Clinical Investigation: Study Monitoring.

1. Dr. Obumneke Amadi-Onuoha_Scripts_ 10
Clinical Investigation_CRA
Study Monitoring
Clinical trial as is known is a research investigation that involves people(human subjects). I have no experience
with clinical trail investigations, I believe there are diverse issues that principal investigators(PI) will encounter
leading a clinical trial, moreover, most clinical trails with knowledge are lead by a doctor as the PI that
prepares a protocol for the trail. Thou, am not a doctor, I can also be a PI leading a clinical trial based on my
academic credentials but work in collaborations with, and supervised by a doctor, therefore the issues that I can
foresee taking on this lead for a clinical trail may include: recruitment failure, either because of inadequate
organization from poor survey of problem studied, the patients of interest and trail site. If target patients are so
rare it will make it impracticable to recruit the required sample for the study, thus, the need for appropriate
sample size for any research study is inevitable as it is the base to answer the study primary questions. Also,
incurring cost may super exceed the budgeted cost thereby not matching the available funding received for the
project.
Consequent issues in poor compliance or overall prognosis from enrolled patients will lead to subjective
exclusion that will impact the study on-going process ( Umscheid, Margolis, & Grossman,2011). In addition,
as a PI, I foresee the issue of patient retention, from discontinuing participation in the trail, and loss of patient
follow up therefore, it is important to analyze properly and account for subjects dropping out of the study to
avoid biased result conclusions.
Reference
Umscheid, C. A., Margolis, D. J., & Grossman, C. E. (2011). Key concepts of clinical trials: a narrative review.
Postgraduate medicine, 123(5), 194-204