Impact of Precision Medicine on Efficiencies of Novel Drug Development in Cancer

Menée à partir de données portant sur 15 anticancéreux ayant été autorisés par la "U.S. Food and Drug Administration" entre 2010 et 2014, cette étude évalue l'impact de la médecine de précision sur l'efficacité du développement de nouveaux anticancéreux

Résumé en anglais

Precision medicine offers opportunities for reducing the costs, burdens, and time associated with drug development. We examined time, number of trials, indications tested and patient burden needed to achieve first FDA license for all 5 novel anti-cancer precision-medicine drugs and all 10 novel non-precision medicine drugs receiving FDA approval 2010-2014. The 15 drug portfolios encompassed 242 trials: 87 for precision medicine drugs and 155 for non-precision medicine drugs. Embase and MEDLINE databases were searched for all pre-licensure clinical trials, and data on time, patient numbers, indications tested and total treatment-emergent grade 3-5 adverse events were measured from the first trial of each drug. We did not find patterns suggesting greater efficiencies in precision medicine compared to non-precision medicine. Gains in efficiency for precision-medicine drug development may be offset by challenges with recruitment.