Clinical trial designing

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Clinical trial designing:

Clinical trial designing

Objectives :

Objectives Define key members of the research team Review key components of a clinical trial Describe the purpose of the randomization, stratification, and blinding in clinical trial protocols Name common statistical methods used to interpret clinical trial results

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Clinical trials follow strict scientific guidelines that dictate how a study is designed and who participates in it. The reasons for these guidelines may not be immediately clear to a person urgently seeking treatment, but they protect people and provide scientifically sound results that can lead to truly effective therapies and techniques.

Research Team Members :

Research Team Members Designing and implementing a clinical trial requires the many talents of a multidisciplinary research team. Typical team members and their responsibilities include:

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Principal investigator - oversees all aspects of a clinical trial, specifically, concept development, protocol writing, protocol submission for institutional review board (IRB) approval, participant recruitment, informed consent, and data collection, analysis, interpretation, and presentation.

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Research nurse - coordinates the clinical trial and educates staff, participants, and referring health care providers. This nurse acts as an information conduit from the clinical setting to the principal investigator and vice versa, and assists the principal investigator with toxicity and response monitoring, quality assurance, audits, and data management and analysis.

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Data manager - handles the management of clinical trial data, including electronic data entry. Collaborates with the principal investigator and research nurse to identify what participant data will be tracked. The data manager also provides data to monitoring agencies and prepares summaries for interim and final data analysis.

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Staff physicians and nurses - administer treatment to participants as specified in the protocol; Assess and record toxicity, drug tolerance, and adverse events Collaborate with the principal investigator and research nurse in observing and reporting clinical trends Provide clinical management and participant education.

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Components of a Clinical Trial Protocol Every trial has a written, detailed action plan, called a protocol. The protocol provides the background, specifies the objectives, and describes the design and organization of the trial. Every site participating in the trial uses the same protocol, ensuring consistency of procedures and enhancing communication. This uniformity ensures that results from all sites can be combined and compared.

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The clinical trial protocol answers the following questions: What is the scientific rationale or basis for conducting the trial? What are the objectives? How many participants will be in the trial? Who is eligible to participate? (This is determined on the basis of factors such as age and disease status.) what is its duration or schedule?

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What side effects might there be? What medical tests or follow-up visits will participants have? How often? What information will be gathered about participants? What are the endpoints of the trial?

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The following FDA-required protocol elements help investigators answer the questions above and assist participants and health care professionals in understanding the goals of a clinical trial: General information Background information (with relevant references from the scientific literature) Trial objectives and purpose Trial design Participant selection and withdrawal

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Participant treatment Efficacy assessment Safety assessment Statistics Direct access to source data and documents Quality control and quality assurance Ethics Data handling and record keeping Financing and insurance Publication policy Supplements

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Eligibility Criteria Participant eligibility criteria can range from general (age, sex, type of cancer) to specific (prior treatment, tumor characteristics, blood cell counts, organ function). Eligibility criteria may also vary with trial phase. In phase 1 and 2 trials, the criteria often focus on making sure that people who might be harmed because of abnormal organ function or other factors are not put at risk.

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Phase 2 and 3 trials often add criteria regarding disease type and stage, and number of prior treatments. Eligibility criteria might be very detailed if researchers think that a drug will work best on a specific type of cancer or population. Trials with narrow eligibility criteria might be complicated to conduct and might produce less widely applicable results.

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Researchers therefore attempt to include as many types of people as possible in a clinical trial without making the study population too diverse to tell whether the treatment might be as effective on a more narrowly defined population. The more diverse the trial's population, the more useful the results could be to the general population, particularly in phase 3 trials. Results of phase 3 trials should be as generally applicable as possible in order to benefit the maximum number of people.

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Endpoints An endpoint is a measurable outcome that indicates an intervention's effectiveness. Endpoints differ depending on the phase and type of trial. For instance, a treatment trial endpoint could be tumor response or participant survival. Quality-of-life or supportive care trial endpoints could include participants' welfare and control of symptoms

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Examples of endpoints include: Tumor response rate - the proportion of trial participants whose tumor was reduced in size by a specific amount, usually described as a percentage. If 7 of 10 patients responded, the response rate is 70 percent. Disease-free survival - the amount of time a participant survives without cancer occurring or recurring, usually measured in months. Overall survival - the amount of time a participant lives, typically measured from the beginning of the clinical trial until the time of death.

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Randomization In phase 3 trials (and some phase 2 trials) participants are assigned to either the investigational or control group by chance, via a computer program or table of random numbers. This process, called randomization It gives each person the same chance of being assigned to either group. Randomization ensures that unknown factors do not influence the trial results.

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Randomization is a method used to prevent bias in research. A computer or a table of random numbers generates treatment assignments, and participants have an equal chance to be assigned to one of two or more groups (e.g., the control group or the investigational group).

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Randomization tends to produce comparable groups in terms of factors affecting prognosis and other participant characteristics. Randomization guarantees the validity of the conclusion concerning the effectiveness of the treatment.

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Stratification Stratification is used in randomized trials when factors that can influence the intervention's success are known. For instance, participants whose cancer has spread from the original tumor site can be separated, or stratified, from those whose cancer has not spread. Assignment of interventions within the two groups is then randomized.

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Stratification enables researchers to look at factors in both groups.

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Blinding Trials set so that participants do not know which intervention they are receiving are known as single-blinded trials. Those in which neither researchers nor participants know who is in the investigational or control group are called double-blinded trials. Double-blinded trials ensure that people assessing the outcome will not be influenced by knowing which intervention a participant is receiving and also that ancillary follow-up treatment will be the same.

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Data Collection and Management Tools Most research teams use standardized and newly created tools to collect, process, analyze, and audit data. Tools vary in format from visual analog scales to open-ended questionnaires. Examples of tools for participants to use to self-report data include diaries, calendars, logs, and surveys.

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The process of designing and carrying out clinical research can be divided mainly into two parts: 1. The first part is to deal with processes required in planning the study before data collection begins 2. Second part deals with execution steps carried out in data collection, analysis and publication.

Planning steps::

Planning steps: Develop hypothesis for research Develop the objectives and establish priorities Define the variables needed Define the study population Finalize the objectives into testable hypothesis Predict error and bias Selection of appropriate study design Determination of sample size

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