Challenges in the study design, conduct and analysis of randomized clinical trials | Pepgra

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CHALLENGES IN THE STUDY DESIGN, CONDUCT AND
ANALYSIS OF RANDOMIZED CLINICAL TRIALS
An Academic presentation by Dr. Nancy Agens,
Head, Technical Operations, Pepgra
Group www.pepgra.com Email sales.cro_at_pepgra.com
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Today's Discussion
OUTLINE OF TOPICS In Brief Introduction Basic
Principle in Conducting Clinical Research
Challenges in Conducting Randomized Clinical
Studies Future Scopes
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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.

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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. 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. Contd..
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Figure 1 Clinical Study Trial
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Basic Principle in Conducting Clinical Research
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. The
analysis of randomized clinical trials can be
misleading by the timeliness or the poor design
of study design. Limitations such as physician
competence and faults in the patient selection
process can also affect the effectiveness of the
clinical study and produce misleading results.
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Challenges in Conducting Randomized Clinical
Studies
They 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. 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.
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Future Scopes
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. 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. The
obtained clinical trial data should be protected
with robust technologies, and individual privacy
must also be considered.
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