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Клиническое исследование 臨床試驗 Klinische Studie Клінічне випробування Uji klinis Assaig clínic Clinical trial Klinisk prövning Essai clinique تجربة سريرية Eksperyment kliniczny Klinisch onderzoek 治験 Ensayo clínico Klinická studie Studio clinico 임상시험 Ensaio clínico
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Eksperyment kliniczny (właściwe określenie: kliniczne badanie eksperymentalne) – badanie naukowe, którego zasadniczym celem jest określenie skuteczności oraz bezpieczeństwa stosowania produktu leczniczego, wyrobu medycznego lub innej techniki medycznej (zabiegu, testu diagnostycznego). Za „złoty standard” eksperymentów klinicznych uważa się randomizowane kontrolowane badania kliniczne (ang. randomized controlled trial lub randomized control trial, (RCT). Prawidłowo przeprowadzone badanie kliniczne interwencji terapeutycznych charakteryzuje się: Fazy eksperymentu klinicznego: Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted. Uji klinis (bahasa Inggris: clinical trial) adalah eksperimen atau pengamatan yang dilakukan dalam penelitian klinis. Studi penelitian biomedis atau perilaku pada peserta manusia dirancang untuk menjawab pertanyaan spesifik tentang intervensi biomedis atau perilaku, termasuk perawatan baru (seperti vaksin baru, obat-obatan, pilihan makanan, suplemen makanan, dan peralatan medis) dan intervensi yang dikenal yang memerlukan studi lebih lanjut dan perbandingan. Uji klinis menghasilkan data tentang keamanan dan . Mereka dilakukan hanya setelah mereka menerima persetujuan komite etika / otoritas kesehatan di negara tempat persetujuan terapi dicari. Un ensayo clínico es una evaluación experimental de un producto, sustancia, medicamento, técnica diagnóstica o terapéutica que, en su aplicación a seres humanos, pretende valorar su eficacia y seguridad. Los estudios de prometedores tratamientos nuevos o experimentales en pacientes se conocen como ensayos clínicos. Un ensayo clínico se realiza sólo cuando hay razones para creer que el tratamiento que se estudia puede beneficiar al paciente. Los tratamientos que se evalúan mediante los ensayos clínicos a menudo resultan ser verdaderamente beneficiosos. Los investigadores realizan estudios sobre nuevos tratamientos para conocer la utilidad del nuevo tratamiento, el mecanismo de acción del nuevo tratamiento, si es más eficaz que otros tratamientos ya disponibles, los efectos secundarios del n Os ensaios clínicos são um conjunto de procedimentos de investigação e desenvolvimento de medicamentos, que são realizados para permitir que dados de segurança (ou mais especificamente, informações sobre reações adversas e efeitos adversos de outros tratamentos) e eficácia a recolher para as intervenções de saúde (por exemplo, drogas, diagnóstico, dispositivos, protocolos de terapia). Estes ensaios só podem ter lugar após informação satisfatória ser recolhida sobre a qualidade da segurança não-clínica(testes invitro e ensaios com animais) e as autoridades de saúde aprovarem a realização dos ensaios no país no qual será realizado.. Eine klinische Studie ist in der evidenzbasierten Medizin und klinischen Forschung eine systematische Erhebung. Sie wird mit Patienten oder gesunden Probanden durchgeführt. Ziel ist es, Medikamente, bestimmte Behandlungsformen, medizinische Interventionen oder Medizinprodukte auf ihre Leistung, Wirksamkeit, Sicherheit und (klinischen) Nutzen zu überprüfen. Klinische Studien werden durchgeführt, um wissenschaftliche Fragestellungen zu beantworten und die medizinische Behandlung zu verbessern. 臨床試驗(英語:clinical trial)是一種临床研究方法,指根據研究方案採用已上市藥物或安慰劑作為對照組,對藥物或其他醫學治療在受試者身上進行比較測試的過程。在臨床試驗中,研究者要先決定所要測試的療法,例如藥物或裝置,再決定用哪種療法與它比較,以及須要找哪一類型的病人來作為測試對象。治療用藥物的話要證明它能有效延長病人的生命、減輕特定症狀或降低不良事件之發生以改善病人生活品質。 Klinické studie jsou studie na lidech nebo na zvířatech, jejichž úkolem je ověření bezpečnosti a účinnosti nového léčiva, vakcíny, léčebného postupu, vyšetření, doplňků stravy či přístrojů. V závislosti na typu produktu a fázi vývoje jsou nejprve prováděny malé pilotní studie na dobrovolnících nebo pacientech, v případě pozitivních výsledků počet pacientů či dobrovolníků postupně stoupá. Klinické testy mohou mít různý rozsah, od jednoho výzkumného zařízení v jedné zemi až po mnoho zařízení v několika zemích. Kompletní řada klinických testů může stát desetitisíce až miliardy Kč. Klinisk prövning, även kallad klinisk studie, är en undersökning på friska eller sjuka människor för att studera effekten