The value of comparative effectiveness research: projected return on investment of the RxPONDER trial (SWOG S1007).

OBJECTIVE

The objective of this study was to assess the value of research of the RxPONDER study, an ongoing comparative effectiveness RCT designed to evaluate a 21-gene profile in early stage, node-positive breast cancer.

METHODS

We developed a disease-based decision-analytic model to compare use of the 21-gene profile versus standard care. Key clinical data were derived from SWOG-8814, an RCT of chemotherapy in lymph node-positive breast cancer. Other model parameters were obtained from published sources. Probabilistic simulations and value of information calculations were used to assess the expected value of sample information (EVSI) and the expected value of sample parameter information (EVSPI).

RESULTS

The cost of the RxPONDER trial is expected to be at least $27 million. The expected value of research of the RxPONDER trial ranged from $450 million to $1 billion, representing a return of 17 to 39 times the projected cost of the trial. The primary objective of RxPONDER, to assess survival, had the largest estimated value relative to other model inputs. The value of RxPONDER increased by $50 million to $100 million after stakeholder input on additional data collection.

CONCLUSION

The RxPONDER study appears to represent a good investment of public research funds. Stakeholder engagement and assessment of the return on investment should be considered to optimize and quantify the value of comparative effectiveness studies.