real world evidence

Real World Evidence (RWE) continues to play an increasingly important role within the realm of healthcare, informing healthcare payers on the cost/health benefits of new-to-the-market medicines, or providing pharmaceuticals and biotechs with invaluble insights into new indications and label expansions for approved drugs.

real world evidence How can we harness the power of Real World Evidence?

Our Data Management team weighs in on considerations for RWE data collection.

Real World Evidence is any data gathered outside of conventional clinical trials through various means such as:

  • Electronic medical records
  • Patient registries
  • Observational/Non intervational studies
  • Wearable and other devices
  • Economic social indicators

In simple terms, RWD provides “the proof in the pudding…”, with data from groups of patients in real settings and under normal conditions. Although the robustness of conventional randomised clinical trials (RCTs) is the gold standard by providing efficacy and safety data used to inform product registration and prescribing in common clinical practice, rigid eligibility criteria restricts the data pool. This leaves many unanswered/unexplored questions.

This gap is being bridged by RWE.

The FDA, EMA and other regulatory authorities have for years used this Real World Evidence to further understand drug safety and efficacy once put on the market.

More recently, the pharmaceutical industry has shifted their focus in this area, many dedicating teams to RWE including health economists and epidemiologists . Thanks to advanced analytical techniques, data visualisation and intelligent machine learning, key links on diseases/comorbidities of interest within anonymised data are being found.

An opportunity to collect this critical data is presented in Observational non- Interventional studies. These studies collect data of interest either prospectively or retrospectively within routine clinical practice from large patient pools.

However, the larger volume of patients and data points present challenges to those responsible for data collection. Site compliance issues often arise, where conventional trials are seen as ground breaking, observational studies are not always viewed in the same way, and perhaps are less financially rewarding. Approaching these studies as stringently as convential trials from a data collection and cleaning prespective maximises the potential to obtain real life product effective and safety data. Using this approach, the data managers ensure the quality of the data collected is as robust as clinical trials with as few gaps as possible. The challenge is to delicately balance this with the flexibility and adjustment required to accomodate each patient’s usual routine of care. Again, patient centricity is key.

Site staff are key contibutors, sifting through volumes of data in order to fill in the EDC accurately. With this in mind, as many facilities in terms of data collection/reporting offered to sites as possible are rewarded with greater compliance. Stretching the EDC build budget as far as possible allows for:

  • clear, quick and concise data entry
  • ensuring that edit checks are programmed accurately to take into account the retrospective data collections
  • offering dynamic forms
  • ease of movement/view between repeat log forms

Without quality RWD, innovative RWE results cannot be achieved. This common goal requires collaboration, respectful handling of all data, and most importantly passion for optimal patient care.

patient centricity RWECROS NT understands the importance of conducting post-market studies to test the safety of drugs on patients, and we have extensive experience in providing statistical analysis and data management services for post-market trials to analyze “real world data”. We have conducted numerous studies in a wide range of therapeutic areas (including oncology) using both paper and electronic diaries.

Implementing patient-centered technology solutions has been an important enhancement in the collection and analysis of real world data. CROS NT has conducted post-market, observational studies implementing EDC systems, ePRO  and IoT devices in order to access data in real time and make critical decisions based on accumulated data. CROS NT also provides Sponsors with web portal access to clinical data through the implementation of a next-generation clinical data visualization tool which allows data analysis across multiple, disparate data sources.

References:

https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence

https://www.ema.europa.eu/en/documents/presentation/presentation-real-world-evidence-rwe-introduction-how-it-relevant-medicines-regulatory-system-emas_en.pdf

https://ec.europa.eu/health/sites/health/files/files/committee/stamp/stamp_9_41_2_en.pdf