<> %���� 2 0 obj endobj That is, the Responsible Party indicated that the trial includes a device not previously approved or cleared by the Food and Drug Administration (U.S. FDA) for any use. page provides an interactive map of studies that are registered on ClinicalTrials.gov. <>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 720 540] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> 3 0 obj The graph and table below show the total number of studies posted on ClinicalTrials.gov since 2000, based on the The first version of ClinicalTrials.gov was made available to the public on February 29, 2000. 4.3.1 Distribution of ASAT by Time and Treatment *** Results are required to be submitted only for certain studies. COVID-19 is an emerging, rapidly evolving situation. ECG graphs are generated to display 95% CI interval for Mean Change in ECG parameter and also number of subjects at risk. Because of this, the sum of counts by type of intervention do not equal the total number of interventional studies. See About the Results Database for more information. endobj The table below shows the number and types of studies that are registered and have results posted on ClinicalTrials.gov. The graph and table below show the number of registered studies with results posted on ClinicalTrials.gov, based on the The graphs below consist of three sections. 4 0 obj <> applicable device clinical trials were submitted as "delayed posting" under the Food and Drug Administration Amendments Act of 2007 (FDAAA). First Posted date. ** A total of $.' Types of Registered Studies 5. %PDF-1.5 Locations of Recruiting Studies 3. 5 0 obj A table of subjects in the study by treatment is at the bottom, and the number of subjects with value > 2 by treatment is at the top of the graph. The main body of the graph contains the display of ASAT by Week and Treatment in the middle. * A study may include more than one type of intervention, meaning that a single study may be counted more than once. Percentage of Registered Studies by Location (as of October 19, 2020) Total of 355,127 studies. <>>> The chart below shows the distribution of locations for all studies registered on ClinicalTrials.gov. Number of Registered Studies With Posted Results Over Time For example, results submission is generally not required for observational studies; trials completed before 2008; and trials that include drug, biological, or device products not previously approved by the U.S. FDA for any use (if the Primary Completion Date is before January 18, 2017). ClinicalTrials.gov launched its results database in September 2008, at which time sponsors or investigators could begin submitting results for their registered studies. Clinical Trials – Graphs make a Difference! see examples of increasing information using modern graphics, whether static or interactive Built on nearly 25 years of real-world data capture expertise, our ecosystem of hardware and software tools delivers high quality, real-world activity and sleep data through a flexible cloud-based technology platform designed around the challenges and complexities of the clinical development process. As of March 2020, ClinicalTrials.gov receives about 3.5 million visitors monthly. with locations in all 50 States and in 217 countries. ECG GRAPHS Changes in ECG parameters like QRS, QT, and QTc are summarized over time in clinical trials. ICMJE: Indicates when the International Committee of Medical Journal Editors (ICMJE) began requiring trial registration as a condition of publication (September 2005), FDAAA: Indicates when the registration requirements of FDAAA began and were implemented on ClinicalTrials.gov (December 2007).

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