How to conduct medical research
Pmcid: pmc2590769nihmsid: nihms79490a basic introduction to research: how not to do researchandrew j. Vickers, memorial sloan-kettering cancer center, 1275 york avenue, ny, ny 10021, @asrekciv, t: 646 735 8142author information ► copyright and license information ►copyright notice and disclaimersee other articles in pmc that cite the published ctin this didactic paper, i review some prevalent “myths” about clinical research: anyone can do research; you can learn how to do research from a book or journal articles; all you need to do statistics is the right software (although excel will also do); you can do good quality research at your kitchen sink; what is important is that you did your best. They are based on a clear double standard: most clinicians would express shock and horror at the very thought that someone without appropriate clinical training and qualifications might treat a patient; meanwhile many clinicians do research with no research qualifications whatsoever. But clinical research can guide clinical decisions that affect the health and well-being of millions of people: it is therefore arguable that poorly conducted research is potentially far more harmful than poor medical practice. As such, it is doubly important that clinical research is conducted by those with appropriate training, statistical help and institutional ds: research design, complementary medicineintroductionin this didactic paper, i offer some personal reflections on perhaps the most common mistake made by beginning researchers: that clinical research is not particularly difficult and can be done by pretty much anyone, regardless of training and experience. I will explain my views by examining several “myths” about research that i believe to be particularly common in the complementary and alternative medicine community. I will end by making some practical suggestions to counter each of these 1: anyone can do clinical researcha friend of mine who is a professional mountaineer recently received the following email from a local hiking group: “dear sir, we would like to climb a mountain in the himalayas, perhaps something 22 – 25,000 feet high. That is because it is obvious to anyone: try to climb a himalayan mountain without an experienced leader and you are going to get yourself al research appears to be a different matter, however. There is a widespread impression that clinical research can be done by almost anyone, regardless of prior skills or experience. I get emails similar in form to the one above regularly; for a recent example, “i want to do some research on massage and need an outcome measure. What i suggested was that the enquirer find an experienced researcher with whom to work. Many clinicians i have met have a double standard: on the one hand, those engaged in clinical activities must have the proper training and experience; on the other hand, anyone can do research. Meanwhile many clinicians do research with no research qualifications is perhaps most clearly brought home at ‘research days’ where complementary practitioners, acupuncturists say, attend a few seminars hoping to learn how to do clinical research. Yet whilst ‘research days’ continue to proliferate and ‘acupuncture days’ are unheard of, it is arguable that it is medical research that requires more training (see table). And qualifications for acupuncture compared to researchmyth 2: you can learn how to do research from a book or journal articlesi was recently asked to review a paper that described an ‘n-of-1’ trial of a complementary therapy. It was not hard to see why the authors had gone so badly wrong: they had no formal training in research methods, they had never previously conducted an n-of-1 trial and they were not working at an institution where such trials (or anything remotely similarly) had been conducted. The authors had based their methods on a chapter in a complementary medicine research textbook. The first problem, which is fairly typical of those writing about complementary medicine research, is that the author of this chapter had no experience whatsoever of n-of-1 methodology (similarly, the journal that asked me to review this paper published one entitled ‘how to conduct a survey’, written by an author with no significant survey publications). Give an inexperienced researcher a methodology textbook and similarly, all you’ll end up with is broken 3: all you need to do statistics is the right software (although excel will also do)the other day i sat down in front of microsoft word and typed ‘now is the winter of our discontent. Again we see the double standard: to be a clinician takes years of training; to be a statistician, all you need is some software and familiarity with the ‘paste’ i read any medical paper, one of the first things i do is to glance over the list of authors. On balance though, if i’m sick, i want to see someone with a plaque on the 4: you can do good quality research at your kitchen sinkit is almost impossible to enumerate in full the physical and intellectual resources that are taken for granted by those working in large research institutions. Working at such a hospital also means that research protocols are evaluated by expert committees of researchers who can offer guidance and it really possible that the isolated practitioner, working alone without expert help or any significant research facilities, can really produce good clinical science? I can’t say i’m 100% sure, but it is difficult to think of many 5: what is important is that you did your besti was once asked to read a report of a clinical trial conducted by a medical student. A medical researcher who tried to treat a sick patient and messed up through lack of skills, knowledge and training would rightly be excoriated; “it was my first patient” or “i did my best” would be no defense, and no comfort, to the injured party. Why the double standard such that it is somehow okay to mess up research, but not medicine, through inexperience, ignorance and lack of resources? Clinical research can guide clinical decisions that affect the health and well-being of millions of people. Bad research can therefore be just as harmful as bad medicine, perhaps even more so. Until this is more widely realized, and clinicians accordingly pay much more attention to the skills, training and resources needed for high quality science, it is likely that much of the research we see in journals will continue to be little more than the intellectual equivalent of karaoke night. How not how not to do research” isn’t very catchy, but when you think about it, that pretty much describes