Search

An increase in the number of identified therapeutic cancer targets achieved through recent biomedical research has resulted in the generation of a large number of molecules that need to be tested further. Current development of (anticancer) drugs is a rather inefficient process that for an average new molecule takes around 10–15 years. It is also a challenging process as it is associated with high costs and a low rate of approval. It is known that less than 10% of new molecular entities entering clinical Phase I testing progress beyond the investigational programme and reach the market; this probability is even lower for anticancer agents. In 2003, the US Food and Drug Administration (US FDA) declared the urgent need for new toolkits to improve the critical development path that leads from scientific discovery to the patient. In this scenario, Phase 0 (zero) trials should allow an early evaluation in humans of pharmacokinetic and pharmacodynamic profiles of test compounds through administration of sub-pharmacological doses and for a short time period to a low number of humans. Typically, Phase 0 studies have no therapeutic or diagnostic intent. Owing to the low doses administered and the low risk of toxicity, shorter preclinical packages to support these studies are required. Phase 0 trials have been proposed to help in making an early selection of promising candidates for further evaluation in Phase I–III trials, providing a potentially useful instrument for drug discovery, particularly in the field of oncology. Phase 0 studies are expected to reduce costs of drug development, and to limit the preclinical in vitro and in vivo testing and the time period of drug development. However, there are also concerns about the utility and feasibility of Phase 0 studies. In January 2006, guidelines on exploratory investigational new drug studies in humans have been published by the US FDA, and currently a Phase 0 programme is ongoing at the National Cancer Institute to evaluate the impact (feasibility and utility) of Phase 0 studies on drug development. In Europe, a Position Paper produced by the Evaluation of Medicinal Products (EMEA) in 2004 raised the possibility of a reduced preclinical safety package to support early microdose clinical studies, and, as announced by a recent Concept Paper on medicinal products published by the committee for medicinal products for human use of the EMEA, EMEA's guidelines on Phase 0 studies are expected shortly. The true impact of Phase 0 studies on the drug development process as well as on the safety needs to be carefully explored.British Journal of Cancer (2007) 97, 577–581. doi:10.1038/sj.bjc.6603925 www.bjcancer.com Published online 28 August 2007 [ABSTRACT FROM AUTHOR]

In 1961, the USA severed diplomatic relations with Cuba, and in 1962 an embargo was imposed on trade and financial relations with that country. It was not until five decades later that the USA and Cuba would reestablish relations. This opened the way for the New York State Trade Mission to Cuba in April 2015, during which Cuba's Molecular Immunology Center and Buffalo, New York's Roswell Park Cancer Institute signed a formal agreement that would set in motion biotechnology research collaboration to address one of the most important causes of death in both countries. Significant research from Cuba led to this groundbreaking collaboration. The purpose of this paper is to discuss the development of this cooperation, from the Molecular Immunology Center's initial investigations, through the opening of a phase I clinical trial at Roswell Park Cancer Institute with therapies developed at the Center. This cooperation was responsible for the first clinical trial for CIMAvax-EGF involving advanced-stage non-small cell lung cancer patients in the USA. A license was also approved by the US Department of the Treasury's Office of Foreign Assets Control authorizing a commercial partnership for development of biotechnology products, combining the cancer research efforts of both institutions. This unusual collaboration between Cuba and the USA--the US economic embargo and travel restrictions not withstanding--opens good prospects for expanded medical research between the two countries. While political and logistical challenges remain, the shared mission and dedication of these Cuban and US scientists points the way towards relationships that can lead to development, testing, approval and use of promising new therapies for cancer patients. [ABSTRACT FROM AUTHOR]

Patients with limited English proficiency receive worse care due to communication barriers. Little is known about which cancer hospitals have written language access policies addressing bilingual clinicians. We conducted a cross-sectional survey of healthcare organizations, matching survey data to American Hospital Association Survey and American Community Survey data. We analyzed characteristics associated with hospitals having bilingual clinician policies. The response rate was 71% (127/178). Many hospitals (53 [42%]) did not have written policies on bilingual clinicians. Having bilingual clinicians available at the hospital was associated with having a written policy on bilingual clinicians, while being an NCORP site was associated with not having a written policy on bilingual clinicians. Patient demographic characteristics were not associated with hospitals having written policies on bilingual clinicians. A substantial proportion of cancer hospitals do not have policies that cover language use by bilingual clinicians, particularly at NCORP sites. Having written policies on bilingual clinicians has the potential to mitigate cancer disparities by facilitating accountability, improving communication, and reducing errors. [ABSTRACT FROM AUTHOR]

