The FDA published a new draft guidance on August 10, 2018 entitled, Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics. The comment period for the draft guidance closed on October 12, 2018 and approximately 20 comments were submitted to the docket. The guidance provides sponsors with recommendations for designing and conducting first-in-human (FIH) multiple expansion cohort trials within their oncology development programs.
The true effect of an intervention is often not seen until real-world usage takes place, but with such a delay between R&D and healthcare delivery, how can the industry close the gap? And what is needed to deliver more effective interventions that patients really want?
Imagine your company just received FDA approval of a new pharmaceutical, the result of years of clinical research and difficult regulatory scrutiny. The product is being manufactured and is shipping to distributors and wholesalers. Providers and patient advocacy groups seem excited for the launch, and sales goals are considered aggressive. However, one key variable remains: coverage.
Commercial viability of pharmaceuticals depends on getting medicines to patients, which requires developers to evaluate investigative therapies using outcomes that are quantifiable, easy to interpret, and clinically relevant. However, clinical relevance is often a matter of stakeholder perspective: what developers view as meaningful may not appear as such to patients and caregivers.
In recent years, a growing number of pharmaceutical companies have recognized the potential benefits of pre-launch access programs, either as components of later-stage clinical development or early access programs or to support importation of drugs into countries recognizing an FDA or European Medicines Agency (EMA) approval.
Fall is in the air, and Halloween is just around the corner. I always associate Halloween with “The Wizard of Oz.” When I grew up, Halloween meant reruns of the movie and was a highly anticipated annual family viewing event. Dorothy, the Wicked Witch of the West, those creepy flying monkeys, and, of course, the Wizard. We all had our favorite characters, and my poor parents had to contend with my post-movie nightmares for days. But it’s the Cowardly Lion who's been on my mind recently.
“A bad system will beat a good person every time.”1 This quote by legendary management thinker W. Edwards Deming introduces the fundamental concept underlying process thinking. Process thinking, as the name implies, is a human factors-derived philosophy concerned with viewing the world through a process-oriented perspective. Processes are the essential components of our systems that enable them to execute their purpose: any set of steps designed to achieve an objective can be considered a process. The wide scope of this definition reflects the abundance of processes in all areas of our lives – both inside and outside the workplace. Based on this definition, a process is an objective-driven task.
This is the third article in a series examining strategies that allow quality groups to collaborate with good clinical practice (GCP) and good manufacturing practice (GMP) divisions to improve compliance, increase clinical study robustness, and enhance data integrity.
The high cost and failure rate of new drug candidates going through clinical trials are well documented and a recurring subject of research both by industry and academia.1 Further, the cost of drug development is a debated topic, and there is no consensus on what the “true cost” is because of the different methods used for these calculations.2 The lack of adequate comparable cost data and value measures also makes it difficult for pharmaceutical sponsors and trial sites to implement financial benchmarking for planning, costing, and budget management.
While controversy continues to simmer over who is accountable for posting results on ClinicalTrials.gov, perhaps the “results debate” masks the more challenging problem: ClinicalTrials.gov is not working for its intended audience.
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