Designing the Right Clinical Trial to Yield the Greatest Value

A Registration Trial May Provide Data For Approval, But Is It Sufficient To Answer Treatment Decisions From Healthcare Providers And Payors?

Designing the Right Clinical Trial to Yield the Greatest Value

By: David Melnick, MD  and Cristina Larkin  January 7th, 2019 In today’s health care environment, a randomized, well-controlled trial must not only meet the requirements for approval, but just as importantly, it must encourage early physician use and provide payors a justification for payment. Today, we announced positive feedback from our pre-Phase 3 FDA meeting for SPR994 for […]

Antibiotic Drug Development:

By: Ankit Mahadevia, David Melnick, and Paul Ambrose March 26th, 2018 A recent analysis of drug development success rates from Phase I to approval found that the average infectious disease drug is 10 times more likely to succeed compared to the average oncology drug (a complementary analysis here–  different magnitude, same directionality).  Why? In our opinion, highly accurate […]