ICMIND DMS ANSWER SHEETS - Explain the steps involved in “Designing Clinical Trials
ICMIND DMS ANSWER SHEETS - Explain the steps involved in “Designing Clinical Trials
ICMIND DMS ANSWER SHEETS - Explain the steps involved in “Designing Clinical Trials
For answersheets contact
info.answersheets@gmail.com
+91 95030-94040
Clinical Research Management
Section
1:
Solve
any 2 Questions :
1. Explain the steps involved in
“Designing Clinical Trials?”
2.Explain in detail
Responsibilities of CRC(Clinical Research Coordinator) and CRA(Clinical
Research Associate)?
3. Explain in your words the
“Ethical issues in patient recruitment”?
4. Explain in detail different
types of audits involved in Clinical Trials?
Section
2:
Solve
any 2 Case Studies:
Case
1:
Mr. Joe Smith, a 59-year-old African American male, presents to
his primary care physician, Dr. Bob Brown, in rural Wisconsin. He has been
complaining of difficulty with initiating urination and frequency. He presents
clinically with an abnormal rectal exam and an elevated prostate-specific
antigen (PSA) of 8 ng/ml (normal in a 59-year-old Black male is less than 4
ng/ml). Mr. Smith's mass is biopsied and the results reveal a prostatic tumor.
The nearest comprehensive cancer center is 100 miles away, and Mr. Smith wants
to be treated by Dr. Brown. He says he wants to stay close to his home and
family, and does not want to be cared for by "those big city
doctors."
Mr. Smith decides to undergo a radical prostatectomy at his
community hospital. Surgery reveals a 1.5 cm tumor with clear margins, negative
pelvic node involvement, and unilateral seminal vesicle involvement, which puts
Mr. Smith at high risk for eventual tumor spread. To complete his clinical
staging, a bone scan and CT scan are completed. Mr. Smith's tumor is formally
staged. At his 3-month follow up visit, post-operatively, his PSA is 0.2
(undetectable).
Dr. Brown closely follows Mr. Smith. Three years after his surgery
his PSA has slowly risen to 11, but his bone scan and CT scans remain negative.
Dr. Brown informs Mr. Smith that there are many clinical trials for men with
prostate cancer at all stages. He explains that these trials are being
conducted to try to find the best methods for cancer prevention, early
detection, and treatment. At this point in his disease, Mr. Smith does not wish
to consider a clinical trial, so he continues to receive standard care. Dr.
Brown recommends starting standard treatment with hormone therapy injections
monthly. The patient's PSA drops to less than 0.2 again.
Two years later, the PSA begins to rise to 15 and a bone scan now
shows abnormal uptake in multiple ribs and the thoracic spine. Mr. Smith is
started on an anti-androgen drug and his PSA drops to 10 at his 3-month
followup visit. One year later his PSA has risen to 40, and he now says he has
mild rib pain. Dr. Brown explains to Mr. Smith that he needs to consult with an
oncologist from the cancer center, Dr. Mary Jones, and that Mr. Smith may need
to see her. Mr. Smith somewhat reluctantly agrees to see Dr. Jones. Dr. Jones recommends
exploring available clinical trials because Mr. Smith is young, is in good
health with mild symptoms, and has a tumor that now appears to be progressing.
Question:
1. How can Dr. Brown or Dr. Jones find an appropriate clinical trial
for Mr. Smith?
Case 2: Payment for Research Subjects
In research involving healthy subjects, payment
for subject is the norm. For example, people can volunteer as subjects of sleep
research in exchange for money. In research involving unhealthy people, such as
cancer treatment studies, subjects are not paid for participating, although
they may be provided a degree of medical care in addition to the intervention.
Most commentary acknowledges that payment to subject for therapeutic research
may lead down a slippery slope, from inducement to coercion to unequal
distribution of risks for poorer populations. Nevertheless, more and more subjects
are being offered some compensation for being involved in research studies.
One standard for paying research subjects is the
compensation model, according to which payment should be equal only to the cost
of participation. Researchers may pay subjects at modest rates for travel
costs, time and so on, but not enough for subjects to make a profit. This model
clearly avoids problems of undue influence over subjects.
Another standard is the market model, which
holds that research subject should be paid whatever is necessary to recruit
them. When subjects are easy to recruit, they will be paid less than when
subjects are harder to recruit. This model would probably be the most
efficient, as it does not require that participants endure financial sacrifices
to participate in research. On the contrary, subjects are motivated by the
prospect of economic gain. However, commercialization of research may create
professional volunteers who are vulnerable to exploitation. Compensating
participants might also create unhealthy competition among researchers for
subjects and raise the cost of research overall, thereby slowing progress.
