In August 2013, the FDA produced guidance on Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring. In March 2019, the agency produced an eight-page question-and-answer draft guidance seeking to provide additional insights and facilitate sponsors’ implementation of RBM.
The costs of drug development have increased exponentially over the years, while clinical trial participation and retention have decreased.1 Sponsor companies are seeking new and innovative ways to reduce costs while increasing patient participation by becoming more patient-centric. One such method is through designing a "siteless" trial. Siteless trials offer convenience to patients while being cost-efficient for sponsors.
“Patient-led drug development” has matured in recent years from an industry buzzword to a maxim practiced in pockets of pharma organizations each day. Yet, much more can be learned by looking through the patient lens, deeply considering their needs, and focusing on their quality of life. In recent years, companies have galvanized their efforts to develop additional methods for gathering patient input, to redesign clinical programs that improve patient experiences, and to track surrogate measures of “patient-centricity” at key stages.
Though estimates vary, it is generally accepted that a significant and unacceptable percentage of IT projects fail. According to a 2017 report from the Project Management Institute, 14 percent of all IT projects were total failures; a remaining 31 percent didn’t meet their goals, while 43 percent were over budget and 49 percent exceeded timelines. According to a Gartner survey, 20 to 28 percent (depending on the size of the project) of all IT projects fail. And McKinsey’s data shows, on average, IT projects run 45 percent over budget while delivering 56 percent fewer benefits than predicted.
In 2015, Vivli was launched as a centralized platform for those willing and able to share data. Vivli gained 501(c)(3) status, formed its executive leadership team, and held its first board meeting in 2017. That is the same year it began constructing a data sharing platform and research environment.
Pharmaceutical companies have three targeted users: physicians, pharmacists, and patients. Various digital platforms are used to create a good customer experience for educating these end users. The core focus is on patients driving patient care, education, and adherence.
Most in the life sciences agree that artificial intelligence (AI) will reshape the sector from R&D through commercial. Although AI has only just left the starting gate, and most activity is in exploratory phases, some benefits are starting to emerge. And there are pockets of early adopters trailblazing new approaches and seeking a competitive edge.
As the Otsuka VP of Applied Innovation and Process Improvement, Debbie Profit spends a lot of her time thinking about the future of clinical trials. “There are changes occurring in the industry that will force clinical development executives to shift their mindset,” says Profit. “I am trying to understand what clinical trial sites will look like going forward.”
Many companies are exploring ways to continue to innovate and bring novel drugs to patients while reducing the overall costs of drug development process. Enter… remote clinical trials.
For companies conducting clinical trials, study startup remains a major hurdle. A new report from Industry Standard Research (ISR) titled, eClinical Technology Adoption and Challenges in Study Startup, shines a light on the issues surrounding startup and how eClinical technologies are helping companies overcome these challenges.
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