ICMIND BMS SOLUTIONS – Define project management in clinical trails

ICMIND BMS SOLUTIONS – Define project management in clinical trails




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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.
  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.
  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 BMS SOLUTIONS – Define project management in clinical trails

ICMIND BMS SOLUTIONS – Define project management in clinical trails


  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?

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