Institutional Review Board
... 2. There is no comparable or satisfactory alternative drug or other therapy available to treat that stage of the disease in the intended patient population. 3. The drug is under investigation in a controlled clinical trial under an IND in effect for the trial, or all clinical trials have been comple ...
... 2. There is no comparable or satisfactory alternative drug or other therapy available to treat that stage of the disease in the intended patient population. 3. The drug is under investigation in a controlled clinical trial under an IND in effect for the trial, or all clinical trials have been comple ...
Cornerstone Pharmaceuticals, Inc
... lead drug, CPI-613, is currently being evaluated in three ongoing Phase I and Phase I/II clinical trials in a variety of tumor types. About CPI-613 CPI-613 is the first drug in a new chemical class that, through a novel mechanism, targets metabolic changes considered to be common to many, if not all ...
... lead drug, CPI-613, is currently being evaluated in three ongoing Phase I and Phase I/II clinical trials in a variety of tumor types. About CPI-613 CPI-613 is the first drug in a new chemical class that, through a novel mechanism, targets metabolic changes considered to be common to many, if not all ...
Safety monitoring and reporting
... A standard for clinical trials/studies which encompasses the design, conduct, performance, monitoring, termination, auditing, recording, analysis, and reporting and documentation of clinical trials/studies and which ensures that the trials/studies are scientifically and ethically sound and that the ...
... A standard for clinical trials/studies which encompasses the design, conduct, performance, monitoring, termination, auditing, recording, analysis, and reporting and documentation of clinical trials/studies and which ensures that the trials/studies are scientifically and ethically sound and that the ...
Clinical guidelines, standards and protocols
... disease (COPD) covers the full range of care that should be available from the NHS to adults with COPD. They include how the diagnosis should be made and the treatments that should be offered at different times. The review conducted in March 2008 has concluded that this guideline warrants a partial ...
... disease (COPD) covers the full range of care that should be available from the NHS to adults with COPD. They include how the diagnosis should be made and the treatments that should be offered at different times. The review conducted in March 2008 has concluded that this guideline warrants a partial ...
Clinical trial designs for rare diseases: Studies developed and
... held in Amsterdam in September 2013. Other as-yet unrealised methods were also discussed. Results: The IRCI trials are each presented to exemplify possible approaches to designing credible trials in rare cancers. Researchers may consider these for use in future trials and understand the choices made ...
... held in Amsterdam in September 2013. Other as-yet unrealised methods were also discussed. Results: The IRCI trials are each presented to exemplify possible approaches to designing credible trials in rare cancers. Researchers may consider these for use in future trials and understand the choices made ...
FDA - AIDS Action Baltimore
... and Postmarket Safety: The Secretary shall: Conduct regular, biweekly screening of the Adverse Event Reporting System database and post a quarterly report on the Adverse Event Reporting System web site, including new safety information or potential serious risk signals identified within the last q ...
... and Postmarket Safety: The Secretary shall: Conduct regular, biweekly screening of the Adverse Event Reporting System database and post a quarterly report on the Adverse Event Reporting System web site, including new safety information or potential serious risk signals identified within the last q ...
Analyze This? Supporting Clinical Decisions Graphically When Not Enough Data is Available A Study Case: Challenges in NCI CTCAE Version 4 Grading
... (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure.” Generally speaking, the collection of adverse events is required during the conduct ...
... (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure.” Generally speaking, the collection of adverse events is required during the conduct ...
שקופית 1
... - failure of the clinical trial team to elicit participant's symptoms - Steps the volunteer or family may take to prevent or minimize AEs - Explanation of how and by whom the AE will be treated, and to what medical and chronological extent - Explanation of how the study drug affects the standard tre ...
... - failure of the clinical trial team to elicit participant's symptoms - Steps the volunteer or family may take to prevent or minimize AEs - Explanation of how and by whom the AE will be treated, and to what medical and chronological extent - Explanation of how the study drug affects the standard tre ...
introduction: the philosophy of evidence- based medicine
... The same strategies that minimize bias in conventional therapeutic trials involving multiple patients can guard against misleading results in studies involving single patients.7 In the N of 1 randomized controlled trial (RCT), patients undertake pairs of treatment periods in which they receive a tar ...
