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61-458: The National Institute for Health and Care Research ( NIHR ) is the British government's major funder of clinical , public health , social care and translational research . With a budget of over £1.2 billion in 2020–21, its mission is to "improve the health and wealth of the nation through research". The NIHR was established in 2006 under the government's Best Research for Best Health strategy, and

122-550: A budget of over £1.2 billion in 2020–21, its mission is to "improve the health and wealth of the nation through research". The NIHR was established in 2006 under the government's Best Research for Best Health strategy, and is funded by the Department of Health and Social Care . As a research funder and research partner of the NHS , public health and social care, the NIHR complements the work of

183-509: A clinical trial, members of the public can actively collaborate with researchers in designing and conducting clinical research. This is known as patient and public involvement (PPI). Public involvement involves a working partnership between patients, caregivers, people with lived experience, and researchers to shape and influence what is researched and how. PPI can improve the quality of research and make it more relevant and accessible. People with current or past experience of illness can provide

244-430: A different perspective than professionals and compliment their knowledge. Through their personal knowledge they can identify research topics that are relevant and important to those living with an illness or using a service. They can also help to make the research more grounded in the needs of the specific communities they are part of. Public contributors can also ensure that the research is presented in plain language that

305-526: A practice known in the global health context as Community Engagement and Involvement (CEI). NIHR funds research infrastructure that provides expertise, specialist facilities, a delivery workforce and support services. This infrastructure supports and delivers research funded by government bodies, medical research charities, the life sciences industry and other relevant industries. NIHR coordinates and supports clinical research through its Research Delivery Network (RDN). With 12 regional networks across England,

366-523: A practice known in the global health context as Community Engagement and Involvement (CEI). NIHR funds research infrastructure that provides expertise, specialist facilities, a delivery workforce and support services. This infrastructure supports and delivers research funded by government bodies, medical research charities, the life sciences industry and other relevant industries. NIHR coordinates and supports clinical research through its Research Delivery Network (RDN). With 12 regional networks across England,

427-560: A priority topic, for example blood donation, healthcare-associated infections , and adult social care. Supporting the UK International Development Strategy and the United Nations' Sustainable Development Goals , NIHR launched its Global Health portfolio in 2016. It funds applied health research that directly addresses the diverse health needs of people in low- and middle-income countries (LMICs) using UK Aid from

488-423: A priority topic, for example blood donation, healthcare-associated infections , and adult social care. Supporting the UK International Development Strategy and the United Nations' Sustainable Development Goals , NIHR launched its Global Health portfolio in 2016. It funds applied health research that directly addresses the diverse health needs of people in low- and middle-income countries (LMICs) using UK Aid from

549-422: A treatment. The term "clinical research" refers to the entire process of studying and writing about a drug, a medical device or a form of treatment, which includes conducting interventional studies ( clinical trials ) or observational studies on human participants. Clinical research can cover any medical method or product from its inception in the lab to its introduction to the consumer market and beyond. Once

610-413: Is clear to the wider society and the specific groups it is most relevant for. Following preclinical research , clinical trials involving new drugs are commonly classified into four phases. Each phase of the drug approval process is treated as a separate clinical trial . If the drug successfully passes through Phases I, II, and III, it will be approved by the national regulatory authority for use in

671-516: Is funded by the Department of Health and Social Care . As a research funder and research partner of the NHS , public health and social care, the NIHR complements the work of the Medical Research Council . NIHR focuses on translational research (translating discoveries from the laboratory to the clinic), clinical research and applied health and social care research. The NIHR (originally named National Institute for Health Research )

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732-428: Is often conducted at academic medical centers and affiliated research study sites. These centers and sites provide the prestige of the academic institution as well as access to larger metropolitan areas, providing a larger pool of medical participants. These academic medical centers often have their internal Institutional Review Boards that oversee the ethical conduct of medical research. Besides being participants in

793-660: Is the Research Professorship which funds the clinical and applied health research of outstanding academics for 5-years. Similarly, the Global Health Research Professorship funds research that benefits low and middle income countries. Responsibility for the NIHR lies with the Chief Scientific Advisor to the Department of Health and Social Care (DHSC). Professor Sally Davies (Dame Sally from 2009) held this post from 2004 to 2016, and led

