FDA Issues Guidance for Conducting Clinical Trials During COVID-19
On March 18, 2020, the U.S. Food and Drug Administration (FDA) issued a guidance for industry, investigators, and institutional review boards conducting clinical trials during the COVID-19 coronavirus pandemic in recognition that it may affect the conduct of clinical trials of medical products, including drugs, devices, and biologic products.
Clinical Trial Participants Average 6.5 Years Younger Than Actual Cancer Populations
For the four most common cancer sites (breast, prostate, colorectal, and lung cancer), the median age of patients in clinical trials is an average of 6.5 years younger than the median age of patients diagnosed with that cancer. And the age disparity is worsening, researchers reported in JAMA Oncology.
New CAR T-Cell Targets Show Safe Results in Early Clinical Trials
Findings from two phase I clinical trials presented at the American Association for Cancer Research 2019 annual meeting indicate that targeting CAR T cells against mesothelin for advanced solid tumors and HER2 for advanced sarcoma is safe and shows clinical antitumor activity.
Nurses Must Be Pharmacovigilant With Emerging Cancer Treatments
The field of cancer care is changing and evolving like never before. In 2018, the U.S. Food and Drug Administration (FDA) approved a number of new biosimilars, targeted agents, and agents that target certain mutations regardless of tumor site. New requirements for accreditation and reimbursement mean oncology nurses are being used in a growing number of new or developing roles including navigation and survivorship. On Thursday, April 11, 2019, Kathleen Wiley, RN, MSN, AOCNS®, addressed these emerging trends and more in a clinical chat at the ONS 44th Annual Congress in Anaheim, CA.
Drug Pricing Talks; Clinical Trial Barriers; Survivorship Challenges
Rising prescription medication costs has been a major focus area for both the Trump administration and the 116th Congress. In January 2019, both the House and Senate committees of jurisdiction held public hearings on soaring drug costs. Despite constant media attention and mounting pressure from government officials, no pharmaceutical company executives chose to testify. Congress threatened to subpoena the industry if it happened again.
VA and NCI Collaborate on Access to Cancer Clinical Trials
A new cross-government program is underway to improve veterans’ access to clinical cancer trials. Together with the National Cancer Institute (NCI), the Department of Veterans Affairs (VA) Interagency Group to Accelerate Trials Enrollment launched in 12 VA facilities in summer 2018.
How Is CTCAE Improving Research and Patient Care?
The Common Terminology Criteria for Adverse Events (CTCAE) is a list of adverse event (AE) terms most often encountered in oncology. It’s been in ongoing development since the 1980s and was previously referred to as the Common Toxicity Criteria. Through continual development and support from the National Cancer Institute’s Cancer Therapy Evaluation Program, CTCAE aids in the documentation and analysis of adverse events in oncology-related clinical trials.
What Would You Say if Your Patient on a Clinical Trial Needs to Visit the Dentist?
One of your patients is enrolled in a clinical trial and is scheduled to receive an investigational drug today. She reports a cracked tooth and asks if it’s okay to get dental work. What should you tell her?
A. To Set up an appointment with her dentist between treatment cycles.
B. To check with her research team before setting up a dental appointment.
C. Not to have any dental work done since she’s on a clinical trial.
D. Have her tooth fixed right away and let the research team know if you have any problems.
Consider a Role in Clinical Trials Research as an Evolution of Your Nursing Career
Nurses can do it all. After all, the often-unsung heroes of health care use their unique skills to positively impact patients and their families in more ways than most people can ever imagine. Unfortunately, role confusion and a lack of awareness of a vital specialty have led to a dire need of nurses in clinical trials.
Communication, Organization Are Top Drivers of Oral Adherence in Clinical Trials
Oncology nurses know the challenges of patient adherence to oral cancer therapies. Every dose a patient misses can affect their outcomes and chance of survival. But in clinical trials, oral adherence has even broader implications: when a study is evaluating the efficacy of a drug, it depends on study participants taking it exactly as the trial outlines.
What You Need to Know About Obtaining Informed Consent
Informed consent is a comprehensive process as opposed to a check mark on a list of tasks to complete prior to starting cancer therapy. The American Society of Clinical Oncology/ONS Chemotherapy Administration Safety Standards explain that informed consent provides a patient with “sufficient information about the disease diagnosis and treatment options so that the individual can make a reasonable decision about treatment on the basis of an understanding of the potential risks and anticipated benefits of the treatment.”
Geographic Health Disparities Affect Access to Clinical Trials
Geographic location impacts life expectancy and even cancer care. Marylynn Ostrowski Ireland, PhD, of Viability, Inc., and Deborah Watkins Bruner, PhD, RN, FAAN, of Emory University in Atlanta, GA, discussed geographic health disparities during a session at the 43rd Annual Congress in Washington, DC.
The Case of the Pain Paradox: Follow-Up and Clinical Trial
The January 2018 case study introduced Vince, a 55-year-old man receiving chemotherapy and radiation for recurrent bladder cancer. He suffers from chronic back pain because of spinal stenosis and has been on opioid therapy for nearly two years.
How the FDA Provides New Approaches to Old Problems
Every quadrennial presidential cycle, as the newly elected leader moves into the Oval Office, he selects a core group of advisors who are philosophically aligned and eager to make changes in the federal government’s process. However, this is often not as simple as the new administration believes.
How Do You Find Clinical Trials Through the NCI’s Advanced Clinical Trials Search?
As part of the National Cancer Moonshot Initiative and in collaboration with the Presidential Innovation Fellows, the National Cancer Institute (NCI) developed and launched a new website in 2016. It provides user-friendly access to the repository of abstracts of cancer clinical trials that NCI supported.
Oncology Nurses Drive Change In Cancer Care With Clinical Trials
Clinical trials are responsible for discovering new treatments for cancer as well as the continued evolution of standards of care in clinical practice. Nationally, less than 5% of all eligible adult patients with cancer enroll in clinical trials. Additionally, it takes a drug an average of six to eight years from when it is first introduced in trials to become fully available to all patients who could benefit from it.
FDA Halts Two Clinical Trials Evaluating Pembrolizumab in Patients With Multiple Myeloma
On August 31, 2017, based on data from two recently halted clinical trials, the U.S. Food and Drug Administration (FDA) is issuing a statement to inform the public, healthcare professionals, and oncology clinical investigators about the risks associated with the use of Keytruda (pembrolizumab) in combination with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) for the treatment of patients with multiple myeloma. Keytruda (pembrolizumab) is not approved for treatment of multiple myeloma.
How Are Patients Randomized to Cancer Clinical Trials?
Before any new treatment or approach is used with people in clinical trials, researchers work to understand its effects on cancer cells in the lab and in animals. Researchers design cancer clinical trials to test new ways to treat, detect, diagnose, and prevent cancer, and manage symptoms of cancer and side effects from treatment.
How One Institution Improved Accrual to Cancer Clinical Trials
One of the key factors to a cancer clinical trial’s success is the ability to enroll an adequate number of patients in an appropriate timeframe. Identifying barriers to slow accrual and ways to address them can help researchers and nurse scientists make big steps in the fight against cancer in the era of the National Cancer Moonshot Initiative.
How Oncology Nurses Can Contribute to Immunotherapy Clinical Trials
Using the human immune system to target cancer has made tremendous strides in recent years. Jaruska Naidoo, MBBCh, from the Sidney Kimmel Comprehensive Cancer Center, and Joanne Riemer, RN, BSN, from Johns Hopkins University, discussed the progress made in immunotherapy and how nurses play a role in clinical trials during a session at the 42nd Annual Congress in Denver, CO.