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Increased Focus Being Placed On Using “Real World Evidence” In Regulatory Decision Making

Jobs For Epidemiologists Have Increased Several Fold

The traditional pathway to getting new drugs approved has been through the conduct of randomized control trials (RCTs). More recently, an intensifying focus on using non-clinical trial, real world data (RWD) and real world evidence (RWE) as part of a pathway to drug licensure is creating new possibilities and raising new challenges for all parties involved--- regulators, scientists, and drug and insurance companies. At the same time, this new pragmatism about observational data is creating a huge boost for epidemiologists already inside biopharma and is creating new job opportunities for others.

New Realities

These new realities were the focus of a presentation made by Amgen’s Cathy Critchlow at the recent American College of Epidemiology meeting in New Orleans last month. The session was organized around the theme of epidemiology in the current political climate, and she provided her thoughts based on her work in the pharmaceutical Industry.

According to Critchlow, RWD includes electronic health records, administrative/claims data, patient generated/reported data, prospective cohort studies, and other non-clinical trial health-related data such as that collected from wearable devices.

Questions Addressed

Among the types of questions being addressed or uses for RWE are a better understanding of a product’s benefit/risk profile and drug utilization in real world (clinical practice) settings, a better picture of the characteristics of patients most likely to benefit from a drug, better grasp of the patient response to therapy targets from genomics data linked to electronic health records, the extent of unmet medical need and size of populations that might benefit from specific drugs.


Some of the drivers for this invigorated interest in using non-clinical trial data comes from the fact that there are simply more and better data being collected from a variety of sources and computing power, methodology, and data science competency are “advancing significantly”, according to Critchlow. In addition, requirements embedded in the Prescription Drug User Fee Act VI and the 21st Century Cures legislation call for the Food and Drug Administration (FDA) to utilize real-world observational data and to evaluate the use of RWE in informing regulatory decisions.

Case Examples

Given the opportunities but at the same time the limitations of RWE, all parties involved are trying to decipher just how RWE can be effectively used. There are as yet no official standards by which to evaluate the quality of RWE, and this is a hot topic in the field, says Critchlow. Companies are beginning to accumulate a body of case examples to stimulate discussions of potential ways in which RWE could be used in reaching decisions about a variety of product labeling, drug safety, reimbursement, and other issues. The hope is that accumulating a body of case examples will together inform and help establish acceptable non-clinical trial data pathways to approval for drug utilization.


Needless to say, it is critical to ensure that any RWE used in regulatory submissions is of sufficient quality to enable valid assessment of a drug’s benefits and risks, yet increasing costs of drug development, the greater need to address questions that cannot be addressed by clinical trials, and the greater availability of RWD, all argue for taking a more pragmatic approach.


According to Critchlow, some of the issues being faced to allow for more impactful use of RWE are:

1) Data accessibility, quality, and standards

2) Interoperability of electronic medical records and other systems

3) Analytic methods that ensure study validity

4) Preserving data privacy

The Future

In looking toward the future, Critchlow told the ACE audience that she sees growing capabilities to leverage real world data to inform decision making by regulatory and reimbursement agencies. However, with greater use will come greater scrutiny, and valid study designs and methods will remain critical.  ■

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