{"id":48087,"date":"2020-07-21T16:20:01","date_gmt":"2020-07-21T15:20:01","guid":{"rendered":"https:\/\/blogs.bmj.com\/bmj\/?p=48087"},"modified":"2020-07-27T19:38:50","modified_gmt":"2020-07-27T18:38:50","slug":"we-know-enough-about-the-problems-in-research-to-start-demanding-solutions","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/bmj\/2020\/07\/21\/we-know-enough-about-the-problems-in-research-to-start-demanding-solutions\/","title":{"rendered":"We know enough about the problems in research to start demanding solutions"},"content":{"rendered":"

Several problems with health research are now widely recognised. But to challenge the status quo we need to offer clear solutions and convince patients, the public, and policy makers to support change, say Stephen Bradley, Kath Sansom, and Erick H Turner<\/p>\n

Serious concerns have <\/span>dogged health research for decades<\/span><\/a>. The coronavirus pandemic has exposed these systemic failures to a wider public that has never been more engaged in science and medicine. As doctors and researchers, we have failed to fix these problems on our own. We now have an opportunity to join patients and the public to demand solutions.\u00a0\u00a0\u00a0\u00a0\u00a0<\/span><\/p>\n

The problems include, but are not restricted to, failure to publish all research findings, inadequate sharing of study methodologies, and inconsistent disclosure of conflicts of interest. As a consequence of these failures, much of the global expenditure spent on medical research is <\/span>wasted<\/span><\/a> and genuine <\/span>scientific discovery<\/span><\/a> is <\/span>hindered by<\/span><\/a> findings that <\/span>cannot be reproduced<\/span><\/a>.<\/span><\/p>\n

Haven\u2019t these problems already been fixed?<\/b><\/p>\n

Reforms like mandatory clinical trial registration have brought some additional transparency. Unfortunately, registration information is often cursory and usually doesn\u2019t include trial protocols and analytic plans. So-called \u201coutcome switching\u201d is easily concealed and, even when called out, <\/span>rarely rectified<\/span><\/a>. Crucially, the expectation to register studies does not extend to most non-trial research, such as observational or lab-based studies, which are equally vulnerable to shoddy practices.\u00a0<\/span><\/p>\n

While many of the problems in medical research have been well described, there is little agreement as to their solutions. Where solutions have been proposed, they are often vague, such as \u201cimproving education.\u201d As profound biases in medical research continue to reward \u201cpositive,\u201d interesting, or novel findings, worthy sentiments are not enough.<\/span><\/p>\n

Our failure to remedy this situation is a betrayal of public trust. Attempts to ascertain whether study authors have conflicts of interest should not be met with frustration, as <\/span>experienced by one of us (KS)<\/span><\/a>. These concerns have been echoed by Baroness Cumberlege\u2019s inquiry into women affected by the <\/span>hormone pregnancy test Primodos, sodium valproate, and pelvic mesh<\/span><\/a>. Hopefully, the inquiry\u2019s recommendations, including that the GMC register doctors\u2019 financial and non-financial interests, will be acted on.\u00a0\u00a0\u00a0\u00a0\u00a0<\/span><\/p>\n

Campaign with patients and the public to demand change<\/b><\/p>\n

Yet aside from some researchers and patients who have tried to get answers for themselves, awareness of the crisis in research remains limited. Excluding the wider public from this debate is a wasted opportunity, since, as both funders of research and as patients, they have the biggest stake in rectifying these problems. Without mobilising support for reform from outside, as well as inside, the research establishment, it seems unlikely that we can challenge the status quo of mediocre and opaque research practices.\u00a0\u00a0<\/span><\/p>\n

Fortunately, research and patient campaigners have a compelling message to offer the public and policy makers: <\/span>implementing simple measures to improve openness and quality could increase the effectiveness of medical research expenditure<\/span><\/i>. The pressure exerted by the House of Commons Science and Technology Committee, under Norman Lamb, to <\/span>improve publication of trial results<\/span><\/a> by NHS organisations and universities suggests that there is a willingness among policy makers to address these issues.<\/span><\/p>\n

What are the solutions?<\/b><\/p>\n

One barrier to achieving change is that it is difficult to explain these complex problems, as they are not fully understood even by many in healthcare and research. Perhaps more important has been our failure to articulate clear, achievable solutions to these problems. The lesson of successful reform movements of the past is that achieving change requires campaigners to cohere around an achievable, yet impactful set of demands.\u00a0\u00a0<\/span><\/p>\n

As members of an international collaboration of patients and researchers, we have drafted a declaration that includes three demands to improve health research:\u00a0<\/span><\/p>\n

1) Mandatory registration of conflicts of interest<\/span><\/i><\/p>\n

Researchers could maintain a comprehensive and up to date register of their interests, for example through <\/span>ORCID<\/span><\/a>, which could be linked to all publications.\u00a0<\/span><\/p>\n

2) Journals\u2019 adoption of<\/span><\/i> Registered Reports<\/span><\/i><\/p>\n

Registered Reports are a publication format whereby authors submit methods prior to data collection and analysis and, if these satisfy peer review, journals preliminarily commit to publication, regardless of whether the subsequently obtained results are statistically significant or \u201cnoteworthy.\u201d\u00a0 Currently, the number of participating journals is approximately 250, but <\/span>this is only 1% of all journals indexed in MEDLINE<\/span><\/a>.<\/span><\/p>\n

3) Mandatory registration of publicly funded research<\/span><\/i><\/p>\n

Comprehensive documentation, such as protocols, <\/span>analytic code<\/span><\/a>, and, when possible, study data for all publicly funded research, should be made available on a repository affiliated to the World Health Organization. This will allow researchers and the public who fund research to verify it is reproducible.\u00a0<\/span><\/p>\n

These demands were chosen as well defined and implementable measures to increase transparency and reduce waste in medical research. They are real world measures and our demands are necessarily imperfect. Even if they were achieved overnight, many serious problems would remain.\u00a0 <\/span><\/p>\n

We accept that our demands might not be the <\/span>right <\/span><\/i>ones\u2013we welcome suggestions for alternatives. But to begin to rectify the scandal of poor medical research, those who are serious about overcoming the problems need to unite to win the backing of the public and policy makers in order to promote and implement practical solutions.<\/span><\/p>\n

The Declaration to Improve Health Research is available at osf.io\/k3w7m<\/a>. <\/span><\/i>Follow on twitter: @TA_Declaration\u00a0\u00a0\u00a0<\/a><\/span><\/p>\n

Stephen Bradley<\/b> is a GP and clinical research fellow at the University of Leeds. Twitter @DryBreadnRadio<\/a><\/span><\/em><\/p>\n

Kath Sansom<\/b> is a journalist, patient campaigner, and founder of \u201cSling the Mesh.\u201d Twitter @KathSansom<\/a> @MeshCampaign<\/a> (https:\/\/slingthemesh.wordpress.com<\/a>)<\/span><\/em><\/p>\n

Erick Turner<\/b> is a psychiatrist-researcher and transparency advocate. He previously worked on drug regulation in the United States Food and Drug Administration (FDA) @eturnermd1<\/a><\/span><\/em><\/p>\n

Conflicts of interest: <\/strong>Stephen Bradley receives funding from Cancer Research UK for PhD research. He is also a member of the executive committee of the Fabian Society, which is a think tank affiliated to the Labour Party. Kath Sansom works as a journalist. She was harmed by vaginal mesh and leads the \u201cSling the Mesh\u201d campaign.\u00a0 <\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

Several problems with health research are now widely recognised. But to challenge the status quo we need to offer clear solutions and convince patients, the public, and policy makers to […]<\/p>\n

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