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Imaging Clinical Trials. Imaging clinical trialists face complexities not shared by other clinicians conducting clinical experiments. Although much has been written on the subject of Clinical Trials, this Wiki should serve as a resource for those imaging professionals who need more than just superficial familiarity with the design and conduct of clinical trials. Its' content is derived from the key modules of the intense mentoring program conducted for the past several years jointly by RSNA and NCI for select young imaging faculty who plan to become professional clinical trialists. Consult the User's Guide for information on using the wiki software.----== Concepts and FAQ's addressed in this course ==How does a screening trial differ from a therapeutic trial?How does a randomized control trial (RCT) differ from an observational trial?Must the control arm of a therapeutic RCT always be a placebo?What distinguishes Phase 1, 2, 3 and 4 trials?What are ‘Phase 0’ trials and what role would imaging have in them?What data do you need to determine a statistically valid study size?When does a trial need a Data Safety Monitoring (DSM) board?What functions do interim and futility analyses serve?What are the definitions of type 1 and type 2 errors?How do you constitute an imaging central reading review panel and how does it function?What is the regulatory definition (e.g.: FDA) of a “surrogate’ biomarker?How do “prognostic” biomarkers differ from ‘predictive’ markers?What happens if an ‘adverse event’ occurs to a study subject?== Abbreviations and Definitions ==CR (Complete Response) DFS (Disease Free Survival)ORR (Objective Response Rate)in solid tumors represents measurable reduction in the dimension of target tumor masses when depicted on imagingOS (Overall Survival)PD (Progressive Disease)PR (Partial Response)PFS (Progression Free Survival)RR (Response Rate) represents data that implies an attenuation of the amount of tumor burden realtive to the degree present at baseline and can include either reduced symptoms or shrinkage of measured tumor size.SD (Stable Disease)TTP (Time to Progression)== Key out-of-Wiki Links ==#List of Cancers. http://www.cancer.gov/cancertopics/alphalist#PDQ. http://www.cancer.gov/cancertopics/pdq peer-reviewed summaries of cancer treatment, screening, genetics and a clinical trials directory#Learning about Clinical Trials. http://www.cancer.gov/clinicaltrials/learning#Search for Clinical Trials. http://www.cancer.gov/search/clinicaltrials#Conducting Clinical Trials http://www.cancer.gov/clinicaltrials/conducting#NCI Cancer Therapy Evaluation Program (CTEP) http://ctep.cancer.gov#NCI Cancer Imaging Program http://imaging.cancer.gov== Software that's essential for your efficiency ==You can't be efficient until you have a thorough knowledge of the following software applications. Spend some time learning them intimately - it will be worth it.Acrobat Professional – especially when you need to extract text (Select Tool) and images (Advanced ->export all images); track changes (Comments & Markup); or publish a smaller, unchangeable PPT as a PDF; Word – convert to Adobe PDF using an Acrobat plug-in; Track changes (ctrl+shift+E); email document as a draft for comment; add images; has hierarchical outline view Endnote – links to Word; does its’ own PUBmed searching, constructs a complete bibliography and dynamically formats your references while you writePowerPoint (PPT) – you can incorporate and edit web pages and images for presentations. And it's an easy way to construct protocol flow schemasQuosa – http://www.quosa.com/ connects automatically to PubMed and extracts full article PDFs if you are allowed to do so by your institutional license.== Informed Consent and Ethics ==Informed consent is an essential part of the ethical conduct of clinical trials.