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HUBS2408 Clinical Research Design

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HUBS2408 Clinical Research Design

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HUBS2408 Clinical Research Design

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Course Code: HUBS2408
University: The University Of Newcastle is not sponsored or endorsed by this college or university

Country: Australia

What is a Clinical Study Protocol?
Describe the development process of a clinical study protocol in detail.?

A clinical protocol is a document that illustrates how a clinical trial will be conducted. It contains the background, rationale, design, objective, methodology, selection and the exclusion criteria, assessment of the efficacy, assessment of safety, adverse events, discontinuation of the study, statistical considerations, quality control and assurance, Ethical approval, data handling and record keeping, publication policy, project time frame, references, Appendices (1).
Aims of the protocol
The aim is to raise the research question and clarify the importance of the question, collect the current knowledge and review the findings of the other researchers who have researched on the related topic, formulation of the hypothesis and objectives, obtaining ethical approval from registered organizations, to propose a perfect method required for explaining the question for the achievement of the objective (2).
Protocol writing enables a researcher to critically examine and evaluate the current available works on a particular topic, design and review the levels of the project and finally helps throughout the conduction of the research work (3).  
Title of the study:
It should be short, accurate and concise (3).The title should make the aim of the project clear, convey the actual motive of the research, mentioning the primary stakeholders.
Project summary:
The summary of the project should be distinct and should add up all the essential components of the protocol.
The introduction of the subject should be able to link up with the subject in a straight forward manner. While writing a protocol, it is necessary to consider the strength of the study.  Every study has its own limitations related to the method and hence should be clearly mentioned. (1). the introduction should end with how the current research would benefit mankind. The literature review should progress in a logical manner towards the purpose of the project topic (2).
The aims of the project should logically arrive from the literature review and should be explicitly stated. It is necessary to state the goals that is required to be achieved. The aims should be logical, coherent,     feasible, realistic and concise and should   consider local conditions, phrased to serve the study purpose (2). SMART aims should be followed while writing the project:

Time based.

Specific aims
A detailed account of the objectives would help in the extraction of specific aims. Use of too many objectives can lead to erroneous and poor results. Verbs such as “to compare, to determine, to calculate, to verify etc.” can be used.
It is a statement that is based on the scientific theory, that recognizes the relationship between two or additional variables that are assessable (6). It is always constructed considering the research question made. Types of hypothesis statement:-
Null hypothesis: This consists of a statement where there is no association between the variables (H0 or HN). H0 states in contradiction to what the researcher wants (6). The final results will ultimately decide whether the null hypothesis has to be accepted or rejected in support of an alternate hypothesis.
Alternate hypothesis: The statement proposes a potential outcome that researchers can anticipate. The hypothesis is generated from the previous conducted researches that had displayed an apparent distinction between the groups (6). Alternate hypothesis mainly recognized when the null hypothesis is rejected.
For example:
Research question:
Does reduction of stress among the nurses helps to reduce medication errors?
Null hypothesis: Reduction of stress among the nurses do not reduce medication errors.
Alternate hypothesis: Reduction of stress among the nurses helps to reduce medication errors.
The problem statement should be able to provide a summary of the aim of the project.

What exactly do we want to study?
Was the study worth conducting?
How will the clinical study serve the priorities of the nation?
What knowledge would be obtained from the study?
Is there any ultimate purpose of the knowledge obtained?
How will the findings be disseminated?
Who will be the beneficiaries of the study?

Methods and materials
 A clinical protocol should be able to give a detailed explanation of the study design, procedures and techniques for achieving the objectives. It normally defines the variables. It also validates the methods for assessing the variables. It gives an account of the proposed methodology of the data collection and processing (5). It is the methodology portion of a protocol that decides whether a hypothesis will be accepted or rejected. The methodology can be subdivided in to following headings.

Study design: A study design is the plan of the researcher for acquiring the answer to the hypothesis that is being tested (5).
Study population: It describes about all the aspects of the selection procedure.
Sample size: The sample size should be taken appropriately for economical and ethical reasons. Each level of the recruitment should be mentioned as per the selection criteria (6).
Proposed intervention: this involves recording of all the activities in order of the occurrence. For example while mentioning about the drugs, both the brand and the scientific names should be mentioned.
Data collection method : Proper data collection tools should be used such as retrospective data, questionnaires, laboratory test reports, clinical examinations, tolls for data collection (2).

Data Analysis
This portion has to be done under the guidance of a  statistician. Which statistical tests should be used should be mentioned properly. The variables that has been analyzed in the case study and the statistical analysis that has to be performed for measuring the outcome should be mentioned (5).
Strengths and limitations
Strengths and limitations: a paper can have many flaws, such as weak study design, faulty sample size and objectives (7). Limitations are the influences that cannot be controlled by the researcher that places restrictions on the methodology and the conclusions (6).
Ethical approval
Researchers should consider the following points before the conduction of the study:

The benefits and the risks of the participants
The participants or the subjects should be informed about details of the study.
Informed consent form should be signed by the participants, containing a detailed information about the study, justifications, risks involved, privacy and confidentiality (1). Confidentiality should be maintained while the preservation of the patient data.

Budgeting system:
The budget requirements have to be highlighted showing the head wise spending for the transportation, manpower, laboratory tests, instruments, and costs of drugs. The estimation of the budget should be attached to the appendices. Cost for each of the items should be justified (1).
This is one of the most important part of writing a clinical protocol. It is the way in which  the information taken from the other person’s work, are recognised. Failure to reference a particular concept used in the writing can lead to plagiarism issues and can be considered as criminal action and hence referencing is such an important issue in clinical protocol development (1).
The most challenging step in the conduction of a research project is to prepare a protocol that is short and yet inclusive and clearly provides the summary of the project. Before the writing of the protocol it is necessary to recognize the steps in the development of a research protocol for obtaining reliable results. A poorly prepared clinical study protocol would lessen the chance of selling the ideas to the reviewer of the granting organization.

Al-JunDi A, SAkkA S. Protocol writing in clinical research. Journal of clinical and diagnostic research: JCDR. 2016 Nov;10(11):ZE10.
O’Brien K, Wright J. How to write a protocol. Journal of orthodontics. 2002 Mar 1;29(1):58-61.
Toy A, Eaton KA, Santini A. An Introduction to Research for Primary Dental Care Clinicians Part 2: Stage 4. Planning the Study. Primary Dental Care (UK). 2011 Jan 10;18(1):36.
Rosenthal R, Schäfer J, Briel M, Bucher HC, Oertli D, Dell-Kuster S. How to write a surgical clinical research protocol: literature review and practical guide. The American Journal of Surgery. 2014 Feb 1;207(2):299-312.
Woodward M. Epidemiology: study design and data analysis. CRC press; 2013 Dec 19.
Toledo-Pereyra LH. Research design. Journal of Investigative Surgery. 2012 Sep 25;25(5):279-80.
Pan American Health Organization. Guidelines for writing a research protocol, 2014. Available from:

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