the scientific process: we find out what leads us astray (contaminated test tubes, uncontrolled studies) and try to avoid it (wash glassware, randomize). Here are some practical suggestions to counter each of the myths i discuss in this 1: anyone can do research irrespective of skills and experiencewe can take the mountain climbing analogy one step further. You wouldn’t try to climb annapurna without going along with someone who had already some experience of himalayan mountaineering; accordingly, if you want to do a clinical trial, have a researcher on your team who has done a trial previously; if you want to do molecular marker study, include someone with a track record of publications in that 2: you can learn how to do research from a book or journal articlesmost researchers will tell you that some kind of formal training in research methods is an essential basis for a research career, but also that hands-on experience is critical. If you really want an active research career, you will need to consider a higher degree. Someone who wants to specialize in research should think about a doctorate, otherwise, a masters’ in clinical epidemiology, public health or biostatistics would provide an excellent foundation for subsequent clinical research activities. In either case, you will need to get experience on as many different research studies as possible during and after you complete your 3: all you need to do statistics is the right softwareincorporation of biostatistical help is cited by experienced investigators as one of the key determinants of the success or failure of a research program.
4: you can do good quality research at your kitchen sinkobtain a position at an institution that has a good research infrastructure and high-quality 5: what is important is that you did your bestconstantly ask whether you are doing research for the right reasons: why is it that you want that grant? Medical research shouldn’t be about the researcher, it should be about the people who might be helped by the researcher’s ledgmentsdr vickers’ work on this research was funded by a p50-ca92629 spore from the national cancer s:article | pubreader | epub (beta) | pdf (270k) | hare uses cookies to improve functionality and performance, and to provide you with relevant advertising. 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Clinical study involves research using human volunteers (also called participants) that is intended to add to medical are two main types of clinical studies: clinical trials (also called interventional studies) and observational a clinical trial, participants receive specific interventions according to the research plan or protocol created by the interventions may be medical products, such as drugs or devices; procedures; or changes to participants' behavior, such as al trials may compare a new medical approach to a standard one that is already available, to o that contains no active ingredients, or to no intervention. Information on expanded access from the national library of ational an observational study, investigators assess health outcomes in groups of participants according to a research plan or ipants may receive interventions (which can include medical products such as drugs or devices). Procedures as part of their routine medical care, but participants are not assigned to specific interventions by the investigator. Example, investigators may observe a group of older adults to learn more about the effects of different lifestyles on cardiac conducts clinical studies? Clinical study is led by a principal investigator, who is often a medical al studies also have a research team that may include doctors, nurses, social workers, and other health care al studies can be sponsored, or funded, by pharmaceutical companies, academic medical centers, voluntary groups,And other organizations, in addition to federal agencies such as the national institutes of health,The u. Department of veterans s, other health care providers, and other individuals can also sponsor clinical are clinical studies conducted? Studies can take place in many locations, including hospitals, universities, doctors' offices, and community location depends on who is conducting the long do clinical studies last? Length of a clinical study varies, depending on what is being ipants are told how long the study will last before they s for conducting clinical general, clinical studies are designed to add to medical knowledge related to the treatment, diagnosis, and prevention of diseases or common reasons for conducting clinical studies include:Evaluating one or more interventions (for example, drugs, medical devices, approaches to surgery or radiation therapy) for treating a disease, syndrome, or g ways to prevent the initial development or recurrence of a disease or condition. The protocol is designed to answer specific research questions and safeguard the health of participants. It contains the following information:The reason for conducting the may participate in the study (the eligibility criteria). Some research studies seek participants who have the illnesses or conditions that will be studied, other studies are looking for healthy participants, and some studies are limited to a predetermined group of people who are asked by researchers to ility. They are based on characteristics such as age, gender, the type and stage of a disease, previous treatment history, and other medical are participants protected? Consent is a process used by researchers to provide potential and enrolled participants with information about a clinical study. See the questions to ask section on this page for questions to ask a health care provider or researcher about participating in a clinical utional review boards. Each federally supported or conducted clinical study and each study of a drug, biological product, or medical device regulated by fda must be reviewed, approved, and monitored by an institutional review board (irb). This includes making sure that research risks are minimized and are reasonable in relation to any potential benefits, among other responsibilities. Federal agencies, including the office of human subjects research protection and fda, have the authority to determine whether sponsors of certain clinical studies are adequately protecting research onship to usual health lly, participants continue to see their usual health care providers while enrolled in a clinical study. While most clinical studies provide participants with medical products or interventions related to the illness or condition being studied, they do not provide extended or complete health care.