... The same strategies that minimize bias in conventional therapeutic trials involving multiple patients can guard against misleading results in studies involving single patients.7 In the N of 1 randomized controlled trial (RCT), patients undertake pairs of treatment periods in which they receive a tar ...
Idiopathic pulmonary fibrosis: treatment options in pursuit of evidence-based approaches EDITORIAL
... In the current issue of the European Respiratory Journal, ANTONIOU et al. [15] report their observation in a cohort of patients with IPF treated with IFN-c-1b. The investigators prospectively randomised a selected subgroup of patients with IPF (mild-to-moderate functional impairment, based on FVC 55 ...
... In the current issue of the European Respiratory Journal, ANTONIOU et al. [15] report their observation in a cohort of patients with IPF treated with IFN-c-1b. The investigators prospectively randomised a selected subgroup of patients with IPF (mild-to-moderate functional impairment, based on FVC 55 ...
New Technologies in Superficial Vein Treatment
... Proebstle, T et al., The European Multicenter Cohort Study on Cyanoacrylate Embolization of Refluxing Great Saphenous Veins. JVS: Venous and Lymphatic Disorders 2014; 26 Accepted for publication. ...
... Proebstle, T et al., The European Multicenter Cohort Study on Cyanoacrylate Embolization of Refluxing Great Saphenous Veins. JVS: Venous and Lymphatic Disorders 2014; 26 Accepted for publication. ...
ESTUDO ACT
... CIN is associated with mortality and prolonged hospitalization. The incidence in patients with risk factors (such as renal failure, diabetes, age > 70 y) varies between 9% and 38%. ...
... CIN is associated with mortality and prolonged hospitalization. The incidence in patients with risk factors (such as renal failure, diabetes, age > 70 y) varies between 9% and 38%. ...
EHR Clinical Research Value Case Workgroup Call
... and Judy Kramer, to provide a brief overview of information flow during clinical research from an industry and academic standpoint, respectively. Linda King mentioned that there is a flow chart in the eClinicalForum’s White Paper illustrating this data flow. This will be distributed to the workgroup ...
... and Judy Kramer, to provide a brief overview of information flow during clinical research from an industry and academic standpoint, respectively. Linda King mentioned that there is a flow chart in the eClinicalForum’s White Paper illustrating this data flow. This will be distributed to the workgroup ...
International prospective register of systematic reviews
... potentially eligible studies will be retrieved and independently assessed using the predefined inclusion criteria. Discrepancies will be resolved through discussion and, when necessary, by consulting a third investigator. Two investigators will independently extract the following data about each stu ...
... potentially eligible studies will be retrieved and independently assessed using the predefined inclusion criteria. Discrepancies will be resolved through discussion and, when necessary, by consulting a third investigator. Two investigators will independently extract the following data about each stu ...
The Music Never Stops
... was all the rage at the recently concluded American Society of Clinical Oncology (ASCO) meeting. While it is widely acknowledged that before ASCO, Bristol was the leader in the space followed by Merck, and Roche. At the conference, however, AstraZeneca showcased its I-O pipeline as the competitive l ...
... was all the rage at the recently concluded American Society of Clinical Oncology (ASCO) meeting. While it is widely acknowledged that before ASCO, Bristol was the leader in the space followed by Merck, and Roche. At the conference, however, AstraZeneca showcased its I-O pipeline as the competitive l ...
and treatments
... standard in establishing efficacy other types of published studies may be informative Published studies are clearly different from real world clinical practice ...
... standard in establishing efficacy other types of published studies may be informative Published studies are clearly different from real world clinical practice ...
Detailed non-confidential information about this
... NWP007 is an engineered protein capsule (EPC) to be developed as a therapeutic vaccine against PML. It is derived from the major capsid protein VP1 of the human John Cunningham virus (JCV). JCV is a ubiquitous virus that exclusively infects humans. About 50-90% of adults are infected with JCV withou ...
... NWP007 is an engineered protein capsule (EPC) to be developed as a therapeutic vaccine against PML. It is derived from the major capsid protein VP1 of the human John Cunningham virus (JCV). JCV is a ubiquitous virus that exclusively infects humans. About 50-90% of adults are infected with JCV withou ...
