Despite changing demographics in aging populations, regulatory guidance specific to drug development for geriatrics has been limited, with guidances dating back to the 1990s.
The Association of Clinical Research Professionals (ACRP) and The Avoca Group surveyed nearly 300 clinical trial study site staff earlier this year to determine the most important factors for advancing quality in studies from their perspectives. A total of 151 respondents assessed sponsor organizations and 130 evaluated contract research organizations (CROs). Respondents were asked to comment on up to three companies they’d worked with during the previous 12 months.
Unmet medical need (UMN) is not a new concept, but it is an increasingly important one. Regulators and payers are nudging the industry to steer R&D investments toward areas with higher unmet need and less crowded pipelines.
Our industry is unintentionally discouraging clinical research sites from investing in infrastructure. As a generalization, sites have the fewest resources of all the stakeholders involved in the successful execution of a clinical research trial. Most sites are very small and struggle to break even. Most sites have little to no IT infrastructure and can’t afford to build it. Most sites have staffing models where employees and physicians have too many disparate roles and responsibilities without the support or training to be successful. Employees are shared between research and non-research functions. The thin operating margins limit sites’ ability to build a meaningful, robust infrastructure, and this limits sites’ ability to be profitable.
Our rapidly increasing genetic-level disease knowledge and exponential technology advances are changing the way we manage health. But we may never fully seize these opportunities if we limit our clinical research approach to past models. Changing societal attitudes around sharing personal data and new consumer technology make innovative study designs and operations possible. This includes new possibilities in designing and operationalizing patient registries by moving to “virtual” setups.
It’s ruefully referred to throughout the clinical trial industry as the “one and done” phenomenon, and it’s a problem that has plagued us for years. The term refers to physicians and other medical professionals who jump into a trial to assume the duties of principal investigators (PIs). Unfortunately, many are completely or relatively inexperienced in clinical trials; they’ve taken on the role of PI in hope of adding a new revenue stream to their practice or boosting their academic credentials.
For the first time ever, GCP collaborations between the FDA and Medicines and Healthcare products Regulatory Agency (MHRA) were the focus of a workshop for the drug development industry. In what is projected to be the initial installment in a series, the FDA hosted the MHRA and invited interested individuals to join the workshop “Data Integrity in Global Clinical Trials — Are We There Yet?”
If we take for granted that there will always be new and changing processes, systems, and digital platforms and the organizational complexity within Big Pharma will not abate, how do we ensure we optimize the entire clinical trial process and make the best use of our technology and process investments?
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?
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