By having his or her usual health care provider work with the research team, a participant can make sure that the study protocol will not conflict with other medications or treatments that he or she erations for ipating in a clinical study contributes to medical knowledge. The results of these studies can make a difference in the care of future patients by providing information about the benefits and risks of therapeutic, preventative, or diagnostic products or al trials provide the basis for the development and marketing of new drugs, biological products, and medical devices. Some trials may provide participants with the prospect of receiving direct medical benefits, while others do not. Most trials involve some risk of harm or injury to the participant, although it may not be greater than the risks related to routine medical care or disease progression. A potential participant should also discuss these issues with members of the research team and with his or her usual health care interested in participating in a clinical study should know as much as possible about the study and feel comfortable asking the research team questions about the study, the related procedures, and any expenses. It is not to be confused with biomedical university of florida cancer and genetics research complex is one of the largest medical research facilities in the united ical research (or experimental medicine) encompasses a wide array of research from "basic research" (also called bench science or bench research),[1] involving the elucidation of more fundamental scientific principles, to clinical research, which is distinguished by the involvement of patients. Within this spectrum is applied research, or translational research conducted to aid and support the development of knowledge in the field of medicine, and pre-clinical research, for example involving clinical and pre-clinical research phases exist in the pharmaceutical industry's drug development pipelines, where the clinical phase is denoted by the term clinical trial. However, only part of the clinical or pre-clinical research is oriented towards a specific pharmaceutical purpose. The need for fundamental and mechanistic understanding, diagnostics, medical devices and non-pharmaceutical therapies means that pharmaceutical research is only a small part of medical increased longevity of humans over the past century can be significantly attributed to advances resulting from medical research. Among the major benefits of medical research have been vaccines for measles and polio, insulin treatment for diabetes, classes of antibiotics for treating a host of maladies, medication for high blood pressure, improved treatments for aids, statins and other treatments for atherosclerosis, new surgical techniques such as microsurgery, and increasingly successful treatments for cancer. Many challenges remain, however, including the appearance of antibiotic resistance and the obesity of the research in the field is pursued by biomedical scientists, however significant contributions are made by other biologists, as well as chemists and physicists. Medical research, done on humans, has to strictly follow the medical ethics as sanctioned in the declaration of helsinki and elsewhere. Spring harbor laboratory on long island, home to eight scientists awarded the nobel prize in physiology or medicine, is an internationally renowned basic medical research tackled in the most fundamental parts of medical research include cellular and molecular biology, medical genetics, immunology, neuroscience, and psychology. Researchers, mainly in universities or government-funded research institutes, aim to establish an understanding of the cellular, molecular and physiological mechanisms underpinning human health and disease. Many organisms share a common evolutionary history with humans and hence common features and systems, the basic end of medical research these days shades into basic nical research[edit]. Typically the work requires no ethical approval (though work with animals does), is supervised by scientists rather than medical doctors, and is carried out in a university or company rather than a al research[edit]. It is generally supervised by doctors in a medical setting such as a hospital and requires ethical r information: research headquarters of the wellcome trust in london, united ical research and development expenditures classified by country in 2012 in billions of u. Funding in many countries derives from research bodies and private organizations 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. The united states, the most recent data from 2003[5] suggest that about 94 billion dollars were provided for biomedical research in the united states. Was spent on biomedical research,[6] with just under half ($800m, 47%) sourced from the commonwealth government (all sources). 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 a$700 million in 2008–09. 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 ment-funded biomedical research[edit]. From 1995 to 2010, nih support of biomedical research increased from 11 billion to 27 billion [8] despite the jump in federal spending, advancements measured by citations to publications and the number of drugs passed by the fda along with other measures of scientific achievement remained stagnant over the same time span. National institutes of health (nih) is the agency that is responsible for management of the lion's share of federal funding of biomedical research. 