REWARD / EQUATOR Conference 2015 Edinburgh, UK 28-30 September 2015

 

REWARD people on a hillThe 2015 REWARD / EQUATOR Conference

Increasing value and reducing waste in biomedical research

28-30 September 2015, John McIntyre Conference Centre, Edinburgh, UK

Click on the links below to watch each day of the conference as it happened (YouTube). We will provide links and descriptions for each individual presentation in due course.

Monday 28 September
EQUATOR / EASE expert session for journal editors:
How to publish `fit for purpose’ research papers and make your journal stand out
YouTube video; Day one programme
(Click talk titles below to download presentation pdfs where available)

Why: Deficiencies of the research literature (Doug Altman)
Who: Who should be involved in improving research publications (Elizabeth Wager)
What: What can be done by editors to influence other players and to change their own practices (David Moher)
How: How to implement effective interventions (Ana Marusic)
EQUATOR: Reporting guidelines and other resources for editors (Iveta Simera)
Towards successful implementation of reporting guidelines at biomedical journals (Jason Roberts)
Completing the published record: a thread of evidence (Daniel Shanahan)
Minimizing waste: sex and gender equity in research (Shirin Heidari and Sylwia Ufnalska)

Tuesday 29 September
Meeting Launch
YouTube video; Day two programme

REWARD
Recap on The Lancet Series (Rustam Al-Shahi Salman)
Who’s listening to the Lancet Series? (David Moher)
Life after the Lancet Series (Joan Marsh)
EQUATOR Network: promoting research reports that are fit for purpose (Iveta Simera)

STAKEHOLDER PLENARY: FUNDERS
Reducing Waste: the Scottish Experience (Andrew Morris)
NIHR: Adding value in research (Matt Westmore)
Improving quality and reducing waste in research funded by NHMRC (Davina Ghersi)
Research waste: view from a global research foundation (David Carr)

STAKEHOLDER PLENARY: PUBLISHING AND PHARMACEUTICAL INDUSTRIES
What can journals do to reduce research waste? View from the BMJ (Trish Groves)
Systematic reviews can prevent and create waste: what is Cochrane doing? (David Tovey)
COPE’s role in reducing waste – it’s not just about publishing (Virginia Barbour)
GSK (Stephen McDonough)

STAKEHOLDER PLENARY: RESEARCHERS AND REGULATORS
Science in transition (Frank Miedema)
Trial Forge: working together to make trials more efficient (Shaun Treweek)
Health Research Authority (Janet Wisely)
Innovation and Clinical Research (Louisa Stuwe)

Wednesday 30 September
YouTube videoDay three programme

The talks included the EQUATOR Annual Lecture (at 3:12:41 on YouTube video) presented by Dr Luis Gabriel CuervoSenior Advisor for Research Promotion & Development, Office of Knowledge Management, Bioethics and Research, Pan American Health Organization.
Please scroll to time 3:12:41 to listen to his lecture.  Download the slides and notes from this lecture and click here for more details.

STAKEHOLDER PLENARY: THE GLOBAL VIEW
Reducing research waste in Sub-Saharan countries (Nelson Sewankambo)
Initiatives at the WHO (Roderik Viergever)

STAKEHOLDER PLENARY: PATIENTS
Waste Not, Want Not, Whatnot – Random thoughts from a randomised patient and participant (Richard Stephens)
Public Knowledge: an information science perspective (Douglas Badenoch)

EQUATOR Lecture: Luis Gabriel Cuervo
at 3:12:41 on YouTube video; slides and notes

REWARD ACTION PLAN AND LANCET REWARD CAMPAIGN ANNOUNCEMENT 

CLOSING PLENARY: John Ioannidis

Download full conference program here

Conference focus 

  • Findings and recommendations from The Lancet Increasing Value and Reducing Waste series
  • Progress made by researchers, funders, regulators, publishers, industry, and research users against The Lancet Increasing Value and Reducing Waste series recommendations
  • Perspectives of key players involved in initiatives to improve research
  • Development and endorsement of a consensus statement
  • Action plan for accelerating progress against The Lancet Increasing Value and Reducing Waste series recommendations

Speakers:

Prof Doug Altman,  Prof Rustam Al-Shahi Salman, Sir Iain Chalmers, Dr An-Wen Chan, Prof Paul Glasziou, Dr Trish Groves, Prof John Ioannidis, Prof Frank Miedema, Dr David Moher, Prof Andrew Morris, Dr Janet Wisely

Local organising committee:

Judi Clarke, Rustam Al-Shahi Salman, Malcolm Macleod

Programme committee:

EQUATOR: Doug Altman, Philippe Ravaud, David Moher, Ana Marusic, Iveta Simera

REWARD: Paul Glasziou, Iain Chalmers, Rustam Al-Shahi Salman, Malcolm Macleod, John Ioannidis, An-Wen Chan

Conference website: http://researchwaste.net/research-wasteequator-conference/

 

Good Publication Practice for communicating company-sponsored medical research: GPP3

The updated Good Publication Practice guideline (GPP3, replacing GPP2) has been published by the Annals of Internal Medicine.
The guideline focuses on the publication of company-sponsored medical research; however, the principles of GPP3 apply to all research and will be useful for all medical and health care professionals involved in research publication.

Full details for GPP3 and links to previous versions of the guideline are available here.

