Clinical Trials Day 2022: Insights from SOCRA Nominee Aryn Knight

Aryn Knight, CCRP

Administrative Director

Texas Heart Institute

Houston, Texas

On May 20, the world will honor clinical research professionals in an annual celebration of Clinical Trials Day (CTD). This internationally recognized event raises awareness of clinical trials and the many career opportunities in this wonderfully rewarding field, and it is our honor to kick off the 2022 celebration. In keeping with tradition, we’ve invited SOCRA members to nominate each other for their outstanding work and contributions to public health, medical advancement, and improved health outcomes.

In this article, we’re sharing the insights and perspectives of Aryn Knight, Administrative Director for the Center for Clinical Research at Texas Heart Institute. We are recognizing Aryn for her positive contributions to clinical research education and advocacy.

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Clinicaltrials.gov Registration and Results Reporting for Investigator-initiated Trials

Kate Anderton, MPH, CCRP

Clinical Trial Lead Firststring Research Inc.

Abstract: Trial registration and results reporting is an important aspect of investigator-initiated trials. This article provides an overview of ClinicalTrials.gov, the purpose of clinical trial registration and results reporting, and how to register and report results for investigator-initiated trials. The new ClinicalTrials.gov requirements and the meaning of the changes are also covered.

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Revenue Optimization Clinical Trial Challenges

Headshot of Kelly Willenberg, DBA, RN, CHRC, CHC, CCRP

Kelly Willenberg, DBA, RN, CHRC, CHC, CCRP

Kelly Willenberg & Associates

Abstract: Data is a powerful tool that can be leveraged to drive key decisions for a health system. This article describes various data elements, metrics, and key performance indicators that aid a health system with making key decisions about its research portfolio. Using denials management is one example of leveraging the data to build a robust Coverage Analysis, increasing revenue for the health system. This article also provides information that can be used to develop staffing models and productivity models.

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Research Recruitment Study – MyChart Message Recruitment

Andrew Snyder MBA, PMP, FACMPE

One of the most common challenges of conducting clinical trials is related to problems with recruitment.   Insufficient or untimely patient recruitment for clinical trials may have serious consequences.   The length of the study may be extended, leading to increased costs and staffing concerns.   Trials that do not recruit the required number of patients may impact the data integrity.  Study teams that cannot recruit patients may not be invited to participate in future studies by industry partners or may have difficulty securing future grants.   In some cases, a trial may have to be terminated resulting in unpublishable results, poor financial outcomes, and disappointed stakeholders.

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Career Progression in Clinical Research: Transitioning from a Clinical Research Coordinator to a Monitoring Clinical Research Associate (CRA)

Thomas Boothby, MS, CCRP CRA II, Boston Scientific

Abstract: Research coordinators may transition to clinical research associates/monitors during their careers. This article provides an overview of how to determine whether it is the right time to make this transition, how to evaluate current competencies and gaps that must be filled in order to make this transition, and how to address needs during the on-boarding process. A roadmap in the form of a checklist is provided to help make the transition from research coordinator to clinical research associate (CRA) a smooth one.

Disclosure: The author has a relevant financial relationship with respect to this article with Boston Scientific, where he is employed as a monitoring CRA.

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Understanding Research Wrongdoing: Lessons from the Professionalism & Integrity in Research Program and the Bioethics Research Center

Headshot of James M DuBois, DSC, PhD from the Professionalism & Integrity in Research Program.

James M. DuBois, DSC, PhD, Director, PI Program and Bioethics Research Center, Washington University School of Medicine

Abstract: Many factors increase the risk of research integrity violations or serious non-compliance. This article explores these factors, highlighting wrongdoing and “right-doing” in research, using data from the first 68 participants in the Professionalism & Integrity in Research Program and the Bioethics Research Center at Washington University School of Medicine. The Professionalism & Integrity in Research Program serves investigators following professional lapses. The Bioethics Research Center studies the factors that contribute to violations of research integrity and also to exemplary research. The implications of these findings for remediation and prevention of research integrity violations are described.

Disclosures: The author has no financial conflicts of interest. He is the director of the Professionalism & Integrity in Research Program. Projects described in this article were funded by NIH CTSA, R01, K01, R21, ORI RRI Program, and CITI sponsorship from 2014-2016.

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Partnering with Patients to Accelerate Cancer Research: Count Me In

Sara Balch, author

Sara Balch, BS, Project Manager, Count Me In and the Broad Institute of MIT and Harvard

Abstract: Count Me In is a research initiative whose aim is to engage patients living with all major cancer types, as well as those with rare cancers. Along with this goal, Count Me In hopes to bring about a cultural shift that empowers patients, researchers, and clinicians to work in partnership and accelerate medical progress by allowing  researchers to work directly with patients and advocacy groups along with software engineers and computational scientists, to collect, analyze, and share de-identified data. The combined power of thousands of individual experiences will assist researchers in understanding, why patients respond differently to treatments, uncover new genetic targets for therapies, and help propel groundbreaking discoveries that transform cancer care.

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Health Disparities: Why Inclusion and Health Equity Matter in Clinical Research

health disparities

Nancy A. Wintering, LCSW, CCRP

Elaine Wang, BS Thomas Jefferson University

Abstract: The content of this paper was presented at the 2018 SOCRA Annual Conference by the first author. The purpose of this paper is to discuss Health Disparities in the context of clinical research. Inclusive conduct of clinical research can reduce bias and improve outcomes to benefit society as a whole. This article describes the historical, social, and cultural indicators and consequences of inequality in health care and research. Strategies to reduce disparities to promote ethical inclusive practices in research are provided.

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Clinical Research Studies During the COVID-19 Pandemic Public Health Emergency

Corona Virus Molecule Rendering Public Health Crisis

Defining a “New Normal” in Clinical Research to Support the World’s 336,747 Research Studies

By: Jennifer Goldfarb – MSN, RN, CCRP

As of April 21, 2020, according to clinicaltrials.gov, there were 336,747 research studies registered by organizations in all 50 states and 210 countries throughout the world. Clinical Research is a delicate ecosystem within healthcare that can be easily advocated for as an essential healthcare service. It is a highly complex, intensely regulated and regimented, environment. It is a critical component of healthcare that drives scientific and medical advances to promote health and treat illness. This environment has suffered unprecedented disruption and chaos during this pandemic. While people hunker down in their homes, waiting for this storm to pass, clinical research conduct is being adapted, paused, and even discontinued, in every therapeutic area.

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FDA Continues to Support Transparency and Collaboration in Drug Approval Process as the Clinical Data Summary Pilot Concludes

FDA Drug Approval Process

U.S. Food and Drug Administration, Center for Drug Evaluation and Research Small Business and Industry Assistance (CDER SBIA).
As our society becomes more global, it has become increasingly clear that the U.S. Food and Drug Administration needs to take a more collaborative approach to our drug approval process. Today, drugs that are approved by the FDA to be marketed in the United States are developed both in and out of the United States.

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