•The major steps in conducting a clinical trial study are study design, study conduct, data analysis and reporting of the findings. •Randomized clinical trials are deemed as a gold standard method for analyzing and evaluating the safety and effectiveness of medical devices or pharmaceutical drugs. •The most challenging part of conducting a randomized clinical trial are related to handling ethical and regulatory systems. To Continue Reading : https://bit.ly/3eypDDm Contact Us: Website : https://bit.ly/3fQY0p0 Email Id: sales.cro@pepgra.com

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Challenges in the Study Design, Conduct and Analysis of Randomized
Clinical Trials
Dr. Nancy Agens, Head,
Technical Operations, Pepgra
Sales.cro@pepgra.com
In brief
The major steps in conducting a clinical
trial study are study design, study
conduct, data analysis and reporting of
the findings. Randomized clinical trials
are deemed as a gold standard method for
analyzing and evaluating the safety and
effectiveness of medical devices or
pharmaceutical drugs. The most
challenging part of conducting a
randomized clinical trial are related to
handling ethical and regulatory systems.
Keywords: Clinical trial study, study
design, the conduct of clinical trial,
analysis of clinical trial, randomized
clinical trial, gold-standard evaluation,
patient selection, randomization, clinical
trial challenges, clinical research, clinical
study design, contract research
organization, data collection,
investigators
I. INTRODUCTION
Clinical study trial is majorly comprising
of four components which include study
design, the conduct of the clinical trial,
analysis of acquired data and reporting the
results. In this article, we will discuss the
details of the major components and the
challenges that come at every stage and
finally, the limitations and future
prospects.
Randomized clinical trial (RCT) is
considered as the gold standard method to
understand the medical interventions by
evaluating the effectiveness of the
treatment and the safety of the patients or
participants. In clinical research, studies
like RCT are known for the evidence-
based decision making, and a well-
constructed clinical trial study will provide
with the most reliable data with the
effectiveness of clinical interventions.
Although, RCT is the reliable method for
measuring the effectiveness, the quality of
these studies has always been considered
because of its multidisciplinary nature and
the multistep process as they face different
challenges that vary among countries.
The basic principle in conducting clinical
research is that the data collection must be
keenly monitored as it is the major source
of information that will later be analyzed.
Such monitoring helps in avoiding the bias
later and ensures the risk of the patients or
participants present in the clinical trial
study. This can also be mentioned as a
challenging section in conducting a
clinical study, and many institutions
conducting the study have less awareness
of the research priorities and conducting
the study in developing countries often
cause infrastructural barriers, ethical and
cultural issues, organizational problems,
etc.
The analysis of randomized clinical trials
can be misleading by the timeliness or the
poor design of study design and
misinterpretation of well-designed
randomized clinical trials. Besides, several
limitations such as physician competence,
faults in the patient selection process,
applicability, randomization, and the
populations used for study can also affect

2. Copyright © 2020 pepgra. All rights reserved 2
the effectiveness of the clinical study and
produce misleading results.
The major challenges in conducting
randomized clinical studies are associated
with patient recruitment suitable for the
clinical research, barriers in handling
ethical concerns and regulatory systems,
lack of skilled support staffs and
experienced clinical investigators, lack of
infrastructure, awareness and motivation
and lack of time for conducting a clinical
trial study, and these challenges can be
avoided using a complete well-driven
planning, proper design of the study and
support from a contract research
organization.
On the future prospect, the randomized
clinical trial must adapt to the situation and
evolve in responding to the environmental
changes so as to conduct a high-quality
clinical trial study. In addition, a
collaborative effort will also drive the
clinical research in the right direction, and
by reconsidering the existing challenges, a
clinical trial study should arise with
innovation from utilizing the shared
patient data to drive the development of
medical technologies and pharmaceutical
drugs for the human use. However, the
obtained clinical trial data should be
protected with robust technologies, and
individual privacy must also be
considered.
REFERENCE
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Masoud Solaymani-Dodaran, Hamid Reza
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design, conduct, analysis, and reporting in
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