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ImplementatIon ScIence In ClInIcal TrIals

Biopharmaceutical companies can prevent real-world challenges by asking the right questions during clinical trials.

The phases in the traditional research-to-practice pipeline differ in their questions and designs:

  • Pre-clinical: Basic scientific questions about disease and therapeutic targets.

  • Efficacy: Determines if an intervention works under ideal conditions (randomized controlled trials).

  • Effectiveness: Tests the intervention in real-world settings (observational studies or pragmatic trials).

  • Implementation: Explores strategies to put interventions into practice on a broad scale (mixed-methods, qualitative, and quantitative research).

By covering these phases, the research-to-practice pipeline ensures a comprehensive approach to developing and applying medical interventions, ultimately aiming to improve public health outcomes.

  • Randomized Clinical Trials (RCTs) are experimental clinical studies where participants are randomly assigned to intervention groups OR a control group and followed over a predetermined amount of time.
  • Biopharmaceutical companies are uniquely positioned to research and develop tools and strategies that can address provider and patient challenges for products in-development. These tools and strategies can help facilitate access to new therapies faster.

There are several types of studies to bring an implementation research component forward into traditional biopharmaceutical RCTs, including effectiveness-implementation hybrid studies.[1,2]

Hybrid studies can be started in the effectiveness stage of the research pipeline to help accelerate the adoption of interventions into clinical practice.

Some of the advantages of using effectiveness-implementation hybrid 
studies include:[2,3-4]

  • Accelerate the implementation of interventions into routine practice
  • Support the development of the more effective implementation strategies
  • Provide more useful information for researchers and decision makers

References:

  1. Adapted from: Westfall J, et al. JAMA 2007;297:403–6 
  2. Adapted from: Curran GMM, et al. Med Care 2012;50:217–26
  3. Landes S, et al. Psychiatry Res 2019;280:112513
  4. Bernet A, et al. Implement Sci 2013;8:1–2

NP-GBL-HVU-WCNT-250002 | January 2025

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