Health informatics professionals may work closely with clinical trial professionals because
of their expertise in managing health information. Their role on the clinical trials team will
vary depending on the type of research being performed within the healthcare
organization. They may help to develop research study protocol and consent forms, or they
may serve more as an educational resource to medical providers and patients. They can
serve as a consultant at all levels of clinical research because they are subject matter
experts in data and information handling and in patient confidentiality and privacy
matters.
Task Begins Here:
A. Create an informational document (suggested length of 1-2 pages) based on the attached
“Stats Scenario” 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 (suggested length of 1 page) based on the attached “Stats Scenario” that
will be distributed to the medical providers by doing the following: - Develop eight questions to gather appropriate responses.
- Develop a cover letter (suggested length of 1 page) to accompany the survey.
- Describe the statistical analysis you would use to evaluate the survey results.
- Explain whether interviews would be appropriate to this process.
Works Cited/Bibliography must be included with this paper. STOP
Info only for the writer below:
Health Informatics and Research Design 2
C. If you use sources, include all in-text citations and references in APA format.
Health Informatics and Research Design
Informational Document
Effects of a research protocol
A research protocol is an official document, which is used as a guide by giving a
description of the procedures that will be followed in the study. Elements included in the
protocol include research questions, research design, objectives of the research, statistical
analysis method, and data management among others. A research protocol is important in cases
where the medical provider is also an investigator as it guides him or her to comply with
HIPAA’s privacy rule, good clinical procedures, and other regulatory requirements (Gad, 2008).
As such, it will restrain them from any repercussions that may arise from the sharing confidential
information of their subjects (Chin & Lee, 2008). However, the benefit of a research protocol is
that it shields the medical practitioner from lawsuits and subsequent penalties with regard to
disclosure of information.
Phases of clinical trial
There are four phases of clinical trial namely phases I, II, III, and IV (Rossi, 2010). Phase
I is concerned with determining the efficacy, side effects and safety of a new drug and usually
involves only a small number of participants from few locations. If the results of phase one seem
to be positive, then trials move to phase II to confirm the findings of phase one by carrying it out
Health Informatics and Research Design 3
on a large number of subject (Rossi, 2010). It should be planned in such a manner that it gives
further information on the efficient dosage, the extent of the side effects and how to control the
side effects. If the drug is confirmed to be harmless and successful, then phase III is designed to
provide further information for assessing the overall risk-benefit relationship of the medicine.
This is done by comparing the effectiveness of the drug with that of the typical drug that is
currently being used. If the drug is successfully accepted as being effective, then it is taken to
phase IV, which is designed to assess the long-standing efficiency and safety of the drug under
study. From the findings of phase IV, the medicine may be banned from getting into the market
or restrictions may be placed on the usage of the drug (Rossi, 2010).
Following HIPAA guidelines
For clinical trials, it is required that disclosures be made of the covered entity, who is the medical
practitioner in this case, to the sponsor. Exposé is permissible either under Institutional Review
Board or Privacy Board Waiver; or HIPAA authorization by the subject; or de-identification of
the subjects (Chin &Lee, 2008).
The informed consent process
The informed consent process will involve continuous communication between the subject and
the investigator concerning the study process. The process will involve providing information
about the justification, study objectives, the risks and benefits of potential treatment, the side
effects of the medication and how they will be controlled, and the research considerations (Chin
&Lee, 2008). All these should be documented in an informed consent document.
Ethics in clinical trials
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A clinical trial should have a research protocol, which will give information on who
should take part in the trial, the period it will take, the study questions, the medication used, what
the trial will entail and the dosage of the drug to be used among other concerns. The concerned
authorities should approve clinical trials before they are carried out. For instance, in the United
States, an autonomous committee made up of biostatisticians, physicians, and community
members must approve a clinical trial in order to make sure that the risks are just mild and that
they are worth taking by determining the potential of the drug (Rossi, 2010).
