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.
Patient-centricity. Patient at the center. Voice of the patient. The pharmaceutical/biotech industry frequently uses these phrases when discussing the inclusion of patients and caregivers in clinical trial development. I used them when I was in the pharmaceutical industry, and they meant something to my R&D diversity and patient engagement team. We believed bringing patient and caregiver insights, experiences, and opinions into the drug development process was paramount. Without them, we wouldn’t understand their priorities and obstacles.
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 to accelerate products to market, improve patient outcomes and care, and drive cost efficiencies.
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?
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6(R2) regulations have created a buzz within the industry regarding newly required expectations for quality tolerance limits (QTLs) when conducting good clinical practice (GCP) clinical trials. QTLs have historically been required for good manufacturing practice (GMP) activities, inferring limits at which significant actions must be taken to ensure the manufactured product achieves quality and usability limits.
|
|
|
|
|
|
|
|
|