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Patient recruitment is the process of finding and enrolling suitable participants for clinical trials. It is a crucial aspect of drug development and medical research, as it affects the validity, reliability, and generalizability of the results. Patient recruitment can also be challenging, time-consuming, and costly, involving various ethical ...
Adaptive design (medicine) Appearance. Schematic block diagram of an adaptive design for a clinical trial [ 1 ] In an adaptive design of a clinical trial, the parameters and conduct of the trial for a candidate drug or vaccine may be changed based on an interim analysis. [ 2 ][ 1 ][ 3 ] Adaptive design typically involves advanced statistics to ...
A clinical trial participant receives an injection. Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further ...
Clinical equipoise, also known as the principle of equipoise, provides the ethical basis for medical research that involves assigning patients to different treatment arms of a clinical trial. The term was first used by Benjamin Freedman in 1987, although references to its use go back to 1795 by Edward Jenner. [1][2] In short, clinical equipoise ...
The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. [1] For drug development, the clinical phases start with testing for drug safety in a few human subjects, then expand to many study ...
PICO process. The PICO process (or framework) is a mnemonic used in evidence-based practice (and specifically evidence-based medicine) to frame and answer a clinical or health care related question, [1] though it is also argued that PICO "can be used universally for every scientific endeavour in any discipline with all study designs". [2]
STAMPEDE (clinical trial) Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy (STAMPEDE) is a clinical trial investigating treatments for high risk or terminal prostate cancer. Recruitment started in 2005 and ended in 2022; as of January 2020, over 10,000 participants had joined the trial.
Clinical data management (CDM) is a critical process in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. [1] Clinical data management ensures collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and ...