The December issue of Clinical Researcher delivers fresh insights on research ethics, including everyday situations in which you can see these ethics in action.
Contributors to the March 2018 issue approach the theme of privacy in clinical research from the viewpoints of multiple stakeholders in the enterprise. Also included in this issue is an introduction to the ACRP Class of 2018 Fellows.
The February 2018 issue of Clinical Researcher focuses on the role of project management in clinical trial conduct. Topics include why today’s project leads need to evolve their roles as part of strategic contract research organizations and more.
The January 2018 issue of Clinical Researcher challenges everyone on the clinical trials team to be involved in patient recruitment and retention. Peer-reviewed articles cover study participants as consumers, surveying participant experiences, the “unified clinical” concept, and more.
The December 2017 issue of Clinical Researcher focuses on careers in clinical research, and how they can evolve in both expected and unexpected ways. Our clinical research careers are not stagnant. They change, but what makes them change? Do we take steps as individuals to do it ourselves, or do external forces push us along?
The October 2017 issue of Clinical Researcher focuses on how regulations and compliance expectations benefit the entirety of the global clinical research enterprise. There are more similarities than differences in the conduct of research, whether it is a drug or a device product, or a U.S.-based study versus one conducted elsewhere.
The August 2017 issue of Clinical Researcher considers tactics and triumphs from study sites on the front lines of the research enterprise. Virtually all other organizations are connected to, or dependent on, sites: sponsors, contract research organizations, institutional review boards, electronic data capture vendors, and more.
The June 2017 issue of Clinical Researcher looks at a variety of challenges researchers face when applying quality improvement efforts to clinical trials. Quality improvement is a formal approach for the analysis of performance and systematic efforts to improve it, and is distinct from quality control and quality assurance.
The April 2017 issue of Clinical Researcher focuses on technology-related trends and insights in data management, regulatory expectations, study coordination, and more for the clinical research enterprise. There’s no escaping the impacts of new and improved technology on the conduct of clinical trials.
The February 2017 issue of Clinical Researcher features tactics for making your studies smarter while also meeting industry demands to make them faster, cheaper, and more efficient. The peer-reviewed content includes articles on quality assurance coordinators, investigational drug management, reporting adverse events, and more.
2016
The December 2016 issue of Clinical Researcher spotlights why workforce development is important and why it should be an ongoing priority for all clinical research professionals. A skilled workforce is essential, and the only way it can be accomplished is through education and ongoing professional development.
The October 2016 issue of Clinical Researcher focuses on some of the many barriers that exist to achieving increased research efficiency at study sites. Peer-reviewed content includes articles on remote monitoring, informed consent, investigator-initiated research, marketing research within your organization, and more.
The August 2016 issue of Clinical Researcher looks at performance improvement to help describe the selection, use, and interpretation of metrics in research. Understanding performance and components which define performance improvements helps us to describe the appropriate selection, use, and interpretation of metrics.
The June 2016 issue of the Clinical Researcher helps you keep pace with technological trends happening in the research enterprise. While it can be exciting to see how technology makes impacts us professionally, we also need to think about how technologies are regulated and how they can affect human subjects protections.
The April 2016 issue of Clinical Researcher celebrates ACRP’s 40th anniversary and looks to the future of the clinical research enterprise. In addition to peer-reviewed content, this issue features special contributions on “living the research life,” three “givens” that will always drive successful drug development, and more.
The February 2016 issue of Clinical Researcher issue considers the past, present, and future of ethical issues at sites and beyond. Ethical issues arise in innumerable aspects of clinical research. Various ethical constructs and codes direct and support clinical research and form the basis for most of the regulations.
2015
The December 2015 issue of Clinical Researcher looks at tips and trends for clinical research careers. These careers are increasingly sought after thanks, in part, to a booming biotechnology industry bringing new products to market and prompting high demand for many positions tied to drug and device discovery.
The October 2015 issue of Clinical Researcher covers the clinical research revenue cycle and understanding research finance. Functional areas throughout the research management process act sequentially on a participant’s visit, adding critical information required for procuring payment from sponsors and third-party payers.
