Nearly one in three clinical trial protocols require avoidable amendments, according to a study from Medidata.
The combined cost of the delays caused by these amendments averages at over half a million dollars for Phase III trials, and increase the average trial duration by three months.
It is therefore unsurprising that the NIH-FDA Joint Leadership Council have addressed these losses with a new CTP template, promoting more efficient and accurate development of CTPs. It is hoped this development will streamline the trial process from the ground up, getting medicines on the market faster.
Saving time and money
Aimed at clinical investigators, this template provides instructions and sample text for each phase of the trial, including objectives, trial design, methodology, statistics, and trial logistics. By guiding investigators through the process of creating clear, compliant documents, the template will ensure all parties involved with carrying out clinical procedures are on the same page.
Whereas previous CTPs, which differ in format from company to company, took up to 30 days to be approved, this standardised format will make it quicker and easier for regulators and review boards to set the wheels of the trial in motion.
Reflecting the International Conference on Harmonisation (ICH) E6 Good Clinical Practice guidelines, the template also includes specific FDA guidance on human subject protection and patient-centricity, ensuring the next wave of trials will be designed with patient matters truly at their cores.
Data quality is another concern that the protocol addresses, ensuring all parties involved in gathering and analysing data are given clear guidelines as to avoiding misleading or poor-quality observations.
Most interestingly, the template has been created with significant input from the public, including nearly 200 comments from over 60 individuals with experience across the clinical trial process.
This is a significant step in crowdsourcing pharmaceutical information and advice from those affected by it. Medical crowdsourcing has been used by companies such as CrowdMed and SERMO for some time, gathering valuable knowledge from physicians to be shared with patients and professionals across the globe. However, this is the first time central authorities have actively crowdsourced comments to be used in an official document.
Significantly, the template has taken several cues from a separate protocol template developed by the private sector organization, Transcelerate Biopharma. This document, which was designed for industry-sponsored research, was built with the goal of developing a common structure and model language to be used across the industry.
Utilising feedback from stakeholders across the industry, as well as libraries to ensure localised and comprehensible clinical information, the company refers to it as “a foundational element in the longer-term movement towards an electronic protocol.”
The future of trial design
This reliance on combined public experience - creating a template that will speak for all who use it - is an edifying sign toward a future in which collective information has core value in the healthcare industry.
While this guideline has utilised advice from professionals across the industry, we can imagine this paradigm taking patient centricity to new heights, allowing those most affected by clinical trials to have a say in their design