Medical Research

Biomedical research (or experimental medicine), in general simply known as medical research, is the basic research, applied research, or translational research conducted to aid and support the body of knowledge in the field of medicine. Medical research can be divided into two general categories: the  
evaluation of new treatments for both safety and efficacy in what are termed clinical trials, and all other research that contributes to the development of new treatments. The latter is termed preclinical research if its goal is specifically to elaborate knowledge for the development of new therapeutic strategies. A new paradigm to biomedical research is being termed translational research, which focuses on iterative feedback loops between the basic and clinical research domains to accelerate knowledge translation from the bedside to the bench, and back again. Medical research may involve doing research on public health, biochemistry, clinical research, microbiology, physiology, oncology, surgery and research on many other non-communicable diseases such as diabetes and cardiovascular diseases.

Preclinical research

Preclinical research is research in basic science, which precedes the clinical trials, and is almost purely based on theory and animal experiments. Much of these experiments involve preclinical imaging modalities to aid in vivo, longitudinal studies.
New treatments come about as a result of other, earlier discoveries — often unconnected to each other, and in various fields. Sometimes the research is done for non-medical purposes, and only by accident contributes to the field of medicine (for example, the discovery of penicillin). Clinicians use these discoveries to create a treatment regimen, which is then tested in clinical trials

Clinical trials

A clinical trial is a comparison test of a medication or other medical treatment, versus a placebo, other medications and devices, or the standard medical treatment for a patient's condition. Clinical trials vary greatly in size: from a single researcher in one hospital or clinic to an international multicenter trial with several hundred participating researchers on several continents. The number of patients tested can range from as few as a dozen to several thousands.
Every new drug formulation used in a clinical trial has to first undergo rigorous tests in a laboratory. Once the results from those tests confirm that the formulation is safe to be taken by humans, the drug is given to healthy volunteers in what are called Phase I clinical trials

Funding

The headquarters of the Wellcome Trust in London, United Kingdom

Research funding in many countries comes from research bodies which distribute money for equipment and salaries. In the United Kingdom, funding bodies such as the Medical Research Council derive their assets from UK tax payers, and distribute this to institutions in a competitive manner. The Wellcome Trust is the UK's largest non-governmental source of funds for biomedical research and provides over £600 million per year in grants to scientists and funds for research centres.
In the United States, the most recent data from 2003 suggest that about 94 billion dollars were provided for biomedical research in the United States. The National Institutes of Health and pharmaceutical companies collectively contribute 26.4 billion dollars and 27.0 billion dollars, respectively, which constitute 28% and 29% of the total, respectively. Other significant contributors include biotechnology companies (17.9 billion dollars, 19% of total), medical device companies (9.2 billion dollars, 10% of total), other federal sources, and state and local governments. Foundations and charities, led by the Bill and Melinda Gates Foundation, contributed about 3% of the funding.
In Australia, in 2000/01 (the most recent data available), about $1.7B was spent on biomedical research , with just under half ($800M, 47%) sourced from the Commonwealth government (all sources). About $540M came from business investments/funding and a further $220M from private or not-for-profit organisations (totalling 44%). The balance was from state and local governments. Since then there has been a significant in government funding through the National Health and Medical Research Council (NHMRC), whose expenditure on research was nearly $AUD700 million in 2008-09.
The enactment of orphan drug legislation in some countries has increased funding available to develop drugs meant to treat rare conditions, resulting in breakthroughs that previously were uneconomical to pursue.

Regulations and guidelines

Medical research is highly regulated. National regulatory authorities oversee and monitor medical research, such as for the development of new drugs. In the USA the Food and Drug Administration oversees new drug development, in Europe the European Medicines Agency (see also EudraLex), and in Japan the Ministry of Health, Labour and Welfare (Japan). The World Medical Association develops the ethical standards for the medical profession, involved in medical research. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) works on the creation of rules and guidelines for the development of new medication, such as the guidelines for Good Clinical Practice (GCP). All ideas of regulation are based on a country's ethical standards code. This is why treatment of a particular disease in one country may not be allowed, but is in another.

Conflicts of interest

In 2001, the editors of 12 major journals issued a joint editorial, published in each journal, on the control over clinical trials exerted by sponsors, particularly targeting the use of contracts which allow sponsors to review the studies prior to publication and withhold publication. They strengthened editorial restrictions to counter the effect. The editorial noted that contract research organizations had, by 2000, received 60% of the grants from pharmaceutical companies. In the U.S. researchers may be restricted from contributing to the trial design, accessing the raw data, and interpreting the results.

The wealth of electronic health data within the NHS provides unique opportunities for researchers to identify more effective treatments, improve drug safety, assess risks to public health and study the causes of diseases and disability. Infrastructure initiatives currently under development in England, Scotland and Wales are allowing researchers access to e-health records in a secure environment that protects patient confidentiality. Linking UK e-health records with other forms of routinely collected environmental, social and economic data or with research data sets offers unprecedented opportunities to enhance patient and public health and advance social and medical research.

The UK research funders recognise the enormous benefits of linking electronic health data in research. In 2009 the funders, under the auspices of the Office for Strategic Coordination of Health Research (OSCHR), developed a Strategic Framework for Health Informatics in Support of Research. The Framework builds on the funders’ existing investments in health informatics research by identifying the major issues that need to be addressed to fully realise the research potential offered by increasing access to electronic health-related data sources.

To understand how well the UK is placed to capitalise on these growing research opportunities, the MRC led a mapping exercise in 2010 on behalf of the UK research funders(1) and the Association of British Pharmaceutical Industries (ABPI) to review the UK capability in e-health records research and determine the requirements to support a sustainable e-health informatics research base in the future. Key findings documented in the resulting report were:

• There is a shortage of people with the breadth of skills necessary to carry out the complex linkage and analyses required in health informatics research.
• There is an absence of career structure in enabling roles such as data managers, software engineers, informaticians and data analysts.
• Methodological research in complex data linkage requires further development.
• There are no clear interfaces between researchers and industry, policy makers or the NHS and there is no ready means for sharing best practice.

Responding to the capacity and capability issues highlighted in the report, the ten largest government and charity research funders have launched a £15m partnership to establish centres of excellence in research linking electronic health data.

For more information see http://www.mrc.ac.uk/E-healthCentresCall

The centres will undertake cutting edge research linking e-health records with other forms of research and routinely collected data, with the aim of building and sustaining a vibrant e-health informatics research capability in the UK.

1. Cancer Research UK (CRUK), Chief Scientist’s Office, Scottish Government Health Directorates (CSO), Engineering and Physical Sciences Research Council (EPSRC), Economic and Social Research Council (ESRC), Medical Research Council (MRC), National Institute for Health Research (NIHR), National Institute for Social Care and Health Research (NISCHR), and The Wellcome Trust.