 

Fewer large clinical trials are reporting positive findings since the introduction of measures designed to improve transparency

Kaplan and Irwin analysed all large NHLBI supported RCTs between 1970 and 2012 evaluating drugs or dietary supplements for the treatment or prevention of cardiovascular disease. Trials were included if direct costs >$500,000/year, participants were adult humans, and the primary outcome was cardiovascular risk, disease or death. The 55 trials meeting these criteria were coded for whether they were published prior to or after the year 2000, whether they registered in clinicaltrials.gov prior to publication, used active or placebo comparator, and whether or not the trial had industry co-sponsorship. We tabulated whether the study reported a positive, negative, or null result on the primary outcome variable and for total mortality.

The analysis of 55 trials meeting the inclusion criteria showed that 17 of 30 studies (57%) published prior to 2000 showed a significant benefit of intervention on the primary outcome in comparison to only 2 among the 25 (8%) trials published after 2000 (χ2=12.2,df= 1, p=0.0005).

The authors also looked into various aspects of transparent reporting: improvement in time in including diagrams reporting patient flow throughout the study, registration of studies on ClinicalTrials.gov and a prospective declaration of the primary outcome (see the last 3 paragraphs of the Results).

The authors note various important initiatives improving transparency of RCTs – including major journals requiring trial registration and following the CONSORT recommendation when reporting trial methods and findings. They state: “All of their (NHLBI) large trials published after 2000 were preregistered and transparently reported. Although we cannot say that stricter reporting requirements caused the trend toward more null reports from NHLBI trials, we do find the association worthy of more investigation.”

And implications for us: “A growing collection of trials suggests that promising treatments do not match their potential when systematically tested and transparently reported. Publication of these trials may lead to the protection of patients from treatments that use resources while not enhancing patient outcomes. For example, a recent economic analysis of the Women’s Health Initiative clinical trial suggested that the publication of the study may have resulted in 126,000 fewer breast cancer deaths, and 76,000 deaths from heart disease between 2003 and 2012. The economic analysis estimated that there was about $140 returned for each dollar invested in the study. Transparent and impartial reporting of clinical trial results will ultimately identify the treatments most likely to maximize benefit and reduce harm.”

Reference:

Kaplan RM, Irvin VL. Likelihood of null effects of large NHLBI clinical trials has increased over time. PLoS One 2015; http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0132382

What trials are really supposed to be – a succinct reminder from J. Ioannidis

In his recent editorial for the BMJ John Ioannidis writes:

“Trials should be properly randomized (currently more than half are not randomized at all) and use optimal study designs. They should ask key questions that matter to patients and the public, and they should be informed by a systematic examination of previous evidence. Trials should be well powered and use the best comparators, with pre-registration of their design and outcomes, and, whenever possible, of the analysis plan. They should avoid overt conflicts in their funding. They should be designed and conducted by non-conflicted trialists. Their results and their raw data should be publicly available and transparent. Eventually, randomized controlled trials could be the pride of clinical investigators who collaborate in research that matters, and the best source of information on how to improve health. This is what trials were supposed to be, even if we have almost totally forgotten this over the years.”

JPA Ioannidis. Clinical trials: what a waste. BMJ 2014;349:g7089. doi: http://dx.doi.org/10.1136/bmj.g7089 (Published 10 December 2014)

Linked publications from a single trial: a thread of evidence

A new Trials editorial by Douglas G Altman, Curt D Furberg, Jeremy M Grimshaw and Daniel R Shanahan

Abstract:

The medical literature is vast and it is impossible to keep up with the deluge of new research articles. With ongoing concerns regarding manipulation of the outcomes and analyses reported in medical research, it is increasingly important that researchers are able to easily identify and access all publications relating to a specific clinical trial, in order to get the complete picture and to reliably evaluate bias or selective reporting. Recent developments and innovations within the threaded publications initiative and the Linked Reports of Clinical Trials project demonstrate progress towards the ideal of making all trial information readily available.

Full text: http://www.trialsjournal.com/content/15/1/369/abstract

STRATOS initiative

The STRATOS (STRengthening Analytical Thinking for Observational Studies) initiative has been set up to develop accessible and accurate guidance in the design and analysis of observational studies.

The STRATOS website (http://www.stratos-initiative.org/) has been launched recently. The website provides more details about the group and its plans.

Publications:

Sauerbrei W., Abrahamowicz M., Altman D. G., Cessie S., Carpenter J., on behalf of the STRATOS initiative (2014), STRengthening Analytical Thinking for Observational Studies: the STRATOS initiative, Statist. Med., doi: 10.1002/sim.6265

New actions by PLoS Medicine Editors to advance research transparency – focus on observational studies

An editorial published in PLoS Medicine introduces new measure to further support transparency and usability of published research. PLoS editors are strengthening their reporting requirements for observational and diagnostic accuracy studies (requiring the use of STROBE and STARD reporting guidelines when preparing research manuscripts). Further changes in editorial policies relate to extending journals’ data sharing policies and protocol availability to observational studies.

This move should undoubtedly provide inspiration to other journal editors (see EQUATOR toolkits for editors for more resources, guidance, examples and editorials from other journals, etc.)

Reference:

The PLOS Medicine Editors (2014) Observational Studies: Getting Clear about Transparency. PLoS Med 11(8): e1001711. doi:10.1371/journal.pmed.1001711

EQUATOR toolkits: Editors. /toolkits/editors/

Montreal Statement (on research collaboration) is now available in Spanish

The Montreal Statement on Research Integrity in Cross-Boundary Research Collaborations was developed as part of the 3rd World Conference on Research Integrity, 5 – 8 May 2013, in Montréal, as a global guide to the responsible conduct of research.

The full text of the statement (in English and Spanish) is available at the research integrity conferences website.

The next conference on research integrity will take place next year in Rio de Janeiro (http://www.wcri2015.org/)