854-449: Is the Research Professorship which funds the clinical and applied health research of outstanding academics for 5-years. Similarly, the Global Health Research Professorship funds research that benefits low and middle income countries. Responsibility for the NIHR lies with the Chief Scientific Advisor to the Department of Health and Social Care (DHSC). Professor Sally Davies (Dame Sally from 2009) held this post from 2004 to 2016, and led

915-524: The Creative Commons attribution (CC BY) or the Open Government Licence (OGL). Clinical research Clinical research is different from clinical practice: in clinical practice, established treatments are used to improve the condition of a person, while in clinical research, evidence is collected under rigorous study conditions on groups of people to determine the efficacy and safety of

976-620: The European Union , the European Medicines Agency acts in a similar fashion for studies conducted in their region. These human studies are conducted in four phases in research subjects that give consent to participate in the clinical trials. National Institute for Health Research#Open access The National Institute for Health and Care Research ( NIHR ) is the British government's major funder of clinical , public health , social care and translational research . With

1037-450: The Medical Research Council . NIHR focuses on translational research (translating discoveries from the laboratory to the clinic), clinical research and applied health and social care research. The NIHR (originally named National Institute for Health Research ) was created in April 2006 under the government's health research strategy, Best Research for Best Health. This strategy outlined

1098-531: The University of Oxford or the University College London . The NIHR has also established Clinical Research Facilities (CRFs), dedicated spaces for delivering research and trials, at 28 NHS hospitals. The NIHR also funds three Patient Safety Translational Research Centres which focus on translating discoveries on patient safety into practice. Researching specific regional health and care issues,

1159-407: The University of Oxford or the University College London . The NIHR has also established Clinical Research Facilities (CRFs), dedicated spaces for delivering research and trials, at 28 NHS hospitals. The NIHR also funds three Patient Safety Translational Research Centres which focus on translating discoveries on patient safety into practice. Researching specific regional health and care issues,

1220-685: The 2006 Best Research for Best Health strategy, outlined the updated operational principles, core work-streams and areas of strategic focus of the NIHR. Their work-streams include funding research for the NHS, public and global health and social care ; investing in expertise and facilities; and involving patients and communities in research . Their current areas of strategic focus include learning from impact of COVID-19 on research and healthcare; researching for patients with multiple long-term conditions , involving under-served communities and regions in research; and improving equality, diversity and inclusion across

1281-607: The FDA in support of an Investigational New Drug application. Where devices are concerned the submission to the FDA would be for an Investigational Device Exemption application if the device is a significant risk device or is not in some way exempt from prior submission to the FDA. In addition, clinical research may require Institutional Review Board or Research Ethics Board and possibly other institutional committee reviews, Privacy Board, Conflict of Interest Committee, Radiation Safety Committee or Radioactive Drug Research Committee. In

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1342-544: The Institution. The NIHR's funding programmes offer a focused source of funding for researchers within the health and care system in England. Scotland, Wales and Northern Ireland also participate in some of these programmes. The programmes give researchers access to funding to undertake clinical and applied health and social care research. NIHR's funding programmes are: The NIHR has established three national research schools:

1403-437: The Institution. The NIHR's funding programmes offer a focused source of funding for researchers within the health and care system in England. Scotland, Wales and Northern Ireland also participate in some of these programmes. The programmes give researchers access to funding to undertake clinical and applied health and social care research. NIHR's funding programmes are: The NIHR has established three national research schools:

1464-749: The NIHR Academy and the Research Programme Directors are also contracted by the DHSC. The NIHR publishes five peer-reviewed , open access journals which make up the NIHR Journals Library. The journals are titled Efficacy and Mechanism Evaluation, Health and Social Care Delivery Research, Health Technology Assessment , Public Health Research, and Programme Grants for Applied Research. Researchers working in relevant, NIHR-funded projects are required to publish in an NIHR journal. Besides publishing

1525-510: The NIHR Academy and the Research Programme Directors are also contracted by the DHSC. The NIHR publishes five peer-reviewed , open access journals which make up the NIHR Journals Library. The journals are titled Efficacy and Mechanism Evaluation, Health and Social Care Delivery Research, Health Technology Assessment , Public Health Research, and Programme Grants for Applied Research. Researchers working in relevant, NIHR-funded projects are required to publish in an NIHR journal. Besides publishing

