How Do I Write a Clinical Development Plan?

By Dr Simon Cumiskey, Senior Lead Medical Writer at Mantra Systems Ltd. ?

A Clinical Development Plan (CDP) outlines the progression of a medical device’s development, starting from preliminary research (e.g., first-in-man studies, feasibility research, pilot studies) and leading to conclusive research, including pivotal clinical investigations and Post Market Clinical Follow-up (PMCF).?

The previous article in our series, “What is a Clinical Development Plan and when do you need one?”, covers when you may need to write a CDP. This article will guide you through the process of creating this critical document.?

Requirements Under the MDR?

ANNEX XIV, PART A, 1(a) describes the requirement for a CDP, which should indicate progression from exploratory investigations, such as first-in-man studies, feasibility and pilot studies, to confirmatory investigations, such as pivotal clinical investigations.?

Your CDP may describe the clinical investigations that will generate any new or additional clinical data necessary to address outstanding issues.?

What Are the Clinical Development Stages??

ISO 14155:2020 Annex I describes the various stages of clinical development. These include:?

• Pilot stage: These studies are used to capture preliminary information on a medical device at an early stage of device development. This may guide future design changes or clinical development plans.?Examples of pilot stage studies include first in human and feasibility clinical investigations.?
• Pivotal stage:?These studies are used to capture safety and performance data that confirm the clinical effect of a device. This data will act as a primary input to the clinical evaluation.?Examples of pivotal stage studies include confirmatory clinical investigations with an appropriate design, including a hypothesis and statistical analysis.
• Post-market stage: These studies are used to capture additional safety and performance data in real-world use.??Post-market stage studies can include any study design, including observational studies.?

Key Elements of a CDP

A well-structured CDP ensures clarity, regulatory compliance, and alignment with your development goals. Below are the essential components to include:?

• Executive Summary?

The executive summary provides a high-level overview of your CDP. It should briefly introduce the medical device, its intended purpose, the key objectives of the CDP, and the overall strategy.?

• Clinical Development Objectives?

Define the specific objectives of your CDP, such as demonstrating safety and performance, and collecting data to support desired marketing claims or additional clinical benefits.

• Clinical Investigation Strategy?

This section should outline the progress through the pilot, pivotal, and post-market stages of clinical development. Describe both the activities performed so far and those planned, including, where applicable, the objectives, hypothesis, design/method, subject demographics, results, and conclusions.

• Timelines?

Outline the expected timelines for each stage/activity in the Clinical Development Plan.?

• Resource planning?

Outline the resources needed to execute the plan, including personnel, clinical sites, and financial considerations.?

Conclusion?

A clear and concise CDP can not only ensure regulatory compliance but also describe the process through which additional clinical evidence can be generated throughout the lifecycle of the medical device. This will be crucial for demonstrating that you have met your regulatory obligations while ensuring the successful commercialisation of your product.