Leading medical journals propose mandate on clinical data sharing

The International Committee of Medical Journal Editors (ICMJE) proposes new rules that will require authors to share clinical trial data as a prerequisite for their manuscripts to be considered for publication. The goal is to improve the benefit to society from the efforts of patients who volunteer to participate in clinical trials. The ICMJE proposal is outlined in an editorial published simultaneously today in Annals of Internal Medicine and 13 other ICMJE member journals.

"Enabling responsible data sharing is a major endeavor that will affect the fabric of how clinical trials are planned and conducted and how their data are used," writes lead author Darren Taichman, MD, PhD, Secretary, ICMJE and Executive Deputy Editor of Annals of Internal Medicine. "By changing the requirements of the manuscripts we will consider for publication in our journals, editors can help foster this endeavor."

The ICMJE defines a clinical trial as any research project that prospectively assigns people or a group of people to an intervention to study the cause-and-effect relationship between a health-related intervention and a health outcome. The ICMJE believes there is an ethical obligation to share data generated by interventional clinical trials because participants put themselves at risk. They say that sharing data should increase confidence and trust in the conclusions drawn from clinical trials, enable independent confirmation of results, and foster the development and testing of new hypotheses. If done well, data sharing will benefit patients, investigators, sponsors, and society.

The ICMJE is seeking and will consider feedback before it adopts new data sharing requirements. Comments are welcome at http://www.icmje.org/ and should be received by April 2016. It anticipates that new data-sharing requirement will go into effect for clinical trials that begin to enroll participants beginning 1 year after the ICMJE adopts the new policy.

About the International Committee of Medical Journal Editors
The ICMJE is a small working group of general medical journal editors whose participants meet annually and fund their own work on the Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals.

About Annals of Internal Medicine
Annals of Internal Medicine is one of the most widely cited and influential medical journals in the world, with an impact factor of 17.810 - the highest of any specialty journal in its category. Annals' mission is to promote excellence in medicine, enable physicians and other health care professionals to be well informed members of the medical community and society, advance standards in the conduct and reporting of medical research, and contribute to improving the health of people worldwide. Established in 1927, Annals is the flagship journal of the American College of Physicians (ACP).

Most Popular Now

Fasenra (benralizumab) receives US FDA approval fo…

AstraZeneca and its global biologics research and development arm, MedImmune, announced that the US Food and Drug Administration (FDA) has approved Fasenra (benralizumab)...

A great place to do great things: Developing game-…

Science has spoken: Abbott (NYSE: ABT) is, again, among the best science-based companies to work for in the world. For the 14th year, the journal Science today recognized...

Alzheimer's disease might be a 'whole body' proble…

Alzheimer's disease, the leading cause of dementia, has long been assumed to originate in the brain. But research from the University of British Columbia and Chinese scie...

Cancer cells destroyed with dinosaur extinction me…

Cancer cells can be targeted and destroyed with the metal from the asteroid that caused the extinction of the dinosaurs, according to new research by an international col...

Novartis confirms leadership in multiple sclerosis…

Novartis today announced it will present 54 scientific abstracts from across its multiple sclerosis (MS) research portfolio at the 7th Joint European and Americas Committ...

Amgen and Novartis announce expanded collaboration…

Amgen (NASDAQ:AMGN) and Novartis announced an expanded collaboration with the Banner Alzheimer's Institute (BAI) to initiate a new trial - the Alzheimer's Prevention Init...

Transplanted hematopoietic stem cells reverse dama…

Researchers at University of California San Diego School of Medicine report that a single infusion of wildtype hematopoietic stem and progenitor cells (HSPCs) into a mous...

Novartis announces the planned acquisition of Adva…

Novartis announced today, that it has entered a memorandum of understanding with Advanced Accelerator Applications (AAA) under which Novartis intends to commence a tender...

'Precision Medicine' may not always be so precise

Precision Medicine in oncology, where genetic testing is used to determine the best drugs to treat cancer patients, is not always so precise when applied to some of the w...

New tissue-engineered blood vessel replacements on…

Researchers at the University of Minnesota have created a new lab-grown blood vessel replacement that is composed completely of biological materials, but surprisingly doe...

China's out of control 'silent killer' affects one…

More than one-third of adults in China have high blood pressure - often dubbed the "silent killer" for its lack of symptoms - but only about one in 20 have the condition ...

New US study reveals key reasons why millions of p…

Few of the more than 90 million Americans(1) with obesity are seeking and receiving long-term obesity care, according to new data from the Awareness, Care and Treatment I...

Pharmaceutical Companies

[ A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Z ]