av ett läkemedel eller behandlingsmetod. Kliniska prövningar delas upp i olika faser. Dessa faserna benämns Fas I, Fas II, Fas III och Fas IV. Fas II brukar indelas i tidig fas (Fas IIa) och sen fas (Fas IIb). Exempel på en klinisk prövning är för att utvärdera substansers lämplighet som läkemedel, för att studera effekterna av olika dieter, samt för att studera olika behandlingars effekt inom mentalsjukvården. Un assaig clínic és un tipus d'estudi clínic en què s'investiga una pregunta important en medicina i farmàcia, per a augmentar el coneixement. Per tal que un estudi sigui legalment considerat com un assaig clínic, ha de complir una de les següents condicions: * Que sigui aleatoritzat. * Que en el marc de l'estudi es dugui a terme algun procediment no previst dins de la pràctica clínica habitual. * Que en el marc de l'estudi s'utilitzi un medicament en unes condicions diferents a les autoritzades. Клінічне випробування — будь-яке дослідження на людях — суб'єктах випробування, призначене для виявлення чи перевірки фармакологічних і/або інших фармакодинамічних властивостей досліджуваного(их) препарату(ів), його (їх) впливу на клінічні прояви захворювання і/або для виявлення побічних реакцій, і/або для вивчення абсорбції, розподілу, метаболізму та виведення, і проведене з метою підтвердження його (їх) безпеки та/чи ефективності. Терміни «клінічне випробування» і «клінічне дослідження» — синоніми. La locuzione studio clinico (o trial clinico, dall'inglese) viene utilizzata in diversi contesti e talvolta con diversi significati. Generalmente nell'accezione più generale si intende uno studio epidemiologico con cui si cerca di aumentare la conoscenza sulla incidenza, eziologia, diagnosi e terapia di uno stato morboso o del suo opposto ovvero lo stato di salute; due casi tipici sono quando si cerca di dimostrare un'associazione statistica fra una malattia e un ipotizzato agente causale, oppure un'associazione tra una terapia per una malattia e un beneficio. 治験(ちけん、英: Clinical trial)とは、臨床試験のうち未承認や適応外の医薬品もしくは医療機器の製造販売に関して、医薬品医療機器等法上の承認を得るために行われる試験である。臨床試験は、ヒトを対象とした医学系研究(臨床研究)のうち、医薬品や治療などにより人体に変化を伴う研究(介入研究)を行うものを指す。治験以外の臨床試験は、医薬品や医療機器、外科的手技などの治療を試験的に行い、有効性や安全性を調べることを目的とする。ヒトを対象にする前に細胞や実験動物を用いた非臨床試験で検討し、有効性が期待でき、安全性にも問題がないと考えられた場合に行われる。 治験は薬事承認を取得することが目的であるため、製薬企業が医師に依頼をする「企業治験」が行われてきた。2003年に薬事法が改正され、「医師主導治験」として医師が主体となって治験を行えるようになった。それにより医師自らが国内未承認薬や適応外処方薬の薬事承認を取得して、臨床の場で使うことが可能となった。 臨床試験には3つの段階があり、各段階で安全性や有効性を確認しながら進めていく。この3段階を、第Ⅰ相(フェーズ1)、第Ⅱ相(フェーズ2)、第Ⅲ相(フェーズ3)と呼ぶ。第Ⅰ相よりも第Ⅱ相、第Ⅱ相よりも第Ⅲ相のほうが治療法の開発が進んだ段階にあり、より承認に近い状況にある。 Een klinisch onderzoek, klinische studie of klinische trial (Engels: clinical trial) is het testen van behandelingen of andere medische 'interventies' op menselijke proefpersonen. Zulke onderzoeken zijn bijvoorbeeld nodig om de werkzaamheid en veiligheid van (potentiële) nieuwe geneesmiddelen aan te tonen. Een geneesmiddel wordt alleen toegelaten wanneer uit klinisch onderzoek blijkt dat het middel werkzaam is en geen ernstige bijwerkingen vertoont. Klinische onderzoeken vormen een van de pijlers onder de zogeheten evidence-based medicine. التجارب السريرية هي دراسات تهتم بتقييم التدخلات العلاجية أو الدوائية أو الجراحية أو الغذائية، وذلك عن طريق تقسيم المرضى أو الأشخاص الذين ستجرى عليهم التجربة إلى مجموعتين بشكل عشوائي، حيث يطلق على المجموعة الأولى: «مجموعة التجربة» والأخرى تكون مجموعة المراقبة (انظر إذا كان الاختبار يتم لـ دواء على سبيل المثال فإن مجموعة التجربة ستقوم بأخذ الدواء الجديد المراد تجربته بينما تأخذ مجموعة المراقبة مادة غفل، بلا فعالية (خاملة المفعول، انظر غفل) ثم تقارن نتائج مجموعة التجربة مع نتائج مجموعة المشاهدة ولإزالة التحيز يتم في أغلب الأحيان اللجوء إلى أحد نظم التعمية السريرية Клини́ческое иссле́дование — научное исследование с участием людей, которое проводится с целью оценки эффективности и безопасности нового лекарственного препарата или расширения показаний к применению уже известного лекарственного препарата. Клинические исследования могут также изучать эффективность и безопасность новых инвазивных (в том числе хирургических) и неинвазивных методов лечения и диагностики. Un essai clinique, ou étude clinique, ou encore essai thérapeutique, est une étude scientifique réalisée en thérapeutique médicale humaine pour évaluer l'efficacité et la tolérance d'une méthode diagnostique ou d'un traitement. L'objectif d'un essai n'est pas d'apporter un bénéfice thérapeutique au volontaire. Le Comité international des rédacteurs de revue médicales en donne la définition suivante : « Tout projet de recherche qui affecte de façon prospective des sujets humains à des groupes d'intervention et de comparaison afin d'étudier la relation de cause à effet entre un acte médical et l'évolution d'un état de santé ». 