Review Process
Sobi awards research support on a highly competitive basis. Proposals will be reviewed by an ISS Evaluation Committee (ISS EC) consisting of Sobi personnel from medical affairs, research and development, biostatistics, and safety with ad hoc personnel as appropriate. In order to be approved for support by Sobi ISS EC, a study must meet all of the following requirements:
- The proposed research is aligned with Sobi’s research objectives and established areas of interest for the product.
- The study has a clearly specified and sound scientific rationale, meets a justifiable scientific need and will provide additional scientific knowledge.
- Research should be based on a thorough knowledge of the scientific background, a careful assessment of risks and benefits, have a reasonable likelihood of benefit to the population studied, be conducted by suitably trained investigators using approved protocols, and be subject to independent ethical review and oversight.
- The intent of the study is to obtain scientific data suitable for publication, preferably in a peer reviewed journal. The investigator agrees to disclose study information on relevant public databases, e.g., clinicaltrials.gov as appropriate.
- The study has sufficient power to meet the defined objective(s) and such calculation is based on sound scientific, statistical and clinical assumptions. For exploratory studies, the sample size should be justified and a rationale for the sample size included.
- The fundamental principle of respect for the individual, their right to self-determination and the right to make informed decisions regarding participation in research, both initially and during the course of the research must always be honored.
In addition to the scientific evaluation described above, the Sobi ISS EC will also ensure that requested funds are justified and reasonable and are commensurate with fair market value and that submitting investigators are eligible to conduct the proposed research.
Sobi’s local medical representative will represent the study proposal to the Sobi ISS EC. Therefore, it is highly recommended that investigators contact their local Sobi Medical Science Liaison (MSL) or local Medical Director prior to submitting a study proposal to address any questions and to ensure the proposal and associated budget are complete and compliant. Investigators who do not know who their local Sobi contact is should email for assistance.