The CONSERVE 2021 Statement for reporting changes in studies

September 7, 2021

A clinical study may undergo important modifications in response to extenuating circumstances such as the COVID-19 pandemic. The CONSERVE* 2021 Statement offers guidance for writing clinical study reports (CSRs) and clinical study protocols (CSPs) related to studies that undergo modifications that:

• have substantial implications at a scientific, ethical, feasibility, inferential or analytical level; and
• were prompted by unavoidable situations beyond the control of study investigators, sponsors, or funders.

CONSERVE 2021 is an extension to the core CONSORT 2010 and SPIRIT 2013 statements; it should be used in conjunction with these statements and their explanatory materials.

The CONSERVE statement incorporates:

• an implementation tool that provides a pathway to determine when CONSERVE should be used; and
• checklists to support authors in reporting how the study addressed important modifications in extenuating circumstances: the CONSERVE-CONSORT checklist and the CONSERVE-SPIRIT checklist.

The aim is to transparently report which extenuating circumstances have led to important modifications in randomized trials and trial protocols.

Our services include clinical study report writing and clinical study protocol writing. Every medical writer at Santé Active Édition – Synergy Pharm pays particular attention to keeping informed of new medical writing recommendations.

*CONSORT and SPIRIT Extension for RCTs Revised in Extenuating Circumstances