Reshaping the future of global clinical trials practice

Researchers at the University of Liverpool have developed a new international guideline to help standardise how results from clinical trial studies are reported. Use of the COS-STAR guideline, which is published in PLOS Medicine, could increase the efficiency and value of clinical research across the globe.

Every year, hundreds of thousands of members of the public are recruited into tens of thousands of clinical trials in health and social care, and thousands of researchers prepare systematic reviews to bring together the findings of existing trials.

Much of this effort can be wasted if the outcomes measured and reported are not those necessarily needed by health service users, practitioners, policy makers and others making choices between different interventions, actions and strategies.

To address these issues, a standardised set of outcomes, known as a 'core outcome set' (COS) can be used. These sets should represent the minimum that should be measured and reported in all clinical trials, audits of practice or other forms of research for a specific condition.

The credibility of a COS depends on both the use of sound methodology in its development and clear and transparent reporting of the processes adopted. However, to date there has been no guideline for reporting COS studies.

Now, an international group of researchers, led by Dr Jamie Kirkham and Professor Paula Williamson from the University of Liverpool, and made up of experienced COS developers, methodologists, journal editors, potential users of COS and patient representatives, have developed the COS-STAR (Core Outcome Set-STAndards for Reporting) Statement, which consists of a checklist of 18 items considered essential for transparent and complete reporting in all COS studies.

Professor Paula Williamson, Head of the University's Department of Biostatistics, said: "The current gap between clinical researchers, patients and other decision makers throughout the world needs to be closed.

"COS will be a key element in reshaping the future of global clinical trials practice, increasing the efficiency and value of the research process by reducing inefficiencies that arise when trials in similar areas measure the same outcomes in different ways.

"In order to realise this impact, COS studies need to be well-reported, and so the new COS-STAR guidelines will facilitate good reporting and therefore uptake."

Kirkham JJ, Gorst S, Altman DG, Blazeby JM, Clarke M, Devane D, Gargon E, Moher D, Schmitt J, Tugwell P, Tunis S, Williamson PR.
Core Outcome Set-STAndards for Reporting: The COS-STAR Statement.
PLoS Med. 2016 Oct 18;13(10):e1002148. doi: 10.1371/journal.pmed.1002148.

Most Popular Now

Therapy using dual immune system cells effectively…

A newly developed immunotherapy that simultaneously uses modified immune-fighting cells to home in on and attack two antigens, or foreign substances, on cancer cells was ...

How to develop new drugs based on merged datasets

Polymorphs are molecules that have different molecular packing arrangements despite identical chemical compositions. In a recent paper, researchers at GlaxoSmithKline (GS...

New drug combination effective against SARS-CoV-2 …

More countries with greater resources are opening up for a more normal life. But COVID-19 and the SARS-CoV-2 virus are still a significant threat in large parts of the wo...

Cleveland Clinic study suggests steroid nasal spra…

A recent Cleveland Clinic study found that patients who regularly use steroid nasal sprays are less likely to develop severe COVID-19-related disease, including a 20 to 2...

Sanofi to focus its COVID-19 development efforts o…

Recent positive interim results of Sanofi's mRNA-based COVID-19 vaccine candidate Phase 1/2 study confirm the company's platform robust capabilities and strategy in mRNA...

Discovery of mechanics of drug targets for COVID-1…

A team of international researchers, including McGill Professor Stéphane Laporte, have discovered the working mechanism of potential drug targets for various diseases suc...

Phase II/III trial shows Ronapreve™ (casirivimab a…

Roche (SIX: RO, ROG; OTCQX: RHHBY) today confirmed positive data from the phase II/III 2066 study, investigating Ronapreve™ (casirivimab and imdevimab) in patients hospit...

Pfizer and BioNTech receive first U.S. FDA Emergen…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced that the U.S. Food and Drug Administration (FDA) has authorized for emergency use a booster dose of the P...

AZD7442 request for Emergency Use Authorization fo…

AstraZeneca has submitted a request to the US Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) for AZD7442, its long-acting antibody (LAAB) com...

Pfizer and BioNTech receive CHMP positive opinion …

Pfizer Inc. (NYSE: PFE, "Pfizer") and BioNTech SE (Nasdaq: BNTX, "BioNTech") today announced that the Committee for Medicinal Products for Human Use (CHMP) of the Europea...

Boehringer Ingelheim acquires Abexxa Biologics to …

Boehringer Ingelheim announced the acquisition of Abexxa Biologics Inc., a biopharmaceutical company taking a new approach in the fields of immuno-oncology and oncology r...

GSK welcomes WHO recommendation for broad roll-out…

GlaxoSmithKline (GSK) plc welcomes and applauds the WHO recommendation for the broader deployment of GSK's RTS,S malaria vaccine to reduce childhood illness and deaths fr...