The Academy of Medical Sciences is undertaking a project to examine how we can all best use evidence to judge the potential benefits and harms of medicines.Launched
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- How can we all best use evidence?
How can we all best use evidence?
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Over the past few years, questions have been raised in both the general and scientific media about the evidence underlying decisions about treatment options, for example the use of statins to prevent heart disease and stroke, of Tamiflu to treat influenza and of hormone replacement therapy to treat the symptoms of the menopause. The validity of the different ways of collecting and analysing evidence has been part of this debate, as have broader discussions of issues such as medicalisation (or the reliance on prescribing drugs over lifestyle changes) and conflicts of interest in the way that evidence collection is funded and/or analysed.
The Academy’s report, ‘Enhancing the use of scientific evidence to judge the potential benefits and harms of medicines’, explores these issues further. It concludes that scientific evidence should be at the heart of decisions about the use of medicines, as it is open to check and challenge. To enable this, the report calls for improvements to:
- The generation of scientific evidence to ensure it is robust, reliable and relevant to patients.
- The trustworthiness of scientific evidence so that information is disclosed in an accessible, assessable, and usable manner.
- The communication of evidence to ensure it is presented in a clear, accurate and actionable way.
Making progress on these fronts will require a collective effort from a wide range of stakeholders across the biomedical community.
The report, and its associated annexes and case studies, are available to download on the right hand side of this page. A summary of the report’s recommendations is provided in ‘The report’s recommendations in brief’ tab. A summary of the report and questions that patients could consider asking their doctor during consultations are also available to download on the right hand side of this page.
We would welcome your comments on the report (please send your feedback to email@example.com).
Evidence feeding into the project
The report brings together a series of sub-projects that considered elements relating to:
- The strengths and limitations of different sources of evidence used to evaluate benefits and harms of medicines.
- The ways in which conflicts of interest impact on the validity (or perception of validity) of evidence.
- The communication of evidence to support discussion and decision-making.
- The perceptions and perspectives of society on scientific evidence (including in the context of shared decision making between patients and their clinicians).
Evidence that has contributed to this report, including workshop reports from the sub-projects are available in the evidence repository for this project.
Financial contributions towards the project
Arthritis Research UK, the British Heart Foundation (through a Strategic Funding Award), the British Pharmacological Society, the British Society for Immunology, the Medical Research Council, the Naji Foundation and the National Institute of Health Research Health Technology Assessment Programme kindly provided financial contributions towards this work. Funding from a core grant
from the Department for Business, Energy and Industrial Strategy to the Academy was also used to support this project. This was an independent project that had the support of the Chief Medical Officer. Funders did not approve the conclusions and recommendations and were not sent a draft of the report for approval.
Based on a forthcoming editorial in the British Journal of General Practice.
Ensuring evidence is robust and relevant
- Patients, carers and the public should be more involved in the direction, delivery and dissemination of clinical research.
- All those involved in clinical research and all healthcare professionals (at all career stages) should receive a grounding in the research methods and statistics used to evaluate the benefits and harms of treatment options.
- The importance of robust, reproducible and reliable research should be recognised and emphasised.
- New sources of evidence should be used to best advantage, with more emphasis on finding ways to extract and share useful data from different sources.
Ensuring evidence is trustworthy
- Research findings and data should be published in as open, balanced and complete way as possible.
- Any interests should be routinely declared and any potential conflicts of interest managed in an open and transparent way.
- Academia-industry relationships should be managed under a set of clear guidelines.
Ensuring evidence is communicated and used effectively
- Patient information leaflets should be improved to give a clear and balanced appraisal of the potential benefits and harms of treatment options.
- NHS Choices should become a central repository of clear, balanced and up-to-date evidence on healthcare options.
- Improved reporting of scientific evidence in the media should be encouraged, with a role for academic establishments and researchers in ensuring their research is accurately reflected.
- Increased support for shared decision-making should be provided, including adequate resourcing of primary care services and the provision of decision aids through NHS Choices.
- Continued dialogue and engagement with patients and the public is needed to monitor the impact of these recommendations and ensure responsiveness to changing public needs in healthcare.
