Patient Clinical Trial Protocols

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Patient Clinical Trial Protocols

A research protocol refers to a guideline, which offers a systematic, clear and precise description of the process involved in conducting a clinical research. These guideline  is based on the elements which includes the  research  question, protocol  summary, objectives of the  study, methodology,  methods of statistical  analysis, management  of data and management of the entire study. This guideline  or protocol is in most cases created  in a manner that could be  assessed  by the  study’s  ethical committee  in making sure that the  study  or researchers  comply with the ethical requirement(Angell, 1997).

The relation of a research protocol with a medical practitioner is based on the protection of the patient’s privacy and consideration of safety measures during the research process. In a research pertaining to clinical aspects, the participants or patients in this case may be easily forced to take part in the study. Moreover, there is likelihood for the medical practitioner to misuse the information obtained from such patients for their personal purposes. Therefore, a research protocol is a mandatory document that is required before any clinical research is undertaken. Further, the research protocol should be accompanied with an affirmation document indicating that the HIPAA’s privacy rules will be adhered to in the course of the study with the main goal of enhancing patient’s health. The bioethics committee may not accept a research protocol, which does not include HIPAA privacy regulations on the proper usage or utilization of PHI (Biotech, 2013).

Clinical trials concerning new therapies are normally categorized into four phases. It is presumed that the process of trails involving drugs would pass all the phases over a long time. If the trial undergoes Phases I, through to phase 111, then there is a likelihood of it being accepted by the regulatory agencies for utilization in the public arena. Phase 1 is the first stage of the trial while phase II involves the assessment on the effectiveness of the drug being developed. Apparently, the purpose of phase 111 is to evaluate the actual value of the new drug in medical practice. Phase IV is the last “approval” stage for marketing which also involves the evaluation of the drug’s safety aspects (Holland, 2013).

Informed consent is a requirement that patients make decisions concerning the medical care they are expected to receive based on their understanding of possible alternatives. It can be a verbal agreement or involve legal documentation indicating that the patient is willing to participate in the Medicare or trial being offered. The process involved in obtaining informed consent is threefold. In the first step, the person conducting the research  or researcher  in this case  explains the purpose of the study to the respective participants, providing all the necessary details including, the aim, risks, advantages,   and alternative to taking part. In this process, the participant’s are also required to ask any querry they may have. The second step is where the participants are given written consent forms to fill. They should be accorded enough time to figure out whether they should participate or not. Step 3 is where the researcher meets the respective participants and answers any questions and clarification that may be needed (University of California, 2011).

Survey Cover Letter

Dear respondent

My name is ( ) and I am a health care informatics at ( ) medical facility. Our organization is currently involved in diabetes and cancer drug trials where we are presently at phase 111 and IV phase of cancer therapy research. The main aim of this survey is to found out whether medical practitioners in this firm were interested in being involved in the clinical trials. Your participation will be deemed important since you are among the medical practitioners and part of this organization. You have been randomly selected to take part in the study through completing the surveys.

The attached questionnaire may only take about 15 minutes of your time to complete. You are also informed that participation in this study is voluntary and no compensenation may arise as such. You may also not include your name in the survey. Information that you will present will be kept confidential. If you decide to participate in this trail, please respond to the questions as honestly as you may be able to. Please return the questionnaire through the email address that was used to send to you.

Thank you very much for taking your time to contribute to the medical knowledge and progress of this organization. The information you present will be deemed significant concerning whether medical practitioner had interest in being involved in the ongoing clinical trials. This information will assist us in determining the way forward on how to cultivate or nature such interest among physicians to improve the phase of clinical trials.

Yours Faithfully,

Name:

 

 

Name:

 

Specialty:

Department:

 

  1. What is your perception concerning clinical trials in general? Please explain ____________________
  2. Do you think clinical trials are beneficial to this organization? Please explain how you think  they may or may not be beneficial__________________________________
  3. Have you ever been involved in any clinical trails

Yes [___]

No [___]

 

  1. If yes please explain your experience concerning the same_________________________________________________________________

 

  1. If no please state the reasons on why you have not been involved
  2. Not Interested________
  3. Not approached to participate_____________
  4. Too busy with other cores___________
  5. Any other reason________________________________
  6. Not aware______________

 

  1. 6. Which trials among the current ones of cancer and diabetes do you think will achieve the most positive outcome?
  2. Cancer [___]
  3. Diabetes  [___]

 

Explain your answer?___________________________

 

7Which other trails do you think the organization should   also be involved in

  1. a) Aids_________________________ __________
  2. Heart diseases__________________________
  3. Other _________
  4. Please tick where appropriate to you
Statement SA A D SA
It is the responsibility of each physician to  take part in clinical trials

 

       
Clinical trials  consumes  a lot of time for  physicians        
Awareness should be created to entire medical fraternity on the essence of clinical trials        
Clinical trails will generate financial benefits to the organization        
Clinical trials should be conducted by independent entities        

 

 

Key

SA: Strongly agree

A: Agree

D: Disagree

SA: Strongly agree

 

Analysis Procedure

In analyzing the outcome of this survey, I will employ statistical analysis. This is a description of the major features that were noted in a study. Descriptive statistics offers straightforward summaries on the measures, sample and information obtained in the study. Trochim, (2006) explains that descriptive statistics are employed to provide descriptions that are quantitative in nature (such as the ones in this case) in a form that can be managed. Moreover, this type of analysis could be employed on a large sample and on many measures. In our case, it will be of assistance since we will deal with large number of participants (approximately 250) in a manner that is sensible. Every descriptive statistic transforms the large quality of information in a simple summary.

References

Angell, M. (1997). “The Ethics of Clinical Research in the Third World.” New England Journal of Medicine 337(12):847-849

Biotech base, (2013). “The Impact of Clinical Trial Protocol on Healthcare Providers”.

            Available  from http://www.biotechbase.com/archives/364

Holland, J (2013). “Fixing a broken drug development process”. Journal of Commercial

            Biotechnology 19

Trochim, W.M (2006). “Descriptive Statistics”. Available from

            http://www.socialresearchmethods.net/kb/statdesc.php

University of California, (2011). “Informed Consent Process” Available from

            http://www.research.uci.edu/ora/hrpp/informedconsentprocess.htm

 

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