Investigator Initiated Studies
Cubist Pharmaceuticals provides limited funding for investigator-initiated research each year via the Investigator Initiated Study (IIS) program.
The IIS Program consists of two separate programs: Medical Affairs Studies and Discovery Biology Studies.
Medical Affairs studies are defined as any study conducted in humans, either prospectively or retrospectively. Prospective studies are generally those studies in patients where study drug is administered and/or informed consent is required. Retrospective studies typically include chart reviews or database analyses.
Discovery Biology studies are defined as studies conducted in-vitro or in animals.
Cubist may support legitimate medical or scientific research through an IIS for pre-marketed or marketed products. The study is designed, implemented, and sponsored by a clinical investigator(s), which is supported by Cubist through the provision of monetary funding and/or Cubist product. Cubist cannot design, conduct, or supervise an IIS, but may provide limited scientific or technical assistance consistent with applicable regulations. Any assistance provided by Cubist must be acknowledged in any publications or presentations resulting from the study. Cubist may consider support for both prospective and retrospective clinical research as well as for in vitro or in vivo research.
Grants will not be given without thorough scientific review of all study-related materials and without certification that the proposed research has been approved by the proper governing bodies including an IRB and the US FDA, as applicable. Cubist may, upon review of study materials, provide to the investigator scientific comments and mandatory revisions to the proposed research materials to be considered for incorporation into the study.
Cubist's Sales & Marketing department does not participate in the approval of an IIS.