This workstream examined the evaluation of scientific evidence for medicinal products and how this evidence is interpreted and assimilated by different groups (including, but not limited to, patients, the public, healthcare professionals, researchers and communicators). It aimed to better align evidence generation with user expectations, and facilitate decision-making about therapeutic options. In doing so, the workstream explored:
- How different groups’ perspectives and perceptions affect their evaluation of evidence. This formed the basis of dialogue activitiesthroughout the project.
- The strengths and limitations of results and conclusions that originate from different study types or data sources to evaluate the benefits and harms of medicinal products. This was examined by a sub-group studylaunched in summer 2015.
- How interests (including, but not limited to, different models and sources of funding) impact on the validity, or the perception of validity, of evidence. This was informed by a workshopin November 2015.
- How to effectively communicate research findings to improve the understanding of evidence about the benefits and harms of medicinal products. This was informed by a workshopin June 2016.
The overarching report embraced and informed decision-making about medicines, and developed a list of practical recommendations relating to the interpretation, weighting, and communication of evidence. These aimed to enable a wide range of groups (as described above) to better consider the benefits and harms of medicinal products. The report drew on examples of dilemmas in current therapeutic practice, but did not seek to address all such areas of contention, nor to replicate the work performed by the Medicines and Healthcare products Regulatory Agency and the National Institute of Health and Care Excellence. The remit of this project required expertise from outside of the Academy, and we therefore engaged widely via a call for evidence, workshops, and further dialogue with a broad range of stakeholders.
Professor Sir John Tooke FMedSci (Chair of the Oversight Group) is Co-Chair of the Centre for the Advancement of Sustainable Medical Innovation, a joint initiative between Oxford University and University College London (UCL). His research interests relate to the pathogenesis of diabetic complications and their management, and the development of academic health science systems. He was Vice Provost (Health) at UCL and Academic Director of UCL Partners until July 2015, and in the past has served as Chair of the Medical Schools Council. He is a Non-Executive Director of Bupa and Executive Chairman of Academic Health Solutions, a company that offers advice to international governments, universities and other agencies on the development of academic health science systems. He served as President of the Academy of Medical Sciences for four years until December 2015. He was in receipt of a National Institute for Health Research (NIHR) grant for the UCL Hospitals Biomedical Research Centre. He serves on the International Advisory Boards for both the Qatar Academic Health System and the National University of Singapore Medical School and is a member of Google DeepMind Health’s Independent Advisory Board.
Professor Dorothy Bishop FRS FBA FMedSci is a Wellcome Trust Principal Research Fellow and Professor of Developmental Neuropsychology at the University of Oxford, where she heads a programme of research into children’s communication impairments. Her main interests are in the nature and causes of developmental language impairments, with a particular focus on psycholinguistics, neurobiology and genetics. She is a supernumerary fellow of St John’s College Oxford. She has honorary degrees from the Universities of Lund, Western Australia, and Newcastle upon Tyne. As well as publishing in conventional academic outlets, she writes a popular blog with personal reactions to scientific and academic matters. She is in receipt of a Wellcome Trust Programme Grant and is Director of Scholars Mews Residents.
Michael Blastland is a writer and broadcaster. Now freelance, he devised the ‘More or Less’ programme and continues to present ‘The Human Zoo’, both on Radio 4, and ‘The Inquiry’, on BBC World Service. He also recently produced and co-wrote with Andrew Dilnot for Radio 4 two series of ‘A History of Britain in Numbers’. He presents and advises widely about data, statistics and risk, and also about journalism and communication. This has included work for the Said Business School Executive Leadership programme, at the BBC’s College of Journalism, and for business, the public sector and in academia. He has written three books – the first about autism, the second about making sense of numbers in the news, and most recently a book about risk, co-authored with Professor Sir David Spiegelhalter OBE FRS. He has received payment for conference presentations on the representation of risk by Biogen Idec Limited and by the Association of the British Pharmaceutical Industry. A member of his family is a Non-Executive Director of the Hillingdon Hospitals NHS Foundation Trust.