1586-520: The NIHR has a network of 15 Applied Research Collaborations (ARCs). The ARCs are made up of partnerships between universities, NHS providers, local authorities and other organisations. Based at NHS organisations, the NIHR Medtech and In vitro diagnostic Co-operatives (MICs) work with commercial companies on developing new medical technologies and research in vitro diagnostic tests. Established by its Office for Clinical Research Infrastructure in 2011,

1647-463: The NIHR has a network of 15 Applied Research Collaborations (ARCs). The ARCs are made up of partnerships between universities, NHS providers, local authorities and other organisations. Based at NHS organisations, the NIHR Medtech and In vitro diagnostic Co-operatives (MICs) work with commercial companies on developing new medical technologies and research in vitro diagnostic tests. Established by its Office for Clinical Research Infrastructure in 2011,

1708-465: The NIHR has eight Translational Research Collaborations – ready-formed networks of the UK's leading universities, NHS trusts and research centres that conduct early-phase translational research and tackle experimental medicine challenges in selected therapeutic themes. The NIHR Academy, launched in 2018, develops and coordinates the NIHR's academic training, career and research capacity development. Its launch

1769-416: The NIHR has eight Translational Research Collaborations – ready-formed networks of the UK's leading universities, NHS trusts and research centres that conduct early-phase translational research and tackle experimental medicine challenges in selected therapeutic themes. The NIHR Academy, launched in 2018, develops and coordinates the NIHR's academic training, career and research capacity development. Its launch

1830-497: The NIHR. Their work-streams include funding research for the NHS, public and global health and social care ; investing in expertise and facilities; and involving patients and communities in research . Their current areas of strategic focus include learning from impact of COVID-19 on research and healthcare; researching for patients with multiple long-term conditions , involving under-served communities and regions in research; and improving equality, diversity and inclusion across

1891-697: The RDN provides help to patients, the public and health and care organisations to participate in research. In 2021-22, the network recruited more than a million participants to clinical research studies, most of whom were taking part in research to help discover new treatments and vaccines for the COVID-19 pandemic. Since 2007, the NIHR also supports translating scientific developments into direct clinical treatments and applications through its twenty Biomedical Research Centres (BRCs). The BRCs operate as partnerships between local NHS organisations and academic institutions such as

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1952-596: The RDN provides help to patients, the public and health and care organisations to participate in research. In 2021-22, the network recruited more than a million participants to clinical research studies, most of whom were taking part in research to help discover new treatments and vaccines for the COVID-19 pandemic. Since 2007, the NIHR also supports translating scientific developments into direct clinical treatments and applications through its twenty Biomedical Research Centres (BRCs). The BRCs operate as partnerships between local NHS organisations and academic institutions such as

2013-642: The School for Primary Care Research, the School for Social Care Research, and the School for Public Health Research. Each national school is a research collaboration between academic centres in England. The three schools take part in developing evidence for use in practice and provide training and career development opportunities for researchers in their respective sectors. NIHR funds a range of university-based collaborations that undertake research in priority areas: blood and organ donor health, health protection, and health and social care policy. Each unit focuses on

2074-585: The School for Primary Care Research, the School for Social Care Research, and the School for Public Health Research. Each national school is a research collaboration between academic centres in England. The three schools take part in developing evidence for use in practice and provide training and career development opportunities for researchers in their respective sectors. NIHR funds a range of university-based collaborations that undertake research in priority areas: blood and organ donor health, health protection, and health and social care policy. Each unit focuses on

2135-410: The UK government. As well as funding Global Health Research Units and Groups, partnerships between British universities and LMIC institutions, NIHR invests in training and development in global health research and strengthening the research capacity of LMICs at individual, institutional and system level. Engaging and involving local communities in the design and delivery of health research is also part of

2196-409: The UK government. As well as funding Global Health Research Units and Groups, partnerships between British universities and LMIC institutions, NIHR invests in training and development in global health research and strengthening the research capacity of LMICs at individual, institutional and system level. Engaging and involving local communities in the design and delivery of health research is also part of

