Recently added articles from Applied Clinical Trials:

Internet Resources

May 01, 2008; Anonymous ... The following Web sites are focused on oncology trials for the professional and/or potential participant. Please note that many pharmaceutical companies currently running trials offer access to them through their own Web sites. In addition, many cancer patient advocacy groups and organizations ...

Real-World Workload Needs

May 01, 2008; Briggs, Jacqueline ... Developing a process and management tool for scoring complexity in cancer clinical trials. Measurement of workload is a complex, multifaceted area and an important but difficult subject. In reviews of measurement methods, radiotherapy workload is described as being "poorly represented" ...

EDC Possibilities in Oncology

May 01, 2008; Claypool, William ... Functional challenges aside, electronic data capture can improve cancer clinical trials. Oncology compounds comprise about one third of the development projects in the pharmaceutical and biotech industry (see Figure 1). The features of oncology projects, while not unique to this ...

Latest Imaging Technology a Good Fit for New Therapies

May 01, 2008; Pomeranz, Stephen; Mendi, Resham ... Dynamic contrast-enhanced MRI meets the needs of emerging cancer therapies that suffocate tumors. In oncology research, medical imaging is used to evaluate anatomical biomarkers such as change in tumor size. To document and quantitatively measure tumor change due to cytotoxic drug ...

From the Publisher

May 01, 2008; Blow, Wayne K ... Welcome to our fourth Oncology & Clinical Trials in the 21st Century supplement. We realize that the clinical trials industry and the world of oncology are on the brink of promising changes and new drug discoveries. New technologies have facilitated advances in the treatment of cancer, and ...

Extreme Makeover: Web Edition

May 01, 2008; Henderson, Lisa ... Take a minute to visit our redesigned Web site at actmagazine.com and see what we've done with the place. Have a penchant for home decorating or remodeling shows? The phrase "Move that bus" then means a lot to you. If not, imagine a large vehicle being driven out of view on your computer ...

Letters to the Editor

May 01, 2008; Anonymous ... Top 5 Peer-Review FAQs The peer-review process for journals is well-known and used primarily in the medical and life sciences fields. The following FAQs are specific to Applied Clinical Trials magazine: Who are the peer-reviewers? Our Editorial Advisory Board provides ...

Trials Where They Make Sense

May 01, 2008; Henderson, Lisa ... Oncology trials in the community are making strides for one research network. The Accelerated Community Oncology Research Network (ACORN), a national oncology clinical trial network, recently achieved two important milestones. The first is a doubling from its projected number of studies ...

Study Assesses Clinical Trial Disparities

May 01, 2008; Etkin, Samantha ... It's no secret that the clinical trial process is imperfect While clinical research paves the way for innumerable medical benefits, it is not without its faults-and according to a recent report, some of these deficiencies are undoubtedly cause for concern. The EDICT (Eliminating ...

CDISC and HL7: aBRIDGed

May 01, 2008; Nelen, Kerri ... In October 2003, former FDA Commissioner Mark McClellan told an audience in Bethesda, Maryland: "The kinds of information bottlenecks created by poorly accessible paper records is dangerous, inefficient, and expensive, whether it's our own evaluation of a new drug application or a doctor's ...

Global News: Briefs

May 01, 2008; Anonymous ... * The Drugs for Neglected Diseases initiative QDNDi; Geneva, Switzerland) received euro5 million from Spain's Agencia Espanola de Cooperation Internacional, based in Madrid, to aid in the research and development of new, effective, and affordable drugs for neglected diseases, including Chagas ...

Exploring Hong Kong as a Trial Destination

May 01, 2008; Anonymous ... Synarc Inc. (San Francisco, CA), which provides medical image analysis, biochemical marker, and subject recruitment services, announced in January the opening of its first Clinical Research Center in Hong Kong. Synarc's President and Chief Executive Officer Gary Velasquez and Dr. Edith Lau, the ...

eShowcase

May 01, 2008; Anonymous ... Send your new product info to: Kerri Nelen, knelen@advanstar.com Latest EDC Version Addresses the Site CRF navigation and layout improved for data entry considerations Oracle (Redwood Shores, CA) introduced the latest version of its EDC solution, Oracle Remote Data ...

FDA Struggles to Meet Review Goals

May 01, 2008; Wechsler, Jill ... Pressure to monitor more postmarket data undermines research advisory and review activities. The Food and Drug Administration is having difficulty fulfilling the high expectations of all its constituencies. It faces an ever-expanding portfolio of oversight and regulatory ...

EU Rolls Out New Medicines Initiative

May 01, 2008; O'Donnell, Peter ... With backing from pharma and high hopes, EU takes steps to improve front-end approaches to R&D. By the time you read this, the European Union will have announced the formal start of its so-called Innovative Medicines Initiative-and the clinical trials support programs that go with ...

The Heavy Burden of Protocol Design

May 01, 2008; Getz, Kenneth A ... More complex and demanding protocols are hurting clinical trial performance and success. For two decades now, companies sponsoring clinical research have openly acknowledged that protocol design negatively impacts clinical trial performance and may well be the single largest source of ...

From the Ground Up

May 01, 2008; Deyermond, Rich ... Leveraging technology to build a scalable and reliable infrastructure for clinical trial data capture. As biopharma firms, medical device companies, research institutions, and CROs make the transition to EDC, they must ensure that their IT infrastructures are up to the rigorous ...

CRAs Rate EDC

May 01, 2008; Jahn, Elke; Pröve, Johann ... According to results from a recent survey, clinical research is poised for the eClinical journey ahead. Today, many businesses routinely capture data electronically for regulatory and business purposes. However, health care providers, regulatory authorities, and the pharmaceutical ...

Dissecting Adaptive Design

May 01, 2008; Miller, Eva R; Ehinger, Marisa; Shea, Ellen; Higgins, Valarie ... Team and technology benefits are realized at the front-end of the adaptive trial design process. Adaptive or flexible trial design refers to a conceptual clinical trial methodology that allows for modifications to take place after the trial has started without compromising the scientific ...

BUSINESS AND PEOPLE UPDATE

May 01, 2008; Anonymous ... People * After spending the past 10 years in a business development role at Essential Group (Gurnee, IL), Caroline Redeker was promoted to vice president of business development and will now manage customer relationships and the sales and marketing of Essential's CRO and subject ...