Professor Dame Nicky Cullum DBE FMedSci (from August 2016) is Professor of Nursing and Head of the Division of Nursing, Midwifery and Social Work at the University of Manchester and Honorary Professor of Nursing at Central Manchester University Hospitals NHS Foundation Trust. Her research mainly focuses on the epidemiology and management of complex wounds such as leg, foot and pressure ulcers and non-healing surgical wounds. She was a founding member of the Cochrane Collaboration and has been Coordinating Editor of the Cochrane Wounds Group since 1995. A particular interest is how research evidence of relevance to clinical nursing decisions is produced and that evidence is translated into practice. She founded the Centre for Evidence-Based Nursing at the University of York in 1995. She has been a NIHR Senior Investigator since 2008, is a member of the Royal College of Nursing and a Fellow of the American Academy of Nursing. She has a number of current grants, either as a principal or co-applicant, from NIHR.
Professor Sarah Cunningham-Burley is Professor of Medical and Family Sociology, and Dean of Molecular, Genetic and Population Health Sciences at Edinburgh Medical School, University of Edinburgh. Her research spans the study of health and family life and the analysis of social issues in relation to new technologies and health, including developments in genomic medicine. She combines the disciplines of medical sociology and science and technology studies with methodological expertise in qualitative research. She currently holds a Wellcome Trust Senior Investigator Award, jointly with Professor Anne Kerr, University of Leeds. She is strongly committed to public engagement in research as well as wider knowledge exchange for and with policy and practice communities. She was elected to the Academy of Social Sciences in 2012, the Royal Society of Edinburgh in 2014 and the Faculty of Public Health in 2015. She is or has recently been a member of the Medical Research Council (MRC) Methodology Research Panel (Deputy Chair), Wellcome Trust Society and Ethics Investigator and Collaborative Award Expert Review Group, Ireland’s Health Research Board Expert Panels and the French National Cancer Institute’s Scientific Evaluation Committee for social and Human Sciences, Epidemiology and Public Health (Co-Chair). She has grants for her current work, either as a principal or co-applicant, from the Wellcome Trust, the Economic and Social Research Council (ESRC)/Ministry of Defence, the Chief Scientist Office, NIHR Health Technology Assessment, and leads the public engagement research programmes for the ESRC Administrative Data Research Centre, Scotland and MRC-led Farr Institute, Scotland.
Professor Jane Dacre is President of the Royal College of Physicians (RCP), an Honorary Consultant Physician and Rheumatologist at the Whittington Hospital in North London, Professor of Medical Education and was former Director of UCL Medical School. She was also the Medical Director of the Membership of the RCP of the United Kingdom examination until December 2013, and prior to that Academic Vice-President of the RCP. She was a General Medical Council (GMC) Council Member, chaired the GMC Education and Training Committee (2008–2012) and leads a research programme in medical education focussing on assessment. Professor Dacre has been instrumental in the development, implementation and evaluation of assessment systems in medicine. She is a Trustee of the RCP.
Simon Denegri is National Director for Patients and the Public in Research at the National Institute for Health Research (NIHR), and Chair of INVOLVE – the national advisory group for the promotion and support of public involvement in research funded by NIHR. He was Chief Executive of the Association of Medical Research Charities (AMRC) from 2006 until 2011 and, prior to this, Director of Corporate Communications at the RCP from 2003. He also worked in corporate communications for Procter & Gamble in the United States from 1997 to 2000. He has a long-standing personal and professional interest in the needs and priorities of people with dementia and their carers, and currently chairs the Lay Champions Group for the national portal on dementia research that is to be launched this year. He is a member of the NIHR Advisory and Strategy Boards, and a Board member of the UK Clinical Research Collaboration, Farr Institute and care.data programme respectively. He also writes a blog about the public and health research. He is Chair of the UK Clinical Trials Gateway Project Board, the NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) North Thames International Expert Advisory Board, and the Patient and Public Involvement Strategic Group at the North Thames Genomic Medicine Centre. He is a member of a number of Advisory Boards and Groups (Clinical Practice Research Datalink, British Medical Journal, WEB-RADR, Open Trials, Engineering and Physical Sciences Research Council MeDe Innovation, EU Joint Programme on Neurodegenerative Disease Research). He is also a member of the NIHR Greater Manchester Primary Care Patient Safety Translational Research Centre, COMET Patient and Public Involvement and Engagement Working Group, the Canadian Institutes for Health Research Adjunction Panel for Support for Patient Orientated Research Units, and sits on the editorial boards of the International Journal for Engagement and Involvement and Research for All.
