 0.1 MB) For IIT related questions, please contact the medical team in your Novartis local country office. Related Links Novartis announces lift of partial clinical trial hold and plans to initiate a new, pivotal Phase 3 study of intrathecal OAV-101 in older patients with SMA Novartis announces plan to initiate clinical trial of canakinumab for patients with COVID-19 pneumonia Strategic projects and initiatives Investigating the myopia mystery Novartis Navigate Patients and Caregivers Healthcare Professionals Researchers Job Seekers Journalists Investors Partners Suppliers Topics Clinical Trials COVID-19 Info Center ESG Explore Stories Diseases Locations Companies Sandoz Advanced Accelerator Applications Footer Bottom © 2021 Novartis AG Terms of Use Privacy Contacts Cookie Settings Site Map Novartis Site Directory This site is intended for a global audience Your privacy is important for us. We use cookies to enhance your experience when visiting our websites: performance cookies show us how you use this website, functional cookies remember your preferences and targeting cookies help us to share content relevant to you. Select “Accept all” for giving your consent to all cookies, select “Cookie settings” for managing the different cookies or select “Reject all” for using only strictly necessary cookies. You can change your cookie settings at any point of time by pressing the cookie settings link on the website. Cookie Settings Reject all Accept all