CASE STUDY: 1
Rancip co. wants to discover and develop a new drug costs $ 800-1000 million and takes longer than 12 years. Clinical development the most important step prior to a drug entering the market takes 7 years. Each day’s delay in completing the drug development and launching the product in the market means a revenue loss of $ 1 million. So they appoint Mr. Kate as a project mager and the company expects the company expects the project management techniques to reduce this increasing cost and time pressure.
Q.1) What are the important responsibilities of Mr. Kate?
Q.2) What are the different stages Mr. Kate will use in the Process to set up the project and run it?
Q.3) On what elements will Mr. Kate focus?
Q.4) What are your Suggestions?
CASE STUDY: 2
IPTA lab discovered one drug on white cells and the company wants a clinical trial which is properly planned and executed for assessing the effectiveness of intervention, company appoints Mr. Simpson as a planner for above because company knows careful planning is required before the collection of data begins for conducting successful clinical research.
Now Mr. Simpson appoints two investigators who knows the planning process and to recognize the difficulty encountered in studies with human subjects and planning any clinical trial and attempt to estimate the magnitude of participant’s failure to protocol compliance.
Q.1) What is a clinical trial?
Q.2) What is the process of designing and carrying out clinical research?
Q.3) Explain the Planning Steps of Mr. Simpson.
Q.4) What are the important considerations to conduct of any type of clinical trial?
CASE STUDY: 3
Dr. Reddy is a leading pharma company; they discover lot of new products or drugs in last 20 years. Over the years it has become more and more necessary to have multidisciplinary specialist approach in planning & Conducting clinical trials. The team conducting the clinical trial usually consist of the principal investigators, the company investigators and the clinical research associates (CRAS). The clinical Research Co-ordinators (CRC’S) because Dr. Reddy knows the CRC and CRA are like the two pillars of any critical trial and they are the key members who ensure that the data is obtained faster and is clean.
Q.1) Define CRC.
Q.2) Define CRA.
Q.3) Who can be appointed as a CRC/CRA?
Q.4) Elaborate the responsibilities of the CRC and CRA?
CASE STUDY: 4
Fraud and misconduct in clinical research has received intense attention in medical field, literature and media in the recent years.
Dr. Rajesh was working with Damur India Limited as a chief nutritionist. He started working on the project of effectiveness of multivitamin in improving cognitive dysfunction in elderly patients. In 2006, he allegedly produced fraudulent data on the effectiveness of multivitamin in improving cognitive dysfunction in elderly patients.
Suspicion of the data presented arose because of values that were abnormal and a full investigation uncovered the fact that the data was concoted. The company came to know about this when they appointed Dr. Kunte to investigate the effectiveness of research done by Mr. Rajesh.
The investigation study nurse testified before the committee enquiring into the matter. A full investigation of his previous publications appeared to prove that he has a long record of similar fabrication and falsifications. Company asked Dr. Rajesh to resign.
Q.1) What is the definition of fraud and misconduct in clinical research?
Q.2) According to you what are the steps and procedures adopted by Mr. Kunte to investigate fraud?
Q.3) What are the penalties you can suggest to Dr. Kunte for proven fraud and misconduct?
Q.4) Explain the responsibilities of Dr. Kunte as an investigator in the Whole process.