Professor Rob Horne is Professor of Behavioural Medicine at UCL School of Pharmacy, where he is Director of the Centre for Behavioural Medicine. Following an initial decade in clinical pharmacy and medicines management within the NHS he completed a PhD in health psychology at Guys Medical School followed by a 17-year programme of research in behavioural medicine, focussing on the role of psychological and behavioural factors in explaining variation in response to treatment. His current interests centre on the development of interventions to support optimal engagement with essential treatments and effective medical innovations and on optimising the non-specific effects (placebo and nocebo components) of medicines. Professor Horne was appointed as a Founding Fellow of the Royal Pharmaceutical Society of Great Britain in 2010 and, in 2011, a NIHR Senior Investigator. In 2012, Professor Horne became UCL’s academic lead for the Centre for the Advancement of Sustainable Medical Innovation (CASMI), a joint undertaking with the University of Oxford. He is also academic lead for CASMI’s Medical Innovation Academic Consortium and lead for the UCL School of Pharmacy Research Cluster. He is on the Management Board for the UCL Centre of Behaviour Change and the Steering Committee for the UCL Institute of Digital Health and UCL Personalised Medicine Health Domain. He is a member of the Management Group for the NIHR North Thames Collaboration for Leadership in Applied Health Research and Care (CLAHRC) and of the Management Board for Asthma UK Centre for Applied Research. He is an Honorary Fellow of the RCP and the Faculty of Pharmaceutical Medicine, a Fellow of the Royal Pharmaceutical Society, a member of the Martin Fisher Foundation Board of Trustees and the Asthma UK Research Board. He has received grants for his work, either as a principal or co-applicant, from Amgen, Asthma UK, Bupa Foundation, Crohn’s and Colitis UK, Department of Health, Health Foundation, MRC, NIHR, NIHR North Thames CLAHRC, and the Wellcome Trust. He is Director of a Spoonful of Sugar Ltd (a UCL business spinout company) and Pharmed Research Ltd. He has received consultancy fees from GlaxoSmithKline (Salford Lung Study and Medication Taking Behaviour in COPD Advisory Board), Merck Sharp & Dohme (Summer Summit and Workshop Adherence Concept), the Norwegian Association of Pharmacists, Pfizer (Consumer Men’s Health Advisory Board) and the Swiss Society for Infectious Diseases.
Professor Peter Johnson FMedSci is Professor of Medical Oncology at the University of Southampton and Chief Clinician for Cancer Research UK. He is responsible for bringing together a broad multidisciplinary group of basic, translational and clinical researchers, and linking the research of the academic unit to the extensive clinical practice in cancer treatment in the Southampton Cancer Centre. His research interests are in applied immunology and immunotherapy, lymphoma biology and clinical trials. He is Chief Investigator for lymphoma trials ranging from first in man novel antibody therapeutics to international randomised studies, and for the Cancer Research UK Stratified Medicine Programme. He was Chair of the UK National Cancer Research Institute Lymphoma Group from 2005 to 2011 and has been a member of national trials committees for the MRC, Cancer Research UK, and Leukaemia and Lymphoma Research. He has received grants from Bloodwise, Cancer Research UK, Eisai and Janssen for his scientific work, and is a Director of Cancer Research UK. He has carried out advisory work for Boehringer Ingelheim, Bristol-Myers Squibb, Epizyme and Pfizer.
Professor Martin Marshall CBE is Professor of Healthcare Improvement at UCL and leads Improvement Science London, an initiative to promote and embed the science of improvement across both the health service and academic sectors. Previously he was Director of Research and Development at the Health Foundation, Deputy Chief Medical Officer and Director General in the Department of Health, and a clinical academic at the University of Manchester. He has been a General Practitioner for 27 years, now serving an inner-city community in Newham, East London. He is a Fellow of the Royal College of General Practitioners (RCGP), RCP and Faculty of Public Health Medicine, and was a Non-Executive Director of the Care Quality Commission until 2012. He was awarded a CBE in the Queen’s Birthday Honours for Services to Health Care. He is a member of Tower Hamlets Clinical Commissioning Group Primary Care Commissioning Board, the Newham Health and Wellbeing Board and the RCGP’s Council, and was elected Vice-Chair for External Affairs of the RCGP in November 2016. He is also an External Examiner at Imperial College London.
