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Background Randomized clinical trials (RCTs) are an important component of comparative effectiveness (CE) research because they are the optimal design for head-to-head comparisons of different treatment options.
Purpose To describe decisions made in the design of the Multicenter Uveitis Steroid Treatment (MUST) Trial to ensure that the results would be widely generalizable.
Methods Review of design and implementation decisions and their rationale for the trial.
Results The MUST Trial is a multicenter randomized controlled CE trial evaluating a novel local therapy (intraocular fluocinolone acetonide implant) versus the systemic therapy standard of care for noninfectious uveitis. Decisions made in protocol design in order to broaden enrollment included allowing patients with very poor vision and media opacity to enroll and including clinical sites outside the United States. The treatment protocol was designed to follow standard care. The primary outcome, visual acuity, is important to patients and can be evaluated in all eyes with uveitis. Other outcomes include patient-reported visual function, quality of life, and disease and treatment related complications.
Limitations The trial population is too small for subgroup analyses that are of interest and the trial is being conducted at tertiary medical centers.
Conclusion CE trials require greater emphasis on generalizability than many RCTs but otherwise face similar challenges for design choices as any RCT. The increase in heterogeneity in patients and treatment required to ensure generalizability can be balanced with a rigorous approach to implementation, outcome assessment, and statistical design. This approach requires significant resources that may limit implementation in many RCTs, especially in clinical practice settings.
Background and Purpose Power and sample size calculations for cluster randomized trials require prediction of the degree of correlation that will be realized among outcomes of participants in the same cluster. This correlation is typically quantified as the intraclass correlation coefficient (ICC), defined as the Pearson correlation between two members of the same cluster or proportion of the total variance attributable to variance between clusters. It is widely known but perhaps not fully appreciated that for binary outcomes, the ICC is a function of outcome prevalence. Hence, the ICC and the outcome prevalence are intrinsically related, making the ICC poorly generalizable across study conditions and between studies with different outcome prevalences.
Methods We use a simple parametrization of the ICC that aims to isolate that part of the ICC that measures dependence among responses within a cluster from the outcome prevalence. We incorporate this parametrization into sample size calculations for cluster randomized trials and compare our method to the traditional approach using the ICC.
Results Our dependence parameter, R, may be less influenced by outcome prevalence and has an intuitive meaning that facilitates interpretation. Estimates of R from previous studies can be obtained using simple statistics. Comparison of methods showed that the traditional ICC approach to sample size determination tends to overpower studies under many scenarios, calling for more clusters than truly required.
Limitations The methods are developed for equal-sized clusters, whereas cluster size may vary in practice.
Conclusions The dependence parameter R is an alternative measure of dependence among binary outcomes in cluster randomized trials that has a number of advantages over the ICC.
Background In contrast to the gradual pace of conventional vaccine trials, evaluation of influenza vaccines often must be accelerated for use in a pandemic or for annual re-licensure. Descriptions of how best to design studies for rapid completion are few.
Purpose In August, 2010, we conducted a rapid trial with a seasonal influenza vaccine for 2010–2011 given to persons vaccinated with an adjuvanted H1N1 vaccine in 2009, to determine whether re-exposure to the H1N12009 component of the seasonal vaccine would cause increased reactions. We describe the strategies that we believe were responsible for success in meeting the desired timeline.
Methods The key means for expediting the study were: use of a few experienced, well-staffed centers; efficient completion of administrative approvals; advance recruitment of volunteers; synchronized start among centers with rapid completion (≤1 week) of first visits; rapid data assembly via the Internet; and a well-prepared data analysis plan. We chose to use a randomized, blinded, cross-over design to allow estimation of vaccine-attributable adverse event rates, with sufficient power (320 participants) to detect events occurring at true rates ≥1% with ≥90% probability.
Results Planned enrollment numbers, center synchronization, and timelines, including review by a safety board prior to the cross-over step (second doses), were achieved. A detailed safety report was delivered to federal health officials just 32 days after study initiation and was used to fine-tune public messaging prior to the mass vaccination programs across Canada.
Limitations This aggressive timeline could not have been met without opportunities for careful planning and the prior existence of a network of experienced, collaborating trial centers.
Conclusions The means used to accelerate this study timeline were successful and could be used in other urgent situations but the mechanics of collaborative trials must be well rehearsed as a precondition.
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Posted by Kishore Bennabhaktula on July 19, 2010 at 2:00pm — 1 Comment
Posted by PRIYANKA on July 2, 2010 at 7:30pm
Catalyst has invited you to the event 'Clinical Trial Methodology and Management Workshop'
Program Outline
* Overview of the Drug Discovery and Clinical Trial process.
* Essential Clinical Trial Documents.
* Foundation of GCP guidelines.
* Informed Consent Process.
