How and why clinical trials are used in drugdevelopment: Clinicaltrials help doctors understand how to treat a particular disease or condition.

It may benefit people in the future. Clinicalresearch refers to studies, or trials, that are done in people.  Studies on human participants are designed toanswer specific questions about biomedical uncertainties including newtreatments (such as vaccines, drugs, dietary choices, dietary supplements, andmedical devices). Trialsmay take place with the objective of repeating previous events to try and getthe same evidence. Others may be solely testing a new drug/treatment andobserving reactions. And, there are randomized controlled trials where somepeople may receive a placebo to see if a control group will differ to onereceiving a new drug.

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This can be done using the singleor double blind practice. Single involvesthe subject not knowing whether the drug is a placebo or not. With adouble blind trial, the information to if the drug is a placebo or not is withheld from the subject and the person administeringit, this prevents biases.  Phasesof trials:Preclinical – This is the stage where researchis carried out to discover how a desired target could be reached. Phase 1 – A small number of people, who may be healthy volunteers, are given the medicine. Thedrug is being trialled in human volunteers for the first time. Researchers testfor side effects and calculate what the correctdose might be to use in treatment.

They start with small doses and onlyincrease the dose if the volunteers don’t experience any side effects. Phase 2- The new medicine is tested on a larger group of people who are ill. This is toget a better idea of its effects in the short term.

 Phase 3- This is carried out on medicines thathave passed phases one and two. The medicine is tested in larger groups ofpeople who are ill, and compared against anexisting treatment or a placebo to see if it’s better in practice and ifit has important side effects. Trials often last a year or more and involveseveral thousand patients.

 Phase 4 – The drug has been licenced. There is sufficient information aboutthe side affects.  The role of NICE in providing guidelines on clinicalpractise: Standingfor The National Institute for Health and Care Excellence, NICE improve healthand social care through evidence based guidance from clinical trial aspreviously mentioned.Theypublish guidelines for four areas in medicine: -The useof health technologies within the NHS.-Clinicalpractice and guidance on the appropriate treatment for people with specificdiseases and conditions.-Guidancefor public sector workers on health promotion and ill-health avoidance-Guidancefor social care services and users.

 Theseappraisals are based primarily on evaluations of likelihood of producing usefulresults (efficacy) and cost–effectiveness in various circumstances.  Importance of economic considerations in theproduction of guidelines: The NHShas a limited budget and a vast number of potential spending options so thereneeds to be a process involving the decision of how much gets spent on what.Economic evaluations are carried out within a health technology assessmentframework (HTAF) to compare the cost-effectiveness of alternative means and toconsider the opportunity cost associated with their decisions(how much moneycan be made off of the item under trial).


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