By David Kerr, Kirstine Knox, Diane Robertson, Derek Stewart, Renee Watson
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Additional info for Clinical Trials Explained: A Guide to Clinical Trials in the NHS for Healthcare Professionals
The purpose of the placebo is so that factors other than the effects of the test intervention itself can be calculated and taken into account when analysing trial results; r Blinding is a technique that is used to reduce bias in clinical trials. Blinding can take two forms: – Single blinding – to reduce patient bias by not telling a patient whether he or she is in the test intervention or the control group; and – Double blinding – to reduce patient and doctor bias by not telling either patients or healthcare professionals whether the patients are receiving the test intervention or the control treatment.
R Audit: Regulatory organisations, funding bodies and sponsors may want to conduct an audit of the place where the clinical trial will take place. R&D ofﬁces will be auditing research in their organisation as part of their responsibilities under Research Governance Framework. r Urgent safety measures: If an adverse event occurs or in any other emergency situation, the trial management team must contact the MHRA and REC, who will decide whether or not the trial is safe to proceed. The trial doctor Clinical Trial Approval, Regulation and Funding 27 can change trial procedures if a patient is in immediate danger.
No placebo was given because doctors felt it would be too painful (several injections daily) for patients not actually receiving the experimental drug. Ninety-seven patients with severe TB were randomly assigned to receive either the drug injections or hospital bed rest. Neither doctors nor patients knew beforehand which treatment a particular patient was going to receive. The results published in 1948 in the British Medical Journal showed that 51% of the 55 patients in the treatment group had signiﬁcant improvement after six months compared to only 8% of 52 patients in the bed rest group.