Professor Dame Theresa Marteau DBE FMedSci is Director of the Behaviour and Health Research Unit in the Clinical School at the University of Cambridge, Director of Studies in Psychological and Behavioural Sciences at Christ’s College, Cambridge, and a NIHR Senior Investigator. Her research focuses on: the development and evaluation of interventions to change behaviour (principally diet, physical activity, tobacco and alcohol consumption) to improve population health and reduce health inequalities, with a particular focus on targeting non-conscious processes; risk perception and communication, particularly of biomarker-derived risks and their weak links with behaviour change; and acceptability to the public and policymakers of government intervention to change behaviour. She is a member of the Academy of Medical Sciences’ Council, the International Scientific Advisory Board of the French National Cancer Institute and the Scientific Advisory Panel of the Behavioural Insights Team (Cabinet Office and Nesta). She is a Fellow of the Academy of Social Sciences and the Royal College of Physicians of Edinburgh, and is an Associate Fellow at the Cambridge Centre for Science and Policy. She has funding from the Department of Health Policy Research Programme.
Professor Jonathan Montgomery is Chair of the Health Research Authority and Professor of Health Care Law at UCL. His research work concerns healthcare law and bioethics governance systems. His previous national Chair roles include the Advisory Committee on Clinical Excellence Awards (2005–14), the Human Genetics Commission (2009–12), and the Nuffield Council on Bioethics (2012–17). He has been involved in the preparation of ethical guidance in a number of areas of health practice and chaired a task and finish group for the GMC overseeing the revision of its guidance on confidentiality published in 2017. He is an Honorary Fellow of the Royal College of Paediatrics and Child Health. In his role as Chair of the Nuffield Council on Bioethics, he was in receipt of grants from the Nuffield Foundation, MRC and Wellcome Trust, which co-fund the organisation.
Baroness Onora O’Neill CH CBE HonFRS FBA FMedSci combines writing on political philosophy and ethics with a range of public activities. She was Principal of Newnham College, Cambridge from 1992 to 2006, President of the British Academy from 2005 to 2009, chaired the Nuffield Foundation from 1998 to 2010 and has been a crossbench member of the House of Lords since 2000 (Baroness O’Neill of Bengarve). She currently chairs the UK’s Equality and Human Rights Commission and is on the Boards of the MRC and the Banking Standards Review. She lectures and writes on justice and ethics, accountability and trust, justice and borders, as well as on the future of universities, the quality of legislation and the ethics of communication. She is Emeritus Professor of Philosophy at the University of Cambridge. She chairs the University of London’s Institute of Philosophy Advisory Board, is a Council Member for the Royal Institute of Philosophy and the Foundation for Science & Technology, a Trustee of the American University of Sharjah, and a member of the Demos Advisory Group. She is a member of the University of London/British Academy Panel advising on an inquiry into the future of Public Service Broadcasting and of the advisory Board for the Huxley Summit (a British Science Association event), was a member of the Royal United Services Institute Independent Surveillance Review and the Nurse Review Reference Group, and is on the Committee for the appointment of the next British Judge on the European Court of Human Rights.
Dr Imran Rafi is a General Practitioner and Principal and Senior Lecturer in Primary Care Education at St George’s, University of London. He is Chair of the RCGP Clinical Innovation and Research Centre (CIRC), which oversees the clinical priority programme, and programmes that support research and promote quality improvements in general practice. CIRC receive the bulk of their funding from other charities and foundations, NHS England, Public Health England, Department of Health and the European Commission. Historically, CIRC have received unrestricted educational grants from Pfizer, Novartis and Grunenthal Pharma. Dr Rafi has an interest in genetics and has been a member of the Health Education England Genome Advisory Board and the Human Genome Strategy Group Service working group. He was a founder member of the Primary Care Genetics Society and the World Organisation of Family Doctors specialist interest group in primary care genetics, as well as the Society for Academic Primary Care specialist group on primary care genetics. He is currently funded by Health Education England on the Masters Medical Genomics course at the University of Cambridge. He is a member of the RCGP and a fellow of the RCP.
