CMTP conducted a six-month initiative with the overarching goal of developing recommendations on methods and strategies to improve the validity, relevance and consistency of clinical research designed to assess the comparative effectiveness and value of oncology drugs used for off-label indications. As part of this initiative, CMTP convened a one-day multi-stakeholder New Indications for Oncology Drugs Think Tank to improve the systematic generation of evidence about the effectiveness of oncology drugs for new indications, providing a neutral ground to establish the steps necessary for improved evidence for drug therapy in cancer. A series of semi-structured interviews was also held with approximately twenty-five leading experts and stakeholders.
Ultimately, this will address the unmet medical needs of oncology patients by establishing the value of oncology drugs in new indications. To accomplish the goal, there is a need to reach consensus among experts and stakeholders on better ways to more frequently and consistently design, fund, and implement prospective clinical studies of new indications for oncology drugs that will be more informative to:
- Patients making decisions to enter, continue, or switch treatment
- Physicians making treatment recommendations
- Investigators designing clinical trials to improve treatment
- Professional societies developing clinical guidelines
- Producers of compendia drug information
- Expert panels making decisions about compendia listing
- Payers making coverage and reimbursement decisions