임상시험(臨床試驗, 영어: clinical trial) 또는 임상연구는 사람을 직접 대상으로, 사람에게서 추출(또는 적출)된 검체나 사람에 대한 정보를 이용하여 이루어지는 모든 시험 또는 연구이자 개발중인 신약의 사용 허가 전에 그 약의 효과와 안전성을 증명하는 과정이다. 참가자에 대한 이러한 전향적 생의학이나 행동 치료는 새로운 치료법 (신규 백신, 약물, 식이 선택, 식이 보충제 및 의료 기기 등) 및 추가 연구와 비교가 필요한 이미 알려진 치료를 포함하여, 생의학 또는 행동 치료에 관한 특정 질문에 답하도록 설계되었다. 임상시험 단계는 비임상, 1상, 2상, 3상, 4상 시험으로 구분된다. 과거, 임상실험이라는 용어와 혼용되었던 적이 있으나, 현재는 임상시험으로 통일하여 사용하며 임상실험이라는 용어는 사용하지 않는다. 임상시험 비용은 승인 된 약물 당 수십억 달러에 이를 수 있다. 정부 단체나 제약, 생명공학기술, 의료기기 기업이 이를 후원한다. 모니터링 및 실험실 작업과 같은 시험에 필요한 특정 기능은 임상시험 수탁 기관 (CRO) 또는 중앙 실험실과 같은 외주 파트너가 관리 할 수 있다.
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La locuzione studio clinico (o trial clinico, dall'inglese) viene utilizzata in diversi contesti e talvolta con diversi significati. Generalmente nell'accezione più generale si intende uno studio epidemiologico con cui si cerca di aumentare la conoscenza sulla incidenza, eziologia, diagnosi e terapia di uno stato morboso o del suo opposto ovvero lo stato di salute; due casi tipici sono quando si cerca di dimostrare un'associazione statistica fra una malattia e un ipotizzato agente causale, oppure un'associazione tra una terapia per una malattia e un beneficio. Nell'accezione più tradizionale uno studio clinico è un tipo di ricerca condotto per raccogliere dati sulla sicurezza e sull'efficacia di nuovi farmaci o di nuovi dispositivi. Questi trial possono essere condotti solo dopo che siano state raccolte sufficienti informazioni sulle caratteristiche del prodotto e sulla sua sicurezza preclinica, e un comitato etico garantisca per lo staff medico che seguirà ed effettuerà lo studio. Molti trial clinici sono piccoli. Essi possono essere sponsorizzati da singoli medici o da piccoli gruppi di medici e sono progettati per studiare semplici questioni. Nel campo delle malattie rare, a volte il numero dei pazienti potrebbe essere il fattore limitante per i trial clinici. In epidemiologia, gli studi osservazionali, così come gli studi di coorte e gli studi caso-controllo, forniscono prove meno impressionanti degli studi controllati randomizzati. Negli studi osservazionali, i ricercatori osservano solo la correlazione tra il trattamento sperimentato dai partecipanti e il loro stato di salute o di malattia. Uno studio controllato randomizzato è il metodo più efficace per dimostrare che un determinato trattamento causi gli effetti attesi sulla salute umana. I trial clinici più comunemente eseguiti valutano nuovi farmaci, presidi, terapie biologiche, terapie psicologiche, o altri tipi di interventi. Possono richiedere che l'autorità nazionale regolatrice approvi l'immissione sul mercato dei farmaci o dei presidi, o di un nuovo dosaggio di un farmaco, prima dell'uso sui pazienti. Vengono qui riportati alcuni esempi di progetti di trial clinico: * accertamenti sulla sicurezza e l'efficacia di nuovi medicamenti o presidi, su uno specifico tipo di paziente (ad esempio pazienti cui è stata fatta diagnosi di malattia di Alzheimer) * accertamenti sulla sicurezza ed efficacia di differenti dosi di un farmaco già utilizzato comunemente (ad esempio dosi di 10 mg anziché dosi di 5 mg) * accertamenti sulla sicurezza e l'efficacia di farmaci o presidi per nuove indicazioni, ovvero malattie per le quali il farmaco non sia ancora stato specificatamente approvato. * accertamenti per valutare se i nuovi medicamenti o presidi siano più efficaci per la condizione del paziente, rispetto a farmaci/presidi già utilizzati da tempo e considerati come il rimedio o il presidio standard. * comparare l'efficacia su pazienti con una determinata malattia, di uno o più interventi per quella stessa malattia, che siano già approvati, oppure di pratica comune (ad esempio, presidio A contro presidio B, oppure terapia A contro terapia B). Klinisk prövning, även kallad klinisk studie, är en undersökning på friska eller sjuka människor för att studera effekten av ett läkemedel eller behandlingsmetod. Kliniska prövningar delas upp i olika faser. Dessa faserna benämns Fas I, Fas II, Fas III och Fas IV. Fas II brukar indelas i tidig fas (Fas IIa) och sen fas (Fas IIb). Idén med kontrollerade kliniska prövningar är att man skall jämföra en kontrollgrupp som inte får behandlingen med en grupp som faktiskt får den (interventionsgrupp). En randomiserad kontrollerad studie kan anses vara den gyllene standarden för att jämföra två olika behandlingsformer (till exempel läkemedel). Exempel på en klinisk prövning är för att utvärdera substansers lämplighet som läkemedel, för att studera effekterna av olika dieter, samt för att studera olika behandlingars effekt inom mentalsjukvården. Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted. Depending on product type and development stage, investigators initially enroll volunteers or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary in size and cost, and they can involve a single research center or multiple centers, in one country or in multiple countries. Clinical study design aims to ensure the scientific validity and reproducibility of the results. Costs for clinical trials can range into the billions of dollars per approved drug. The sponsor may be a governmental organization or a pharmaceutical, biotechnology or medical device company. Certain functions necessary to the trial, such as monitoring and lab work, may be managed by an outsourced partner, such as a contract research organization or a central laboratory. Only 10 percent of all drugs started in human clinical trials become approved drugs. Eine klinische Studie ist in der evidenzbasierten Medizin und klinischen Forschung eine systematische Erhebung. Sie wird mit Patienten oder gesunden Probanden durchgeführt. Ziel ist es, Medikamente, bestimmte Behandlungsformen, medizinische Interventionen oder Medizinprodukte auf ihre Leistung, Wirksamkeit, Sicherheit und (klinischen) Nutzen zu überprüfen. Klinische Studien werden durchgeführt, um wissenschaftliche Fragestellungen zu beantworten und die medizinische Behandlung zu verbessern. Wird ein Arzneimittel, Medizinprodukt oder ein anderes Produkt vor einer Zulassung auf Leistung, Wirkung, Sicherheit oder (klinischen) Nutzen am Menschen untersucht spricht man auch von einer klinischen Prüfung. Klinische Prüfungen sind eine Voraussetzung für die behördliche Arzneimittelzulassung, sowie abhängig von den Eigenschaften eines Medizinproduktes eine Grundlage des Konformitätsbewertungsverfahrens. Der erste Einsatz einer erfolgversprechenden medizinischen Behandlung am Menschen sollte daher eine klinische Studie mit dem Ziel sein, Wirksamkeit und Verträglichkeit neuer Therapien zu testen. Eine solche Studie kann allerdings erst dann stattfinden, wenn ausreichend Daten für eine sichere Durchführung vorhanden sind und ein positives Votum der zuständigen Ethikkommission, sowie ggf. die Zustimmung der Zuständigen Bundesoberbehörde vorliegt. Um äußerliche Störeinflüsse zu minimieren, werden derartige Studien in einem kontrollierten Umfeld durchgeführt. Un ensayo clínico es una evaluación experimental de un producto, sustancia, medicamento, técnica diagnóstica o terapéutica que, en su aplicación a seres humanos, pretende valorar su eficacia y seguridad. Los estudios de prometedores tratamientos nuevos o experimentales en pacientes se conocen como ensayos clínicos. Un ensayo clínico se realiza sólo cuando hay razones para creer que el tratamiento que se estudia puede beneficiar al paciente. Los tratamientos que se evalúan mediante los ensayos clínicos a menudo resultan ser verdaderamente beneficiosos. Los investigadores realizan estudios sobre nuevos tratamientos para conocer la utilidad del nuevo tratamiento, el mecanismo de acción del nuevo tratamiento, si es más eficaz que otros tratamientos ya disponibles, los efectos secundarios del nuevo tratamiento y si son mayores o menores que los del tratamiento convencional, si los beneficios exceden las desventajas de los efectos secundarios y en cuáles pacientes es más útil el nuevo tratamiento . Un assaig clínic és un tipus d'estudi clínic en què s'investiga una pregunta important en medicina i farmàcia, per a augmentar el coneixement. Per tal que un estudi sigui legalment considerat com un assaig clínic, ha de complir una de les següents condicions: * Que sigui aleatoritzat. * Que en el marc de l'estudi es dugui a terme algun procediment no previst dins de la pràctica clínica habitual. * Que en el marc de l'estudi s'utilitzi un medicament en unes condicions diferents a les autoritzades. La majoria dels assajos clínics que es duen a terme, avaluen nous fàrmacs o tractaments mèdics; d'altres, comparen un tractament nou amb un que ja es troba disponible. Tots segueixen un protocol d'investigació estrictament controlat. Un assaig clínic medicamentós és tota avaluació