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Independence of cli...
Independence of clinical events committees : A consensus statement from clinical research organizations
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- Spitzer, Ernest (författare)
- Erasmus MC, Dept Cardiol & Thoraxctr, Rotterdam, Netherlands.;Cardialysis Clin Trial Management & Core Labs, Rotterdam, Netherlands
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- Fanaroff, Alexander C. (författare)
- Univ Penn, Leonard Davis Inst Hlth Econ, Cardiovasc Outcomes Qual & Evaluat Res Ctr, Philadelphia, PA 19104 USA.;Univ Penn, Div Cardiovasc Med, Philadelphia, PA USA
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- Gibson, C. Michael (författare)
- Harvard Med Sch, Boston, MA 02115 USA.;Baim Inst Clin Res, Boston, MA USA
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- Seltzer, Jonathan (författare)
- Sandpiper Res, Narberth, PA USA
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- McFadden, Eugene (författare)
- Cardialysis Clin Trial Management & Core Labs, Rotterdam, Netherlands.;Cork Univ Hosp, Dept Cardiol, Cork, Ireland
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- Ali, Maria (författare)
- George Clin, Newtown, Tas, Australia
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- Wilson, Matthew (författare)
- Duke Univ, Med Ctr, Div Cardiol, Duke Clin Res Inst, Durham, NC 27710 USA
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- Menon, Venu (författare)
- Cleveland Clin, Cardiac Intens Care Unit, Heart & Vasc Inst, Cleveland, OH 44106 USA.;Cleveland Clin, Heart & Vasc Inst, C5Res, Cleveland, OH 44106 USA
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- Mehran, Roxana (författare)
- Icahn Sch Med Mt Sinai, New York, NY 10029 USA
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- Held, Claes, 1956- (författare)
- Uppsala universitet,Uppsala kliniska forskningscentrum (UCR),Kardiologi
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- Mahaffey, Kenneth W. (författare)
- Stanford Univ, Stanford Ctr Clin Res, Dept Med, Sch Med, Palo Alto, CA 94304 USA
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- Lopes, Renato D. (författare)
- Duke Univ, Med Ctr, Div Cardiol, Duke Clin Res Inst, Durham, NC 27710 USA
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Erasmus MC, Dept Cardiol & Thoraxctr, Rotterdam, Netherlands;Cardialysis Clin Trial Management & Core Labs, Rotterdam, Netherlands Univ Penn, Leonard Davis Inst Hlth Econ, Cardiovasc Outcomes Qual & Evaluat Res Ctr, Philadelphia, PA 19104 USA.;Univ Penn, Div Cardiovasc Med, Philadelphia, PA USA (creator_code:org_t)
- Elsevier, 2022
- 2022
- Engelska.
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Ingår i: American Heart Journal. - : Elsevier. - 0002-8703 .- 1097-6744. ; 248, s. 120-129
- Relaterad länk:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
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- Background Randomized clinical trials are the gold standard to assess the causal relationship between an intervention and subsequent outcomes, also known as clinical endpoints. In order to limit bias, central clinical events committees (CEC) are established to ensure consistent event reporting across participating centers, as well as complete and accurate ascertainment of endpoints. However, defining independence is challenging.Methods This consensus statement was generated by teleconferences and electronic communications among clinical research organizations from the United States, Europe and Australia. This document does not constitute regulatory guidance.Results An independent CEC is defined when the adjudicators are not primarily involved in designing, funding, sponsoring, organizing, conducting, analyzing or regulating the clinical trial for which they serve as an adjudicator, beyond their role as CEC member. Moreover, independence requires absence of conflicts of interest with the steering committee, sponsor, grant giver, manufacturer, coordinating center, other independent committees, core laboratories, medical monitor, safety physician, participating clinical sites, statistician or data manager, regulatory agencies or authorities, which could influence (or be perceived to influence) a member's objectivity in evaluating trial data. Such conflicts of interest include financial benefits, directing or advisory role (paid or unpaid), decision-making position, as well as being a direct relative. An independent adjudicator has no other role within a clinical trial.Conclusions This consensus statement presents a standardized definition of an independent CEC to be considered by clinical research organizations, manufacturers, and investigators. In addition, it provides recommendations on best practices for implementation of an independent CEC.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
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Spitzer, Ernest
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Fanaroff, Alexan ...
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Gibson, C. Micha ...
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Seltzer, Jonatha ...
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McFadden, Eugene
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Ali, Maria
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Wilson, Matthew
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Menon, Venu
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Mehran, Roxana
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Held, Claes, 195 ...
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Mahaffey, Kennet ...
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Lopes, Renato D.
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