A. Create an informational document (length of 2 pages) based on the “Stats Scenario”
below that will be given to the medical providers as an overview of clinical trials by
doing the following:
- Explain how research protocol would impact the medical providers’ practice.
- Describe Phase I, II, III, and IV clinical trials.
- Explain how HIPAA guidelines are followed.
- Explain the process of informed consent.
- Discuss how ethics is addressed in clinical trials.
a. Include information on bioethics committees. - Explain how the clinical trials team uses the Internet for information on trials.
B. Create a survey (length of 1 page) based on the attached “Stats Scenario” that will be
distributed to the medical providers by doing the following:
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
CLINICAL TRIAL PROTOCOLS 4
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
CLINICAL TRIAL PROTOCOLS 5
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
CLINICAL TRIAL PROTOCOLS 6
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:
- What is your perception concerning clinical trials in general? Please explain
- Do you think clinical trials are beneficial to this organization? Please explain how you
think they may or may not be beneficial__________________________________ - Have you ever been involved in any clinical trails
Yes [] No [] - If yes please explain your experience concerning the
same_________________________________________________________________ - If no please state the reasons on why you have not been involved
a) Not Interested________
b) Not approached to participate_____________
c) Too busy with other cores___________
d) Any other reason________________________________
e) Not aware______________ - Which trials among the current ones of cancer and diabetes do you think will achieve the
most positive outcome?
a) Cancer [] b) Diabetes []
Explain your answer?_______________
7Which other trails do you think the organization should also be involved in
CLINICAL TRIAL PROTOCOLS 7
a) Aids_________________________ _
c) Heart diseases_______________________
d) Other _
- 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
CLINICAL TRIAL PROTOCOLS 8
a manner that is sensible. Every descriptive statistic transforms the large quality of information
in a simple summary.
CLINICAL TRIAL PROTOCOLS 9
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”.
Holland, J (2013). “Fixing a broken drug development process”. Journal of Commercial
Biotechnology 19
Trochim, W.M (2006). “Descriptive Statistics”.
University of California, (2011). “Informed Consent Process”