experimental d'una substància o medicament, a través de la seua administració o aplicació a éssers humans, orientada a algun dels fins següents : * Posar de manifest els seus efectes farmacodinàmics o recollir dades referents a la seua absorció, distribució, metabolisme i excreció en l'organisme humà. * Establir l'eficàcia per a una indicació terapèutica, profilàctica o diagnòstica determinada. * Conèixer el perfil de les seves reaccions adverses i establir la seua seguretat. Els assajos clínics, després de ser dissenyats, han de ser aprovats per un Comitè d'Ètica d'Investigacions Clíniques (CEIC) i autoritzats per l'autoritat sanitària corresponent (a Espanya, l'Agencia Española de Medicamentos y Productos Sanitarios). El promotor de l'assaig ha de contractar una pòlissa d'assegurança que cobreixi els possibles efectes indesitjats del tractament estudiat. Els pacients que hi participen han de conèixer els objectius de l'estudi, els seus riscos i beneficis i signar un consentiment informat. Els pacients podran abandonar l'estudi quan vulguen. L'assaig clínic finalitza quan acaben els terminis de temps definits en el protocol, o de forma prematura, quan així ho decideix l'equip investigador (quan, per exemple, els efectes en el braç experimental són manifestament perjudicials o beneficiosos, o quan el nombre de pacients reclutats no és suficientment elevat perquè les anàlisis estadístiques siguin significatives). Un assaig clínic s'inicia quan sorgeix una hipòtesi a partir d'estudis no controlats observacionals, descriptius o retrospectius, o d'estudis preclínics. Sovint es descobreixen en investigacions preclíniques possibilitats terapèutiques que no tenen cap benefici en un assaig clínic. Moltes vegades es realitzen activitats mèdiques la utilitat de les quals no ha sigut demostrada mitjançant un assaig clínic, no obstant portar-lo a la pràctica és difícil, sobretot pel cost econòmic i de temps. Eksperyment kliniczny (właściwe określenie: kliniczne badanie eksperymentalne) – badanie naukowe, którego zasadniczym celem jest określenie skuteczności oraz bezpieczeństwa stosowania produktu leczniczego, wyrobu medycznego lub innej techniki medycznej (zabiegu, testu diagnostycznego). Za „złoty standard” eksperymentów klinicznych uważa się randomizowane kontrolowane badania kliniczne (ang. randomized controlled trial lub randomized control trial, (RCT). Prawidłowo przeprowadzone badanie kliniczne interwencji terapeutycznych charakteryzuje się: * dużą, niejednolitą grupą pacjentów, na której badano lekarstwo lub procedurę medyczną * zastosowaniem randomizacji * zastosowaniem podwójnie ślepej próby (w celu wykluczenia lub potwierdzenia efektu placebo). Aspekty etyczne w tego typu badaniach ustalone są przez Deklarację helsińską oraz komisje bioetyczne. Fazy eksperymentu klinicznego: * badania przedkliniczne (in vitro i na zwierzętach) * faza 0 – na bardzo małej grupie (10–15 osób) – nowo wprowadzona w Stanach Zjednoczonych faza mająca na celu przyspieszenie rozwoju obiecujących leków poprzez wczesne ustalenie czy lek oddziałuje na ludzi w sposób oczekiwany po badaniach przedklinicznych. Uzyskuje się w ten sposób wstępne dane o bezpieczeństwie, toksyczności, farmakokinetyki i farmakodynamiki terapii. * faza I – na niewielkiej grupie zdrowych ochotników (20–80 osób). Ma na celu zbadanie bezpieczeństwa, toksyczności, farmakokinetyki i farmakodynamiki terapii. W badaniach nad niektórymi lekami (np. przeciwnowotworowymi czy anty-HIV) w tej fazie badań biorą udział pacjenci w zaawansowanym stadium choroby. * faza II – na większej grupie (20–300 osób). Ma na celu zbadanie klinicznej skuteczności terapii. * faza III – randomizowane badania na dużej grupie pacjentów (powyżej 300 osób). Ma na celu pełną ocenę skuteczności nowej terapii. * faza IV – przedłużone badania kliniczne badające dokładniej bezpieczeństwo stosowania produktu leczniczego po dopuszczeniu go do obrotu. Obserwuje się rzadkie, lub wynikającego z długotrwałego stosowania, działania niepożądane, objawy przedawkowania, interakcje nowego leku z innymi, specyfikę działania u dzieci, osób starszych, kobiet w ciąży, chorych na inne choroby. Przed rozpoczęciem badania klinicznego fazy I-III bezwzględnie należy uzyskać zgodę: * Ministerstwa Zdrowia, na wniosek Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych Centralnej Ewidencji Badań Klinicznych * Centralnej Komisji Bioetycznej * innych urzędów regulacyjnych (w zależności od państwa). W przypadku badań IV fazy, w zależności