Real-World Science and Late Phase
From full-service real-world late phase programs to standalone services that utilize cost-effective, decentralized strategies to deliver real-world data and observational studies.
A more efficient, cost-effective path from development to commercialization
Nontraditional data points, particularly real-world data (RWD) and real-world evidence (RWE), are becoming increasingly important in the current research climate, and Premier Research offers services to help you develop and execute a real-world data strategy from the very beginning of your development program.
Real-world data development planning, trial design, and regulatory strategy
Global regulators have started to embrace the use of real-world, unstructured data alongside traditional randomized control trial data, a paradigm shift that sets the stage for new, more creative approaches to drug development. This trend is paving the way for a more accelerated pathway to market for sponsors of the most innovative therapies, especially for developers of oncology, rare disease, and emergency use products.
Premier real-world data and evidence services help you:
- Determine which study designs and study endpoints are most meaningful for patients and caregivers
- Shed light on the existing population size and demographics, which can help better define inclusion and exclusion criteria and reduce screen failures
- Help identify the most appropriate study design and drug development pathway
- Reduce failures through improved protocol design
- Replace elements of the clinical trial process, thereby reducing drug development costs, lowering prices, and increasing incentives for life science research and development investment
Real-world late phase (RWLP) trials
In a multilateral shift, sponsors, payers, regulators, physicians, and patients are increasingly recognizing the value of real-world late phase data to clinical trials. RWLP data is invaluable in bridging the gap from development to commercialization and is a fast-growing segment of the clinical research space; some already view it as critical.
Premier Research’s RWLP trials serve as the critical bridge from clinical effectiveness to a commercially viable brand. They can be used to support:
- The evidence of value needed by payers to authorize and pay for drugs
- The evidence physicians need to prescribe a drug with confidence
- The right information for patients to continue using a drug, so they experience the desired outcomes
Well-designed real-world studies shorten timelines, lower cost, improve the impact of research investments, and get therapies to patients faster. Our offerings range from full-service programs to standalone services that utilize cost-effective, decentralized strategies to deliver real-world data and observational studies.
Benefits of a Real-World Data Strategy
- More accurate patient recruitment
- Faster trial design validation
- Establishing data trends to support endpoints
- Real-time access to data
- Support of fast-track regulatory submissions
- Better decision-making across the health care landscape
- Support 505(b)(2) submissions with RWD
- Link clinical trial data with RWE
- Manage regulatory and non-regulatory grade data in support of product development
RWD/RWE as a synthetic control arm
Single-arm trials demonstrate clinical benefit by showing the positive effects of a new therapy or treatment without the need to use a placebo or standard of care as a control. Instead, RWD and RWE comparisons — leveraging a variety of sources — can serve as the comparator.
How regulators are sizing up evidence today
Adopting decentralized trials and embracing real-world data allow trials to proceed at a time when typical site visits are fraught. Once global regulators are confident the data are still valid and clean, these processes are likely to be more widely implemented.