New Guideline Lays Out Minimum Content of a Clinical Trial Protocol

By Zachary Brennan

- Last updated on GMT

New Guideline Lays Out Minimum Content of a Clinical Trial Protocol

Related tags: Clinical trial, Clinical trial protocol

Experts have created a new minimum content guideline addressing quality gaps seen in many trial protocols.

The guideline is the result of Canadian research that found more than half of clinical trials inadequately identified treatment allocation methods, about one quarter of trials failed to adequately describe their primary outcomes, and more than 40 percent of trials lacked adequate methods for reporting adverse events.

To address this, the guideline​ for the minimum content of a protocol was published in the Annals of Internal Medicine​ last week.

Comprised of a 33-item checklist called the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT 2013), the guideline calls for:

  • A specific measurement variable, analysis metric and  method aggregation and time point for each primary and secondary endpoint;
  • The estimated number of participants necessary to  achieve a study’s objectives and how that number was established; and
  • Details on which trial participants, care providers and  data analysts will be blinded in the study and how they will be blinded.

An-Wen Chan of the Women’s College Hospital in Toronto and a lead author of the guideline told Outsourcing-Pharma.com​ that the researchers are not focusing on a specific country or working directly with drug regulators at this time.

The guideline, however, does encompass parts of the International Conference on Harmonisation’s (ICH) Good Clinical Practice E6 guidance, as well as other requirements from the World Health Organization (WHO), International Committee of Medical Journal Editors and the U.S.-based ClinicalTrials.gov.

Funded by the Canadian Institutes for Health Research (CIHR), the Canadian Cancer Society and the Canadian Agency for Drugs and Technology, the draft checklist was pilot tested on University of Toronto graduate students in 2010 and 2011.

The CIHR told Outsourcing-Pharma.com​ that it awarded the grant for SPIRIT based on “a rigorous and meticulous review of the scientific merit​” of its application to ensure that it meets or surpasses “international standards of excellence​.”

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