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Research and clinical trials: An overviewRResearch and clinical trials: An overviewResearch and clinical trials: An overviewEnglishNAChild (0-12 years);Teen (13-18 years)NANANon-drug treatmentCaregivers Adult (19+)NA2009-12-11T05:00:00ZJonathan Hellmann, MBBCh, MHSc, FCP(SA), FRCPC9.0000000000000055.0000000000000976.000000000000Health (A-Z) - ProcedureHealth A-Z<p>Learn about the different kinds of health research and how research leads to better health care.</p><h2>What are the different kinds of research?</h2> <p>A lot of research is conducted to learn more about diseases that only happen in children, or that have a different course in children than in adults. Doctors, nurses, and other health professionals also study children's mental and physical development in research that can ultimately benefit all children. </p> <p>Different types of research studies include:</p> <ul> <li>"chart reviews," which look at children's existing hospital records to study what happened before, during and after treatment of a disease</li> <li>questionnaires, surveys and interviews, used to collect information on disease outcomes, behaviour, opinions, quality of life or patient satisfaction</li> <li>standard research on sick patients using physical examinations, imaging and specimen collection to study diseases or diagnostic methods</li> <li>intervention studies, which look at a therapy such as a drug, medical device, surgery or physical therapy. Intervention studies include clinical trials.</li> </ul> <h3>What is a clinical trial?</h3> <p>A <a href="/Article?contentid=1264&language=English">clinical trial</a> is a research study that examines the use of drugs or other therapies in treatment. It asks a specific question to try and find better ways of preventing, diagnosing or treating different medical conditions. For example, clinical trials could study new drugs or new combinations of known drugs. </p> <p>Usually, there are four different phases of clinical drug trials. Phase I and Phase II trials determine the safety of a drug. By the time a treatment reaches a phase III clinical trial, it has been well studied and deemed safe for humans. Phase III trials are conducted by an organizing group of experts and under a set of strict rules called a protocol. </p><h2>Key points</h2> <ul> <li>There are many kinds of health research, ranging from chart reviews all the way up to clinical trials.</li> <li>Research is the only way to improve medical treatment and make sure that new treatments are safe and effective.</li> </ul><h2>Research and treatment protocols</h2> <h3>What is a protocol?</h3> <p>A formal protocol is a written plan that describes in detail how to treat a particular illness. It describes the drugs, dosages and tests that are needed. It tells the treatment team how often and when each drug should be given based on a schedule. Each protocol is based on research that shows which treatments are more effective.</p> <p>Experts from many hospitals work together to develop protocols. The results from each hospital are gathered and studied. Researchers have developed international groups to oversee and coordinate these efforts. Protocols can change if new research shows there are other drugs or combinations of drugs that are more effective. Drug companies, while involved in research protocols that initially establish the safety, dosage limits and efficacy of drugs, are not involved in organizing treatment protocols.</p> <h3>What is randomization?</h3> <p>Randomization is used in studies that involve two or more groups. Each group gets a different treatment and patients have to be placed in one of the groups. Randomization means that the patients are placed in a group by chance. This makes sure the results are not biased. A bias may be possible if a person decides who goes in which group. Usually a computer will assign a patient to a group. Most research protocols need randomization at diagnosis, or shortly after diagnosis. </p>
Recherches et essais cliniques : un aperçuRRecherches et essais cliniques : un aperçuResearch and clinical trials: An overviewFrenchNAChild (0-12 years);Teen (13-18 years)NANANon-drug treatmentCaregivers Adult (19+)NA2009-12-11T05:00:00ZJonathan Hellmann, MBBCh, MHSc, FCP(SA), FRCPC9.0000000000000055.0000000000000976.000000000000Health (A-Z) - ProcedureHealth A-Z<p> Un guide destiné à initier les parents aux différentes modalités de la recherche en santé et à la façon dont la recherche donne lieu à de meilleurs soins de </p><h2>Quels sont les différents types de recherche? </h2> <p>De nombreuses recherches sont menées pour en apprendre davantage sur les maladies qui surviennent uniquement chez les enfants ou qui ont une évolution différente chez les enfants. Les médecins, les infirmières et autres professionnels de la santé étudient également le développement physique et mental des enfants dans le cadre de recherches dont tous les enfants pourront, ultimement, tirer avantage. </p> <p>Voici quelques exemples de types de travaux de recherche:</p> <ul> <li>les analyses de dossiers médicaux, qui portent sur l’analyse des dossiers d’enfants à l’hôpital afin d’étudier ce qui s’est produit avant, pendant et après le traitement d’une maladie; </li> <li>les questionnaires, les sondages et les entrevues, utilisés pour recueillir des informations sur l’évolution de la