Copyright © 2021 pepgra. All rights reserved 1

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.

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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

Copyright © 2021 pepgra. All rights reserved 2

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-

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

1. 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.

2. 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), 777-

781.

3. 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.