As applied to the clinical research enterprise, "cultural humility" is a continuous process of self-orientation toward caring for others based on self-reflection and assessment, appreciation of others' experiences, and expertise on the social and cultural context of their lives, with an openness to establishing strong relationships within the research team and with study subjects. Applying cultural humility training to a clinical research infrastructure provides open awareness of biases, privileges, and the limitations of one's own knowledge. These insights may enhance one's approaches to interactions with potential subjects during recruitment and with actual subjects during study conduct while complementing existing cultural competency training and, in turn, supporting diversity among team members and research subjects.
Corresponding author; katelyn.le@nih.gov. Note: Since the writing of this article, the Secretary’s Advisory Committee on Human Research Protections (SACHRP) of the U.S. Department of Health and Human Services has released recommendations on writing Key Information. The recommendations can be found online at https://www.hhs.gov/ohrp/sachrpcommittee/recommendations/attachment-c-november-132018/index.html. HHS Public Access Author manuscript Clin Res (Alex). Author manuscript; available in PMC 2019 February 14.
BACKGROUND:Under-enrolling minority patients in clinical trials reduces generalizability. CLEAR III, a randomized controlled trial, presented an opportunity to assess African American (AA) participation.METHODS:AA enrollment was compared to U.S. population and NINDS trial data then stratified by region; census data for 42 recruitment cities were compared to screening and randomization percentages, using simple linear regression.RESULTS:AAs were 25% of screens and 45.1% of enrollments (n=370), more than twice the 19.8% participation rate reported by the 2011 NINDS Advisory Panel on Health Disparities Research and triple the projected 13.9% 2014 U.S. population. Conversion rates were (AA vs. non-AA): overall (8.7% vs. 3.4%, p<0.001); Northeast (7.7% vs. 2.9%, p<0.001); South (8.2% vs. 4.0%, p<0.001); Midwest (10.3% vs. 3.6%, p<0.01); and West (8.9% vs. 3.8%, p=0.02). AA enrollments ranged from 0% to 100% (mean: 40.4%). AA screening ranged from 0% to 63.7% (mean: 23.2%). AA city census ranged from 1.3% to 82.7% (mean: 28.0%); higher census was associated with higher screening (p<0.0001) and enrollment (p=0.004).CONCLUSIONS:AAs were willing to enroll in an acute stroke trial. AA city census rates should be considered when selecting enrollment centers and setting recruitment goals. Factors leading to successful AA recruitment should be further investigated, as population-based participation is a goal in all trials.
As hospital systems and healthcare institutions adopt electronic medical records (EMRs), this creates a new challenge in the normal conduct of clinical research. When protected health information (PHI) is stored in an EMR, there is inherent risk that general access to these systems for source verification purposes could allow research monitors to also have access to the PHI of non-study participants.
Providing educational programs designed to promote clinical research coordinators' (CRCs') implementation of competency skills is essential to workforce development; however, little is known about how programs address CRCs' needs. The purpose of this study was to assess CRCs' experiences in a six-month course. Using focus group methods, six participants revealed how the training assisted them in daily work. The findings supported previous study results, and led to the identification of two competencies which are missing from the existing Joint Task Force for Clinical Trial Competency framework domains of "Communication and Teamwork" and "Leadership and Professionalism." The authors explain why these competencies are important for coordinators. The authors also discuss the instrumentality of qualitative research to ensure that competency domains reflect the needs of those for whom they are developed.
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.
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.
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.
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
This descriptive case study covers the development of a survey to assess research subject satisfaction among those participating in clinical research studies at an academic medical center (AMC). The purpose was twofold: to gauge the effectiveness of the survey, as well as to determine the level of satisfaction of the research participants. The authors developed and implemented an electronic research participant satisfaction survey. It was created to provide research teams at the authors' AMC with a common instrument to capture research participant experiences in order to improve upon the quality of research operations. The instrument captured participant responses in a standardized format. Ultimately, the results are to serve as a means to improve the research experience of participants for single studies, studies conducted within a division or department of the AMC, or across the entire research enterprise at the institution. For ease of use, the survey was created within an electronic data capture system known as REDCap, which is used by a consortium of more than 1,800 institutional partners as a tool from the Clinical and Translational Science Awards (CTSA) program of the National Institutes of Health (NIH). Participants in the survey described in this article were more than 18 years of age and participating in an institutional review board (IRB)-approved study. Results showed that the vast majority of participants surveyed had a positive experience engaging in research at the authors' AMC. Further, the tool was found to be effective in making that determination. The authors hope to expand the use of the survey as a means to increase research satisfaction and quality at their university.
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.
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.
As the population health framework transforms the way clinical care is delivered to individuals and communities, it is expected to influence research agendas and broaden the scope of information available for clinical research. This article provides insight on how the shift toward population health will impact Phase III trials. The findings were derived through an expert panel discussion, involving an evidence review and survey of stakeholders with backgrounds in population health and clinical trials. Overall, there was consensus that the population health framework will have an impact on the future of Phase III clinical trials, and that researchers have an opportunity to incorporate these concepts to evolve the clinical trial model. In particular, there are promising trends related to technology and data.
In September 2015, the U.S. Department of Health and Human Services (HHS) released a Notice of Proposed Rulemaking (NPRM) to significantly revise the human subject protection and informed consent regulations known as the “Common Rule.”[1][1] If enacted, it will be the first substantial change to
Culture, not language, is the greatest impediment to enrolling patients in international clinical trials. While language obstacles can be overcome with accurate and timely translation, culture’s impact is often overlooked or disregarded when it comes to generating patient participation. Involving a good translation team in the process and leveraging collaboration between its members and local review teams can overcome these barriers, and can increase the efficiency of recruitment and retention programs.
