How to Manage Risks in Clinical Studies. Top 5 Tips
Dr. Nancy Agnes, Head,
Technical Operations, Pepgra
Sales.cro@pepgra.com
In-Brief
Fronting ever-increasing costs of running
a clinical trial, sponsors must guarantee
they are correctly directing their financial
plan and resolving the highest risk areas
while preserving patient safety and data
reliability in Patient recruitment for
clinical trials. How can sponsors
implement a vigorous process to allow
earlier documentation of emerging risks
during a trial? Pepgra blog covers five tips
for significant risk levels, categorizing risk
and maintaining oversight to confirm that
risks and responses are correctly identified,
documented, tracked, and achieved
throughout the patient recruitment
companies' life cycle and offers patient
recruitment clinical trials.
Keywords:
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SEO, clinical trial recruiting, patient
recruitment clinical trials
I. INTRODUCTION
Risk management includes a series of
activities or processes undertaken through a
clinical trial's life cycle to recognize,
evaluate,
monitor,
switch,
prevent,
moderate, communicate, and analyze any
factor that threatens the test's quality. It
pertains to participants' risks and all other
steps related to the prosecution, especially
the trial data's quality, consistency, and
integrity. Risk management must start at the
trial opening so that risk justification can be
a part of the protocol and additional
essential forms and clinical research patient
recruitment process.
II. TOP 5 TIPS FOR MANAGING RISKS
IN CLINICAL STUDIES
Outlining your levels of risks
Risk is a natural incidence in any trial at the
program, study level, site level and working
level. Defining it is the first step to attaining
control. At a high level, the full risk of a
study can be assessed. For eg, a Phase II
oncology study would specify a higher risk
that needs a more rigorous monitoring
strategy than a low-risk Phase IV
observational work.
Study risks can also differ based on known,
high-performing spots versus new sites with
less knowledge of clinical trial recruitment
companies' helpful area. Finally, operational
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risk can be projected based on real-time
patient acceptance data to compare actual
presentation to the forecast.
Evaluating and categorizing risk
The distinct levels of risk at the study, site
and working levels, and overall risk
valuation can be produced for a protocol and
across a program. The Risk Assessment
Categorization Tool, One module of the
platform, relates an algorithm to generate an
overall category score based on the chance,
impact and detectability of the risks,
permitting sponsors to make a data-driven
decision about the most suitable intervention
levels.
Concentrating on essential areas of risk
After risks are considered, they can also be
riddled through Monitoring's user interface
to highlight those with the most significant
impact on a study, enabling sponsors to
redirect resources appropriately. With Risk
and Issue Management, all study team
members can create, view, and manage real-
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time issues from a single interface using
patient recruitment services.
For instance, if the framework recognizes
key risks as inordinate underreporting and
patient maintenance, the support and CRO
can cooperate to guarantee they are checking
and controlling these regions for the
examination duration. This cycle empowers
early usage of preventive activities and can
help limit quality disappointments.
Observing and controlling risks
While observing the risks defined and
categorized, it's essential to monitor the
changes' status throughout a study's life.
With automatic metrics, the system makes
recommendations to escalation, reduction, or
maintenance Monitoring at a site using
essential risk indicator scoring for clinical
trials patient recruitment. It helps the trial's
project team take action and allows sponsors
and CROs to prioritize and target particular
areas. The automated process also helps
manage growth paths and fulfils regulatory
guidance surrounding adapted and triggered
site monitoring.
Estimating the efficiency of risk
management
As risks are identified, categorized and
achieved over time, sponsors and their
supportive CRO can view the increasing
actions taken month over month, assessing
their level of success and determining if the
activities accomplished helped bring a site
back to a lower risk level in clinical study
recruitment.
Ideally, sponsors should see that a more
significant proportion of sites are moving
into the standard and low-risk categories
over time, with an overall decrease in the
high-risk types. This transparency level
helps with continuous improvement
practices and demonstrates full control and
compliance with regulatory agencies.
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III. CONCLUSION
With today's extensive global trials and
virtual project teams using several systems
acting in separation, sponsors need an
effective method to quicken decision
making and close the gaps in trial error.
Unifying quality and risk supervision across
a single study or a portfolio of studies
support revealing signals before they
become general issues that disrupt a trial.
REFERENCES
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Sundar, S., & Olliaro, P. L. (2007). Miltefosine in the
treatment of leishmaniasis: clinical evidence for
informed clinical risk management. Therapeutics and
clinical risk management, 3(5), 733.
Vincent, C., Taylor-Adams, S., Chapman, E. J.,
Hewett, D., Prior, S., Strange, P., & Tizzard, A.
(2000). How to investigate and analyze clinical
incidents: clinical risk unit and association of litigation
and risk management protocol. Bmj, 320(7237), 777781.
Hall, J. A., Salgado, R., Lively, T., Sweep, F., &
Schuh, A. (2014). A risk-management approach for
effective integration of biomarkers in clinical trials:
perspectives of an NCI, NCRI, and EORTC working
group. The Lancet Oncology, 15(4), e184-e193.
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