Informed and interactive study assessment, feasibility and planning
Oncopartners brings a totally unique methodology to the feasibility of running trials and meeting accrual goals within the IBPC network. Unlike our competitors, who often merely fax investigative sites a list of questions, the relationship between IBPC and Oncopartners allows us to work hand-in-hand with our investigative sites. On staff oncologists evaluate your protocol or protocol synopsis against the prevailing standard of care treatment and treatment therapies and drugs available through the public health system national cancer referral centers.
As part of the study assessment, Oncopartners on staff oncologists, IBPC network PIs (key leaders in Brazilian oncology societies and associations) and our regulatory professionals identify any issues or concerns relating to local Ethics Committee bodies, the national ethics committee (CONEP) and the Brazilian health ministry regulatory agency (ANVISA) submission and approval. Two issues are of paramount concern to each of the three regulatory bodies: 1) to ensure patient safety, ethics and benefits; and 2) to ensure that 100% of the cost of the research protocol and all related treatment and costs is funded by the international research sponsor according to the national legislation. IBPC, as a non-profit OSCIP status NGO founded by Brazil’s leading private and public oncologists to promote patient benefits, and with full access to network hospital sites, PIs and costing information, is recognized by each of the local EC, CONEP and ANVISA as a highly credible, reliable and aligned source of submission expertise and information relating to patient safety and benefit and study costs and as such receives the most favored treatment in regulatory submissions, feedback and approvals. OP provides best practice consulting advice on issues relating to the informed consent and protocol as they might affect approval by the EC, CONEP and ANVISA.
Our on staff oncologists and central office team will identify IBPC sites with the target patient population, standard of care practices and PIs and research staff required for your study protocol. Included are the development of referral strategies and the identification of referral centers for rare diseases, providing quick informal feasibility or full in depth feasibility according to the sponsor’s needs. Also provided are the projected patient enrollments per site, per month and across the selected network sites.
As needed, OP and IBPC can also provide estimates of study drug availability and cost, and a bottom up unit costing of the investigator grant and all related study procedures which can then be applied uniformly across all IBPC network sites