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Writing Development Safety Update Reports for an Investigational New Drugs

During the clinical trials of an investigational drug, timely evaluation
of safety data is crucial to the ongoing assessment of risk to trial subjects.
It is also important to inform health authorities, ethics committees
and IRB at regular intervals about the results of analyses risk and
the evolving safety profile of an investigational drug. Currently, laws
and regulations of some ICH regions require periodic submission of a
DSUR to regulatory authorities to describes the status of ongoing
individual investigations, manufacturing changes and overall development
status and plans [1].
The main objectives of this report are to provide an assessment of
rele-vant safety, efficacy, and risk data received during the reporting
period for the drug under investigation, whether or not it is marketed
by To analyze whether the information provided by the sponsor during
the reporting period is consistent with prior knowledge of the safety of
the investigational drug; To identify potential safety problems that
may affect the health of subjects in clinical trials; To summaries the
current understanding and management of potential and identified
risks; To provide an update on the status of clinical investigation/
development program and study results [1 , 2].
A DSUR should be precise and concise and provide information to
assure health authorities that sponsors are continuously monitoring
and evaluating the evolving safety profile of the investigational drug
throughout clinical trials. All safety issues observed during the reporting
period should be discussed in the DSUR. DSUR main focus on
safety and efficacy related data and findings from interventional clinical
trials of drugs and biologicals that are under investigation, whether
or not they have a marketing approval. After marketing approval
for one indication, clinical trials of a drug may continue for another
indication, so relevant safety data from post-marketing studies should
also be added in the DSUR. The data included in the DSUR based on
the investigational drug and provide information on comparator drug
when relevant to the safety of trial subjects [1,2].
New risk identified during clinical trials communicate with regulatory
authority, principal investigators, and ethics committees associate with
an investigational drug is carried out using several tools, including the
investigators brochure (IB) and expedited reporting of suspected
unexpected serious adverse reactions (SUSARs), expedited individual
case safety report (ICSR). These safety communication tools may lack
in reporting periodicity, data transparency, clarity, or risk message
integrity. However, DSUR has accurate periodicity due to its timely
data lock point and efficiency in documenting a sponsor’s latest comprehensive
and integrated perspective on the safety of an investigational
drug because its completeness like line listing of recent SUSAR
cases from ongoing clinical trials reported during the reporting period
in the cumulative tabulation, it also covers all already SUSARs/ICSRs
reported and also have updated IB attached [3].
The preparation of DSUR or PSUR aggregate safety reports usually
falls to the pharmacovigilance and maximum safety data required for
the preparation of DSUR, including information based on SUSARs
and published literature with new safety and efficacy findings, should
be readily available to sponsor form company’s safety database used
for regulatory reporting. Those reports present in the safety database
have already been reviewed and analyzed when they were submitted
to comply with expedited safety reporting requirements of regulatory
authorities [4].
This guidelines document gives important points that are considered
during evaluating new safety data in the Evaluation of the Risks (e.g.,

changes in already identified risk, newly identified safety issues,
symptoms, signs, and laboratory evidence). The Benefit-Risk Assessment
is an important point in assessing benefits and the identified risks
in accords to the previous submitted DSUR. To identify any changes
with respect to previous knowledge of safety, efficacy and risks profile,
sponsor have to describe how the identified risks have been managed
in the clinical trials and detail risk management actions planned
to address any emerging safety, and efficacy issues. The Summary of
Important Risks, which need to be continuously analyses and updated
from DSUR to DSUR, which provide cumulative list of important
identified and potential risks [5].
Drugs safety and risk monitoring during clinical development is an essential
part of Pharmacovigilance like elixir sulfanilamide tragedy of
1937, and in the late 1950s and early 1960s, more than 10,000 children
were born with deformities due to thalidomide as a consequence of
inadequate safety and risk data of both drugs from clinical trials. Now
the patient safety is one of the important areas during clinical trials [6].

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