Purpose: New cancer therapies are frequently evaluated in multiple disease indications. We evaluated whether the probability of achieving US Food and Drug Administration (FDA) approval for a new cancer therapy changes with time.
Methods: We identified a cohort of anticancer drugs with a first registered efficacy trial from 2007 to 2011 on ClinicalTrials.
Elevated lactate concentrations are implicated in various acute and chronic diseases such as sepsis and mitochondrial dysfunction, respectively. Conversely, ineffective lactate clearance is associated with poor clinical prognoses and high mortality in these diseases. While several groups have proposed using small molecule inhibitors and enzyme replacement to reduce circulating lactate, there are few practical and effective ways to manage this condition.
View Article and Find Full Text PDFPatients endure risk and uncertainty when they participate in clinical trials. We previously estimated that 12,217 patient-participants are required to bring a new cancer drug to market. However, many development efforts are aimed at extending the label of already approved drugs.
View Article and Find Full Text PDFObjectives: To describe the delay for first-in-minor cancer clinical trials and its relationship with the Food and Drug Administration (FDA) approval.
Study Design: We used ClinicalTrials.gov to create a sample of pediatric-relevant cancer drugs starting efficacy testing in adults from 2006 through 2011.