od warunków prowadzenia badania i jego planu zawartego w protokole badania, najczęściej wymagana jest jedynie zgoda komisji bioetycznej. Najczęściej spotykane badania kliniczne dotyczą: * – prowadzone ze szczególną starannością i przestrzeganiem zasad dobrej praktyki klinicznej * wyrobu medycznego – prowadzone ze szczególną starannością i przestrzeganiem norm . Podczas prowadzenia badań klinicznych podstawowe znaczenie ma dokumentacja medyczna zawierająca pełny opis zdarzeń niepożądanych, ciężkich zdarzeń niepożądanych występujących podczas prowadzenia badania, jak również poprawne i poparte oryginalnymi wpisami w historii choroby (tzw. dokumentacja źródłowa) dane zebrane w karcie obserwacji klinicznej. Dane źródłowe to informacje zawarte w oryginalnych raportach i certyfikowanych kopiach oryginalnych raportów, które dotyczą obserwacji medycznych, ocen klinicznych i innych czynności wykonywanych w badaniach klinicznych konieczne do rekonstrukcji i oceny badania klinicznego. Istnieje potrzeba opracowania jednolitych wytycznych regulujących zasady analizy statystycznej danych w ocenie eksperymentów klinicznych. Uznaje się, że pierwsze w historii medycyny badanie kliniczne przeprowadził w XVIII wieku szkocki lekarz James Lind. Jednym z pionierów badań klinicznych był XX-wieczny epidemiolog i statystyk Austin Bradford Hill. Клінічне випробування — будь-яке дослідження на людях — суб'єктах випробування, призначене для виявлення чи перевірки фармакологічних і/або інших фармакодинамічних властивостей досліджуваного(их) препарату(ів), його (їх) впливу на клінічні прояви захворювання і/або для виявлення побічних реакцій, і/або для вивчення абсорбції, розподілу, метаболізму та виведення, і проведене з метою підтвердження його (їх) безпеки та/чи ефективності. Терміни «клінічне випробування» і «клінічне дослідження» — синоніми. * Дослі́джуваний препара́т — лікарська форма діючої речовини або плацебо, що є предметом вивчення чи використовується для контролю у межах , в тому числі лікарський засіб, дозволений до медичного застосування, у разі, якщо спосіб його застосування чи виготовлення (лікарська форма чи ) відрізняється від затвердженого, у разі його використання за новим показанням або для отримання додаткової інформації за затвердженим показанням. Klinické studie jsou studie na lidech nebo na zvířatech, jejichž úkolem je ověření bezpečnosti a účinnosti nového léčiva, vakcíny, léčebného postupu, vyšetření, doplňků stravy či přístrojů. V závislosti na typu produktu a fázi vývoje jsou nejprve prováděny malé pilotní studie na dobrovolnících nebo pacientech, v případě pozitivních výsledků počet pacientů či dobrovolníků postupně stoupá. Klinické testy mohou mít různý rozsah, od jednoho výzkumného zařízení v jedné zemi až po mnoho zařízení v několika zemích. Kompletní řada klinických testů může stát desetitisíce až miliardy Kč. Een klinisch onderzoek, klinische studie of klinische trial (Engels: clinical trial) is het testen van behandelingen of andere medische 'interventies' op menselijke proefpersonen. Zulke onderzoeken zijn bijvoorbeeld nodig om de werkzaamheid en veiligheid van (potentiële) nieuwe geneesmiddelen aan te tonen. Een geneesmiddel wordt alleen toegelaten wanneer uit klinisch onderzoek blijkt dat het middel werkzaam is en geen ernstige bijwerkingen vertoont. Een trial wordt vaak opgezet als gerandomiseerd onderzoek met controlegroep: een deel van de patiënten/vrijwilligers krijgt de beoogde behandeling en een deel een placebo. Wanneer mogelijk (en bij geneesmiddelen vrijwel altijd) wordt het onderzoek ook dubbelblind uitgevoerd: noch de patiënten, noch de artsen die de toediening verzorgen, weten wie het echte middel krijgt toegediend en wie een placebo. Onderzoeken kunnen worden uitgebreid of stopgezet wanneer daar reden toe is. Soms blijkt een behandeling zo succesvol dat het onethisch zou zijn de behandeling nog langer te onthouden aan de controlegroep. Maar het kan ook blijken dat de bijwerkingen zo ernstig zijn en zo vaak voorkomen dat de (mogelijke) werkzaamheid daar niet tegen opweegt. Klinische onderzoeken vormen een van de pijlers onder de zogeheten evidence-based medicine. Uji klinis (bahasa Inggris: clinical trial) adalah eksperimen atau pengamatan yang dilakukan dalam penelitian klinis. Studi penelitian biomedis atau perilaku pada peserta manusia dirancang untuk menjawab pertanyaan spesifik tentang intervensi biomedis atau perilaku, termasuk perawatan baru (seperti vaksin baru, obat-obatan, pilihan