2257-489: The direction that NIHR research and development should take. Its predecessor was the NHS Research & Development programme which was established in 1991. Factors influencing the creation of the NIHR were the growing importance of evidence-based medicine in science and policymaking, the spread of New Public Management thinking and increased government funding. Its budget was over £1.2 billion in 2020–21. As of 2016 it

2318-590: The drug at different doses. Only 25-30% of drugs advance to the end of Phase III. In the United States , when a test article is unapproved or not yet cleared by the Food and Drug Administration ( FDA ), or when an approved or cleared test article is used in a way that may significantly increase the risks (or decreases the acceptability of the risks), the data obtained from the preclinical studies or other supporting evidence, or case studies of off label use are submitted to

2379-555: The final research articles, the NIHR Journals Library supports the model of open science by providing a transparent, 'living' document for each research project which is updated alongside the progress of the study. This involves publishing all relevant materials from the outset of the studies, including the relevant systematic reviews , research protocol , study documentation, plain English descriptions , and data . The NIHR publishes short, easy-to-read summaries and thematic overviews of

2440-503: The final research articles, the NIHR Journals Library supports the model of open science by providing a transparent, 'living' document for each research project which is updated alongside the progress of the study. This involves publishing all relevant materials from the outset of the studies, including the relevant systematic reviews , research protocol , study documentation, plain English descriptions , and data . The NIHR publishes short, easy-to-read summaries and thematic overviews of

2501-454: The founding of the NIHR in 2006. She was succeeded by Professor Chris Whitty (who has also been Chief Medical Officer for England since 2019). Since August 2021, the current holder of the post is Lucy Chappell , Professor of Obstetrics at King's College London . For operating the NIHR, the DHSC contracts with a number of NHS Trusts , universities and life science organisations that host NIHR's two coordinating centres: The Dean of

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2562-448: The founding of the NIHR in 2006. She was succeeded by Professor Chris Whitty (who has also been Chief Medical Officer for England since 2019). Since August 2021, the current holder of the post is Lucy Chappell , Professor of Obstetrics at King's College London . For operating the NIHR, the DHSC contracts with a number of NHS Trusts , universities and life science organisations that host NIHR's two coordinating centres: The Dean of

2623-429: The general population. Phase IV is post-approval studies. Phase I includes 20 to 100 healthy volunteers or individuals with the disease or condition. This study typically lasts several months and its purpose is to prove safety and an effective dosage. Phase II includes a larger number of individual participants in the range of 100–300, and Phase III includes some 1000-3000 participants to assess efficacy and safety of

2684-736: The most important research findings on the NIHR Evidence website. Some of the summaries are also published in The British Medical Journal . The NIHR also has an open science platform where researchers can share any kind of relevant articles, documents and data including negative or null results . NIHR has an open access policy and was one of the original funders of Europe PubMed Central . Their updated policy requires all NIHR-funded, peer-reviewed research articles submitted after June 2022 have to be immediately, freely and openly accessible to all. The articles are required to use

2745-604: The most important research findings on the NIHR Evidence website. Some of the summaries are also published in The British Medical Journal . The NIHR also has an open science platform where researchers can share any kind of relevant articles, documents and data including negative or null results . NIHR has an open access policy and was one of the original funders of Europe PubMed Central . Their updated policy requires all NIHR-funded, peer-reviewed research articles submitted after June 2022 have to be immediately, freely and openly accessible to all. The articles are required to use

2806-512: The position of Head of the Division of Diabetes, Endocrinology & Metabolism at Imperial College London . The award of NIHR Senior Investigator is given to recognise "the most prominent and prestigious researchers funded by the NIHR and the most outstanding leaders of patient and people-based research within the NIHR research community", and held for four years with the possibility of a second term and then alumnus status. The NIHR's flagship award

2867-459: The position of Head of the Division of Diabetes, Endocrinology & Metabolism at Imperial College London . The award of NIHR Senior Investigator is given to recognise "the most prominent and prestigious researchers funded by the NIHR and the most outstanding leaders of patient and people-based research within the NIHR research community", and held for four years with the possibility of a second term and then alumnus status. The NIHR's flagship award

