Concept Protocols: An Insider's Guide to Efficient Study Design

This resource from the Niche medical writing team offers insights into the benefits and best practices for creating concept protocols in clinical research.

It emphasizes that these short, flexible documents facilitate early team alignment and discussion on study design before extensive resource investment. The guide offers advice on what to include and exclude in a concept protocol, highlighting the importance of brevity and focusing on key study objectives and design elements.

Furthermore, it touches upon the evolving role of large language models in drafting protocols, noting their potential to expedite certain sections while underscoring the necessity of human oversight.

Ultimately, the source advocates for the use of concept protocols as a way to improve the efficiency and quality of full protocol development by addressing critical aspects early in the process.

April 7, 2025

- Tim Hardman

Download

Get our latest news and publications

Home Privacy policy Corporate Social Responsibility

Hi ✋

We help your business grow by connecting you to your customers.

Start A Conversation

Click here to chat with me!

Search our website now

Latest Posts

ApaTech

ApaTech was a medical device company that was involved in the manufacturing of orthobiologics, specifically the development of synthetic bone graft materials to enhance bone repair and regeneration.

Astex Pharmaceuticals

Astex employs its proprietary Pyramid™ platform to develop innovative therapies targeting challenging or “intractable” diseases.

MID-Frail Study

A significant European research project aimed at evaluating the impact of a multi-modal intervention on frailty and QoL in older adults.

RASP-UK initiative

The RASP-UK initiative, or Refractory Asthma Stratification Programme, is a UK-based research effort designed to transform the management of severe asthma by adopting a more personalized treatment approach.

FRAILomic

The FRAILOMIC initiative was an international research project aimed at improving the understanding, diagnosis and management of frailty in older populations.

Site Search

Type your Message