Clinical trial feasibility studies of the Collaborative Assessment and Management of Suicidality (CAMS). In: O’Connor R, Platt S, Gordon J, editors. International handbook of suicide prevention: research, policy & practice. West Sussex, UK: Wiley–Blackwell; 2011. p. 383–400.Jobes DA, Com...
Clinical trial feasibility studies of the collaborative assessment and manage- ment of suicidality (CAMS). In: O'Connor R, Platt S, Gordon J, editors. International Handbook of Suicide Prevention: Research, Policy & Practice. London: Wiley; 2011....
Cost of Clinical Trials(9) EMA(5) European Union(8) FDA(5) Feasibility Assessment(1) Medical Devices(90) Nutraceuticals(2) Patient Enrolment(15) Rare Diseases(1) Regulations(12) Social Media(4) summit(28) Uncategorized(28) CRO services...
A) Clinical Trial Risk Assessment 1. Introduction The Research Governance Framework (RGF) specifies the separate responsibilities of the sponsor, main funder, chief investigator (CI), his/her employer and the Trust (or care organisation).In practice, the dividing lines are often blurred in non...
Assessment of the feasibility and clinical value of further research to evaluate the management options for children with Down syndrome and otitis media wi... There is clinical uncertainty of the benefits and costs of different treatment options for children with Down syndrome who have glue ear. ...
And just as data informs better trial design, it can inform patient-centric research strategies. Not relegated to a single data source, we leverage some of the world’s largest identified and de-identified patient databases to support pragmatic feasibility assessment and optimize enrollment. ...
The primary objective of this randomized, parallel-group, superiority trial is to evaluate the feasibility and acceptability of a computer tablet-based prenatal psychosocial assessment (e-screening) compared to paper-based screening. Secondary objectives are to compare the two modes of screening on: (...
Molecularly targeted therapy based on tumour molecular profiling versus conventional therapy for advanced cancer (SHIVA): a multicentre, open-label, proof-of-concept, randomised, controlled phase 2 trial. Lancet Oncol. 2015;16(13):1324-1334. doi:10.1016/S1470-2045(15)00188-6 PubMed...
Premature discontinuation of clinical trial for reasons not related to efficacy, safety, or feasibility. BMJ. 2001;322:603-605. PubMedGoogle ScholarCrossref 6. Psaty BM, Rennie D. Stopping medical research to save money. A broken pact with researchers and patients. JAMA. 2003;289:2128-...
In case of patient discontinuation in a trial, clinical assessment should be made or a preplanned and standardized telephone interview should be attempted. These strategies need to be included in the planned protocol as well as in the consent form. Concomitant therapy Symptomatic drug therapies are...