Investigator initiated studies

IIS_article

Investigator initiated clinical studies can play a key role in answering important medical and scientific questions regarding Roche’s products and their related therapeutic areas. Such clinical studies can contribute towards enhancing the understanding of Roche’s products and their appropriate application, thus improving patient care, and sparking new ideas for further disease-related research aimed at creating improved treatment for patients. 

Investigator initiated studies (IIS) are clinical studies initiated and managed by a non-pharmaceutical company researchers, like individual investigators, institutions, collaborative study groups or cooperative groups. The researcher is responsible for the legal and regulatory responsibilities of the trial sponsor for the conduct and management of the study as defined by all applicable laws and regulations.

Eligibility requirements for IIS

Roche may support investigator initiated studies with drug supply, funding, material and/or information, as allowed under local laws and regulations, provided that they align with the company defined areas of strategic interest.

Types of IIS eligible for support:

  • Clinical studies of approved and investigational uses, involving marketed Roche drugs or those still in development (interventional studies phase I to IV)
  • Clinical observational studies, real world evidence (non-interventional studies)

The following is out of scope:

 The sponsor/investigator has to fulfil (or agree to) the following requirements:

  • have the scientific, technical and operational capabilities to conduct a study as a sponsor including adequately trained staff to execute a study (GCP, GMP, etc.)
  • have expert statistical support
  • submit a scientifically well designed and well-written study proposal
  • deliver to agreed timelines
  • be able to fulfill all regulatory requirements (including submitting a IND/CTA, writing of final study report and manuscripts etc.)
  • deliver a written report of the final study results to Roche (GNE)
  • publish the study in a scientific journal
  • agree to safety reporting to health authorities and to Roche (GNE)
  • agree to provide study updates to Roche (GNE)

How to apply for IIS support

Researchers are invited to submit their concept proposal via the IIS submission portal. Concept submission will be reviewed collectively by the Roche Review Committee based on scientific merit and alignment with corporate research and development plans.

The requester will be informed about the outcome and should Roche be interested in the concept submission, the investigator will be contacted and invited to submit further details and a final protocol on the IIS in order to be considered for full approval.

Roche requires that the following documents are in place before the support can be initiated:

  • a fully executed IIS agreement between the sponsor and Roche
  • a fully executed IIS safety data exchange agreement between the sponsor and Roche
  • an EC/IRB and/or health authority 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.

Glossary

CTA: Clinical Trial Assay

EC: Ethics Committee

GCP: Good Clinical Practice

GMP: Good Manufacturing Practice

IND: Investigational New Drug

IRB: Institutional Review Board