Issues in Oncology

The Importance of Endpoints in Oncology Clinical Trials

Beth Faiman, PhD, MSN, APRN-BC, AOCN®, BMTCN, FAAN, FAPO

Innovative clinical trials identify appropriate endpoints when seeking to evaluate potential new cancer treatments, better ways of using existing medications, or enhanced supportive care techniques. A recent X (formerly Twitter) post hig...

Biomarker-Driven Oncology Clinical Trials: Novel Designs in the Era of Precision Medicine

Donald C. Moore,(1) PharmD, BCPS, BCOP, DPLA, FCCP, and Andrew S. Guinigundo,(2) MSN, RN, CNP, ANP-BC

Oncology drug development historically has followed a path of sequential phase I, II, and III clinical trials using traditional trial designs, with the goal of achieving regulatory approval. These studies are often conducted with inclusi...

Inclusion of Racial and Ethnic Minorities in Cancer Clinical Trials: 30 Years After the NIH Revitalization Act, Where Are We?

Faith Mutale, DNP, CRNP

The lack of diversity in cancer trials is a multifaceted, decades-old problem that has remained persistent despite efforts to increase the number of participants from underrepresented racial and ethnic backgrounds. This lack of meaningfu...

Management of Adverse Events in Early Clinical Trials by Advanced Practice Providers in the Outpatient Setting: The University of Texas MD Anderson Cancer Center Experience

Fedricker D. Barber (1), Erick Campbell (1), Yuko Yamamura (1), Clover J. Patterson (1), Audrey C. Hartnett (1), Holly Kinahan (1), Victoria A. Miller (1), Amanda L. Brink (1), Anna Poullard (1), Gabriele E. Urschel (1), Andre Brantley (1), Isabel G. Cepeda (1), Poonam Goswami (1), Sheena Charles (1), Shincy Philip (1), Sara Bresser (1), Sandra Musekiwa-Adjei (1), Nageli Perez (1), Hung Le (1), Penny Phillips (2), Vivek Subbiah (1), Funda Meric-Bernstam (1,3,4), and Ecaterina E. Dumbrava (1)

Background: Advanced practice providers (APPs) play important roles in enrolling, educating, and caring for patients in clinical trials. However, much remains unknown about the role of APPs in managing adverse events (AEs) in early (phas...

The AP Role in Clinical Research: 2022 ASCO Annual Meeting Highlights for the Advanced Practitioner

Elizabeth Koselke, PharmD, BCOP and Christa Braun-Inglis, DNP, APRN, FNP-BC, AOCNP®

Elizabeth Koselke, PharmD, BCOP, of The US Oncology Network, describes a clinical pharmacist intervention to screen patients and improve clinical trial enrollment. Christa Braun-Inglis, DNP, APRN, FNP-BC, AOCNP®, of the University of Haw...

The Advanced Practice Role in Clinical Trials: Past, Present, and Future

Colleen Lewis, MSN, ANP-BC, AOCNP®

At JADPRO Live Virtual 2021, Colleen Lewis, MSN, ANP-BC, AOCNP®, discussed the trajectory of the advanced practitioner role in clinical research, including the historical experience, potential barriers to practice, and future possibiliti...

Role of Oncology Advanced Practitioners to Enhance Clinical Research

Christa Braun-Inglis, DNP, APRN, FNP-BC, AOCNP®, Leigh M. Boehmer, PharmD, BCOP, Laura J. Zitella, MS, RN, ACNP-BC, AOCN®, Brianna Hoffner, MSN, ANP-BC, AOCNP®, Yurii B. Shvetsov, PhD, Jeffrey L. Berenberg, MD, Randall A. Oyer, MD, and Al B. Benson III, MD

Background: Oncology advanced practitioners (APs), including nurse practitioners, clinical nurse specialists, physician assistants, and clinical pharmacists contribute significantly to quality cancer care. Advanced practitioners enhance ...

Clinical Trial Design and Drug Approval in Oncology: A Primer for the Advanced Practitioner in Oncology

Sandra E. Kurtin,(1) PhD, ANP-C, AOCN®, and Rashida Taher,(2) MPH, PA-C

Evidenced-based practice requires timely and accurate integration of scientific advances. This presents a challenge for the oncology clinician given the robust pace of scientific discovery and the increasing number of new drug approvals ...

Phase 1 Clinical Trials in the Elderly: Enrollment Challenges

Carol Guarnieri, RN, MSN, FNP-C, and Daniel D. Von Hoff, MD, FACP, FASCO, FAACR

Cancer mostly affects older adults. Despite the increased incidence of cancer among older adults, they are underrepresented in oncology clinical trials. Such trials can provide patients with early access to promising interventions. Clini...

Secondary Analysis Research

Rita J. Wickham, PhD, RN, AOCN®

Abstract In secondary data analysis (SDA) studies, investigators use data collected by other researchers to address different questions. Like primary data researchers, SDA investigators must be knowledgeable about their research area to...

The Stepped-Wedge Trial Design: Paving the Way for Cancer Care Delivery Research

Ya-Huei Li, PhD, Elizabeth Mullette, RN, MSN, and Jeannine M. Brant, PhD, APRN, AOCN®, FAAN

Abstract Cancer care delivery research (CCDR) is an emerging field that investigates ways to optimally provide care for patients within complex health-care systems. Novel research designs are essential to efficiently study CCDR research...

The Challenges of Clinical Research in Rare Cancers: Bevacizumab Use in Low-Grade Serous Ovarian and Primary Peritoneal Cancers

There are challenges to conducting rare cancer clinical trials due to issues surrounding clinical trial design, patient recruitment, and analysis of the study outcomes. This article highlights the challenges of research and data analysis...

Participation in Cancer Clinical Trials: Researching the Causes of Low Accrual

Achieving optimal patient accrual numbers for adult oncology clinical trials has been an ongoing problem in cancer care. As advanced practitioners (APs), some of our patients are enrolled in trials, but the number is not as high as we wo...

An Introduction to Survival Statistics: Kaplan-Meier Analysis

Randomized Allocation to Treatment Groups and the Importance of Adjusting for Covariates

Incorporating Clinical Trial Data Into Daily Cancer Care

The objective of clinical trials is to determine the effectiveness and safety of specific interventions. Regulatory agencies, clinicians, and patients depend on clinical trials because they provide the most reliable information about tre...

Overview of the AVADO and RIBBON-1 Clinical Trials

The Maemondo Paper: Understanding Outcomes Assessment in Clinical Trials

Translating Evidence-Based Research into Practice

The demand for a transformation of the health-care system has led to an emphasis on evidence-based practice (EBP) to ensure safe, quality care. The gap between research and translation into practice has resulted in the call for changes i...

The Hodi Paper: A Researcher’s View

Translating Research Into Practice: Overview of Principles