臨床研究、臨床的研究、臨床治験、治験

関: biomedical research、clinical study、clinical test、clinical trial、investigation、investigational、medical research、trial

WordNet

the work of inquiring into something thoroughly and systematically (同)investigating
(law) the determination of a persons innocence or guilt by due process of law; "he had a fair trial and the jury found him guilty"; "most of these complaints are settled before they go to trial"
trying something to find out about it; "a sample for ten days free trial"; "a trial of progesterone failed to relieve the pain" (同)trial_run, test, tryout
an annoying or frustrating or catastrophic event; "his mother-in-laws visits were a great trial for him"; "life is full of tribulations"; "a visitation of the plague" (同)tribulation, visitation
(sports) a preliminary competition to determine qualifications; "the trials for the semifinals began yesterday"
attempt to find out in a systematically and scientific manner; "The student researched the history of that word"
systematic investigation to establish facts
inquire into; "the students had to research the history of the Second World War for their history project"; "He searched for information on his relatives on the web"; "Scientists are exploring the nature of consciousness" (同)search, explore
a healthcare facility for outpatient care
a medical establishment run by a group of medical specialists
meeting for diagnosis of problems and instruction or remedial work in a particular activity
scientifically detached; unemotional; "he spoke in the clipped clinical monotones typical of police testimony"
relating to a clinic or conducted in or as if in a clinic and depending on direct observation of patients; "clinical observation"; "clinical case study"

PrepTutorEJDIC

(…の)『調査』,取り調べ,研究《+『of』(『into』)+『名』》
〈U〉〈C〉『裁判』,公判,審理 / 〈U〉〈C〉(…の)『試験』,ためし《+of+名》 / 〈C〉企て,試み;努力 / 〈C〉(忍耐・徳・信仰などをためす)試練,苦難 / 〈C〉困りもの,迷惑な(やっかいな)人(もの)
(新しい事実などの探究のための,特定の分野の)『研究』,『調査』《+『in』(『into』,『on』)+『名』》 / …‘を'研究する,調査する / (…を)研究する,調査する《+into(on)+名》
〈U〉(医学の)臨床講義 / 〈C〉《集合的に》臨床講義のクラス / 〈C〉臨床講義室 / 〈C〉(病院・医科大学・社会事業団などに付属した)診療所;《形容詞を判って》医療施設,病院 / 〈C〉(警察・学校・社会事業団などに付属した)相談所
臨床の,臨床講義の / 病床の / 臨床的な,客観的な態度の

Wikipedia preview

出典(authority):フリー百科事典『ウィキペディア（Wikipedia）』「2015/05/21 00:19:22」(JST)

wiki en

[Wiki en表示]

Clinical research is a branch of healthcare science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical Research is different from clinical practice. In clinical practice one uses established treatments, while in clinical research evidence is collected to establish a treatment.

The term clinical research refers to the entire bibliography of a drug/device/biologic, in fact any test article from its inception in the lab to its introduction to the consumer market and beyond. Once the promising candidate or the molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where different aspects of the test article (including its safety toxicity if applicable and efficacy, if possible at this early stage) are studied.

In the United States, when a test article is unapproved or not yet cleared by the FDA, or when an approved or cleared test article is used in a way that may significantly increase the risks (or decreases the acceptability of the risks), the data obtained from the pre-clinical studies or other supporting evidence, case studies of off label use, etc. are submitted in support of an Investigational New Drug (IND) application to the Food and Drug Administration (FDA) for review prior to conducting studies that involve even one human and a test article if the results are intended to be submitted to or held for inspection by the FDA at any time in the future (in the case of an already approved test article, if intended to submit or hold for inspection by the FDA in support of a change in labeling or advertising). Where devices are concerned the submission to the FDA would be for an Investigational Device Exemption (IDE) application if the device is a significant risk device or is not in some way exempt from prior submission to the FDA. In addition clinical research may require Institutional Review Board (IRB) or Research Ethics Board (REB) and possibly Other institutional Committee reviews, Privacy Board, Conflict of Interest Committee, Radiation Safety Committee, Radioactive Drug Research Committee, etc. approval whether or not the research requires prior submission to the FDA. Clinical research review criteria will depend on which Federal regulations the research is subject to (e.g., [(Department of Health and Human Services (DHHS) if Federally funded, FDA as already discussed) and will depend on which regulations the institutions subscribe to, in addition to any more stringent criteria added by the institution possibly in response to state or local laws/policies or accreditation entity recommendations. This additional layer of review (IRB/REB in particular) is critical to the protection of human subjects especially when you consider that often research subject to the FDA regulation for prior submission is allowed to proceed, by those same FDA regulations, 3 days after submission to the FDA unless specifically notified by the FDA not to initiate the study.

Clinical research is often conducted at academic medical centers and affiliated research study sites. These centers and sites provide the prestige of the academic institution as well as access to larger metropolitan areas, providing a larger pool of medical participants.

The clinical research ecosystem involves a complex network of sites, pharmaceutical companies and academic research institutions. This has led to a growing field of technologies used for managing the data and operational factors of clinical research. Clinical research management is often aided by eClinical systems to help automate the management and conducting of clinical trials.

In the European Union, the European Medicines Agency (EMA) acts in a similar fashion for studies conducted in their region. These human studies are conducted in four phases in research subjects that give consent to participate in the clinical trials.

Phases

Clinical trials involving new drugs are commonly classified into four phases. Each phase of the drug approval process is treated as a separate clinical trial. The drug-development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. Phase IV are 'post-approval' studies.

Before pharmaceutical companies start clinical trials on a drug, they conduct extensive pre-clinical studies.