* Pharmacovigilance…
ContinuePosted by Mohd Nabid on February 26, 2010 at 5:46pm
Would you be so kind as to click on the link below and answer 10 simple questions regarding job related stress in your role as a CRA? Its totally anonymous! I really appreciate your help with this project! I'm trying to collect a least 100 responses. Please share…Posted by Pame' Sawyer-Smith on February 14, 2010 at 1:11am — 1 Comment
Posted by nice girl on December 12, 2009 at 7:40pm
Posted by βђẮяǻт ş on November 20, 2009 at 5:17pm
Posted by Mohd Nabid on November 18, 2009 at 1:56pm
Posted by Bernard Akabike on October 31, 2009 at 1:42am
Posted by Mayank Gupta on October 4, 2009 at 7:43pm
Posted by Maria Pittman on October 2, 2009 at 10:22am
Are you looking to develop your career in Clinical Research? Are you looking for the opportunity to work within a successful and rewarding environment? Due to the continued success of our Late Phase…Continue
Tags: www.i3careers.com
Started by Jo hawkett. Last reply by vamsi krishna vemuri Sep 5, 2010.
Hellomy name is Gennaro I'm 28 years old I work in Italy for a CRO. I'd like to do a great experience abroad preferably in a Anglophone country for improve my English….I know that is too difficult…Continue
Started by GENNARO FAZZI Sep 1, 2010.
hiii everybody!!!!! My name is yugandhar....I am working as a Clinical Research Coordinator from last 1.6 year of experience in the same and I am looking forward to work as a Clinical Research…Continue
Started by yugandhar. Last reply by yugandhar Aug 14, 2010.
This leading CRO is looking to recruit a Project Manager to manage phase IV clinical research projects throughout Europe. This position has arisen due to expansion, as they have recently won a large…Continue
Started by Kristina Southcott Aug 12, 2010.
Do you have field monitoring experience?Do you have experience of working on oncology studies?Are you based in the Netherlands or Germany?If so, this position could be for you!One of the top ten…Continue
Started by Kristina Southcott Aug 2, 2010.
Hello All,This is to keep the members informed about the vacancies for Trainee Coordinators at Cuttack and Bhuwaneshwar. The Candidate must have a good knowledge of ICH-GCP guidelines and should be…Continue
Tags: research, clinical, crc, job
Started by T Krishna Chaitanya Jul 28, 2010.
Good compensation for these exciting roles with a stable, growing company.Interested parties should reply with a resume in confidence to john.morin@pentacan.comContinue
Tags: positions, jobs, monitoring, Associate, Research
Started by John Morin. Last reply by Donald Hardesty Jul 8, 2010.
BD is a global medical technology company that is focused on improving drug therapies, enhancing the quality and speed of diagnosing infectious diseases, and advancing research and discovery of new…Continue
Tags: Senior, Associate, Research, Clinical
Started by Renee Davidow. Last reply by Trevor Day Jul 7, 2010.
Now hiring Regional Home-based Clinical Research Associates who are located in Florida, midwest and west coast based.If you have at least 2 years of independent field monitoring experience and…Continue
Started by LaRhonda W. Dumas. Last reply by Trevor Day Jul 7, 2010.
Email me with your resume to recruiter@cyberdivan.com or goto my site at http://www.cyberdivan.com/html/jobslist.htmJob ID Job Title Location…Continue
Started by Steven J Pruner. Last reply by Mary Miller May 5, 2010.
These are the few questions which are being asked during the interview and sumtimes it is very difficult to answer them. This document will help you to deal some difficult questions with ease.
Started by Saud Abdul Karim Shaikh. Last reply by vijayvankayala Apr 30, 2010.
Catalyst has invited you to the event 'Clinical Trial Methodology and Management Workshop' Program Outline* Overview of the Drug Discovery and Clinical Trial process.* Essential Clinical Trial…Continue
Started by Mohd Nabid Feb 26, 2010.
Hi Everyone!I'm conducting a small survey amongst CRAs regarding job related stress and stress management. Would you be so kind as to click on the link below and answer 10 simple questions regarding…Continue
Tags: goa, mumbai, india, smo, stress
Started by Pame' Sawyer-Smith Feb 21, 2010.
Hi,Pl suggest me in this.. I have been working as CRA for BA/BE studies for 1.5yrs. Now I would like to shift to pharmacovigilense, Will the companies consider my BA/BE experience? Continue
Started by Raghu Feb 19, 2010.
Global pharmaceutical industry has gained an unmatched momentum in recent times making Clinical Research as one of the most lucrative career avenue. India is fast emerging as a preferred destination…Continue
Started by Mohd Nabid. Last reply by Mohd Nabid Nov 27, 2009.
Dear friendsi'm doing m.pharma in pharmacovigilance from NIMS UNIVERSITY RAJASTHAN jaipurand i need to complete my pg 6 months thesis work in relevant subject please help me to do so.regardsHarpreetContinue
Tags: protocol, crc, clinical, cra, jobs
Started by harpreet singh. Last reply by Lanka Srinivas Nov 27, 2009.
Dear Professional,Become a Certified Clinical Research Professional by joining India’s largest clinical research training program “Professional Diploma in Clinical Research (PDCR®)”.PDCR® is a skill…Continue
Started by Catalyst Nov 23, 2009.
HI ALL,I would like to know if we require to get ethical clearance for a non clinical study. I had worked on Pseudomonas aeruginosa infecting ICU patients. It was purely a Laboratory work i.e i use…Continue
Started by Manasi Kulkarni Nov 21, 2009.
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