There is more investment in lupus drug development than ever before, bringing renewed hope that these investments will expand our knowledge of the disease and how it’s treated. A key reason for this renewed hope is the patient voice, a factor that is even more critical in lupus because the disease impacts each person differently.
The current approach to clinical trial recruitment is prolonged, costly, and inefficient and often causes major delays and challenges for research across multiple disease states. The vast majority (85 to 90 percent) of studies in the U.S. experience significant delays in recruitment and enrollment. Nearly one-third of trials under-enroll, and only 7 percent meet their target enrollment number on deadline.
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.
Clinical research associate (CRA) turnover has long been a complex and challenging issue. We can recruit more CRAs, increase publicity in colleges, and introduce assessment standards. I could quote various statistics regarding turnover, but I won’t.
Over the last 10 years, the face of clinical research & development (R&D) and pharmacovigilance (PV) outsourcing has dramatically changed. What was a common industry scenario by 2010 — a full-scale operational pharma company utilizing both international and U.S.-based contract research organizations (CROs) to execute clinical investigator site monitoring and data management — has evolved into a new common scenario in 2019.
Today’s clinical trial partner is tomorrow’s post-approval patient. They are the experts who can shape a program over time, be a voice during the regulatory approval process, and provide insight on what other patients hope to find in a therapy.
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.
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.
To date, one critical SME has been left out when adopting an eTMF, whether it’s outsourced to a CRO to manage, outsourced to a third-party vendor, or maintained and managed in house at the sponsor (or some combination thereof — which is an article for another day!). Can you guess who that SME is?
Can patient recruitment for clinical trials be more efficient with more involvement by patient relations and market access directors?
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