The Use of Not-Negative Conclusions to Describe Results of Formally Negative Trials Presented at Oncology Meetings

negative trials, not-negative conclusions, oncology

Out of 208 trials reviewed, 91 were formally negative. 29% (26 trials) had "not-negative" conclusions. Reasons for "not-negative" conclusions included better numerical outcomes, positive subgroups or secondary endpoints, and non-inferiority reinterpretations. The study emphasizes the need for c…

Feb 13^th • 2 mins read

Association of Industry and Academic Sponsorship With Negative Phase 3 Oncology Trials and Reported Outcomes on Participant Survival: A Pooled Analysis

pooled analysis, FDA, negative phase 3 trials, phase 3 trial, RCT, PRISMA, RCT's

In this study of trials published in 2016 through 2018, approximately 40% of negative phase 3 RCTs in oncology were conducted without supporting phase 2 trials, and such phase 3 trials were sponsored by both academia and industry. On the basis of our results, proactive steps from regulators and ethi…

May 10^th • 8 mins read

Magnitude of Clinical Benefit of Cancer Drugs Approved by the US Food and Drug Administration

antineoplastic agents, immunologic adjuvants, pharmaceutical adjuvants, phase 3 clinical trials, drug approval, drug labeling, medical oncology, united states food and drug administration, diagnosis, palliative care, surrogate endpoints, weight measureme

Regulatory agencies assess drug safety and efficacy, but thresholds may differ from those accepted by clinicians . Only 43.8% of RCTs for FDA-approved drugs meet the ESMO-MCBS threshold for meaningful benefit, reflecting potential softening of FDA standards. Encouraging trends include an increas…

Dec 13^th • 7 mins read

Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study

clinical guidelines, FDA, accelerated approval cancer drugs, surrogate measures, NCCN, EMA

Six of 18 cancer drugs that initially received accelerated approval have indications that remain on the labeling and are recommended in clinical guidelines despite no improvement in the primary endpoint in post-approval trials. These findings reflect the lack of fulfillment of the compromise between…

Aug 4^th • 12 mins read

Mechanistic Quantitative Pharmacology Strategies for the Early Clinical Development of Bispecific Antibodies in Oncology

bispecific antibodies, mechanistic quantitative, pharmacology, strategies, bsAbs, immune cells, MABEL aproach

Bi-specific antibodies (bsAbs) are crucial in cancer therapy research. BsAbs offer advantages such as enhanced efficacy and reduced systemic toxicity. Early clinical trials face challenges with dose selection and predicting effective doses. Clinical variability is influenced by factors like fun…

Jun 24^th • 18 mins read