Real World Evidence

RWE with Ephicacy

Ephicacy provides Real World Evidence (RWE) analytics services to bridge the gap between Randomized Controlled Trial (RCT) information and Real World Data (RWD) helping clients achieve patient-centricity.

What are RWD & RWE?

RWD is any patient data collected after Randomized Clinical Trials have been completed and have led to adoption of treatment in the real world. Such observational data are needed to address payor and regulatory pressure to demonstrate the value, safety and effectiveness of approved products in a real world setting. Real World Evidence (RWE) is based on insights generated through analytics on RWD. The outlook for RWE is seen as promising as it offers the potential to improve health outcomes and the cost-effectiveness of new treatments.

Data Sources

Before EHR data was available, Companies and healthcare organizations relied on claims data and chart audits to help them understand how their products were performing in the real world. With the prevalence of EHR data, we are now able to effectively analyze RWD to generate RWE.

Real world information is typically obtained from

  1. Medical records (Charts & EHR)
  2. Claims
  3. Hospital
  4. Payor
  5. Economic

Together these data sources can provide a view of the healthcare ecosystem to help with the new drug discovery process and to measure the effectiveness of existing treatments.

Challenges

  1. Low quality data and lack of content
  2. Common standards not established yet for RWD
  3. Methods for analyzing and linking data is limited
  4. Lack of ways to measure the impact of RWE
  5. No governance for data governance and data sharing
  6. Concerns over privacy and data protection

How does Ephicacy help with RWE?

Ephicacy helps Companies address data analysis and linking (challenge 3) and impact measurement (challenge 4) for RWE with data protection and security (challenge 6).

Our approach to RWD & RWE is based on our deep expertise with patient data that includes clinical, EMR/EHR, hospital and lab data. We leverage this expertise to

  • Bridge the gap between RCT (Randomized Clinical Trials) information and observational patient experience
  • Generate deep insights for funding allocation, product performance in a competitive context, identifying new MD and patient targets
  • Understand the impact of value based systems that are becoming more relevant

Ephicacy built its data infrastructure, protection and privacy capabilities to handle both clinical data and real-world data. We are ISO 9001 (Quality) and ISO 27001 (Information Security) certified.

Ephicacy's Example Use Cases for RWD/RWE

Use Case 1: Real World Data and Real World Evidence are core requirements for outcomes-based contracts. Ephicacy helps clients with analytics that help draft robust contracts

Use Case 2: For payors, RWE can help them understand the answer to a key question such as which patients are the appropriate candidates for a drug.

Ephicacy's knowledge of data sources and statistical methodologies helps clients address this key question

Use Case 3: The value of RWD really comes from allowing products to be used with patients with different lifestyles, different age groups, that are outside the trial protocol.

Ephicacy's experience with both clinical trial data analytics and real world data analytics helps clients address the value of RWD

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