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clinical research essay 2

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CLINICAL RESEARCH Title: "Write a clinical trial protocol for a novel drug." "The protocol is at the heart of every clinical trial. It is the plan; it is a critical document for everyone involved in the conduct of the trial."1 Principally a protocol involves selecting investigative sites and designing the data collection tools; it also describes how individual trial subjects should be treated and evaluated. Quite importantly it "serves as a reference for monitoring and auditing trial conduct and it conveys the plan for analysing the data when the study is complete."1 An "Institutional Review Board (IRBs) or Ethics Committees use the protocol as the basis for approving whether a trial can be initiated." A protocol that is constructed thoroughly aids to ensure "common understanding of the study objectives and procedures to be implemented, thereby improving quality and saving time and effort for those using it."1 The International Conference on Harmonization (ICH) defines a protocol as; "a document that describes the objective(s), design, methodology, statistical considerations and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. Throughout the ICH Good Clinical Practice Guideline, the term protocol refers to both protocol and protocol amendments."2 Every clinical trial has a carefully designed plan that provides complete details on the conduct of the trial. The protocol is principally written by the physician or the sponsor of the trial and it is provided to all the physicians helping to carry out the trial.3 The protocol provides details on the following: ...read more.


The treatment dose would normally be a 50mg tablet to be taken daily. 1.5 Trial Conduct The insertion of a statement that the trial will be conducted in compliance with: the protocol, GCP and the applicable regulatory requirement(s). For example: This study will be conducted in compliance with the protocol approved by the Institutional Review Board, and according to Good Clinical Practice standards. No deviation from the protocol will be implemented without the prior review and approval of the IRB except where it may be necessary to eliminate an immediate hazard to a research subject. In such case, the deviation will be reported to the IRB as soon as possible. 1.6 Population A description of the population to be studied will be inserted i.e. 500 people. 1.7 Literature The reference to any literature and data that are relevant to the trial and that provide background for the trial would be included here. 2 Trial Objectives5 A detailed description of the objectives and the purpose of the trial would be inserted here. 3 Trial Design5 The scientific integrity of the trial and the credibility of the data from it depend substantially on the design. A description of the trial design includes the following: 3.1 Primary Study Endpoints/Secondary Endpoints A specific statement of either primary or secondary endpoints if any is to be measured during the trial. 3.2 Study Design/Type A description of the type/design of trial to be conducted (e.g. double-blind, placebo controlled, parallel design) ...read more.


for all studies. Applicable government regulations and Liverpool John Moores University research policies and procedures will also be followed. 11 Data Handling and Record Keeping5 A description of who, what, where and why should be inserted here. 12 Finance and Insurance5 Insert financing and insurance statements if not addressed in a separate agreement. Who will be responsible for paying for research related costs? Who will be responsible for paying for injuries in case of accident? 13 Publication Plan5 Where ownership of the data is not in question - this section may be omitted. Otherwise, insert a publication policy, if not addressed in a separate agreement (most commonly a contract). 14 Supplements5 Insert any other documentation for the trial. Once a draft of the protocol has been produced then it should be distributed for critical review and "comment to all those who have had input."8 Their will be numerous drafts of the protocol before it is finalised. The protocol will be reviewed by a committee of individuals and then it is usually followed by a final sign-off procedure takes place. It should be noted that the review process can be lengthy because the reviewers don't have prior knowledge to any earlier discussions in regards to the protocol.8 Spending time on the protocol in order to ensure an excellent protocol is worthwhile as it saves time and ultimately very few amendments would have to be made. However, the "world is unpredictable and situations can change during the lifetime of a clinical trial, protocol amendments often become necessary. ...read more.

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