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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Pediatric Recruitment: What Works and What Does Not Work

Waseem Muhammad Pediatric Research

Muhammad Waseem, MD, MS, CCRP, CIP, CHSE-A

Abstract: While research involving pediatric patients may be challenging, the rewards can be significant. This article describes challenges in pediatric recruitment and how enrollment in pediatric research is unique versus research involving adult patients. Highlighted are effective approaches for engaging children and their parents and techniques to improve recruitment and adherence and to help reduce dropout rates. Researchers should always put the interests and safety of the participants and their families first and comply with appropriate research guidelines and study protocol.

Disclosure: The author does not have any financial disclosures or conflicts of interest to declare.

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Operationalizing the Serious Adverse Event (SAE) Process at Clinical Research Sites

Operationalizing Serious Adverse Event Process

Tracy Popp, MBA
Previously: Director, Research Financial Operations Norton Healthcare, Inc.
Currently: Senior Director of Clinical Research, Tampa General Hospital

Abstract: It is important for clinical research sites to operationalize the serious adverse event (SAE) process beyond regulatory and clinical. Norton Healthcare, Inc. has developed policies and a workflow for operationalizing SAEs, including clinical, legal, billing, accounting, and budgeting capture. This article provides an overview of the way in which Norton Healthcare has done this as well as how other sites can also operationalize SAEs.

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Conducting Clinical Trials in Canada Inspections of Clinical Investigators

Clinical Investigator Inspections

Mike M. Rashti President, BIMO Auditor and Trainer, LLC

Abstract: This article provides an overview of the U.S. Food and Drug Administration’s (FDA’s) foreign inspection program and the Bioresearch Monitoring Program as it is applied to inspections in Canada. How to prepare for an inspection and differences between inspections of clinical research sites in the United States and Canada are discussed. Protocol violations observed at Canadian sites that have been documented by FDA Form 483s (Inspectional Findings) and Warning Letters are noted in this article.

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Clinical Trials Day 2021: A Time for Celebration and Reflection

May 20th  marks Clinical Trials Day (CTD), an international commemoration of James Lind’s launch of the scurvy clinical trial on May 20, 1747, which would form the foundation for modern clinical research. Celebrated for the first time in 2005, CTD raises clinical trial awareness and honors clinical research professionals across the globe. In celebration of this distinguished occasion, we’ve continued our three-year tradition of inviting SOCRA Members to nominate each other for their outstanding work and contributions to public health, medical advancement, and improved health outcomes. We caught up with our first 2021 nominee to uncover her thoughts and insights on the significance of CTD and the clinical research industry as a whole.

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Tools and Techniques for Effective Clinical Research Start-up at an Academic Medical Center

Michael Mapel, CCRP
Clinical Research Lead
UCLA Pediatrics Office of Finance & Research Children’s Discovery & Innovation Institute1

Abstract: Activating a clinical research project at an academic medical center requires significant planning and effort from study teams. Research sponsors often have difficulty understanding any process lacking in consistency and transparency and so start-up becomes a barrier to study enrollment. This article breaks down such barriers by advocating specific project management and communication tools and techniques that accelerate the study start-up process without sacrificing quality.

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How to Motivate and Retain Clinical Research Staff

Takisha Adair, Clinical Operations Manager, Covance

Abstract: Retaining staff is challenging for clinical research organizations. Motivating employees and engagement can help reduce staff turnover. Organizational leaders who desire to retain a talented workforce should tap into employee motivations and identify ways to incorporate these, where applicable, in employee retention efforts. This article highlights the key elements to motivate and engage research staff, especially millennials. Strategies that have worked well are highlighted from leading generational and change management experts.

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Utilization of Cancer Registrars in Clinical Research

Rossio Y. Rodriquez, HIM, CTR 
Director, Data Management 
Proton Collaborative Group

What is a Cancer Registrar?

A cancer registry is the information system designed for the collection, management, and analysis of data on a person’s diagnosis that contains etiology, diagnosis, treatment of cancer, and patient’s status for as long as the patient is alive. The information in the registry is entered by a cancer registrar.

The men and women in this job role are very dedicated, detail oriented, and passionate about their oncology role.  They utilize many skills in their everyday tasks. However, one important skill that cancer registrars use the most is critical thinking. This is vital when reviewing a patient’s medical chart and putting together their cancer history into one abstract that is later used for cancer statistics. The role of the cancer registrar has a tendency to be overlooked as they are not in the frontline when it comes to the patient’s cancer care.   

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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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Human Factors Testing and Clinical Research

Tim Reeves, CHFP
Founder and Managing Director
Human Factors MD

Abstract: Human factors simulated-use studies provide a valuable tool for evaluating the usability and safety of medical devices, including combination products such as inhalers, injection devices, and transdermal patches. Through human factors studies, researchers evaluate how users and devices perform in low-frequency high-risk situations that may not occur in controlled clinical trials. This article provides an overview of the role of human factors testing in combination product development as well as how human factors studies complement traditional clinical trials in establishing safety and efficiency in drugs and devices.

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