# A Narrative Review of the Strengths and Limitations of Real-World Evidence in Comparison to Randomized Clinical Trials: What Are the Opportunities in Thoracic Oncology for Real-World Evidence to Shine?

## TL;DR

This paper compares real-world evidence to randomized clinical trials, highlighting how real-world data can complement traditional trials in thoracic oncology.

## Contribution

The paper provides a narrative review of real-world evidence's role in thoracic oncology, emphasizing its potential and limitations.

## Key findings

- Real-world evidence can improve generalizability and assess efficacy in under-represented populations.
- Real-world studies have limitations in internal validity and confounding adjustment.
- Real-world data can complement RCTs in evaluating care patterns and outcomes.

## Abstract

Randomized clinical trials (RCTs) are considered the gold standard for the evaluation of new interventions and therapies. However, questions have been raised about the generalizability of findings from RCTs. Real-world evidence and real-world data have gained increasing attention as an alternative to data from RCTs. We undertook a review to examine the strengths and limitations of real-world evidence. Real-world evidence may improve the generalizability of clinical trial findings and the assessment of efficacy in under-represented populations. However, real-world evidence studies have poorer internal validity, are unable to adequately adjust for confounding, and have inherent biases in study design. Real-world data may complement existing data from RCTs and play an important role in evaluating patterns and outcomes of care.

Randomized clinical trials are considered the gold standard for the evaluation of new interventions and therapies. The results from randomized clinical trials are highly influential in treatment decision-making and decisions about the implementation of new therapeutic options within the field of oncology. This article describes a narrative review of the literature to further explore the strengths and limitations of real-world evidence in comparison to randomized clinical trials and provides a commentary on opportunities for real-world evidence in thoracic malignancies. However, randomized trials often exclude oncology patients with poorer functional status or comorbidities which are routinely considered for treatment in real-world practice. Real-world data may complement existing data from randomized clinical trials and play an important role in evaluating patterns and outcomes of care, informing everyday oncology practice. While real-world data is increasingly reported in the medical literature, strengths and limitations exist which can also limit their applicability. More work is needed to standardize methodologies for real-world studies.