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QTc prolongation assessment in the development of anticancer medication: clinical and methodological aspects
G. Curigliano, g. Spitaleri, f. de Braud, Cardinal d., c. Onion, m. Craig, Colombo n., a. Colombo, m. Locatelli, r. Goldhirsch
Cardiac safety Assessments are commonly used in the development of investigational drugs of Clinical Oncology. In the development of anticancer medication were always more consideration to the potential of a compound of causing adverse elettrocardiografici changes, especially QT interval prolongation, that can be associated with risk for and torsades de he exhibited sudden death. Regardless of overt clinical toxicity, potentially QTc evaluation might influence the decision-making at many levels during clinical studies, including the eligibility for therapy protocol, delivery of dose or suspension and analysis of the optimal dose for subsequent development. Given the potential for serious and irreversible morbidity from adverse cardiac events, it is understandable that cardiac safety results may have broad impact on the management of conduct and patient study. The risk management methodologies of QTc prolongation for cardiac medications were developed from experience primarily of drugs used to treat diseases not fatal in a chronic setting or Antihistamines such as antibiotics. Extrapolation of these approaches to medicines to treat cancer for a period of acute may not be appropriate. Some specific guidelines is available for managing the risk of cardiac safety in the development and use of oncology drugs. In this manuscript, clinical and methodological aspects related QTc prolongation assessment will be reviewed. Discussions about the limitations being that design and development of oncology drugs will be highlighted.Efforts are needed to refine strategies for risk management, avoiding unintended consequences that negatively affect access patient and clinical development of promising new cancer treatments. a thoughtful risk management plan generated by organized collaboration between oncologists, cardiologists and regulatory agencies in support of an essential development program for oncology agents with heart problems.
Volume: 3 article number: 130 DOI: 10.3332/ecancer may.2009.130 received: 22/11/2008 published: 12/01/2009
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The role of policies on innovation in the development of the drug in cancer and financing
Fr. Kanavos, r. Sullivan, g. Lewison, w. Schürer, s. Eckhouse, z. Vlachopioti
Over the past two decades, incidence of cancer is consistently increased due to ageing populations, lifestyle and environmental factors, with great personal and national economic consequences. simultaneously, the cancer treatments have improved with more treatment options and disease most and rates of disease-free survival.
The latest innovation in cancer treatments are targeted biological treatment, combining the existing arsenal of surgery, radiotherapy and chemotherapy, particularly significant
in this last stage tumours associated with very poor survival.
Despite this latest breakthrough in cancer treatment, this has just opened the door to start to understand the complexity of cancer molecular and genetic basis.Oncology Research and development (R&D) has the highest rate of failure for new molecular entities (NME) and significantly higher development costs. Although there are huge obstacles scientific and economic information, the development of Oncology market
over the past five years, has twice more.
This report aims to map current Oncology R&D financing and management, mainly in Europe and United States, to examine the reports of the public and private, current Oncology R&D strategies and innovation policies for Oncology. its objectives are:
-To map existing funding and management of Oncology R&D through questionnaire
surveys and interviews with oncology experts;
-To produce a high-resolution analysis bibliometrico oncology drug R&D in
order to better understand the mix of public/private partnerships in research activities;
-To examine the financing cumulative duration of oncology drugs; specific
-To review the current public policy affecting oncology drug R&D, in particular, public
R&D investment policies, transnational investment policies, regulatory policies,
and policies for reimbursement of medication; and
-To propose policies Oncology future support for the R&D process.
Volume: 4 article number: 164 DOI: 10.3332/ecancer. 2010.164 received: 04/11/2009 published: 03/02/2010
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The development of an infrastructure of European network for research on cancer: vision, architecture and services
M. Rueping Tsiknakis, s., l. Martin, s. Sfakianakis, r. Sengstag Bucur, t., m. Pucaski Brochhausen, j., b. Graf
Life sciences are currently in the middle of a informational revolution. The nature and amount of information available now open directions of research that once were in the realm of science fiction.During this revolution statement, data collection capabilities have significantly exceeded the techniques of data analysis. integrating data between heterogeneous data sources and aggregation of data across different aspects of spectrum biomedical, therefore, is at the heart of current biomedical and pharmaceutical R&D.
This paper reports on the results of the integrated project ACGT original focusing on designing and developing a European biomedical grid infrastructure in support of multicentric, post genomic clinical cancer.Post-Genomic clinical trials (CTs) use clinical data and multilevel and advanced genomic analysis tools and computational view to verify the assumptions made in an attempt to identify the reasons for a disease molecular and stratification of patients in terms of treatment.
The document provides a presentation of the needs of users involved in CTs post-genomics and presents indicative scenarios that drive the requirements of the design phase of the project. Subsequently, presents the initial architecture specified by the project and its services are classified and discussed. a range of these key services, including the ontology master on cancer that is located in the heart of the architecture of integration of the project, are presented. Special efforts were taken to describe the technological and methodological framework of the project, allowing the creation of an infrastructure legally compliant and naive.
Finally, a brief discussion of the next job is included and describes the potential involvement of the cancer research community in the further development or the use of infrastructure.
Volume: 1 article number: 56 DOI: 10.3332/ecms. 2007.56 received: 15/07/2007 published: 21/09/2007
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