makanan, suplemen makanan, dan peralatan medis) dan intervensi yang dikenal yang memerlukan studi lebih lanjut dan perbandingan. Uji klinis menghasilkan data tentang keamanan dan . Mereka dilakukan hanya setelah mereka menerima persetujuan komite etika / otoritas kesehatan di negara tempat persetujuan terapi dicari. Pihak berwenang ini bertanggung jawab untuk memeriksa rasio risiko / manfaat dari percobaan - persetujuan mereka tidak berarti bahwa terapi ini 'aman' atau efektif, hanya saja percobaan tersebut dapat dilakukan. Клини́ческое иссле́дование — научное исследование с участием людей, которое проводится с целью оценки эффективности и безопасности нового лекарственного препарата или расширения показаний к применению уже известного лекарственного препарата. Клинические исследования могут также изучать эффективность и безопасность новых инвазивных (в том числе хирургических) и неинвазивных методов лечения и диагностики. Клинические исследования во всём мире являются неотъемлемым этапом разработки препаратов, который предшествует его регистрации и широкому медицинскому применению. В ходе клинических исследований новый препарат изучается для получения данных о его эффективности и безопасности. На основании этих данных уполномоченный орган здравоохранения принимает решение о регистрации препарата или отказе в регистрации. Препарат, не прошедший клинических исследований, не может быть зарегистрирован и выведен на рынок. При разработке нового препарата невозможно обойтись без клинических исследований, поскольку экстраполяция результатов исследований у животных и на биологических моделях на человека возможна только в общем виде, а иногда невозможна вовсе. Например, фармакокинетика (то, как лекарство попадает в кровь, распределяется в организме и выводится из него) у человека отличается даже от фармакокинетики у приматов. Однако анализ доклинических исследований очень важен для оценки вероятности развития и характера побочных эффектов, расчёта стартовой дозы для изучения свойств препарата у человека. Клинические исследования могут быть инициированы только после того, как получены обнадёживающие результаты в ходе доклинических исследований (исследований на биологических моделях и лабораторных животных), а также одобрение этического комитета и положительное решение уполномоченного органа здравоохранения той страны, где планируется проводить исследование. Вначале экспериментальный лекарственный препарат изучается с участием небольшого количества пациентов и (или) здоровых добровольцев. По мере того как накапливаются данные о его безопасности и эффективности, численность пациентов, вовлечённых в исследование, возрастает, а сам препарат сравнивается с уже известными и широко используемыми в медицинской практике лекарствами. Исследование, в котором исследователь знает, кто относится к тестовой группе, а кто — к контрольной, но этого не знают сами участники групп — называется простым слепым. Если о разбиении на группы не знают ни участники групп, ни исследователь, а только внешний контролёр — такое исследование называется двойным слепым. Un essai clinique, ou étude clinique, ou encore essai thérapeutique, est une étude scientifique réalisée en thérapeutique médicale humaine pour évaluer l'efficacité et la tolérance d'une méthode diagnostique ou d'un traitement. L'objectif d'un essai n'est pas d'apporter un bénéfice thérapeutique au volontaire. Le Comité international des rédacteurs de revue médicales en donne la définition suivante : « Tout projet de recherche qui affecte de façon prospective des sujets humains à des groupes d'intervention et de comparaison afin d'étudier la relation de cause à effet entre un acte médical et l'évolution d'un état de santé ». Ces études sont souvent effectuées après des études expérimentales non-cliniques (sur des modèles animaux ou cellulaires) pour confirmer leur pertinence et leur sécurité. Elles nécessitent aussi l'accord des autorités de santé et d'éthique du pays où elles ont lieu.