Use of the internet for clinical trials information
The internet is a very useful source of information on clinical trials. There are web-based
libraries, which contain information about trials, and one such library, as recommended by Rossi
(2010) is provided by Resource Center for Randomized Trials. The library has consent forms for
subjects, checklist for trials, and patient information leaflets. Information about clinical trials can
also be derived from the National Library of Medicine database through their website at
www.clinicaltrials.gov.
Health Informatics and Research Design 5
Questionnaire
This survey is meant to enable the physician leadership understand your interest in the clinical
trial involvement. Please fill in the requested information
- Have you ever been involved in clinical trials? If yes, give a brief description.
- Are you interested in being involved in a clinical trial? If no, state the reason why you are
not. - In your point of view, do you think that it is necessary for medical providers to
participate in clinical trials? Support your response. - In which of the following trials would you participate if you were to participate as an
investigator in a clinical study? (The answer should be relevant to your specialty).
A. Cancer research studies C.Cardiology studies E. Internal medicine
B. Diabetes research study D. Pediatrics
- Is the information provided in the information sheet useful? If yes, how would you rate it
in a scale of 1 to 5? If not, what do you think should be addressed? - In your judgment, do you consider that the clinical trials that the organization is
interested in taking part in are beneficial? Explain your answer. - If you were to participate in these trials, what do you see as a motivating force behind it?
- What are some of the issues that you view as being a hindrance in your interest to
participate in the research?
Health Informatics and Research Design 6
Cover letter to accompany survey
Dear Respondents,
One of the greatest benefits of my job is that it gives me an opportunity to assist clinical
researchers in the professional work as they undertake investigations (Gad, 2008). I respect
people’s opinions regardless, and I work towards ensuring that they achieve their finest. I would
like to make sure that all medical practitioners involved in clinical trials execute their duty
effectively. This is crucial for achieving career satisfaction as well bringing gains to their
organizations.
Given that your opinion is important regarding your participation in the clinical research
exercise, I would like you to participate in the enclosed survey seeking to establish your interest
in participating in the exercise. It is a short and simple survey that will not take much of your
time to complete. After you have finished answering the questions provided, please reply it
through this email address. The answers that you give shall be handled with utmost
confidentiality.
Your responses will be assembled along with responses from other medical providers,
allowing me and the physician leadership to comprehend the issues that are of greatest bother to
you. I in collaboration with the physician leadership will review your responses in order to come
up with a better way of enhancing your participation in clinical trials (Gad, 2008). Should you
have any concern regarding the survey or about any other problem that I can be helpful, please
be free to ask by calling xxxxxxxxx or writing a mal to xxxxxxx@yyyy.com.
Health Informatics and Research Design 7
Thank you very much for assigning your time and agreeing to participate in this survey.
You are helping the management of this organization to make an informed decision on
incorporating you in clinical trials, in various specialties. For that, I am grateful. Best wishes in
your endeavors.
Name
Title
Health Informatics and Research Design 8
Statistical analysis and appropriateness of interviews
For this survey, I will use inferential statistical analysis by basing conclusions on the
answers given by the respondents (Gad, 2008). The hypothesis of the study shall be “After
reading the informational document on clinical trials, medical providers will develop an interest
in clinical trials .” The sample population shall be 20 respondents, and they shall be obtained
through systematic sampling to ensure that all the specialties are represented. After the
respondents have forwarded their answers, I shall analyze each of the questions separately as
answered by them. From the answers given, then I will be able to infer whether the medical
providers are interested in participating in the clinical trials (Gad, 2008). On the other hand,
interviews will not be appropriate in this exercise as the method may take much of my working
time as well as that of the respondents. In addition, the survey is supposed to be done within a
very short time making interviews unsuitable, as the whole exercise will take much time, as it
cannot be carried out simultaneously.
Health Informatics and Research Design 9
References
Chin, R. Y., & Lee, B. Y. (2008). Principles and practice of clinical trial medicine. London:
Academic.
Gad, S. C. (2008). Clinical Trials Handbook. Hoboken: John Wiley & Sons.
Rossi, R. J. (2010). Applied biostatistics for the health sciences. Hoboken, N.J: John Wiley &
Sons.