Speakers
Jeffrey A. Spaeder, MD
Chief Medical and Scientific Officer
Senior Vice President
IQVIA
Adrian F. Hernandez, MD, MHS
Executive Director
Duke Clinical Research Institute
Vice Dean
Duke University School of Medicine
Keywords
Clinical Research; Clinical Trials; Industry Trials; Accelerating Research
Key Points
- The U.S. lags behind in recruitment for cardiology trials. Even though the U.S. has the most sites, significantly fewer patients are enrolled. These trends suggest underlying legal, regulatory, and cost-related barriers, highlighting the need for improved clinical trial infrastructure.
- Additionally, teams are growing, trust in science in the U.S. is low, and some health trends, such as obesity, hypertension, and diabetes, are going the wrong way. The U.S. leads avoidable deaths per 100,000 and could fall further behind, all while health care costs are rising.
- If you are looking at the value of healthcare that is delivered in the U.S., we pay more than other countries but have worse outcomes. Healthcare expenses account for about 28% of the U.S. Federal budget. More than 90% of the volume of prescription drugs are generic with the exception of immunology, obesity, and diabetes. Retail net pricing of prescription drugs in the U.S. accounts for only 14% of all healthcare expenditures. These factors may lead policymakers to see an imbalance of expense to outcome.
- This means for clinical trials there is an increased focus of using real-world data to make informed decisions, shorten timelines, and inform efficacy and safety. It will also be important to make sure endpoints are clinically relevant and more of an emphasis on strategy-focused research. There may also be more of an emphasis on improving outcomes from a lens of prevention
- In industry, biopharma funding levels are increasing, with an emphasis on later-phase assets, and funding trends have returned to pre-COVID-19 levels. An increasing proportion of studies are initiated by emerging bio-pharma (EBP) sponsors. While overall measures of complexity has increased modestly, sites have experienced a greater increase – and so have study participants.
- If there is a desire to increase industry-sponsored or other types of studies at academic medical centers, contracting timelines must be reduced, intellectual property causes significant churn with little value, IRB staffing and responsiveness is critical, cost and efficiency need to be appropriate value for expense, and principle investigators need to have actual availability for study activities.
Discussion Themes
-The U.S. conducts more clinical trials on rare diseases than other countries. Does that impact the numbers? The data from this presentation was from cardiovascular trials. The data was from common chronic cardiovascular diseases. The U.S. is an attractive place to conduct studies because the FDA regulatory timelines are predictable and fast, and the U.S. market is attractive, but enrollment per site is generally lower than it is elsewhere.
-How has IQVIA looked at drivers of cost and efficiency? Cost per patient has increased, driven by the complexity of studies and how imaging and other tools get built into studies. Investigators are trying to make studies more patient-centric, collecting data remotely, making visits fewer. There has also been an increased duration of studies, which is more costly. Time has real cost implications for sponsors.
-Is decentralization of trials a solution? It can be – hybridization can be helpful. How can you meet the patient where they are. You need clinician engagement but there are a lot of things that happen from beginning to end that could be decentralized. It has to be used selectively in the right situation.
-Is a centralized IRB a solution? They have real value if they have expertise and fast turnaround time – if they are credible, rigorous, and have experienced staff. In some situations, studies use a centralized IRB and then go through an institutional IRB as well.