Prototipo con Baycusan® C
5.6.5. Análisis factorial del diseño experimental
Chair: Paul Taylor, University of Melbourne, Australia PT.32
Robust procedures: a key to generating quality results in drug discovery
Malini Dasgupta1, Mariusz Lubomirski1, Tom Lavrijssen2, David Malwitz1, David Gallacher2, Anja Gillis2
1
Janssen Research & Development, Raritan, USA;2Janssen Research & Development, Beerse, Belgium
Correspondence:Malini Dasgupta ([email protected]) - Janssen Research & Development, Raritan, USA
Thein vitroandin vivoexperimental procedures and protocols applied in early discovery in the pharmaceutical industry are the foundation of identi- fying quality drug candidates. This robustness of such preclinical studies is the key to selection of lead candidates that are less likely to fail at a later stage of drug development. In the discovery environment this is often challenging. This is especially true for methods applied for analysis of large molecular entity, where the dynamic range of the detection is limited. A systematic approach to development of robust analytical methods can help ensure reproducible, reliable results. Effective collaboration be- tween researchers and statisticians is most beneficial in determination of the linear range of standards as well as accuracy and precision of data generated. Often in the preclinical research environment, where protocols cannot be based on a full-fledged validation process, statisti- cians can incorporate tools that reduce bias involved in calculation of the results. This poster will provide some examples of how such statis- tical processes can be implemented as part of a quality assurance measure with respect to drug discovery data.
PT.33
Health promotion: criteria for the design and the integrity of a research project
Maria Betânia de Freitas Marques, Laressa Lima Amâncio, Raphaela Dias Fernandes, Oliveira Patrocínio, Cláudia Maria Correia Borges Rech Faculdade de Minas, Minas Gerais, Brazil
Correspondence:Maria Betânia de Freitas Marques
([email protected]) - Faculdade de Minas, Minas Gerais, Brazil Research Integrity and Peer Review2016,1(Suppl 1):PT.33
The promotion of health is one of the strategies of disease prevention, fit- ness and aesthetic and social inclusion. Public health policies has special interest in this aspect due to cost reduction and optimization of the main- tenance of the welfare of the population. Thus the authors of this study have established the criteria for the design and integrity of a research pro- ject on health promotion to be run in a public school in the city of Belo Horizonte - MG with elementary students. Educational activities in science education were planned contemplating intervention actions, for example, personal hygiene and nutrition guidelines in accordance with institutional policies on research advocating merit, relevance, methodological ad- equacy, integrity and qualifications of researchers. The choice of sample space and audience were defined according to the situational diagnosis of the school to which the proposal was submitted and granted authorization by the head. The choice of undergraduate students occurred through se- lection process institutionally disseminated through a notice which in- cluded analysis of Curriculum Vitae and interview candidates. Two members from among 10 candidates met the requirements excellently and were accepted as part of the team. To the funding system was chosen for competition in a notice of a public foundation of the state with the de- tailed description of the fate of the necessary resources to which they were granted 60 % of the items. To ensure transparency in project execution, partial reports are issued periodically for financial support institution and the department of institutional research. The integrity of the proposal is being achieved. Fact which is proved by the institutional indicators, an- swering the original methodology and satisfactory results. The authors ac- knowledge the financial support of Fapemig.
PT.34
Integrity of academic work from the perspective of students graduating in pharmacy: a brief research study
Maria Betânia de Freitas Marques, Cláudia Maria Correia Borges Rech, Adriana Nascimento Sousa
Belo Horizonte Brazil
Correspondence:Maria Betânia de Freitas Marques ([email protected]) - Belo Horizonte Brazil Research Integrity and Peer Review2016,1(Suppl 1):PT.34
Transparency in research involves aspects of ethical and moral character often associated with behavioral conduct of the researcher. Undergraduate courses have a duty to technical training, critical, reflective, entrepreneurial,
human and moral students, tasks that are developed throughout the course and must be accompanied by the professors involved. We note that for running academic work many students are unaware of the issues sur- rounding the integrity of research, which compromises the integrity of the results. Thus the authors of this study proposed a descriptive research on the perception of undergraduate students of Pharmacy from an Institution of Higher Education in the city of Belo Horizonte - MG before the execution of academic work regarding the responsible conduct. For this a semi- structured questionnaire was administered during the school schedule of classes, in which 128 students from different periods participated voluntar- ily and anonymously. The majority (76 %) claimed to have already con- ducted a literature search. When asked about their knowledge of manual standardization institution 88 % confirmed. On ways to source citation researched 78 % know what a direct quote and 74 % know what is an in- direct quote. Most students know the meaning of plagiarism (91 %), but unaware of the significance of self-plagiarism (77 %). Most participants (78 %) said they always cite the source of research, being identified as key: journal articles (50 %), internet (24 %), books (22 %) and newspapers (2 %). It is observed that in general most students have knowledge and adopts appropriate procedures for implementation of academic work, but a small portion features not always intentional misconduct which suggests the need for continuing education.
