Filling Evidence Gaps in Clinical Research

In a recent video interview with Applied Clinical Trials, Michael Andreini, president and CEO of the Multiple Myeloma Research Foundation (MMRF), discussed challenges in multiple myeloma clinical trials, including inefficiency, lack of focus on critical patient questions, and underrepresentation of diverse patient populations. Andreini also highlighted the Horizon clinical trial and how MMRF is working to address unmet need in the myeloma research space.

ACT: Despite many new therapies for multiple myeloma receiving FDA approval, why is there a lack of evidence for how to best use each treatment?

Andreini: Yeah, this is another great question, and taking a big step back, drug development led by biopharma companies appropriately focuses on proving out efficacy and safety for FDA approvals, right? And that's the right thing for biopharma companies to be focused on, but when new drugs come onto the market, that means that there's often a lack of evidence on how best to use these therapies in their approved indications, because they can't evaluate every combination and sequence and dosing schedule as part of that clinical development path to get the FDA approval, so this is where we, as an unbiased third party, as the MMRF, can really partner with biopharma companies to help fill in these evidence gaps, to inform, ultimately, what are the optimal uses of these agents and these approved indications.