A letter from the CEO Letter v17-1.pages
... necessary for enabling batch-to-batch consistent production of our materials since moving to the new campus. In addition, we are also implementing a number of control mechanisms in our chemical reactions and unit operations to enable reproducible product batches. This is an iterative, painstaking, a ...
... necessary for enabling batch-to-batch consistent production of our materials since moving to the new campus. In addition, we are also implementing a number of control mechanisms in our chemical reactions and unit operations to enable reproducible product batches. This is an iterative, painstaking, a ...
Neuroprotection in Dementia
... • preclinical studies: reduction of Aβ production, aggregation and neurotoxicity and improved neuronal function • underlying mechanism is independent of the anti-hypertensive action due to the differential effects seen with the different CCBs • evidence from epidemiological studies support the effic ...
... • preclinical studies: reduction of Aβ production, aggregation and neurotoxicity and improved neuronal function • underlying mechanism is independent of the anti-hypertensive action due to the differential effects seen with the different CCBs • evidence from epidemiological studies support the effic ...
Acucela: Pursuit of Science through Innovation
... should not place undue reliance upon these forward-looking statements. Such forward-looking statements are subject to risks, uncertainties, assumptions and other factors that may cause the actual results of Acucela to be materially different from those reflected in such forward-looking statements. I ...
... should not place undue reliance upon these forward-looking statements. Such forward-looking statements are subject to risks, uncertainties, assumptions and other factors that may cause the actual results of Acucela to be materially different from those reflected in such forward-looking statements. I ...
Vol. 8, No. 3, March 2012 “Happy Trials to You” Adverse Event and
... Proper coding is complete. For example, if an investigator reports a sign or symptom of “gold,” which is not in the MedDRA database, the report should not be ignored. Instead, the sponsor should send a data query to the investigator asking for clarification. Proper coding is accurate. Investigator’s ...
... Proper coding is complete. For example, if an investigator reports a sign or symptom of “gold,” which is not in the MedDRA database, the report should not be ignored. Instead, the sponsor should send a data query to the investigator asking for clarification. Proper coding is accurate. Investigator’s ...
Ethical issues related to the use of placebo in clinical trials
... treatment is not inferior to (or not different from) another treatment (the null hypothesis is that the two treatments do not have the same efficacy). There are different types of control groups used in clinical trials, each trial type addressing different objectives and possessing inherent limitati ...
... treatment is not inferior to (or not different from) another treatment (the null hypothesis is that the two treatments do not have the same efficacy). There are different types of control groups used in clinical trials, each trial type addressing different objectives and possessing inherent limitati ...
TRIPLEFLEX RAPID RELIEF
... White Willow Bark: Four clinical trials on white willow bark with a standardized 15% salicin content found both 240 and 120 mg doses salicin/day effective for joint discomfort relief.10-13 ...
... White Willow Bark: Four clinical trials on white willow bark with a standardized 15% salicin content found both 240 and 120 mg doses salicin/day effective for joint discomfort relief.10-13 ...
EU Initiatives - Global Health Care, LLC
... when there are concerns that serious adverse reactions in first-in-man clinical trials may occur. These concerns may be derived from particular knowledge or uncertainties on: the mode of action; and/or the nature of the target; and/or the relevance of animal models Guidance on quality aspect ...
... when there are concerns that serious adverse reactions in first-in-man clinical trials may occur. These concerns may be derived from particular knowledge or uncertainties on: the mode of action; and/or the nature of the target; and/or the relevance of animal models Guidance on quality aspect ...
General instructions to PI- project submission
... The adaptation process continues throughout the trial. Modifications may include dosage, sample size, drug undergoing trial, patient selection criteria etc. In some cases, trials have become an ongoing process that regularly adds and drops therapies and patient groups as more information is gained. ...
... The adaptation process continues throughout the trial. Modifications may include dosage, sample size, drug undergoing trial, patient selection criteria etc. In some cases, trials have become an ongoing process that regularly adds and drops therapies and patient groups as more information is gained. ...