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STUDY NUMBER: CASE 4318 ClinicalTrials.gov NCT #: 03768856 Version Date: 5/8/2020 STUDY TITLE: Feasibility Study of Temporally Feathered Radiation Therapy (TORT) for Head and Neck Squamous Cell Carcinoma:

How to fill out first-in-human trial proves feasibility

How to fill out first-in-human trial proves feasibility

1. Start by clearly defining the objective of the first-in-human trial, ensuring it focuses on proving the feasibility of the intervention or treatment.
2. Identify the target population for the trial, taking into consideration factors such as age, gender, health condition, and any specific requirements or characteristics.
3. Develop a detailed protocol outlining the study design, including the number of participants, inclusion and exclusion criteria, dosing regimen, and any necessary safety measures.
4. Obtain approval from the relevant ethics committee or institutional review board (IRB) to ensure the trial follows ethical guidelines and safeguards the rights and well-being of participants.
5. Recruit eligible participants who meet the defined criteria and obtain informed consent from them before including them in the trial.
6. Conduct the trial in a controlled and monitored environment, ensuring all necessary equipment, resources, and personnel are available.
7. Follow the study protocol rigorously, collecting and recording relevant data and observations regarding the feasibility of the intervention or treatment.
8. Monitor the safety and tolerability of the intervention throughout the trial, implementing necessary measures to mitigate any potential risks or adverse effects.
9. Analyze the collected data using appropriate statistical methods to evaluate the feasibility outcomes.
10. Interpret the results of the trial and draw conclusions regarding the feasibility of the intervention, considering factors such as efficacy, safety, tolerability, and potential benefits for the target population.
11. Document and report the trial findings accurately and comprehensively, adhering to regulatory requirements and scientific standards.
12. Communicate the results to relevant stakeholders, including researchers, healthcare professionals, regulatory authorities, and potential investors, to contribute to scientific knowledge and inform further development or decision-making.
13. Continually evaluate and learn from the trial process, incorporating any lessons or insights into future research or development efforts.

Who needs first-in-human trial proves feasibility?

1. First-in-human trial proves feasibility is needed by researchers and developers of novel interventions or treatments.
2. Pharmaceutical and biotechnology companies conducting early-stage clinical trials.
3. Regulatory authorities responsible for evaluating the safety and efficacy of new interventions.
4. Investors and stakeholders interested in assessing the potential of a novel intervention or treatment.
5. Healthcare professionals involved in decision-making regarding the adoption and implementation of new therapies.
6. Patients who may benefit from innovative interventions, as the trial helps determine their feasibility and potential benefits.

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What is first-in-human trial proves feasibility?

A first-in-human trial proves feasibility of a new drug or medical device in human subjects for the first time.

Who is required to file first-in-human trial proves feasibility?

The sponsor or manufacturer of the drug or medical device is required to file for the first-in-human trial proving feasibility.

How to fill out first-in-human trial proves feasibility?

To fill out a first-in-human trial proving feasibility, the sponsor or manufacturer must provide detailed information on the study design, objectives, risks, and potential benefits.

What is the purpose of first-in-human trial proves feasibility?

The purpose of a first-in-human trial proving feasibility is to assess the safety and tolerability of a new drug or medical device in human subjects.

What information must be reported on first-in-human trial proves feasibility?

Information that must be reported includes study protocol, informed consent forms, adverse events, and data analysis plan.