Clinical Research Degree

Clinical Research Degree is a research based degree offered by health science medical universities. Clinical Research Degree, offered by medical schools are of three types, undergraduate, post graduate & PhD level which shapes the students to design, evaluate and to discover the new medications that's been used to treat new health problems raised up in current environment by conducting clinical trials.

Clinical trials are research that is carried out in pharmaceutical companies to test new medication to identify the impact of the drug and its side effects. Examples may include:

Undergraduate Degree in Clinical Research Students who have completed their schooling in health sciences are eligible to undergo this course which would take about 3–4 years of duration.
MSc Clinical Research This degree is available to undergraduate medical, pharmaceutical, nursing, and life science students and pg medical students. This requires two years of study.
Students with a post-graduate Life Science degree, PG medical degree, M.Sc. in clinical research M.Sc. in life science and clinical research PG diploma can apply for this doctoral program. The program in most universities consisted of six semesters, lasting up to three years. The first three semesters are theory and seminars, while the last three are for Dissertation work where the students are required to present their research work as a thesis.

Clinical Research Training

Clinical Research Professional Diplomas are taught by professionals from the industry. These professionals and subject matter experts teach in colleges and determine the real value of each institution's training program. The length of a complete professional clinical research program should not exceed 40 weeks since candidates need to join the job market as soon as possible. This is why many long-term Bachelors and Masters degrees offered in universities are not popular and have to offer online courses for people already working in the field seeking for a simple proof of professional development without getting in-class professional experience through workshops and face-to face training. In addition, since on-line courses in Clinical Research cannot be effective, mainly private career colleges with a solid curriculum and well-paid professors from the industry are dominating the market.there are safety and efficacy

References

UpToDate Contents

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1. システマティックレビューおよびメタアナリシス systematic review and meta analysis
2. 複数の併存疾患のマネージメント managing multiple comorbidities
3. 成人における間欠性爆発性障害：疫学、臨床的特徴、評価、および診断 intermittent explosive disorder in adults epidemiology clinical features assessment and diagnosis
4. Sézary症候群の臨床症状、病理学的特徴、および診断 clinical presentation pathologic features and diagnosis of sezary syndrome
5. 後天性表皮水疱症 epidermolysis bullosa acquisita

English Journal

Nursing home director of nursing leadership style and director of nursing-sensitive survey deficiencies.

McKinney SH1, Corazzini K, Anderson RA, Sloane R, Castle NG.
Health care management review.Health Care Manage Rev.2016 Aug 6. [Epub ahead of print]
BACKGROUND: Nursing homes are becoming increasingly complex clinical environments because of rising resident acuity and expansion of postacute services within a context of historically poor quality performance. Discrete quality markers have been linked to director of nursing (DON) leadership behavio
PMID 26259021

Toward a high-performance management system in health care, part 4: Using high-performance work practices to prevent central line-associated blood stream infections-a comparative case study.

McAlearney AS1, Hefner J, Robbins J, Garman AN.
Health care management review.Health Care Manage Rev.2016 May 21. [Epub ahead of print]
BACKGROUND: Central line-associated bloodstream infections (CLABSIs) are among the most harmful health care-associated infections and a major patient safety concern. Nationally, CLABSI rates have been reduced through the implementation of evidence-based interventions; thus far, however, hospitals st
PMID 26002415

Advances in characterisation and biological activities of chitosan and chitosan oligosaccharides.

Zou P1, Yang X1, Wang J2, Li Y3, Yu H3, Zhang Y1, Liu G1.
Food chemistry.Food Chem.2016 Jan 1;190:1174-81. doi: 10.1016/j.foodchem.2015.06.076. Epub 2015 Jun 23.
Chitosan and chitosan oligosaccharides (COS) have been reported to possess various biomedical properties, including antimicrobial activities, immuno-enhancing effects, and anti-tumour activities. COS have attracted considerable interest due to their physicochemical properties, and potential applicat
PMID 26213092

Japanese Journal

Effects of a Public Education Campaign on the Association Between Knowledge of Early Stroke Symptoms and Intention to Call an Ambulance at Stroke Onset: The Acquisition of Stroke Knowledge (ASK) Study

Journal of Epidemiology advpub(0), 2016
NAID 130005101374

疾患知識統合に向けた異常状態オントロジーのLinked Data化

人工知能学会論文誌 advpub(0), 2016
NAID 130005091053

Selective removal of atherosclerotic plaque with a quantum cascade laser in the 5.7 µm wavelength range

Jpn. J. Appl. Phys. 54(11), 112701, 2015-10-09
NAID 150000111496

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★リンクテーブル★

リンク元	「治験」「investigational」「trial」「clinical study」「clinical trial」
拡張検索	「clinical research coordinator」
関連記事	「research」「clinical」「clinic」

「治験」

　　[★]

英: clinical trial、clinical study、clinical research、clinical test、trial、investigation、investigational
関: 研究、試み、試験、試行、調査、臨床試験、検討、臨床研究、臨床治験、臨床的研究

定義

参考1

治験(clinical research）とは医薬品もしくは医療機器の製造販売の承認申請をするために行われる臨床試験のことである。

治験に参加する健常者・患者に対するインフォームドコンセント

参考1

治験を行う者は、治験への参加者に対して、治験に先立ち、実施される試験の目的や内容について説明する義務がある。
また、参加者が患者であるならば、その治療法などについてのメリットとデメリット、他の存在する治療法などを詳しく説明し、予想される最悪の帰結に関してまでの合意がなければならない。
そして、十分な理解の出来た参加者本人の自由意思によってのみ治験への参加は決断されねばならない。
また、いつでも参加者は自由に治験からは離脱でき、治験からの離脱に対して、今後の治療や経済的制裁などの不利益を被ることが一切ないことを保証しなければならない（間接的な強制も許されない）。