Ques 1 -(5 marks) The research group, which has extensive experience in research, went through all the

necessary stages (received permission for research, received information permission from patients and
volunteers, drew up a protocol and an algorithm, made purchases, etc.) and began the study. For this
study, the research group constructed a new research method. Received the results, discussed them,
comparing them with new and newest published literature. The research group drew conclusions. What
type of article can this research group write after the end of this research. Explain, please

ANS – this kind of research is called clinical case or clinical trial study because this kind of study is only
done by experienced researcher and it is not suitable to early career researcher , its is also requires
practical work experience, as well as, high standards of ethics and reliability.5 So this format is more
useful for experienced researchers.

Ques2 – In real-life biomedical research, there are cases where a Phase I clinical trial application is
rejected. What could be the causes?

ANS-1. Failure to demonstrate significant efficacy.

2. Inaccurate maximum tolerated dose.

3. A lack of tailoring.

4. A trial size not right for the investigational agent and indication.

5. Not exploring combinations that include standard of care.

6. Not having a clinically tested biomarker for pre-screening patients

In real-life biomedical research, there are cases where a Phase II clinical trial application is rejected.
What could be the causes?

1) previously unknown toxic side effects occur (50%);

2) the trials show insufficient efficacy to treat the medical condition being tested (30%);

3) commercial viability looks poor (15%)

For CV drugs, 44% of late trial failures are due to poor efficacy and 24% are due to safety concerns .

Phase II trials face many challenges due to small sample size and choice of study design.

In addition, the relatively short duration of phase II trials makes it difficult to identify long-term side
effects and outcomes