maladie, le comportement, les avis, la qualité de vie ou la satisfaction des patients; </li> <li>les recherches standards sur les patients malades en faisant appel à des examens cliniques, à l’imagerie médicale, à des prélèvements pour étudier les maladies ou à des méthodes diagnostiques; </li> <li>les analyses des interventions, qui se penchent sur une thérapie comme la pharmacothérapie, un instrument médical, une intervention chirurgicale ou la physiothérapie. Les études d’intervention comprennent les essais cliniques. </li> </ul> <h3>Qu’est-ce qu’un essai clinique? </h3> <p>Un essai clinique est un travail de recherche qui porte sur l’analyse du recours à certains médicaments ou d’autres moyens thérapeutiques dans le cadre d’un traitement. On pose une question précise pour tenter de trouver de meilleures façons de prévenir, de diagnostiquer ou de traiter différents états pathologiques. Par exemple, les essais cliniques peuvent porter sur l’étude de médicaments nouveaux ou sur de nouvelles associations de médicaments connus.</p> <p>Habituellement, les essais cliniques portant sur des médicaments se divisent en quatre phases distinctes. Les essais des phases I et II évaluent l’innocuité d’un médicament. Au moment où un traitement arrive à l’essai clinique de phase III, le médicament a été bien étudié et est considéré comme sécuritaire pour l’humain. Les essais de phase III sont menés par un groupe organisateur composé de spécialistes et sont assujettis à une série de règles strictes appelée protocole.</p><h2>À retenir</h2> <ul> <li>Il existe plusieurs genres de recherches en santé, depuis les analyses de dossiers médicaux jusqu’aux essais cliniques. </li> <li>La recherche est la seule façon d’améliorer un traitement médical et de garantir l’innocuité et l’efficacité de nouvelles thérapies. </li> </ul><h2>Protocoles de recherche et protocoles thérapeutiques</h2> <h3>Qu’est-ce qu’un protocole? </h3> <p>Un protocole officiel est un plan écrit qui décrit en détail comment traiter une maladie précise. Il décrit les médicaments, la posologie et les examens nécessaires. Il indique à l’équipe thérapeutique à quelle fréquence et à quel moment il faut administrer un médicament selon un programme. Chaque protocole repose sur de la recherche qui indique les traitements qui sont les plus efficaces.</p> <p>Les spécialistes de nombreux hôpitaux collaborent à mettre au point des protocoles. Les résultats de chaque hôpital sont recueillis, puis analysés. Les chercheurs ont créé des groupes internationaux, qui surveillent et coordonnent ces efforts. Les protocoles peuvent changer si de nouvelles recherches démontrent qu’il y a d’autres médicaments ou associations de médicaments qui sont plus efficaces. Bien qu’elles participent aux protocoles de recherche qui portent dans un premier temps sur la détermination de l’innocuité, de la posologie et de l’efficacité des médicaments, les compagnies pharmaceutiques ne participent pas à l’établissement des protocoles thérapeutiques. </p> <h3>Qu’est-ce que la randomisation?</h3> <p>La randomisation est une technique utilisée dans les études qui mettent en cause au moins deux groupes. Chaque groupe reçoit un traitement différent et les patients sont répartis dans l’un de ces groupes. La randomisation signifie que les patients sont placés dans un groupe de façon aléatoire. Cela garantit que l’analyse des résultats n’est pas biaisée. Un biais est possible si une personne décide des participants à placer dans chaque groupe. Habituellement, l’attribution d’un patient à un groupe se fait par ordinateur. La plupart des protocoles de recherche prévoient une randomisation au moment d’établir un diagnostic ou peu de temps après. Pour en savoir davantage sur la participation aux essais cliniques, veuillez lire Les essais cliniques et votre enfant. </p>

 

 

Research and clinical trials: An overview1267.00000000000Research and clinical trials: An overviewResearch and clinical trials: An overviewREnglishNAChild (0-12 years);Teen (13-18 years)NANANon-drug treatmentCaregivers Adult (19+)NA2009-12-11T05:00:00ZJonathan Hellmann, MBBCh, MHSc, FCP(SA), FRCPC9.0000000000000055.0000000000000976.000000000000Health (A-Z) - ProcedureHealth A-Z<p>Learn about the different kinds of health research and how research leads to better health care.</p><h2>What are the different kinds of research?</h2> <p>A lot of research is conducted to learn more about diseases that only happen in children, or that have a different course in children than in adults. Doctors, nurses, and other health professionals also study children's mental and physical development in research that can ultimately benefit all children. </p> <p>Different types of research studies include:</p> <ul> <li>"chart reviews," which look at children's existing hospital records to study what happened before, during and after treatment of a disease</li> <li>questionnaires, surveys and interviews, used to collect information on disease outcomes, behaviour, opinions, quality of life or patient satisfaction</li> <li>standard research on sick patients using physical examinations, imaging and specimen collection to study diseases or diagnostic methods</li> <li>intervention studies, which look at a therapy such as a drug, medical device, surgery or physical therapy. Intervention studies include clinical trials.</li> </ul> <h3>What is a clinical trial?