WITH REAL-WORLD EVIDENCE, ACCESS TO DATA IS JUST THE START
The use of real-world data (RWD) is already common in post-launch observational studies. Data extracted from health records, medical claims, billing databases, medical registries, patient-generated data, mobile devices and other sources are an established way to enhance understanding of drugs that are already on the market.
As our experience grows, so are the opportunities we see to extend the use of RWD to answer both safety and effectiveness questions. And not only in observational studies, also in randomised trial settings (pragmatic trials), to transform RWD into a key source of evidence in a drug development programme.
Advances in the use of RWD sources further fuel the potential for real world research. Notable among these is the mining of structured and unstructured data in electronic medical records. Combined with natural language processing, mapping and integration with other RWD sources, this creates unprecedented opportunities. Registry-based trials and trials within cohort approaches are driving the feasibility, affordability and validity of large programmes with increasingly international reach.
As RWD will progressively need to include Patient Reported Outcomes (PROs), the future of clinical research will be increasingly characterised by blending clinical data and PROs, including the use of smart applications and other digital media.
This step-change from real-world data to real-world evidence involves more than including RWD earlier in drug development. Besides ensuring the best data for a particular study, turning RWD into RWE involves having a thorough understanding of the methodology and the data science required. Our methodological expertise ensures the correct design choices are made at the outset. This, combined with our operational expertise, delivers the required evidence.
REAL-WORLD EVIDENCE AT JULIUS CLINICAL
Julius Clinical’s RWE specialists and data scientists are academic thought leaders in real-world evidence, real-world data and the creation of tailor-made studies. This includes being leading members of the EU IMI GetReal Initiative . Through this, we combine established expertise in RWE methodologies with Julius Clinical’s know-how in data sourcing, study execution and managing extensive scientific networks. As a key partner in the IMI Trials@Home project , Julius Clinical is also at the forefront of technology-driven solutions for clinical studies and has the knowledge, expertise and resources to design and conduct studies that include such approaches.
The result is that we can help design and execute RWE study programmes that are truly tailored to the needs of Sponsors, regulators and HTA bodies. Whether this involves a (pre-launch) pragmatic trial or a (post-launch) observational study, we can help:
- angle studies towards efficacy or effectiveness,
- establish the safety profile of a particular drug,
- investigate possible legacy effects of a treatment or.
- determine how to differentiate a drug in an already crowded space.
BENEFIT FROM OUR INVOLVEMENT IN RWE
- Methodological expertise: Our RWE specialists are members of the IMI GetReal Initiative to promote new and robust real-world evidence methodologies and have ample expertise regarding RWE studies.
- In-depth know-how of RWD sources and data science: Our data scientists are part of the IMI BigData@Heart programme to deliver scalable RWE insights for drug development and personalised medicine and have extensive experience in distributed data sources and the required data extraction, mapping, transformation and loading processes.
- Innovative approach: We are involved in IMI Trials@Home and are experts in risk-based monitoring, which is especially important in relation to pragmatic trials.
- Operational expertise: Julius Clinical is a scientific leader in randomised clinical trials, we have a thorough knowledge of the full Phase I – IV development spectrum.
- RWE infrastructure: Julius Clinical has a global reach, with international scientific investigator networks.
- An agile organisation: With short internal communication and reporting lines so that we can react quickly to study requirements as well as to the changing RWE landscape and adapt processes to optimise study outcomes.
RWE STUDIES YOU CAN TRUST AND ACT ON
Knowledge gained from well-designed and flawlessly executed RWE studies offer benefits all round. It enables prescribers to offer the optimal treatment, enables patients to know what to expect of a treatment and helps decision-maker to determine whether a treatment is adding value. With Julius Clinical as RWE partner, Sponsors can be confident that they are working with an academic and clinical research leader in this specialised field. And that they will get the evidence they need.