The wage-payment model was proposed as an
alternative to the other two. According to this model, all subjects would be
paid standard rates on the theory that people performing similar functions
should be treated similarly. What rate this should be? Participation in
research ordinary requires few skills, but it does require time, effort, and
possibly uncomfortable procedures and undesirable side effects. Payment should therefore
be on a par with unskilled but essential jobs. It would be fairly low, hourly
wage, but subjects could also receive bonuses if they participated in
especially uncomfortable or burdensome interventions. This minimum wage would
avoid problems of inducement, reduce competition for subjects among
researchers, and promote equity in the treatment of subjects. Moreover,
researchers would have an incentive to keep risks to subjects low in order to
avoid paying bonuses.
Questions:
1. What arguments can
be put forward in favor of paying people for participating in clinical trials?
2. How convincing is
the view that the market should decide how much subjects should be paid? That
is, should people be offered as much as is necessary for them to agree to
participate, or is there something about research that makes another standard
of payment appropriate?
3. How convincing is
the notion that participation in clinical trials is like low-skill work and
therefore worthy only of a minimum wage?
Case 3: Inclusion of Pregnant Women in Clinical Trials
The biomedical study of women raises concerns about the effect of
experimental interventions on pregnant women and their fetuses. Pregnancy may
alter the severity of some diseases, and fetuses and women may be put at risk through exposure to new drugs and
devices. To protect against this risks, federal regulations limited the extent
to which researchers could study new drugs and devices in the pregnant women.
This approach had the effect, however, of limiting knowledge about best
clinical care of women during pregnancy. Uneasiness over this effect led to new
regulations in 2001, although it is not clear that all difficulties have been
resolved.
In 1960’s and
1970’s scandals involving unethical medical research led the Department of
Health and Human Services in 1975 to put in place regulations governing
vulnerable populations. Among these affected groups were pregnant women and
fetuses, children, and women of reproductive age, all of whom were to be
excluded from participation in phase I and early phase II clinical trials.
In January 2001,
three days before the end of President Clinton’s term, the DHSS issued an
amendment to regulations governing participation of women in clinical research.
The new rule purported to resolve legal and ethical ambiguities surrounding the
inclusion of pregnant women. Specifically it promised to alter the presumption
of these pregnant to one of including them and to “enhance…… the opportunity
for participation of pregnant women in research by promoting a policy of
presumed inclusion ……” after brief suspension, these regulations took effect in
2002.
The regulation allows
inclusion of pregnant women as long as “scientifically appropriate” preclinical
studies were performed in pregnant animals and clinical studies in nonpregnant
women, to provide data for assessing potential risks during pregnancy. In
addition, the proposed study must pose no greater than minimal risk to the
fetus. In the event of greater than minimal risk, a pregnant women may be
included only if the study is likely to “hold out the prospect of direct
benefit for the woman or the fetus.”
 |
| ICMIND DMS ANSWER SHEETS - Explain the steps involved in “Designing Clinical Trials |
Question:
1.
The goal of Federal
Regulations is to protect research subjects. Do you believe that the original
regulations took an appropriate approach to protecting fertile females,
pregnant women, and fetuses from research risk? What was the effect of this
approach?
2.
The new regulation
permits but does not require inclusion of pregnant women in clinical research.
Do you believe that pharmaceutical manufacturers will be interested in
increasing studies in pregnant women? What are the incentives? What are the
obstacles?
3.
Fear of legal
liability leads researchers and sponsors to guard against participation of
pregnant women in clinical research. Do you think that mechanisms to address
this fear would work to increase the role of women in clinical studies? Such
mechanisms include, for example, caps on the liability sponsors would face,
creation of a federal fund to compensate harmed subjects, and building
liability costs into the costs of doing business. Should one or more of these
mechanisms be put in place to increase involvement of pregnant women in
clinical trials?
Attempt any 8 Quest ions from following.
Q.1 - Explain The role of
CRC & CRA in Clinical Research ?
Q.2 - a) Define project management in clinical trails.
b)Explain
evolution of project management.
Q.3
– Explain the role of contract research organizations in CRM & the role of
CROs in India.
Q.4- What do you mean by Bioequivalence studies?
When it’s needed & not needed? What are the elements of
Bioequivalence studies?
Q.5-
What are the requirements & guidelines to undertake Clinical trials in
India?
Q.6-a)
What do you mean by Medical writing ? Explain in brief.
b)What is communication skills ?How you
can categorize it?
Q.7-
Write a explanation on audits & inspections in Clinical trials?
Q.8-
Write a short note on SOP.
Q.9-
Define Clinical trials for Herbal Drugs & Traditional Medicines.
Q.10-What
is Outsourcing & outsourcing strategy? How it process?
For answersheets contact
info.answersheets@gmail.com
+91 95030-94040
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