</h3> <p>A <a href="/Article?contentid=1264&language=English">clinical trial</a> is a research study that examines the use of drugs or other therapies in treatment. It asks a specific question to try and find better ways of preventing, diagnosing or treating different medical conditions. For example, clinical trials could study new drugs or new combinations of known drugs. </p> <p>Usually, there are four different phases of clinical drug trials. Phase I and Phase II trials determine the safety of a drug. By the time a treatment reaches a phase III clinical trial, it has been well studied and deemed safe for humans. Phase III trials are conducted by an organizing group of experts and under a set of strict rules called a protocol. </p><h2>Why is research important?</h2> <p>Research is the only way of improving the success of treatments. To show how dramatic the effect of research can be, consider the case of immature lungs in premature babies. In the 1960s, premature babies often went on to develop severe and permanent lung problems as adults. This was because their lungs had not developed enough before they began to be used for breathing. Through research, it was found that premature babies given surfactant therapy went on to develop healthier lungs. This research took place in the form of clinical trials. Each time a trial showed an improvement with treatment methods with surfactant, this new treatment could be used more effectively with more children. </p> <h2>How are new drugs developed?</h2> <p>Drug development usually takes a lot of time and research. Researchers, knowing the properties of certain molecules and the working of the body, speculate that a compound may have some benefit. This benefit and the safety of the drug in general are then demonstrated in animals. This stage is called preclinical research. After a drug has shown promise, it will be tested in a clinical trial with humans. Clinical trials move through various phases. </p> <p>After each clinical trial, the researchers will write about their findings. They will describe the procedure, the participants, treatment results, side effects and their understanding of the results. The researchers will send their report to a scientific journal. Other experts who are not connected to the study will read and analyze this report. This is called peer review. If these experts agree that the trial was of high quality, the report will be published. </p> <p>After reading the report, other researchers in different cities and countries should be able to repeat similar trials to see if they get the same results. Larger and larger numbers of patients will participate. </p> <p>After a number of trials that show its effectiveness, a drug or treatment is approved by a national regulatory body, such as Health Canada, the U.S. Food and Drug Administration or the Medicines Control Agency in the United Kingdom. Usually, it is first approved for a very particular disease and situation. Later trials help pave the way for the drug to be approved for use with different diseases or age groups. </p> <p>This long process shows why the discovery of "miracle cures" in science is so rare. Scientific discovery moves in small steps. Each of these steps involves a clinical trial that takes a great deal of time, effort, money, collaboration and thought by many different researchers. </p> <p>This scientific process is not always perfect but it is the best way to make sure that a new treatment is safe and effective before being introduced into routine clinical care.</p><h2>Key points</h2> <ul> <li>There are many kinds of health research, ranging from chart reviews all the way up to clinical trials.</li> <li>Research is the only way to improve medical treatment and make sure that new treatments are safe and effective.</li> </ul><h2>Research and treatment protocols</h2> <h3>What is a protocol?</h3> <p>A formal protocol is a written plan that describes in detail how to treat a particular illness. It describes the drugs, dosages and tests that are needed. It tells the treatment team how often and when each drug should be given based on a schedule. Each protocol is based on research that shows which treatments are more effective.</p> <p>Experts from many hospitals work together to develop protocols. The results from each hospital are gathered and studied. Researchers have developed international groups to oversee and coordinate these efforts. Protocols can change if new research shows there are other drugs or combinations of drugs that are more effective. Drug companies, while involved in research protocols that initially establish the safety, dosage limits and efficacy of drugs, are not involved in organizing treatment protocols.</p> <h3>What is randomization?</h3> <p>Randomization is used in studies that involve two or more groups. Each group gets a different treatment and patients have to be placed in one of the groups. Randomization means that the patients are placed in a group by chance. This makes sure the results are not biased. A bias may be possible if a person decides who goes in which group. Usually a computer will assign a patient to a group. Most research protocols need randomization at diagnosis, or shortly after diagnosis. </p>https://assets.aboutkidshealth.ca/AKHAssets/research_clinical_trials_overview.jpgResearch and clinical trials: An overview

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