The Food and Drug Administration and National Institutes of Health made recent headlines by announcing a draft protocol template for clinical trials. The template is meant to promote efficiency and accuracy and fill in the gaps left by International Council for Harmonization guidelines. For most of the month of April, the draft is open to public comment.
TransCelerate, a nonprofit organization, has a similar common protocol template (CPT) under development. In a blog post announcing the new template, Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, acknowledged TransCelerate’s efforts, saying that the FDA and NIH intend to work with the organization in the future.
Though the two templates, as they exist now, are targeted to different audiences, those in the medical research community might wonder which is best to use. To help you navigate your choices, we’ve completed a side-by-side comparison of the two templates:
Who are the creators?
TransCelerate: On its website, TransCelerate said that “industry stakeholders and regulators” are working with the organization to create the template and bring it to electronic form.
NIH/FDA: Representatives from NIH and FDA medical product centers created the draft, but they are seeking outside help from investigators, sponsors, review board members and stakeholders involved in protocol development.
“This choice is up to your discretion and needs.”
What are the proposed benefits?
TransCelerate: The nonprofit believes the CPT will offer improvements throughout the entire clinical development process for all stakeholders, including regulators, sponsors and patients. In summary, these benefits range from increasing information access to furthering simplicity and improving collaboration and consistency.
NIH/FDA: The emphasis of this template is to provide a standard outline so investigators writing phase 2 or 3 clinical trial protocols can better follow the guidelines outlined by both the ICH and the International Organization for Standardization (ISO). This is meant to increase efficiency and reduce the likelihood of error while avoiding any creative restrictions on the research.
“Our goal is to provide an organized way for creative investigators to describe their plans so that others can understand them,” said Dr. Pamela McInnes of the NIH.
Which is better?
If you’re still wondering about the choice between TransCelerate and NIH/FDA, the truth is, this choice is up to your discretion and needs. Because the two currently intend to help investigators with different goals, the new template offered by the NIH and FDA doesn’t have to derail you if you are leaning toward the common protocol template being developed by TransCelerate. If your concern is ensuring accuracy, and alignment with either format, consider leveraging a structured approach to authoring. With this in mind, you can make sure you’re creating and organizing the right information with quality, speed and accuracy. To echo the points of these templates, structure allows you to save time and resources to focus on the other aspects of clinical research.