Real-World Clinical Trials

Icon: Two equal groups of people, with two different pills.

Lead: Hubert Wong

A clinical trial is a research study that prospectively assigns humans to one or more intervention(s) to evaluate the effects on health outcomes (World Health Organization, 2020). Traditionally, a trial is conducted in an idealized setting to give an intervention its best chance to demonstrate a beneficial effect and often involves: narrow patient populations, well-controlled settings, interventions delivered by experts, close monitoring during study follow-up, and emphasis on one primary outcome (often clinical efficiency).

A real-world clinical trial (also called a pragmatic trial) is a trial intended to answer how well interventions work beyond the traditional clinical trial setting. It seeks to include broad patient populations, deliver interventions in usual care settings using minimal extra resources, and evaluate multiple outcomes that are important to patients.

Consulting with researchers, policy makers, and practitioners, this Cluster:

  • identified 3 priorities to focus on:
    • Addressing real world limitations: making trials feasible and efficient in real world settings (constraints on blinding, randomization, sample size, operational procedures, ethical considerations).
    • Enhancing generalizability and individualized treatment: ensuring treatment needs in the broad population are addressed but with a focus on individual patient priorities (PROMs) and needs (precision medicine).
    • Leveraging external information sources: making use of non-trial information (published literature, health databases/medical records, expert opinion) to get answers more quickly and enhance the value of a trial.
  • funded 7 projects to address them

Browse the priorities and projects below, or use the interactive diagram to the right.

Browse the priorities and projects below.

Icon: Two equal groups of people, with two different pills.
Hubert Wong

Hubert Wong

Icon: Two equal groups of people, with two different pills.
Hubert Wong

Hubert Wong

Developing & Evaluating Causal Inference Methods for Pragmatic Trials

Pragmatic clinical trials, by their nature, capture complicated real-world settings. We are still developing methods to analyze this complex data accurately.

This project studied ways to account for data analysis where patients only receive part of the treatment—such as “partial treatment,” when a patient has to stop receiving treatment part way through the study.

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Latest Updates

Methods Section Blog

There’s still lots to learn about how to pragmatic clinical trials in BC. Hear from key partners in this work on what it will take to make it happen.

Real-World Clinical Trials lead, Hubert Wong, discusses in: “Why are Pragmatic Clinical Trials important for our health system?”

September 2021 Publication

The project, Increasing Statistical Efficiency in RWCTs asked: can we make medical research studies more efficient?

The team has published a paper exploring some of their findings in Computer Methods and Programs in Biomedicine: “CRTpowerdist: An R package to calculate attained power and construct the power distribution for cross-sectional stepped-wedge and parallel cluster randomized trials” via ScienceDirect.

July 2021 Publication

The team behind Evidence Synthesis of Pragmatic Clinical Trial Methodology, including Cluster leads Hubert Wong and Rick Sawatzky, have published a paper based on their work: a scoping review that focuses on methodology for unequal cluster size CRTs.

Read about “Methods for dealing with unequal cluster sizes in cluster randomized trials: A scoping review” in PLOS ONE.