8] the second notable period started in 1997 and ended in 2010, a period where the nih moved to organize research spending for engagement with the scientific community. 10] the american recovery and reinvestment act of 2009 should also be noted in this history of nih funding of biomedical research as it committed further funds in the midst of the great recession. In recent years, the nih has started to publish medical research trials success rates per dollar spent, an initiative which illustrates that research efficiency is viewed as a significant issue both by the public and policy makers. 1980 the share of biomedical research funding from industry sources has grown from 32% to 62%,[11] which has resulted in the development of numerous life-saving medical advances. The relationship between industry and government-funded research in the us has seen great movement over the years. The 1980 bayh dole act was passed by congress to foster a more constructive relationship between the collaboration of government and industry funded biomedical research. The bayh doyle act gave private corporations the option of applying for government funded grants for biomedical research which in turn allowed the private corporations to license the technology. 12] both government and industry research funding increased rapidly from between the years of 1994–2003; industry saw a compound average annual growth rate of 8.
Funding from industry for pharmaceutical research, a large part of all industry funded research, has slowed since 1994 due to multiple perceptions, lower approval rates from the fda, increased costs with clinical trials due to more stringent regulation and longer anticipation for return on investment. Conflict of interest" in the field of medical research has been defined as "a set of conditions in which professional judgment concerning a primary interest (such as a patients welfare or the validity of research) tends to be unduly influenced by a secondary interest (such as financial gain). Relationship that exists with industry funded biomedical research is that of which industry is the financier for academic institutions which in turn employ scientific investigators to conduct research. 15] a list of studies show that public fear of the conflicts of interest that exist when biomedical research is funded by industry can be considered valid after a 2003 publication of "scope and impact of financial conflicts of interest in biomedical research" in the journal of american association of medicine. This publication included 37 different studies that met specific criteria to determine whether or not an academic institution or scientific investigator funded by industry had engaged in behavior that could be deduced to be a conflict of interest in the field of biomedical research. Survey results from one study concluded that 43% of scientific investigators employed by a participating academic institution had received research related gifts and discretionary funds from industry sponsors. Of investigators were financially tied to research sponsors, including paid speaking engagements (34%), consulting arrangements (33%), advisory board positions (32%) and equity (14%). 11] a 1994 study concluded that 58% out of 210 life science companies indicated that investigators were required to withhold information pertaining to their research as to extend the life of the interested companies' patents. 11] rules and regulations regarding conflict of interest disclosures are being studied by experts in the biomedical research field to eliminate conflicts of interest that could possibly affect the outcomes of biomedical earliest narrative describing a medical trial is found in the book of daniel, which says that babylonian king nebuchadnezzar ordered youths of royal blood to eat only red meat and wine for three years, while another group of youths ate only beans and water. In 1945, vannevar bush said that biomedical scientific research was "the pacemaker of technological progress", an idea which contributed to the initiative to found the national institutes of health (nih) in 1948, a historical benchmark that marked the beginning of a near century substantial investment in biomedical research. 19] the nih provides more financial support for medical research that any other agency in the world to date and claims responsibility for numerous innovations that have improved global health. Research spending increased substantially faster than gdp growth over the past decade in the us, between the years of 2003 and 2007 spending increased 14% per year, while gdp growth increased 1% over the same period (both measures adjusted for inflation). 21] due to the immediacy of federal financing priorities and stagnant corporate spending during the recession, biomedical research spending decreased 2% in real terms in 2008. 21] despite an overall increase of investment in biomedical research, there has been stagnation, and in some areas a marked decline in the number of drug and device approvals over the same time period. Industry sponsored research accounts for 58% of expenditures, nih for 27% of expenditures, state governments for 5% of expenditures, non nih-federal sources for 5% of expenditures and not-for-profit entities accounted for 4% of support. Spending from industry-initiated research increased 25% (adjusted for inflation) over the same time period of time, from 2003 to 2007, an increase from $40 billion in 2003, to $58. Industry sponsored research, pharmaceutical firm spending was the greatest contributor from all industry sponsored biomedical research spending, but only increased 15% (adjusted for inflation) from 2003 to 2007, while device and biotechnology firms accounted for the majority of the spending. 