Professor Sir Michael Rutter CBE FRS FBA (until June 2016) is Professor of Developmental Psychopathology at the Social Genetic and Developmental Psychiatry (SGDP) Research Centre at the Institute of Psychiatry, Psychology and Neuroscience, King’s College London. His research interests include the use of natural experiments and animal models to test hypotheses about causation, the use of epidemiological longitudinal studies for the same purpose, gene-environment interplay, and studies of psychosocial risk. He founded the SGDP in 1994 and was its first honorary director. He retired from his administrative posts in 1998 but remains active in research and teaching. His textbook on child and adolescent psychiatry remains distinctive in attention to both conceptual and statistical issues, as well as the integration of science and clinical work. He is Governor of the Coram Foundation and Chair of the Scientific Advisory Group for the Canadian Institute for Advanced Research programme on Children and Brain Development.
Suzie Shepherd is outgoing Lay Chair of the RCP Patient and Carer Network, a Member of the RCP Future Hospital Commission Implementation Group, a full Member of RCP Council, and sits on the Clinical Standards Accreditation Board at a national level. In these roles she works to influence health and public health policy and organisational development within healthcare. Prior to retiring, Ms Shepherd worked for the NHS as a Senior Dental Nurse and, in her role as Improving Working Lives Lead for Leeds Community and Mental Health Trust, supported staff through service reconfigurations, modernisation and redesign. Drawing on her experiences as a patient, carer, parent and former member of NHS staff, she has maintained a key interest in ensuring that the lay patient and carer voice is heard during times of service change and development. She is Director of Leeds Occupational Health Advisory Service and Vice-Chair of the Clinical Services Accreditation Alliance. She is a lay member of a number of national, regional and local Boards and Committees, including at the RCP.
Professor Sir David Spiegelhalter OBE FRS is Winton Professor for the Public Understanding of Risk and Professor of Biostatistics at the University of Cambridge. His background is in medical statistics, particularly the use of Bayesian methods in clinical trials, health technology assessment and drug safety. He leads a small team, attempting to improve the way in which the quantitative aspects of risk and uncertainty are discussed in society. In collaboration with the Millennium Mathematics Project, he is developing an exciting treatment of probability and risk for mathematics education. He advises organisations and government agencies on risk communication and is a regular commentator on current risk issues. He is a Fellow of Churchill College Cambridge, an Honorary Fellow of the Institute for Risk Management, an Honorary Fellow of the RCP and a Fellow of the Royal Society. He was awarded an OBE in 2006 and knighted in 2014, both for Services to Medical Statistics. In 2013, he received an honorarium for a talk on the public perception of risk at a meeting supported by Pfizer.
Dr Julian Treadwell is a General Practitioner based in Wiltshire and an NIHR In-Practice Fellow at the Nuffield Department of Primary Care Health Sciences. He is Vice-Chair of the RCGP Standing Group on Overdiagnosis and a member of the editorial board of the Drug and Therapeutics Bulletin. He has an interest in evidence-informed prescribing and shared decision-making. He is a member of the RCGP and of the British Medical Association.
Professor Patrick Vallance FRS FMedSci is President, R&D at GlaxoSmithKline (GSK). Prior to this, he was Senior Vice President, Medicines Discovery and Development. He joined the company in May 2006 as Head of Drug Discovery. He is a member of the GSK Board and the Corporate Executive Team. Prior to joining GSK, he was a clinical academic and led the Division of Medicine at UCL. He has over 20 years’ experience of research clinical medicine, general internal medicine, cardiovascular medicine and clinical pharmacology. He was elected to the Academy of Medical Sciences in 1999 and to the Royal Society in 2017. He was on the Board of the UK Office for Strategic Co-ordination of Health Research (OSCHR) from 2009 to 2016. He is an Honorary Fellow at both UCL and Imperial College London, a Non-Executive Director and Board member for UK Biobank, a Non-Executive Board member for Genome Research Limited and a Member of the Dementia Discovery Fund, which is managed by SV Life Sciences. He is also a GSK shareholder.
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