SPIRIT 2013 clinical trial protocol guidelines issued

SPIRIT 2013 clinical trial protocol guidelines issued
A panel of experts, including trial investigators, trial coordinators, and representatives from ethics and regulatory agencies, has developed the Standard Protocol Items: Recommendations for Interventional Trials 2013 guidelines for the minimum content of a clinical trial, according to a statement published online Jan. 8 in the Annals of Internal Medicine.

(HealthDay)—A panel of experts, including trial investigators, trial coordinators, and representatives from ethics and regulatory agencies, has developed the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 guidelines for the minimum content of a clinical trial, according to a statement published online Jan. 8 in the Annals of Internal Medicine.

Noting that existing guidelines for protocols vary in their scope and recommendation, seldom describe development, and rarely cite stakeholder involvement or evidence to support their recommendations, An-Wen Chan, M.D., D.Phil., of the University of Toronto, and colleagues developed a 33-item SPIRIT checklist to serve as a guideline for the minimum content of a clinical trial protocol. The authors collaborated with 115 key stakeholders, including trial investigators; ; and representatives from research ethics, industry, and regulatory agencies.

The authors report that the checklist applies to protocols for all clinical trials, with a focus on content, and recommends a full description of the planned trial. The SPIRIT recommendations aim to facilitate drafting of protocols by offering a standard for content. The transparency and completeness of trial protocols would be enhanced by adherence to SPIRIT, benefiting investigators, trial participants, funders, ethics committees, and other relevant parties.

"An extensive range of stakeholders could benefit from widespread use of the SPIRIT 2013 statement and its explanatory paper. Pilot-testing and informal feedback have shown that it is particularly valuable for trial investigators when they draft their protocols," the authors write. "It can also serve as a for new investigators, peer reviewers, and research ethics committee or institutional review board members."

Several authors disclosed to the pharmaceutical industry.

More information: Abstract
Full Text

add to favorites email to friend print save as pdf

Related Stories

Extensive publication bias for Phase I drug trials

Feb 18, 2009

A study published in this week's issue of the open-access journal PLoS Medicine suggests that, in comparison to other types of trials, the results of Phase I drug trials are far less likely to be published.

New migraine clinical trial guidelines

Jan 24, 2012

Experts from the International Headache Society (IHS) have developed new recommendations for conduct of acute and preventive migraine clinical trials. The third edition of Migraine Clinical Trials Guidelines is now available ...

Recommended for you

What are the chances that your dad isn't your dad?

2 hours ago

How confident are you that the man you call dad is really your biological father? If you believe some of the most commonly-quoted figures, you could be forgiven for not being very confident at all. But how ...

New technology that is revealing the science of chewing

Apr 15, 2014

CSIRO's 3D mastication modelling, demonstrated for the first time in Melbourne today, is starting to provide researchers with new understanding of how to reduce salt, sugar and fat in food products, as well ...

After skin cancer, removable model replaces real ear

Apr 11, 2014

(HealthDay)—During his 10-year struggle with basal cell carcinoma, Henry Fiorentini emerged minus his right ear, and minus the hearing that goes with it. The good news: Today, the 56-year-old IT programmer ...

Italy scraps ban on donor-assisted reproduction

Apr 09, 2014

Italy's Constitutional Court on Wednesday struck down a Catholic Church-backed ban against assisted reproduction with sperm or egg donors that has forced thousands of sterile couples to seek help abroad.

User comments