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Cancer pharmacogenomics and pharmacoepidemiology: setting a research agenda to accelerate translation.

ABSTRACT: Recent advances in genomic research have demonstrated a substantial role for genomic factors in predicting response to cancer therapies. Researchers in the fields of cancer pharmacogenomics and pharmacoepidemiology seek to understand why individuals respond differently to drug therapy, in terms of both adverse effects and treatment efficacy. To identify research priorities as well as the resources and infrastructure needed to advance these fields, the National Cancer Institute (NCI) sponsored a workshop titled "Cancer Pharmacogenomics: Setting a Research Agenda to Accelerate Translation" on July 21, 2009, in Bethesda, MD. In this commentary, we summarize and discuss five science-based recommendations and four infrastructure-based recommendations that were identified as a result of discussions held during this workshop. Key recommendations include 1) supporting the routine collection of germline and tumor biospecimens in NCI-sponsored clinical trials and in some observational and population-based studies; 2) incorporating pharmacogenomic markers into clinical trials; 3) addressing the ethical, legal, social, and biospecimen- and data-sharing implications of pharmacogenomic and pharmacoepidemiologic research; and 4) establishing partnerships across NCI, with other federal agencies, and with industry. Together, these recommendations will facilitate the discovery and validation of clinical, sociodemographic, lifestyle, and genomic markers related to cancer treatment response and adverse events, and they will improve both the speed and efficiency by which new pharmacogenomic and pharmacoepidemiologic information is translated into clinical practice.

SUBMITTER: Freedman AN

PROVIDER: S-EPMC2982809 | biostudies-literature | 2010 Nov

REPOSITORIES: biostudies-literature

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Cancer pharmacogenomics and pharmacoepidemiology: setting a research agenda to accelerate translation.

Freedman Andrew N AN Sansbury Leah B LB Figg William D WD Potosky Arnold L AL Weiss Smith Sheila R SR Khoury Muin J MJ Nelson Stefanie A SA Weinshilboum Richard M RM Ratain Mark J MJ McLeod Howard L HL Epstein Robert S RS Ginsburg Geoffrey S GS Schilsky Richard L RL Liu Geoffrey G Flockhart David A DA Ulrich Cornelia M CM Davis Robert L RL Lesko Lawrence J LJ Zineh Issam I Randhawa Gurvaneet G Ambrosone Christine B CB Relling Mary V MV Rothman Nat N Xie Heng H Spitz Margaret R MR Ballard-Barbash Rachel R Doroshow James H JH Minasian Lori M LM

Journal of the National Cancer Institute 20101013 22

Recent advances in genomic research have demonstrated a substantial role for genomic factors in predicting response to cancer therapies. Researchers in the fields of cancer pharmacogenomics and pharmacoepidemiology seek to understand why individuals respond differently to drug therapy, in terms of both adverse effects and treatment efficacy. To identify research priorities as well as the resources and infrastructure needed to advance these fields, the National Cancer Institute (NCI) sponsored a ...[more]

PMID: 20944079

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Project description:BackgroundDespite the increasing mobilization of researchers and funding organizations around knowledge translation (KT) in Canada and elsewhere, many questions have been only partially answered, particularly in the field of population health. This article presents the results of a systematic process to draw out possible avenues of collaboration for researchers, practitioners and decision-makers who work in the area of KT. The main objective was to establish a research agenda on knowledge translation in population health.MethodsUsing the Concept Mapping approach, the research team wanted to identify priority themes for the development of research on KT in population health. Mapping is based on multivariate statistical analyses (multidimensional scaling and hierarchical cluster analysis) in which statements produced during a brainstorming session are grouped in weighted clusters. The final maps are a visual representation of the priority themes of research on KT. Especially designed for facilitating consensus in the understanding and organization of various concepts, the Concept Mapping method proved suitable for achieving this objective.ResultsThe maps were produced by 19 participants from university settings, and from institutions within the health and social services network. Three main perspectives emerge from this operation: (1) The evaluation of the effectiveness of KT efforts is one of the main research priorities; (2) The importance of taking into consideration user contexts in any KT effort; (3) The challenges related to sharing power for decision-making and action-taking among various stakeholder groups. These perspectives open up avenues of collaboration for stakeholders who are involved in research on KT. Besides these three main perspectives, the concept maps reveal three other trends which should be emphasized.ConclusionThe Concept Mapping process reported in this article aimed to provoke collective reflection on the research questions that should be studied, in order to foster coherence in research activities in the field of population health. Based on this, it is appropriate to continue to support the development of research projects in KT and the formation of research teams in this field. Research on KT must lead to concrete outcomes within communities that are interested in the question.

