Key differences between study reports for medicines (pharmaceuticals) and devices (medical devices)

Understanding the key differences between how a study reports information for medicines and medical devices is crucial for professionals navigating the healthcare sector. These two brackets, which ensure patient care, follow distinct and unique developmental strategies, and have different regulatory requirements and evaluation criteria. This blog delves into the key differences, shedding a light on how study reports for medicines and medical devices are tailored to their own fields.

Regulatory Framework

Regulatory frameworks are a set of guidelines and rules established by authorities that are put in place to ensure consistency of standards, ethical operation, and safety. Medicines are regulated by regional authorities including the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe¹. The principal guidelines directing study submissions is the ICH E3 guideline, which outlines the structure and content of clinical study reports (CSRs) for pharmaceuticals². Medical devices are subject to regulatory frameworks that include ISO 14155 for clinical trials using medical devices on human beings and the FDA’s 21 CFR Part 820^3,4.

Different standards may apply to the structure of study reports (clinical investigation reports [CIRs]) for devices compared with pharmaceuticals. For example, medical devices may adhere to the Global Harmonisation Task Force (GHTF) recommendations for the Summary Technical Documentation (STED)⁵.

Study Design and Requirements

The structure of a study’s design can vary depending on whether its focus is on a pharmaceutical or a medical device. Each has it owns unique set of methodical stages, that include tailored outcomes suited to either category.

Clinical trials for medicines typically progress through phase I, phase II, phase III, and phase IV. Phase I clinical trials are centred around safety, followed by phase II which tests efficacy and dosage. Phase III confirms the efficacy in the intended population for treatment and continues monitoring adverse effects. Phase IV follows drug approval, focussing on post-marketing surveillance⁶. Clinical trials for medicines focus heavily on pharmacokinetics, pharmacodynamics, and long-term safety and efficacy.

On the other hand, medical device trials are based on the device’s classification; class I, II, or III¹. Class I constitutes to low risk of illness or injury (eg, gauze or toothbrushes). Class II suggests a moderate risk of illness or injury (eg, sutures or needles). Finally, class III conveys a significant risk of illness or injury (eg, pacemakers or implantable defibrillators)¹. Medical device studies tend to have an engineering performance emphasis, as well as investigating biocompatibility, usability, and comparative effectiveness. They may also include bench testing, animal testing, and clinical evaluations, but do not always follow a phased approach like medicines.

Reporting Structure

Study reports for medicines and medical devices differ in their content, each focussing on different subheadings of information.

Study reports for medicines (CSRs) typically follow the section structure: introduction, objectives, methods, results, discussion, and conclusions^2,7. They focus on detailed statistical analysis, adverse event reporting, pharmacokinetic and pharmacodynamic data, and comprehensive efficacy results.

Study reports for devices (CIRs) tend to follow a different structure surrounding device evaluation. They include detailed descriptions of the device design, manufacturing process, performance standards, and risk analysis⁴. Clinical evaluation reports for devices also address clinical benefits and risks, user experience, and device-specific safety and performance data.

Data and Analysis

Due to their distinct regulatory requirements, the method of collecting, analysing, and presenting data in study reports varies somewhat between medicines and medical devices. These variations demonstrate the different focuses in assessing the safety, effectiveness, and functionality of each category.

In later phases, CSRs for medicines focus heavily on clinical data, including detailed statistical analyses of primary and secondary endpoints, subgroup analyses, and adverse event tables². The emphasis is on demonstrating statistical significance and clinical relevance of treatment effects.

CIRs for medical devices typically include data centred on performance. Data surrounds validation and verification of the device against pre-defined standards. This may include mechanical testing data, software validation, and real-world usability testing⁴. Clinical data is also important but may be presented slightly differently than in CSRs. In clinical evaluation reports, it often focuses on case studies, user feedback, and comparative studies.

Post-market Surveillance

Post-market surveillance refers to the monitoring of medical products, including medicines and medical devices, after they are released to the market. This stage in development is crucial to ensuring safety, efficacy and performance of these products within the wider population.

For medicines, this is considered phase IV of drug development. It utilises observational studies and registries to track safety and efficacy. A vast amount of data is collected which assists in determining any long-term effects, rare adverse effects, and drug-drug interactions⁶.

For medical devices, post market surveillance focusses on post-market clinical follow-up studies⁸. Furthermore, due to the nature of devices, the emphasis is on user feedback, reporting on efficacy, ease of use, safety, and overall satisfaction. This aids in continued compliance of safety and performance standards while the device is being used in the wider population⁸.

Conclusion

Understanding the differences between study reports for medicines and medical devices is crucial. Pharmaceutical reports focus on structured phases, safety, efficacy and long-term monitoring, guided by the FDA and EMA regulations. Medical device studies emphasise performance, usability and safety of the product, following ISO 14155 and 21 CFR Part 820 guidelines. These distinctions reflect specific regulations for medicines and medical devices, ensuring both types of products meet rigorous standards for efficacy and safety.

References

1. Van Norman GA. Drugs and devices: comparison of European and U.S. approval processes. JACC: Basic to Translational Science. 2016;1(5):399-412.
2. European Medicines Agency (1996). ICH Topic E 3 Structure and Content of Clinical Study Reports Step 5 NOTE FOR GUIDANCE ON STRUCTURE AND CONTENT OF CLINICAL STUDY REPORTS. [online] Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-3-structure-and-content-clinical-study-reports-step-5_en.pdf (accessed August 2024).
3. FDA (2019). CFR – Code of Federal Regulations Title 21. Fda.gov. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1 (accessed August 2024).
4. ISO. 2020. Clinical investigation of medical devices for human subjects – Good clinical practice. Available at: https://www.iso.org/standard/71690.html (accessed August 2024).
5. Global Harmonization Task Force (2011). GHTF/SG1/N063:2011 FINAL DOCUMENT Global Harmonization Task Force Title: Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices Authoring Group: Study Group 1 of the Global Harmonization Task Force. [online] Available at: https://www.imdrf.org/sites/default/files/docs/ghtf/archived/sg1/technical-docs/ghtf-sg1-n063-2011-summary-technical-documentation-ivd-safety-conformity-110317.pdf (accessed August 2024).
6. Kandi V, Vadakedath S. Clinical trials and clinical research: a comprehensive review. Cureus. 2023;15(2):e35077.
7. Bandholm T, Thorborg K, Ardern CL, Christensen R, Henriksen M. Writing up your clinical trial report for a scientific journal: the REPORT trial guide for effective and transparent research reporting without spin. Br J Sports Med. 2022;56(12):683-91.
8. Pane J, Francisca RDC, Verhamme KMC, et al. EU postmarket surveillance plans for medical devices. Pharmacoepidemiol Drug Saf. 2019;28(9):1155-65.