[réf. nécessaire] En fonction du type d'étude et du stade du développement du médicament ou du dispositif, les investigateurs enrôlent des volontaires sains ou des patients. Les études peuvent être monocentriques avec un faible nombre de participants (par exemple études pilotes). À l'extrême inverse elles peuvent être multicentriques et inclure des milliers de patients. La fiabilité de ces études repose sur une méthode scientifique rigoureuse et éprouvée afin de limiter tout biais, toute erreur de collecte des données ou d'interprétation des résultats. Les Bonnes Pratiques Cliniques sont une norme internationale relative à la bioéthique s'appliquant aux essais cliniques réalisés sur des sujets humains. Les résultats sont publiés dans des revues médicales et présentés lors de congrès. Dans le cas des médicaments, ils servent à établir le dossier permettant d'en valider l'utilisation auprès d'instances nationales ou internationales. التجارب السريرية هي دراسات تهتم بتقييم التدخلات العلاجية أو الدوائية أو الجراحية أو الغذائية، وذلك عن طريق تقسيم المرضى أو الأشخاص الذين ستجرى عليهم التجربة إلى مجموعتين بشكل عشوائي، حيث يطلق على المجموعة الأولى: «مجموعة التجربة» والأخرى تكون مجموعة المراقبة (انظر إذا كان الاختبار يتم لـ دواء على سبيل المثال فإن مجموعة التجربة ستقوم بأخذ الدواء الجديد المراد تجربته بينما تأخذ مجموعة المراقبة مادة غفل، بلا فعالية (خاملة المفعول، انظر غفل) ثم تقارن نتائج مجموعة التجربة مع نتائج مجموعة المشاهدة ولإزالة التحيز يتم في أغلب الأحيان اللجوء إلى أحد نظم التعمية السريرية 임상시험(臨床試驗, 영어: clinical trial) 또는 임상연구는 사람을 직접 대상으로, 사람에게서 추출(또는 적출)된 검체나 사람에 대한 정보를 이용하여 이루어지는 모든 시험 또는 연구이자 개발중인 신약의 사용 허가 전에 그 약의 효과와 안전성을 증명하는 과정이다. 참가자에 대한 이러한 전향적 생의학이나 행동 치료는 새로운 치료법 (신규 백신, 약물, 식이 선택, 식이 보충제 및 의료 기기 등) 및 추가 연구와 비교가 필요한 이미 알려진 치료를 포함하여, 생의학 또는 행동 치료에 관한 특정 질문에 답하도록 설계되었다. 임상시험 단계는 비임상, 1상, 2상, 3상, 4상 시험으로 구분된다. 과거, 임상실험이라는 용어와 혼용되었던 적이 있으나, 현재는 임상시험으로 통일하여 사용하며 임상실험이라는 용어는 사용하지 않는다. 임상시험은 수많은 요인에 따라 비용이 꽤 들 수 있다. 임상시험은 치료의 승인이 필요한 국가에서 보건 당국과 윤리 위원회 (IRB)의 승인을 받은 후에만 실시 될 수 있다. 이 기관들은 시험의 유익성/위험성 비율을 조사 할 책임이 있다. 이 기관들의 승인이 치료가 안전하거나 유효성이 있음을 나타내는 것은 아니며, 임상시험이 수행될 수 있음을 의미한다. 제품 유형 및 개발 단계에 따라 조사자는 처음에 자원 봉사자 또는 환자를 소규모 파일럿 연구에 등록한 다음 점차적으로 대규모 비교 연구를 수행한다. 임상시험의 규모와 비용은 다양 할 수 있으며, 단일 국가 또는 여러 국가를 포함하거나 단일 연구 센터 또는 여러 센터를 포함 할 수 있다. 임상시험 설계는 결과의 과학적 타당성과 재현성을 보장하는 것을 목표로 한다. 임상시험 비용은 승인 된 약물 당 수십억 달러에 이를 수 있다. 정부 단체나 제약, 생명공학기술, 의료기기 기업이 이를 후원한다. 모니터링 및 실험실 작업과 같은 시험에 필요한 특정 기능은 임상시험 수탁 기관 (CRO) 또는 중앙 실험실과 같은 외주 파트너가 관리 할 수 있다. 인간을 대상으로 한 임상시험을 시작한 모든 약들 가운데 10%정도만이 승인된 약으로 된다. 臨床試驗(英語:clinical trial)是一種临床研究方法,指根據研究方案採用已上市藥物或安慰劑作為對照組,對藥物或其他醫學治療在受試者身上進行比較測試的過程。在臨床試驗中,研究者要先決定所要測試的療法,例如藥物或裝置,再決定用哪種療法與它比較,以及須要找哪一類型的病人來作為測試對象。治療用藥物的話要證明它能有效延長病人的生命、減輕特定症狀或降低不良事件之發生以改善病人生活品質。 治験(ちけん、英: Clinical trial)とは、臨床試験のうち未承認や適応外の医薬品もしくは医療機器の製造販売に関して、医薬品医療機器等法上の承認を得るために行われる試験である。臨床試験は、ヒトを対象とした医学系研究(臨床研究)のうち、医薬品や治療などにより人体に変化を伴う研究(介入研究)を行うものを指す。治験以外の臨床試験は、医薬品や医療機器、外科的手技などの治療を試験的に行い、有効性や安全性を調べることを目的とする。ヒトを対象にする前に細胞や実験動物を用いた非臨床試験で検討し、有効性が期待でき、安全性にも問題がないと考えられた場合に行われる。 治験は薬事承認を取得することが目的であるため、製薬企業が医師に依頼をする「企業治験」が行われてきた。2003年に薬事法が改正され、「医師主導治験」として医師が主体となって治験を行えるようになった。それにより医師自らが国内未承認薬や適応外処方薬の薬事承認を取得して、臨床の場で使うことが可能となった。 臨床試験には3つの段階があり、各段階で安全性や有効性を確認しながら進めていく。この3段階を、第Ⅰ相(フェーズ1)、第Ⅱ相(フェーズ2)、第Ⅲ相(フェーズ3)と呼ぶ。第Ⅰ相よりも第Ⅱ相、第Ⅱ相よりも第Ⅲ相のほうが治療法の開発が進んだ段階にあり、より承認に近い状況にある。 Os ensaios clínicos são um conjunto de procedimentos de investigação e desenvolvimento de medicamentos, que são realizados para permitir que dados de segurança (ou mais especificamente, informações sobre reações adversas e efeitos adversos de outros tratamentos) e eficácia a recolher para as intervenções de saúde (por exemplo, drogas, diagnóstico, dispositivos, protocolos de terapia). Estes ensaios só podem ter lugar após informação satisfatória ser recolhida sobre a qualidade da segurança não-clínica(testes invitro e ensaios com animais) e as autoridades de saúde aprovarem a realização dos ensaios no país no qual será realizado.. Dependendo do tipo de produto e do estágio de seu desenvolvimento, os investigadores inscrevem voluntários saudáveis e/ou pacientes em estudos-piloto, inicialmente pequenos, seguidos por estudos de maior escala, em pacientes que muitas vezes comparam o novo produto com o tratamento atualmente prescrito. Com segurança positiva e dados de eficácia reunidos, o número de pacientes é tipicamente aumentado. Ensaios clínicos podem variar de tamanho de um único centro em um país para estudos multicêntricos em vários países. Devido ao custo considerável uma série completa de ensaios clínicos normalmente é necessário um patrocinador para pagar todas as pessoas e serviços necessários, que pode ser uma organização governamental, um farmacêutico, ou empresa de biotecnologia. Já que a diversidade de papéis pode exceder os recursos do patrocinador, muitas vezes, um ensaio clínico é gerido por um parceiro terceirizado, como uma organização de investigação por contrato ou uma unidade de ensaios clínicos no setor académico
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