The August 2015 issue of Clinical Researcher tackles clinical studies and activities that could be considered “outside the box.” The classic, four-phase drug development model is just the tip of the iceberg one finds when delving deeper into the field, building a career, and sometimes, even realizing a dream.
The June 2015 issue of Clinical Researcher offers insights on risk management/mitigation and optimal performance in trials. Among other factors, clinical trials of any phase have become increasingly demanding due to higher complexity of study protocols, the data to be collected, and the extent of documentation required.
The April 2015 Clinical Researcher brings to light many different aspects of patient centricity in trials. Although it may seem obvious that the ultimate goal of clinical research is to improve patients’ lives, this patient-centric view is sometimes either overlooked or forgotten when it comes to trial implementation.
The February 2015 issue of Clinical Researcher focuses on integrating research into the practice of healthcare. Throughout their evolution, clinical research and the healthcare industry have become more intertwined, with a diverse array of interactions, changes, and applications of thinking affecting their relationship.
2014
The December 2014 issue of Clinical Researcher offers a variety of global regulatory insights for clinical researchers. Clinical research for pharmaceutical and medical devices on a global scale is an area of high complexity. This includes regulations, local laws, and guidance documents that have been developed in recent decades.
The October 2014 issue of Clinical Researcher spotlights international topics and human subject protections. Among other articles, you will find those that focus on research challenges in England, Latin America, and India; on trends in patient advocacy, informed consent, and investigator’s brochures; and more.
The August 2014 issue of Clinical Researcher tackles multiple angles of building quality into the clinical research enterprise. Clinical research can be an extremely fast-paced and high-pressure environment. When we add the regulatory requirements of study execution, it can be easy to lose sight of why we do it in the first place.
The June 2014 issue of Clinical Researcher addresses achieving excellence in research through education and training. Regulations, guidance, and ethical codes of conduct specify that clinical research professionals must be adequately trained and experienced before engaging in research with human subjects.
The April 2014 issue of Clinical Researcher introduces a whole new look, feel, and name to ACRP’s peer-reviewed journal, previously known as The Monitor. It includes 10 articles from a diverse collection of passionate and expert authors covering a wide range of topics related to improving trial performance.
Each issue of Clinical Researcher offers nursing and medical continuing education credits through Home Study tests for Members’ professional development needs, and includes content for myriad facets of the clinical research enterprise.
The majority of the peer-reviewed articles in most issues focus on specific themes, as outlined in the Editorial Calendar, and articles are both solicited and accepted unsolicited from authors globally on topics that target the full range of the Members’ skill levels.
Clinical Researcher also includes information on product and service providers from across the clinical research spectrum.
Although most of the regular bimonthly issues are available to Members only, each year at least one issue is made available to the public at no cost and features either clinical research career-related articles or collected perspectives on broad topics of general interest to the research community and its stakeholders.
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The Editorial Advisory Board (EAB) holds responsibility to contribute to and support the publication of Clinical Researcher as the preeminent resource for peer-reviewed articles about the clinical research profession and to provide members of ACRP with news and information that enhances their professional development as members of the clinical research enterprise.
James Michael Causey, Editor-in-Chief, joined the ACRP staff in 2015, and has been a healthcare journalist for nearly 20 years. As the Editorial Director at FDAnews, he ran an eight-person newsroom and was a frequent contributor to Clinical Trials Monitor, among many other publications. He’s also the author of “50 Best Practices for Clinical Trials: Lessons for Sponsors and Sites” (FDAnews 2012), and “Clinical Trials: Ensuring Patient Safety and Integrity,” (FDAnews 2006). Outside the clinical trials industry, he’s written for PhRMA, blogged about medical devices for AssuRx, and helped to develop webinar content addressing the full spectrum of the healthcare marketplace.
Gary W. Cramer, Managing Editor since 2016, joined the ACRP staff in 2006 as an Editor/Writer and later was promoted to Associate Editor. A 1987 graduate of The Pennsylvania State University, he has also worked as a daily newspaper reporter in Lancaster, Pa., in public/media relations and donor communications for Penn State, and as a writer/editor for Landscape Architecture Magazine from the American Society of Landscape Architects. For ACRP, he also serves as editor of the weekly CRbeat e-newsletter, general editor for training/development and certification resources, and staff liaison to the Regulatory Affairs Committee.
