Today's blog is guest written by SWOG Chief of Administration Nathan Eriksen
March 17, 2017 -
Precision medicine, and targeted treatment trials in particular, makes SWOG an attractive partner for biotech and pharmaceutical companies. We value and welcome these partnerships – and this column aims to help SWOG investigators forge effective and efficient collaborations with industry.
For industry, working with SWOG – and any member of the National Cancer Institute’s (NCI) National Clinical Trials Network (NCTN) – may mean learning new financial needs and different legal processes. For example, our large NCI grants support the basic infrastructure for developing, conducting, analyzing, and publishing studies. Our federal grants also pay our member institutions for enrolling patients on our trials and submitting data in accordance with our protocols.
But many costs are not supported by our federal grants. Our grants do not pay for:
- Screening assays for assignment of patients to targeted therapies
- Non-routine testing or assays for research purposes
- Costs of translational medicine research associated with a trial
- Drug distribution when there is no NCI cooperative research and development agreement (CRADA) or clinical trial agreement (CTA) in place
- Costs to design a study with U.S. Food and Drug Administration registration intent
For these costs, and others, we must rely on support from industry partners, or other targeted federal programs such as the Biomarker, Imaging, and Quality of Life Studies Funding Program (BIQSFP). SWOG requires that investigators work directly with our financial team in the group chair’s office at Oregon Health & Science University to develop study budgets, and to ensure that all budget elements are identified. Please do not submit a budget on your own. Reach out early in the process to Casey Dawson (email@example.com) or Pat Mize (firstname.lastname@example.org) for assistance.
Equally important is the understanding that, as an NCI funded organization, SWOG will use NCI infrastructure, including the Clinical Trials Support Unit (CTSU), the Regulatory Support System (RSS), the Oncology Patient Enrollment Network (OPEN), a common IT trial data management system (RAVE), and a common Adverse Event Reporting System (CTEP-AERS). These systems support SWOG’s work – but also limit our ability to be flexible with contractual terms that speak to these functions. Contracts must be executed with SWOG, and don’t include the investigator or their institution as parties. So it’s very important to work with SWOG’s contracts team as soon as an industry partnership has matured to the point that financial support seems likely. Please reach out early to SWOG contract attorneys Edith Van Putten (email@example.com) or Tristan Parker (firstname.lastname@example.org). They can also assist with understanding the process for executing confidential disclosure agreements (CDAs).
Also remember that:
- The study is a SWOG study – primary funding is from the NCI
- Regulatory and reporting responsibility belongs to SWOG
- Determination of whether an investigational new drug application (IND) or investigational device exemption (IDE) is necessary is made by SWOG in consultation with the pharmaceutical company
- Final IND/IDE determination is made by SWOG, which will contact the FDA, if necessary
- All data from SWOG trials, including analyses of results, translational medicine results, and publications belong to SWOG and, by contract, will be shared with partners
- SWOG contracts stipulate provision of data to industry partners
- Specimen use requires SWOG and NCI review and approval. Companies can request access to specimens, but this is not automatic. Don’t promise tissue for company use.
Please also reach out to the financial team in the group chair’s office early if you are planning to submit an R01 or other grant application in support of a SWOG study. We will be happy to help develop the trial-specific components of the study and provide a letter of support.
SWOG benefits greatly from our hardworking, entrepreneurial investigators – and we are eager to smooth the road for you in developing and activating a SWOG trial. We are here to help!