2928-659: The programme. In accordance with NIHR's open access policy , research created with such funding needs to be published in an open access journal. NIHR's global health spendings can be checked through the database of the International Aid Transparency Initiative . Since 2020, NIHR's global health research units and groups have been involved in efforts to tackle the spread and impact of the Covid-19 pandemic in LMICs. The NIHR offers several ways for patients and

2989-473: The programme. In accordance with NIHR's open access policy , research created with such funding needs to be published in an open access journal. NIHR's global health spendings can be checked through the database of the International Aid Transparency Initiative . Since 2020, NIHR's global health research units and groups have been involved in efforts to tackle the spread and impact of the Covid-19 pandemic in LMICs. The NIHR offers several ways for patients and

3050-428: The promising candidate or the molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where different aspects of the test article (including its safety toxicity if applicable and efficacy , if possible at this early stage) are studied. The clinical research ecosystem involves a complex network of sites, pharmaceutical companies and academic research institutions. Clinical research

3111-434: The public about what health and care research is and to help them find studies that are looking for participants. Patients and the public can also contribute to research through patient and public involvement (PPI). PPI is a partnership between members of the public (including patients, service users, carers) and researchers where public representatives can influence what should be a priority for research and help shape how

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3172-432: The public about what health and care research is and to help them find studies that are looking for participants. Patients and the public can also contribute to research through patient and public involvement (PPI). PPI is a partnership between members of the public (including patients, service users, carers) and researchers where public representatives can influence what should be a priority for research and help shape how

3233-497: The public to participate in health and care research. People can take part in a study as a research participant , for example in a clinical trial that looks for new treatments for a health condition. People who are not affected by a particular condition or who care for someone with a long-term health issue can also take part in research. The NIHR runs the online services Be Part of Research and Join Dementia Research to inform

3294-436: The public to participate in health and care research. People can take part in a study as a research participant , for example in a clinical trial that looks for new treatments for a health condition. People who are not affected by a particular condition or who care for someone with a long-term health issue can also take part in research. The NIHR runs the online services Be Part of Research and Join Dementia Research to inform

3355-526: The research is carried out, applied and communicated. Members of the public can find involvement opportunities in NIHR's research through the database People in Research . The website Learning for Involvement also offers information and resources for learning about public involvement and best practice case studies. The NIHR's global health research funding application process also requires applicants to meaningfully involve affected communities in their research,

3416-471: The research is carried out, applied and communicated. Members of the public can find involvement opportunities in NIHR's research through the database People in Research . The website Learning for Involvement also offers information and resources for learning about public involvement and best practice case studies. The NIHR's global health research funding application process also requires applicants to meaningfully involve affected communities in their research,

3477-494: The spread of New Public Management thinking and increased government funding. Its budget was over £1.2 billion in 2020–21. As of 2016 it was the largest national clinical research funder in Europe. In 2022 NIHR changed its name to National Institute for Health and Care Research in order to emphasise its role in social care research. In June 2021 NIHR published Best Research for Best Health: The Next Chapter. The document, building on

3538-523: Was an output and recommendation of the strategic review of training which looked at the future training and support needs of researchers. The NIHR Academy provides training and career development awards from pre-doctoral level to research professorships. As of 2021 the Dean of the NIHR Academy is Professor Waljit Dhillo , Professor in Endocrinology and Metabolism, and Consultant Endocrinologist. He also holds

3599-416: Was an output and recommendation of the strategic review of training which looked at the future training and support needs of researchers. The NIHR Academy provides training and career development awards from pre-doctoral level to research professorships. As of 2021 the Dean of the NIHR Academy is Professor Waljit Dhillo , Professor in Endocrinology and Metabolism, and Consultant Endocrinologist. He also holds

3660-417: Was created in April 2006 under the government's health research strategy, Best Research for Best Health. This strategy outlined the direction that NIHR research and development should take. Its predecessor was the NHS Research & Development programme which was established in 1991. Factors influencing the creation of the NIHR were the growing importance of evidence-based medicine in science and policymaking,

3721-449: Was the largest national clinical research funder in Europe. In 2022 NIHR changed its name to National Institute for Health and Care Research in order to emphasise its role in social care research. In June 2021 NIHR published Best Research for Best Health: The Next Chapter. The document, building on the 2006 Best Research for Best Health strategy, outlined the updated operational principles, core work-streams and areas of strategic focus of

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