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One of the earliest ePRO studies used a LINC-2 minicomputer to collect patient data. The majority of patients preferred the computer to paper data collection. [7] Similar findings have been reported from many later studies. [8] [9] Elderly patients, and those not familiar with computers, might be expected to have more problems.
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.
Dosing of the 10 patients with Rett syndrome in Part A, the dose escalation portion of the REVEAL Phase 1/2 adolescent/adult trial and the REVEAL Phase 1/2 pediatric trial, has been completed. The dataset includes six patients in cohort two (high dose, 1x10 15 total vector genomes (vg)) and four patients in cohort one (low dose, 5.7x10 14 total ...
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."
Phase I trials most often include healthy volunteers. However, there are some circumstances when clinical patients are used, such as patients who have terminal cancer or HIV and the treatment is likely to make healthy individuals ill. These studies are usually conducted in tightly controlled clinics called Central Pharmacological Units, where ...
The Food and Drug Administration (FDA) approved the first clinical trial in the United States involving human embryonic stem cells on January 23, 2009. Geron Corporation, a biotechnology firm located in Menlo Park, California, originally planned to enroll ten patients with spinal cord injuries to participate in the trial.
Cassava Sciences was founded by Remi Barbier in May 1998 as Pain Therapeutics, [3] [4] focusing on opioids and chronic pain. [5] Barbier first heard of the research led by Stanley M. Crain at the Albert Einstein College of Medicine in New York City around 1993. [5]