Background: Engaging diverse populations in biomedical research, including biospecimen donation, remains a national challenge. This study examined factors associated with an invitation to participate in biomedical research, intent to participate in biomedical research in the future, and participation in biomedical research and biospecimen donation among a diverse, multilingual, community-based sample across 3 distinct geographic areas.Methods: Three National Cancer Institute-designated cancer centers engaged in community partnerships to develop and implement population health assessments, reaching a convenience sample of 4343 participants spanning their respective catchment areas. Data harmonization, multiple imputation, and multivariable logistic modeling were used.Results: African Americans, Hispanic/Latinos, and other racial minority groups were more likely to be offered opportunities to participate in biomedical research compared to whites. Access to care, history of cancer, educational level, survey language, nativity, and rural residence also influenced opportunity, intent, and actual participation in biomedical research.Conclusions: Traditionally underserved racial and ethnic groups reported heightened opportunity and interest in participating in biomedical research. Well-established community partnerships and long-standing community engagement around biomedical research led to a diverse sample being reached at each site and may in part explain the current study findings. However, this study illustrates an ongoing need to establish trust and diversify biomedical research participation through innovative and tailored approaches. National Cancer Institute-designated cancer centers have the potential to increase opportunities for diverse participation in biomedical research through community partnerships and engagement. Additional work remains to identify and address system-level and individual-level barriers to participation in both clinical trials and biospecimen donation for research. [ABSTRACT FROM AUTHOR]

Discusses Dr. Keith Block's biomedical approach to the treatment of cancer in the United States. Recommendations made by Block in his paper on the biomedical treatment of cancer; Details on Block's intervention care program; Author's questions about Block's methods.

Cancer centers, particularly those supported by the National Cancer Institute, are charged with reducing the cancer burden in their catchment area. However, methods to define both the catchment area and the cancer burden are diverse and range in complexity often based on data availability, staff resources, or confusion about what is required. This article presents a review of the current literature identifying 4 studies that have defined various aspects of the cancer burden in a defined geographical area and highlights examples of how some cancer centers and other health institutions have defined their catchment area and characterized the cancer burden within it. We then present a detailed case study of an approach applied by the University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center to define its catchment area and its population cancer burden. We cite examples of how the Cancer Center research portfolio addresses the defined cancer burden. Our case study outlines a systematic approach to using publicly available data, such as cancer registry data, that are accessible by all cancer centers. By identifying gaps and formulating future research directions based on the needs of the population within the catchment area, epidemiologic studies and other types of cancer research can be directed to the population served. This review can help guide cancer centers in developing an approach to defining their own catchment area as mandated and applying research findings to this defined population. [ABSTRACT FROM AUTHOR]

The article examines how often randomized clinical trials (RCT) experimental cancer treatments conducted by the U.S. National Cancer Institute (NCI) result in discovery of successful new interventions. According to the authors, approximately 25% to 50% of new cancer treatments that reach the stage of assessment in RCTs will prove successful. The pattern of success has become more stable over time. The authors mention that the results are consistent with the hypothesis that the ethical principle of equipoise defines limits of discoverability in clinical research and ultimately drives therapeutic advances in clinical medicine.

The US National Cancer Institute (NCI) 60 human tumour cell line anticancer drug screen (NCI60) was developed in the late 1980s as an in vitro drug-discovery tool intended to supplant the use of transplantable animal tumours in anticancer drug screening. This screening model was rapidly recognized as a rich source of information about the mechanisms of growth inhibition and tumour-cell kill. Recently, its role has changed to that of a service screen supporting the cancer research community. Here I review the development, use and productivity of the screen, highlighting several outcomes that have contributed to advances in cancer chemotherapy. [ABSTRACT FROM AUTHOR]

The article highlights several issues related medicine in the U.S. A study on virtual navigaion bronchoscopy suggests that the technique might be an important addition to the diagnostic algorithms. The U.S. Cystic Fibrosis Foundation has developed a tool that shows how individual centres can drive up standards by identifying key metrics and comparing their performance with the rest of the network. A study investigates the effectiveness of paediatric oncologists at curing childhood cancer.