48 research outputs found
Discussant\u27s response to human information processing research in auditing: a review and synthesis
https://egrove.olemiss.edu/dl_proceedings/1145/thumbnail.jp
Discussant\u27s response to Reports on the application of accounting Principles -- A Review of SAS 50
https://egrove.olemiss.edu/dl_proceedings/1042/thumbnail.jp
Discussant\u27s response to the case for the structured audit approach
https://egrove.olemiss.edu/dl_proceedings/1160/thumbnail.jp
Integration of Patient Reported Outcomes in Pharmaceutical Drug Development For Prostate Cancer – Focus on the Patient
Understanding, and adequately articulating how and what the patient feels and experiences
during the progression of a disease and during drug treatment is an important aspect in a
patient’s life. Yet this articulation does not always get appropriate attention and thus the
patient experience may not be fully understood by others. Nor is it fully explored in drug
development programs due to the lack of focus on patient outcomes. Drug development
has in the past primarily focused on meeting the regulatory approval of the new drug. To
gain regulatory approval a company has to provide evidence of the drug’s safety, and
efficacy, combined with a favourable benefit-risk ratio. The patient benefits or patient
concerns, especially in the case of cancer, is thus often masked within the clinical endpoints,
such as overall survival or progression free survival, or if patient outcomes are measured,
they may not be appropriately articulated in dialog between stakeholders, or in
publications.
Recent years have seen an upswing in pharmaceutical companies introducing a so-called
patient-centric research and focus is shifting towards patient relevant endpoints. However,
pharmaceutical companies do not always fully understand how such patient-centric
research is to be conducted, and if data is collected, how to interpret the data and how to
present the data to stakeholders. The two most important pharmaceutical drug regulators
and approval bodies, at least in terms of millions of lives they potentially affect, the
European Medicines Agency (EMA) and the Food and Drug Administration (FDA) have both
in the recent years embraced the concept of patient-centricity, and patient experience in
their guidance to the industry. There is an increased acceptance of this type of evidence in
regulatory submissions, thus, opening opportunities for pharma companies to promote
research towards patient relevant endpoints and evidence.
It is with this background that this thesis is written and compiled, with the aim of discussing
how Patient Reported Outcomes (PRO) research can, and should be integrated into
pharmaceutical drug development, and how such results can be presented, while keeping in
mind the many different stakeholders that need this information, ranging from regulatory
agencies, to payers, physicians and patients. The thesis makes use of eight recent patientcentred
papers published in the field of prostate cancer.
The papers and the research make a number of important contributions by providing
examples of different approaches on how the PRO analyses are conducted, exploring
different way of reporting results and by linking the results of PRO evidence to clinical
outcomes. Through the iterative learning process, which came as a result of the research I
conducted over time and by exploring different analyses methods, ways of presenting
results and presenting results to different journals, I learnt how to conduct this type of
research, all the way from conceptualization, through data collection, analyses and
reporting of results. Thus by combining this learning, which was gained from this research,
with the papers selected for this thesis, this has provided me with the structure and learning
and legacy that I can bring forward from this research. It provides the basis for the construct
of the framework presented in this thesis for how such Outcomes Research can be
implemented in drug development. This blueprint and framework can be adapted to any
disease area and can enhance the impact of the research, enhance new drug treatments,
and help patient’s get the best and most suited treatment options.
As an overall mantra of clinical drug development, we must embrace that the ultimate
raison d’etre of any medicine or intervention, must be to the benefit of the patients and to
improve their health
Impact of technological events and trends on audit evidence in the year 2000: Phase I
https://egrove.olemiss.edu/dl_proceedings/1166/thumbnail.jp
Service Preferences of Parents of Children With Mild Bilateral or Unilateral Hearing Loss: A Conjoint Analysis Study.
Universal newborn hearing screening results in substantially more children with mild bilateral and unilateral hearing loss identified in the early years of life. While intervention services for children with moderate loss and greater are generally well-established, considerable uncertainty and variation surrounds the need for intervention services for children with milder losses. This study was undertaken with parents of young children with permanent mild bilateral and unilateral hearing loss to examine their preferences for characteristics associated with intervention services.Conjoint analysis, a preference-based technique, was employed to study parents' strength of preferences. Using a cross-sectional survey that consisted of eight hypothetical clinic scenarios, we invited parents to make a discrete choice (to select one of two or more different services) between available services with different characteristics. The survey was informed by qualitative interviews conducted for this purpose. The questionnaire was administered to parents receiving intervention services in the province of Ontario, Canada, who were enrolled in a mixed-methods longitudinal study examining outcomes in early-identified children with mild bilateral/unilateral hearing loss. Data were analyzed using a generalized linear model (probit link) to identify attributes of interest for the respondents. Characteristics of the children were entered into the model to control for differences in age of diagnosis, sex, laterality of hearing loss, and hearing aid use.A total of 51 of 62 invited parents completed the questionnaire. All four attributes of care that were included in the survey were found to be statistically significant, that is, parents valued support for amplification, support for speech-language development, emotional support, and communication from professionals. Analysis showed greater preference for enhanced levels relating to support for speech-language development than for support for amplification. Preference for attributes relating to emotional support and communication were also greater than for support for amplification use.Conjoint analysis was used to quantify parents' preferences for service attributes. Parents' values provide insights into the aspects of a service model that should receive consideration in the development of intervention programs for young children with mild bilateral or unilateral hearing loss and their families. Although parents of young children with mild bilateral or unilateral hearing loss valued several components of care, they indicated a clear preference for speech-language support compared with support for amplification use
The Internet And Distance Learning In Accounting Education: A Hypertext-Linked Exploration Of The Topic
this paper is written in a standard format for hard-copy distribution, the numerous references to sources on the world wide web (www) on the Internet are included as hypertext links to the related actual Internet web sites. This allows people who read the electronic version of the paper on their computers to call up the hyperlinked web sites very easily. To do this, readers simply click on the paper's web references to have the hyperlinked web site called up immediately on their monitors, provided they have linked their word processor (such as Word 7.0) to their Internet browsers and are connected to the Internet by an Internet Service Provider (ISP). Readers who are not connected to the Internet may read the paper in the traditional manner. The IFAC Education Committee has decided to place the paper on its web site. (See www.ifac.org/Committees/Education/index.html )