Minimum 1.5 pages for Each Answer. Single space – font 12 – Times new roman With respect to Phase 4 of clinical trials, what are in your opinion, the three (3) most important factors? Justify your...

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Pharmaceutical Research and Relevant Aspects
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Pharmaceutical Research and Relevant Aspects

1.
Three most important factors in Phase IV clinical trials

In my opinion, there could be recognized numerous factors which are important with
espect to Phase four of clinical trial studies out of which, (i) conducting diverse epidemiological
studies, (ii) efficacy, and (iii) security testing within large, varied populations might be kept at
top position. In fact, after getting approval from regulatory bodies, it becomes essential to detect
out the efficiency and safety aspects of product. To solve the purpose, epidemiologists might get
involved with descriptive studies so that, post-marketing scrutiny could become possible, and
elevant signals may be detected further.
In accordance with the norms set by regulatory authorities, sponsors are expected to
gather and submit overall security reports on the basis of voluntary individual safety analysis in a
periodical manner. Such a favorable and/or unfavorable event database provided by a company
can be utilized further for the purpose of post-marketing surveillance. Repeatedly these might be
applied for the development of a case- series or can be used with disproportionality analysis so
that, the purpose of signal detection could get solved (Comroe & Dripps, 1976).
According to experts, during the epidemiological studies, creation of a case-definition for
determination of opposite events that would be involved for analytical purposes could prove to
e valuable particularly in context of case series based on impulsive undesirable event(s) since;
in such type of investigation, there is absence of “non-treated” comparison group in the
unfavorable events database designed by sponsor. In fact, such approach could prove to be
advantageous (i) for development of a clinical spectrum related with the opposite events, (ii) for
description of the comprehensive features of the cases, and (iii) for comparison of identical
events in general population as stated in scientific literature.
Signal detection approaches can also be applied for the purpose of evaluation of
unstructured undesirable event databases. A disproportionality approach is frequently applied for
comparison of observed and expected events related with monitoring of a particular therapeutical
product. This is performed predominantly in case of those drugs which consist of the similar rate
linked with reporting (Lau et al., 1992).
The approaches applied for signal evaluation may involve comparison of the findings to
the outcomes of pre-clinical studies, clinical trials, comparison of products belonging to identical
class, considering the biologic plausibility of discovery, and performance of supplementary
examinations for instance, observational studies or clinical trials.
Another possibility is writing the protocols related with conduction of studies so that,
additional information concerning the security of a product could be collected. Such additional
studies could be performed for estimation of incidence rates of unfavorable events among
consumers of a product. Need of a cohort approach could be understood via the fact that case-
control designs cannot provide any idea regarding the incidence.
Registries related with the ascertainment of patient (suffering from the identical illness)
or product (means; intake of same or similar products) might be designed to assemble extensive
Pharmaceutical Research and Relevant Aspects

information involving demographics, analytical aspects, therapeutical facts (medicines, processes
and so on), medical reserve consumption (hospitalization, outpatient appointments, home
emedy) and mortality. Promising applications of registry data are calculation of estimation of
outcomes, eventual approximation of drifts, and evaluation of therapeutic aspects serving as a
cause of cases for the purpose of case-control studies, or offering a recognized cohort for the
purpose of future studies. Phase IV studies might be reasonably diverse according to the research
question. Besides cohort studies, case-control studies can also be applied for monitoring of
exceptional incidents. Though, the case-control studies could be considered more vulnerable to
assortment and summon up bias, but these are frequently commenced owing to their speed,
comparatively low-cost, and recu
ent nature. Additional character linked with these studies is
evaluation of manifold risk factors for a particular illness.
In this way, via implementation of varied tools and techniques in context of
epidemiological studies, optimum strategies related with the enhancement in efficacy and safety
of drugs could be designed further with the intention that, these could prove to be valuable in
emoval of any adverse effect, and in introduction of advantageous features as well.
Pharmaceutical Research and Relevant Aspects

2.
Political Action Committees (PACs)
PAC means; Political Action Committees (PACs) which work for a political reason that
might include progressive campaigning for instance; protection of environment, educational
development, concerns of oil companies related with the free market, security agreement firms or
medicinal industry. The functional style of PAC could be understood via the fact that few out of
them might try to convince the government for preservation of forests while, others can ask the
administrative party to transform forests into lumber.
PACs assist in preparation of written report, and further delivery of them to congressional
administrative centers, and also create media manifestations so that, they could present their
opinion regarding an issue. Such presentations can be designed for publicity through various
media resources involving T.V, news...