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Elderly patients, and those not familiar with computers, might be expected to have more problems. But these groups also show high acceptance of ePRO, and again often prefer it to paper. [10] [11] [12] Thus there seems to be no great barrier to recruiting representative patient samples in ePRO studies.
Patients use a zero-cost helpline to report outcomes every 2–3 months related to adherence, medicine availability, seizure frequency, healthcare related quality of life, and a few other parameters. All PROMs are analyzed [ 33 ] to help guide public policy and optimize resource allocation for people living with epilepsy in Maharashtra.
The case report form (CRF) is the data collection tool for the clinical trial and can be paper or electronic. Paper CRFs will be printed, often using No Carbon Required paper, and shipped to the investigative sites conducting the clinical trial for completion after which they are couriered back to Data Management.
The report suggested three potential solutions for biotech firms: "Solution 1: Address large markets: Hemophilia is a $9-10bn WW market (hemophilia A, B), growing at ~6-7% annually."
In these studies, a group of patients receives multiple low doses of the drug, while samples (of blood, and other fluids) are collected at various time points and analyzed to acquire information on how the drug is processed within the body. The dose is subsequently escalated for further groups, up to a predetermined level. [8] [14]
Molecular diagnostics uses in vitro biological assays such as PCR-ELISA or Fluorescence in situ hybridization. [19] [20] The assay detects a molecule, often in low concentrations, that is a marker of disease or risk in a sample taken from a patient.
In medicine, a clinical study report (CSR) on a clinical trial is a document, typically very long, providing much detail about the methods and results of a trial. A CSR is a scientific document addressing efficacy and safety, not a sales or marketing tool; its content is similar to that of a peer-reviewed academic paper. [ 1 ]
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