{'fraction_non_alphanumeric': 0.025896414342629483, 'fraction_numerical': 0.0007968127490039841, 'mean_word_length': 5.139364303178484, 'pattern_counts': {'":': 0, '<': 0, '<?xml version=': 0, '>': 0, 'https://': 0, 'lorem ipsum': 0, 'www.': 0, 'xml': 0}, 'pii_count': 0, 'substrings_counts': 0, 'word_list_counts': {'cursed_substrings.json': 0, 'profanity_word_list.json': 0, 'sexual_word_list.json': 0, 'zh_pornsignals.json': 0}}
ODAC, FDA Open Discussions of Accelerated Approval & Dilatory Confirmatory Trials

B ETHESDA, MD—In an unusual meeting of the Oncologic Drugs Advisory Committee, no votes were taken, no one argued about the fine points of efficacy or safety, and there were no debates about the validity of this or that clinical endpoint. Rather, the group was convened to discuss a number of pharmaceutical companies who have been dilatory about conducting Phase 4 clinical trials, otherwise known as post-market testing or confirmatory trials. These trials are required after accelerated approval. Or, as one FDA staffer who preferred to remain anonymous said, “The agency is going to take these guys [pharmaceutical company sponsors] to task and make them fulfill their obligations to finish the trials.” The official purpose of the meeting, as explained by Ramzi Dagher, MD, Medical Officer in the FDA Division of Oncology Drug Products, Center for Drug Evaluation and Research (CDER), was to review a number of past accelerated approvals and discuss the current progress of associated Phase 4 commitments, as well as to solicit input from ODAC members for improving the process. At one point during the meeting, held here last month, a member of ODAC remarked that the general public, and indeed most physicians, do not know the difference between full approval and accelerated approval. FDA apparently agrees, because one of the reasons Richard Pazdur, MD, Director of the CDER Division of Oncology Drug Products, convened the meeting was to make those distinctions clear. “Accelerated approval does not constitute the end of the application process,” he said. “The premise upon which accelerated approval in oncology drugs was established in the first place is that confirmatory trials will be an integral part of a comprehensive drugdevelopment strategy.” Dr. Dagher added that accelerated approval can be granted only under specific conditions: ■ If a disease is serious or lifethreatening. ■ When the drug appears to provide a clinical benefit not found in other drugs. ■ When it is based on a surrogate endpoint that is reasonably likely to predict clinical benefit. In oncology, endpoints include survival, improvement in patient-reported symptoms (clinical benefit), objective response rate, and time to progression. Another ODAC member emphasized that accelerated approval does not mean that the drug was “whizzed through” or that any of the usual steps for establishing safety and clinical efficacy were skipped.