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Category: Data Driven

rw-Response Pilot Moves Forward with Meeting During ASCO

During the American Society of Clinical Oncology (ASCO) Annual Meeting in June, Friends of Cancer Research (Friends) convened rw-Response Pilot participants to discuss initial findings. This pilot expands on Friends’ previous real-world evidence (RWE) work focused on answering the question: “What real-world endpoints can be evaluated and compared across multiple data sources using a common…

Optimizing Dosing in Oncology Drug Development Q & A

  Maximizing Benefit and Improving Tolerability for Patients Through Dose Optimization Virtual Event Questions and Answers   Friends of Cancer Research (Friends) continues to be committed to improving clinical trial design and drug development to support patients. In September 2021, Friends hosted an event called Beyond Breakthrough: Optimizing the Breakthrough Therapy Designation that highlighted ongoing…

Beyond Breakthrough: Key Challenges Between FDA and Sponsors

This is the second of two blog posts highlighting Friends’ upcoming September 20th event discussing the Breakthrough Therapy designation (BTD). This post will focus on the key challenges between the FDA and drug sponsors that we have identified in our work. Read the first here. The regulatory review process for drugs is a resource intensive…

Beyond Breakthrough: Use of Innovative Drug Pathways at FDA

This is the first of two blog posts highlighting Friends’ upcoming September 20th event discussing the Breakthrough Therapy designation (BTD). In this post, we will summarize the recent history of this innovative drug approval pathway and also address potential areas of improvement. BTD is a process that expedites the development and review of drugs intended…

Data Driven Insights – Accelerated Approval

Since 1992, Accelerated Approval has facilitated earlier patient access to promising therapies that treat serious and life-threatening illnesses. While a traditional approval is often based on a therapy’s ability to demonstrate meaningful impact upon a clinical endpoint (e.g. overall survival), Accelerated Approval is granted based upon demonstration of an effect on a surrogate or intermediate endpoint…

Designing the Future of Cell Therapies

“Patients are waiting. These therapies are potentially curative. They’re important for the field.” – Ellen Sigal On May 17, 2019, Friends of Cancer Research (Friends) and the Parker Institute for Cancer Immunotherapy (PICI) held a public meeting on “Designing the Future of Cell Therapies” to explore forward-looking opportunities in the cell therapy field. The meeting…

Data Driven: How Oncologists Perceive FDA-Approved Drug Labeling Compared to Other Major Prescribing Resources

Physicians rely on a variety of sources of information to provide high-quality care to patients. In oncology, some of the most prominent resources that inform provider decision-making are the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) clinical practice guidelines; drug compendia; electronic point-of-care decision support tools, such as UpToDate;…

Data Driven: Molecular Diagnostic Testing in Lung Cancer

Molecular diagnostics are central to the delivery of personalized cancer care. Without these important tools, physicians would not be able to select the appropriate patients for targeted therapy, negating the advantages conferred by recent advances in genomics. In the past fifteen years, there has been an explosion of new technologies to interrogate the genes and…

Data Driven: US Regulatory System Leads the World in New Drug Review Times

In his first speech to Congress last February, President Trump revived a common misconception about drug regulation. The president’s comments reflect a perennial critique of the FDA, that the agency’s drug regulations impede timely access to new medicines. A few years ago, Friends of Cancer Research (Friends) explored whether these claims were true about cancer…

Data Driven: Mining ClinicalTrials.gov – Institutions, Funding, and Areas of Focus

  This is Data Driven, a new series that explore our nation’s health agencies’ publicly available data. This data, which is comprised of searchable online databases and files, presents a unique opportunity to analyze information on broad health care topics. We thought it would be interesting to explore data from agencies whose work most closely…