Intellectual property rights balance the incentive for innovative thought and creative expression with the greatest pubic access to the writings and discoveries that result. The form and function of the intellectual property determine the manner and duration that it may be protected. A well-crafted clinical trial agreement protects the intellectual property rights of the parties engaged in the research.
At a recent industry conference, representatives of a clinical trial site disclosed to a panel of expert mentors that their site had been attacked by ransomware. Ransomware is a type of malware that encrypts a computer’s data, rendering it useless. The ransomware sender offers the decryption key for a price. This column looks at how ransomware attacks happen, what sites can do to prevent attacks, and what to do if you are attacked (or think you are being attacked).
Anyone who works on a particular publication long enough can certainly fall into some comfortable routines that make the birth pangs of each issue easier to bear. For example, using the October issue of ACRP’s journal as a bit of breathing space in between themed issues, giving the editors a chance to “clear the pipeline” of miscellaneous articles that had come in out of the blue.
What is the difference between biomarker and pharmacogenomic (PGx) research? How is this research conducted and what value does it have for patient care? These are just some of the questions that institutional review board and independent ethics committee (IRB/IEC) members may ask themselves when encountering PGx or biomarker research in a clinical protocol. This article summarizes findings from an Industry Pharmacogenomics Working Group survey of IRB/IEC members on related topics.
As clinical trials go global and companies continue to outsource critical functions, technology becomes more important in optimizing stakeholder communications and data management processes throughout the drug development lifecycle.
This issue’s column considers several questions raised by the use of the U.S. Food and Drug Administration (FDA) Form 1572, otherwise known as the “Statement of Investigator” form.
Academic programs offering formal coursework or degrees in clinical research have increased in number over the past decade. As roles in the field of clinical research evolve, and as job titles and descriptions become standardized and professionalized, having an academic pathway to expand knowledge, skills, and abilities better prepares individuals for certification and career advancement. At this juncture in the clinical research enterprise, where the complexity of new medical product development is rapidly escalating, having a well-educated cadre of professionals is important to plan, implement, and evaluate research projects leading to innovative new treatments or diagnostics.
A skilled workforce is essential, and the only way it can be accomplished is through education and ongoing professional development. In an effort to bring new ideas on clinical workforce development to our readers, this issue of Clinical Researcher addresses the topic from multiple angles for a wide array of clinical research roles.
The Joint Task Force for Clinical Trial Competency conducted a multinational survey of clinical research professionals as a first step toward validating its previously published framework. Participants self-assessed their competence level and the relevance of specific core competencies to their current professional activities, as well as their perceived need for further training to enhance performance quality. Significant differences in the perception of competence and relevance for the role were observed among the various members of the clinical research team.
This issue’s column considers some of the complicating factors regarding responsibilities, documentation, branding, and screening in clinical studies.
It is without question that the technological advances that have infiltrated the clinical research industry have created efficient workflows that allow for faster reporting of data with huge cost savings. However, systems powered by technology can often be complicated to use and may require extensive training.
The modern increased push for performance cuts across all industries, including clinical research. Understanding performance and the components which define performance improvement helps us to describe the appropriate selection, use, and interpretation of metrics. For “The Evolving World of Metrics” portion of this issue, the selected authors illustrate varied perspectives on the value and interpretation of metrics in clinical research.
There are endless possibilities for the future of clinical research, but the assurance of continued innovation requires reflection on our past experiences to map a pathway forward. In this article, a clinical research associate reflects on her nearly 15 years of experience in the field, and on where trends in technology and human interaction may take us in the years ahead.
As we celebrate the 40th anniversary of ACRP, this installment of the “QA Q&A Corner” reflects back on the changes in tone and direction that have happened in the realm of good clinical practice—the international quality standard for the conduct of clinical trials—over the past 40 years and more.
A corrective and preventive actions (CAPA) system is an essential component of any quality management system, and is an approach intended to correct and prevent problems from recurring or prevent them from ever happening. This article describes key components of a CAPA system, highlights key
As we head into 2016, clearly there are some significant issues and changes pending and under review regarding the conduct of clinical research following the tenets of good clinical practice. As we begin another year and not too many questions have been coming in to answer in the usual Q&A format
We are living in an exciting time in the field of clinical research. There are changes occurring that will alter how medical care is provided, and it is the work of clinical research professionals that will lead these changes. In this column, the Chair of ACRP’s Association Board of Trustees considers the impact of genetics in medicine and their application through precision medicine.
In 2015, the ACRP Investigator Research Interest Group conducted a survey to gain insights into how investigator-initiated sponsored research (IISR) is conducted, and to provide a valuable benchmark for how researchers and industry manage IISR studies. IISRs are independent research projects in preclinical, clinical, or observational settings where the investigator or institution serves as the sponsor. As presented in this article, it is hoped that the survey findings and follow-up activities will provide a way for both sites and industry to improve their communication about the research their efforts create.
Obtaining informed consent in clinical research is straightforward when the study population includes capable adults, but becomes complex when certain participants require either legally authorized representatives (LARs) or impartial witnesses. This article discusses situations in which LARs and witnesses should participate in the consent process, the regulatory basis of why these issues are scrutinized so closely, and how the study documents can facilitate protocol review.
Many clinical trial sites are part of healthcare providers that either have converted, or are in the process of converting, to electronic health records. As these systems were neither designed nor purchased to support research operations, research staff have struggled with obtaining the internal resources to maximize the benefit of such conversions. This article assists research staff in building and implementing business cases for their institutions to expend resources for tying research operations support functionality into their electronic health records, supported by case histories and suggested resources.