21] the stock performance, a measure that can be an indication of future firm growth or technological direction, has substantially increased for both predominantly medical device and biotechnology producers. 21] another visible shift during the era was a shift in focus to late stage research trials; formerly dispersed, since 1994 an increasingly large portion of industry-sponsored research was late phase trials rather than early-experimental phases now accounting for the majority of industry sponsored research. 21] in 2007 the most heavily funded institutions received 20% of hin medical research funding, and the top 50 institutions received 58% of nih medical research funding, the percent of funding allocated to the largest institutions is a trend which has increased only slightly over data from 1994. 21] relative to federal and private funding, health policy and service research accounted for a nominal amount of sponsored research; health policy and service research was funded $1. To date only two-thirds of published drug trial findings have results that can be re-produced,[22] which raises concerns from a us regulatory standpoint where great investment has been made in research ethics and standards, yet trial results remain inconsistent. Federal agencies have called upon greater regulation to address these problems; a spokesman from the national institute of neurological disorders and stroke, an agency of the nih, stated that there is "widespread poor reporting of experimental design in articles and grant applications, that animal research should follow a core set of research parameters, and that a concerted effort by all stakeholders is needed to disseminate best reporting practices and put them into practice". Laws which are both still in effect, one passed in 2006 and the other in 2010, were instrumental in defining funding reporting standards for biomedical research, and defining for the first time reporting regulations that were previously not required. 23] aside from the main source, , other reporting mechanisms exist: data specifically on biomedical research funding from federal sources is made publicly available by the national health expenditure accounts (nhea), data on health services research, approximately 0. Of federal funding on biomedical research, is available through the coalition of health services research, the agency for healthcare research and quality, the centers for disease control and prevention, the centers for medicare & medicaid services, and the veterans health administration. There are not any funding reporting requirements for industry sponsored research, but there has been voluntary movement toward this goal. 24] in 2014, major pharmaceutical stakeholders such as roche and johnson and johnson have made financial information publicly available and pharmaceutical research and manufacturers of america (phrma), the most prominent professional association for biomedical research companies, has recently begun to provide limited public funding reports. National regulatory authorities are appointed in almost every country worldwide to oversee and monitor medical research, such as for the development and distribution of new drugs. The world medical association develops the ethical standards for the medical profession, involved in medical research. Major flaw and vulnerability in biomedical research appears to be the hypercompetition for the resources and positions that are required to conduct science. Other consequences of today's highly pressured environment for research appear to be a substantial number of research publications whose results cannot be replicated, and perverse incentives in research funding that encourage grantee institutions to grow without making sufficient investments in their own faculty and facilities. 25][26][27][28][29] other risky trends include a decline in the share of key research grants going to younger scientists, as well as a steady rise in the age at which investigators receive their first funding. Of biomedical research include:Biomedical ical l research l scientist training ceutical 21 of the code of federal regulations (us).
Kirschnerb, shirley tilghmanc, and harold varmus, rescuing us biomedical research from its systemic flaws, proceedings of the national academy of sciences of the united states of america, vol. Full dia commons has media related to medical al research and experimental ve clinical ic clinical al study design. Clinical icity and /post-test testing on non-human is of clinical ion-to-treat retation of ation does not imply ries: medical researchhealth researchhealth scienceshidden categories: cs1 errors: dateswikipedia articles in need of updating from august 2017all wikipedia articles in need of logged intalkcontributionscreate accountlog pagecontentsfeatured contentcurrent eventsrandom articledonate to wikipediawikipedia out wikipediacommunity portalrecent changescontact links hererelated changesupload filespecial pagespermanent linkpage informationwikidata itemcite this a bookdownload as pdfprintable version.
