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ANNUAL REVIEW Because evidence matters 2017/18 Picture credit: James Hopkirk That is why, in June 2017, over 100 people came with us to the European Parliament, from different walks of life across the EU, to tell MEPs why evidence matters to them. It is why our AllTrials campaign has pressed forward with patient groups to influence the biggest regulators and research funders in the world; why we are encouraging statisticians and others in public life to engage people more in the creation of independent accountable information; and why our Transparency of Evidence review published in January urged the UK government to place greater trust in the public’s ability to handle the fact that policy evidence is rarely complete and definitive. And that is also why it’s so important that researchers put themselves where people For 15 years, Sense about Science need them. Our Voice of Young Science has been at the sharp end of helping network has been equipping researchers to people to grapple with evidence – to take responsibility for the way their field is appreciate it, discuss it and assess discussed in wider society. whether it can bear the weight Looking ahead, European governments have someone wants to put on it. Our spent billions on data strategies, so at Sense work over that time has changed as about Science we will be making sure that the the debates and issues around us public is equipped to ask searching questions have. Our mission – to promote the about quality from the outset. We will be public interest in sound science and working with the UK parliament on the very first evidence – is the same. Evidence Week, led by community groups, and That mission has seen us working with we will start to name the organisations that do communities seeking access to better not publish their clinical trial results. evidence on subjects from housing to stem Science is not a club. You’re not in or out. We, cells to air quality, and with patient groups all of us in society, have flashpoints in our lives: and doctors across the world, to put a stop to moments when it really matters to understand secrecy about clinical trial results. the nature of our natural or social world. We couldn’t be more aware of how much Science is a means of inquiry, of understanding people care that public life is founded on how things are and, therefore, how they might openness and evidence. otherwise be. We can all do better at that, irrespective of where we get our news. In 2018 our mission has become more challenging. Not, as many have argued, because we are confronted with a post-truth public or a rejection of expertise and reason, but because people in authority are coming to believe that this is the nature of the public they serve. This year, amid these mounting concerns about attitudes to evidence, we have Tracey Brown OBE felt obliged to bring into the heart of public life Director, Sense about Science and the corridors of decision making a much stronger representation of the many ways that evidence matters to people. 3 More great strides this year for the global AllTrials campaign which calls for the registration and reporting of all clinical trials. WHO statement on transparency The World Health Organisation published a statement on transparency and asked non- commercial funders of clinical trials to join the statement and commit to transparency in May 2017. Immediately nine of the world’s largest clinical research funders including the Gates Foundation, Wellcome Trust and Médecins Sans Frontières joined the statement and agreed to write a policy that commits their organisation to making sure that all clinical trials it funds are registered and results from them reported. In the following months 12 more funders joined the statement and committed to writing and implementing a new policy within 12 months. AllTrials will monitor and audit this commitment to ensure they all honour their promise. “This is great news. It’s great news for the patients who volunteered for clinical trials that have never published results; for researchers re-running trials they don’t know already happened; and great news for all of us who expect our doctors to know whether medicines work.” — Dr Sίle Lane, co-founder of the AllTrials campaign Pharma company review in BMJ In July 2017 AllTrials co-founders Dr Sίle Lane and Dr Ben Goldacre published a review of the largest global pharmaceutical companies’ policies on clinical trial transparency in the BMJ. This was a huge moment for the campaign. Their review showed that most large pharma companies have some sort of publicly stated policy on transparency, but policies vary greatly between companies; are sometimes internally contradictory; EU Clinical Trials regulation and none of them have committed to register and report results from all trials past and present and to share data The campaign also wrote to Jeremy Hunt to remind — the gold standard of transparency. This important him that he and the UK government led discussions work showed clearly the gap between forward thinkers on new transparency clauses in the EU Clinical and those lagging behind, as well as providing guidance Trials Regulation and urged him to ensure the UK We run the AllTrials campaign, on steps companies can take to strengthen their doesn’t miss the opportunity to adopt these into policy and increase transparency. Since publication, UK law after Brexit. We have learned that the UK calling for the publication 11 of the 46 companies reviewed have said they will government does intend to adopt the EU CTR rewrite or amend their policies to make stronger wholesale if it comes into force before December of all clinical trials. commitments to transparency. 2020, during the implementation period. 4 5 FDAAA TrialsTracker launched In February 2018 a new law on clinical trial transparency came into force in the USA, and AllTrials launched the FDAAA TrialsTracker to monitor adherence to this law. The FDA Amendment Act (FDAAA) final rule makes it the law for US clinical trials to be registered on the US register ClinicalTrials.gov and to report summary results there within a year of the end of the trial. The FDAAA TrialsTracker was built by Dr Ben Goldacre’s team at the University of Oxford to pull in information about trials captured under the FDAAA final rule and assess whether the trials have reported results. The website flags trials that have breached the law as they go overdue on their reporting deadline and displays ranked lists of trial sponsors who have published the most and the least of their trials. It also displays a rolling total of the amount in fines the FDA could have levied for trials that are in breach of the rules. AllTrials writes to the FDA every week with updated information on all trials that have breached the FDAAA. To date, the FDA has not levied any fines. Visit fdaaa.trialstracker.net for the latest results. Visit alltrials.net or join in the conversation on Twitter using #AllTrials. Unreported trial of the week In March 2018 the BMJ launched a new series: the AllTrials Unreported Clinical Trial of the Week. This is a weekly article shining a spotlight on one of the trials identified by the FDAAA TrialsTracker as having gone overdue to report results. And more... We call for accountability for AllTrials was called to give evidence to the House of Commons Science and Technology Committee’s inquiry into research integrity in December 2017; and invited to speak at Health Research Board Ireland Clinical Trials Symposium, the use of evidence in decision- Dublin, October 2017; Game Changers for Better Medicine in Europe, Brussels, November 2017; Biomedical Transparency Summit, Washington DC, January 2018; and Health Research Authority Transparency Forum, London, March 2018. making in the UK and EU. 6 All picture credits: Frank Pittoors The vast majority of agricultural legislation is coming from Brussels and those decisions have a profound impact on our daily lives. I’m here today to plead with you, to base that impact on science, on evidence. — Eline Vedder, dairy famer, Netherlands Evidence is crucial for our mission to have a healthier ocean. Only common EU policies based on good evidence can change people’s mindsets and Evidence Matters feeling of responsibility. — Dimitar Atanasov, to EU citizens surfer, Bulgaria In June 2017 we took 100+ EU citizens to the European parliament. Coming from all over Europe to Brussels, they explained to MEPs why they care about evidence and why they expect people in authority to use it. 16 of them spoke for a minute — among them a farmer, a surfer, a teacher, a patient, an engineer — about how the use of evidence has impacted their lives. The group told MEPs: We expect the commission to use evidence when making policy 100+ EU citizens came to Brussels. We expect commissioners to explain their reasoning We expect parliament to seek and to scrutinise reasoning behind policies. “While we aspire to make more and better use of science Carlos Moedas, European commissioner for research, science and innovation (pictured internally, I am glad that there right with Mairead McGuinness MEP) responded are initiatives like ‘Sense about to the citizens on behalf of the commission along with six MEPs representing all the main party groups. Science’ which are fighting for evidence-based policymaking We asked the MEPs and parliamentary and commission staff who were at the event to share from the outside and doing what they learned and ask their colleagues to join so by facilitating the direct the #EvidenceMatters movement.
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