CCTR Subsidies for PCRC Services and Setup Rates

Guidelines for Investigators to Request Consideration from Category 4 Study to Category 2

The priority of the Institute of Translational Health Sciences (ITHS) Clinical Research Center Network (CRCN) and the Seattle Children’s Research Institute (SCRI) is to conduct investigator-initiated studies, designated “Category 1”, whose funding sources are nonprofit organizations such as the National Institute of Health (NIH). However, under the new Clinical and Translational Science Award (CTSA), the CRCN can also be used for industry-sponsored studies, designated Category 4. In evaluating resource allocation and utilization in the CRCN, Category 4 studies are charged at full price and are not subsidized by the ITHS-CRC grant or the Seattle Children’s Research Institute’s (SCRI) Center for Clinical Translational Research (CCTR).

The federal government has recognized the need for research in rare diseases, as well as for the testing of therapeutic agents in children. Two congressional acts, the Orphan Drug Act of 1983 and the Best Pharmaceuticals for Children Act of 2002, facilitate the implementation of research in these areas. Consequently, NCRR guidelines permit clinical trials of drugs and other candidate therapies or interventions for rare diseases to be classified as Category 1, regardless of funding source (i.e. including industry-sponsored research).

A rare disease is defined as a) any disease or condition that affects less than 200,000 persons in the USA or b) affects more than 200,000 persons in the USA but for which there is no reasonable expectation that the cost of developing and making available in the USA a drug or other therapeutic agent for such disease or condition will be recovered from sales in the USA.

An industry-sponsored clinical trial must fulfill the following criteria in order to be considered for Category 2 status:

1. Classification by NCRR regulations of the disease being studied as a rare disease
2. Commitment by the Sponsor that the investigators will be allowed to publish the results regardless of the outcome of the trial
3. For multicenter Phase II and III trials, oversight of the protocol by an independent DSMB or safety committee, and establishment of a DSMP acceptable to the RSA.
4. Registration of trial on ClinicalTrials.gov

Determination of Category Study Type will be determined administratively at the time of budget submission.

Financial Requirements for Category 2 Studies:

If an industry-sponsored study is approved as a Category 2 study, the sponsor may receive a 25% subsidy as an investigator-initiated study if the investigator is a member of the ITHS, and in some cases up to 50% subsidy dependent on the investigator’s membership status in the SCHRI CCTR.