PT.35
Research integrity promotion in theEpidemiology and Health Services, the journal of the Brazilian Unified Health System Leila Posenato Garcia ([email protected])
Institute for Applied Economic Research, Rio de Janeiro Brazil Research Integrity and Peer Review2016,1(Suppl 1):PT.35
Epidemiology and Health Services (RESS) is a quarterly and open-access journal, published by the Health Surveillance Secretariat of the Brazilian Ministry of Health. It was created in 1992, under the title Epidemiological Report of the Brazilian Unified Health System, and in 2003, it was renamed to RESS. In 2011, there were set strategies aiming to attain its indexing in broader and international bibliographic databases. In 2012, the authors’ guidelines were revised, including the request to include an authors’contri- bution section, and the information that RESS had adhered to principles defined by the Committee on Publication Ethics (COPE). In 2013, the Portuguese-translated version of the Recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals, from the International Committee of Medical Journal Editors (ICMJE) was published. Thereafter, RESS started to adopt the four criteria for authorship as defined by ICMJE, as well as the statement of responsibility for the en- tire content of the manuscript for all authors. In 2014, the Portuguese- translated version of the Montreal statement on research integrity in cross- boundary research collaborations, from the 3rd World Conference of Re- search Integrity (Montreal, 2013), was published. In 2014, RESS has released to all invited reviewers the Portuguese-translated version of the Guidelines for peer reviewers produced by COPE. In the period 2011-2013, the annual number of articles submitted to RESS increased from 171 to 320, and the number of published articles increased from 54 to 70. Those increases may be partially attributable to the research integrity promotion activities in the journal, which had strengthened the recognition of its scientific character. The publication of Portuguese-translated versions of documents related to research integrity may have contributed to the increasing recognition of research integrity principles within RESS’ community and also in the broader community of public health researchers in Brazil.
PT.36
When are clinical trials registered? An analysis of prospective versus retrospective registration of clinical trials published in the BioMed Central series, UK
Stephanie Harriman, Jigisha Patel BioMed Central, London, UK
Correspondence:Stephanie Harriman
([email protected]) - BioMed Central, London, UK Research Integrity and Peer Review2016,1(Suppl 1):PT.36
Thesis
Clinical trials should be registered with an appropriate trial registry before participant recruitment begins. However, many trials are not registered until a later stage. Our objective was to analyse the per- centage of articles published in BMC-series journals in 2013 reporting clinical trials that were registered prospectively and retrospectively. Methods
We identified all research articles published in 2013 in the BMC series that report outcomes of a clinical trial according to the World Health Organisation definition of a clinical trial. We excluded articles report- ing secondary analyses of results from previously reported clinical tri- als and studies where the primary outcomes had already been published.
For each included article, we identified whether the study was regis- tered prospectively (before the date of recruitment as given in the trial registry record) or retrospectively (after the date of recruitment as given in the trial registry record). For studies that were registered retrospectively, we analysed whether registration occurred before or after submission of the manuscript to the journal. For those studies registered retrospectively, but before submission of the manuscript to the journal, we calculated the number of days between recruit- ment and registration.
We also collected data on the trial registry used and the country of affiliation of the first author.
Results
In 2013, 117 clinical trials were published across 22 different journals in the BMC series. Of these, 28.2 % (33) were registered prospect- ively, 68.4 % (80) were registered retrospectively, and 3.4 % (4) did not give a trial registration number. Of those registered retrospect- ively, 92.5 % (74) were registered before submission to the journal and 7.5 % (6) were registered after submission to the journal. For those registered retrospectively, but before submission to the journal, the mean number of days between participant recruitment and registration was 525. Of these, 14.9 % (11) were registered within 30 days of the study recruitment date. 17.6 % (13) were registered within 50 days of the recruitment date.
Trials were registered across 20 different approved registries, with 61.1 % (69) being registered with clinicaltrials.gov. First author affilia- tions were from 30 countries, across six continents.
76.1 % (89) of included studies were randomised controlled trials (RCTs), 11.1 % (13) reported pilot RCTs and 12.8 % (15) reported interventional studies that did not involve randomisation.
Implications
Almost 10 years on from the International Committee of Medical Journal Editors recommendation that prospective trial registration be a condition of publication, our results show that many clinical trials are still not prospectively registered.
The large number of retrospectively registered trials identified dem- onstrates the importance of allowing retrospective trial registration to prevent non-publication of valuable research involving human subjects. It also highlights, not only the need for further initiatives to improve registration, but also a need for the clear linkage of pub- lished articles to trial registry records and for the transparent inclu- sion of the date of registration in published articles.
PT.37
Maximizing welfare while promoting innovation in drug development
Farida Lada ([email protected])
The City University of New York, NY, USA, and Maastricht University/ United Nations University-MERIT, Maastricht, Netherlands
Research Integrity and Peer Review2016,1(Suppl 1):PT.37
Though current literature identifies ethical uncertainties and risks associ- ated with the conduct of clinical trials, and discusses how to improve in- dividual processes such as the informed consent process and the monitoring process, it does not provide a comprehensive framework and related tools for individual players to use in order to develop their strategies. Additionally, current literature focuses on the decisions that have been or could be made by individual players, without sufficient
consideration of the impact of the decisions or strategies of one player on the subsequent decisions or strategies of the other players. This re- search aims to identify ethical challenges in the conduct of clinical trials, develop a framework for determining the best strategies to convert eth- ical uncertainties into manageable risks, and to provide tools for each of the decision makers to approximate their respective gains and losses based on decisions made by the various players involved in the clinical trial process. This is accomplished using the following methods: i) use of inductive reasoning to develop a conceptual framework based on documentary and literature analysis; ii) validation of frame- work through expert interviews; and iii) using game theoretic ap- proach to illustrate interdependent decision making of the various players in the clinical trial process. The current poster presents the following: i) proposed framework for identification of ethical risks and uncertainties; ii) comparison of how US and India, as examples of a traditional and an emerging market, address these within their respective regulations; iii) enforcement pyramid for regulatory over- sight of clinical trials in the US, and proposed modification to the pyramid based on results of expert interviews; and iv) proposed relationship structure for interdependent decision making based on expert interviews.