Project description:BackgroundEmploying malaria operational research (MOR) findings in planning national malaria control programmes is gaining increased attention. The malaria control foci are diverse, resources are limited; therefore, agreeing on priority areas is critical. Hitherto, the process of prioritising MOR questions in Nigeria has been limited to few stakeholders. In support of the National Malaria Elimination Programme's (NMEP) effort at setting a MOR agenda, the Nigeria Field Epidemiology and Laboratory Training Programme (NFELTP) in collaboration with NMEP conducted preliminary exploratory study to identify key malaria research gaps and needs, and provide data to inform setting a robust national MOR agenda. The process of generating data is presented in this paper.MethodsA twelve-member task-team comprising NFELTP, university researchers and NMEP officers was commissioned. Following an inaugural meeting the task-team developed a framework of activities and held five planning meetings, conducted five-week online and self-administered paper-based surveys, key informant interview (KII), two-day desk review workshop, seven-day qualitative data analysis, ten-day result and five-day report writing workshops. Paired group members conducted the interviews across six geopolitical zones of Nigeria. Abridged study report was used for a two-day MOR setting agenda stakeholders' workshop.ResultsA structured framework, study protocol and data collection instruments were developed and submitted for ethical approval. The instruments included survey questionnaire for detailed information on researchers and other stakeholders' experience with MOR, the gaps and needs in thematic MOR areas; KII and Delphi guides. After an initial scoping review, primary data were collected from purposively selected survey participants using mixed methods: - online survey (n = 100), self-administered paper-based survey (n = 85), KII (n = 40), desk review workshop (n = 22) and Delphi interviews (n = 8). Comprehensive lists of research gaps/bottlenecks and needs were generated for each thematic area in malaria control. These were used at a two-day national MOR setting stakeholder workshop (n = 54) to guide the development of national MOR agenda document.ConclusionsA systematic approach involving broad stakeholder engagement provided data and evidence-based information for development of a robust national MOR agenda. The processes involved are recommended for use in malaria endemic settings.

Project description:BackgroundFear of cancer recurrence (FCR) is common amongst cancer survivors. There is rapidly growing research interest in FCR but a need to prioritize research to address the most pressing clinical issues and reduce duplication and fragmentation of effort. This study aimed to establish international consensus among clinical and academic FCR experts regarding priorities for FCR research.MethodsMembers of the International Psycho-oncology Society (IPOS) Fear of Cancer Recurrence Special Interest Group (FORwards) were invited to participate in an online Delphi study. Research domains identified in Round 1 were presented and discussed at a focus group (Round 2) to consolidate the domains and items prior to presentation in further survey rounds (Round 3) aimed at gaining consensus on research priorities of international significance.ResultsThirty four research items were identified in Round 1 and 33 of the items were consolidated into six overarching themes through a focus group discussion with FCR experts. The 33 research items were presented in subsequent rounds of the delphi technique. Twenty one participants contributed to delphi round 1, 16 in round 2, and 25 and 29 participants for subsequent delphi rounds. Consensus was reached for 27 items in round 3.1. A further four research items were identified by panelists and included in round 3.2. After round 3.2, 35 individual research items were ratified by the panelists. Given the high levels of consensus and stability between rounds, no further rounds were conducted. Overall intervention research was considered the most important focus for FCR research. Panelists identified models of care that facilitate greater access to FCR treatment and evaluation of the effectiveness of FCR interventions in real world settings as the two research items of highest priority. Defining the mechanisms of action and active components across FCR/P interventions was the third highest priority identified.ConclusionThe findings of this study outline a research agenda for international FCR research. Intervention research to identify models of care that increase access to treatment are based on a flexible approach based on symptom severity and can be delivered within routine clinical care were identified as research areas to prioritize. Greater understanding of the active components and mechanisms of action of existing FCR interventions will facilitate increased tailoring of interventions to meet patient need.

Project description:BackgroundOver 40% of all deaths among children under 5 are neonatal deaths (0-28 days), and this proportion is increasing. In 2012, 2.9 million newborns died, with 99% occurring in low- and middle-income countries. Many of the countries with the highest neonatal mortality rates globally are currently or have recently been affected by complex humanitarian emergencies. Despite the global burden of neonatal morbidity and mortality and risks inherent in complex emergency situations, research investments are not commensurate to burden and little is known about the epidemiology or best practices for neonatal survival in these settings.MethodsWe used the Child Health and Nutrition Research Initiative (CHNRI) methodology to prioritize research questions on neonatal health in complex humanitarian emergencies. Experts evaluated 35 questions using four criteria (answerability, feasibility, relevance, equity) with three subcomponents per criterion. Using SAS 9.2, a research prioritization score (RPS) and average expert agreement score (AEA) were calculated for each question.ResultsTwenty-eight experts evaluated all 35 questions. RPS ranged from 0.846 to 0.679 and the AEA ranged from 0.667 to 0.411. The top ten research priorities covered a range of issues but generally fell into two categories- epidemiologic and programmatic components of neonatal health. The highest ranked question in this survey was "What strategies are effective in increasing demand for, and use of skilled attendance?"ConclusionsIn this study, a diverse group of experts used the CHRNI methodology to systematically identify and determine research priorities for neonatal health and survival in complex humanitarian emergencies. The priorities included the need to better understand the magnitude of the disease burden and interventions to improve neonatal health in complex humanitarian emergencies. The findings from this study will provide guidance to researchers and program implementers in neonatal and complex humanitarian fields to engage on the research priorities needed to save lives most at risk.

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Cancer pharmacogenomics and pharmacoepidemiology: setting a research agenda to accelerate translation.

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Cancer pharmacogenomics and pharmacoepidemiology: setting a research agenda to accelerate translation.

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