Newsletter | December 18, 2019

12.18.19 -- Putting Patients First In Clinical Trial Designs

  Central Lab Market Dynamics And Outsourcing Performance (2019 To 2022)

This report will help study sponsors understand the service areas expected to grow in demand and the geographic trends associated with central lab service provider use to ensure study sponsors are up to date with how industry peers are outsourcing their central lab work. For providers, it will help determine the attributes and metrics critical to study sponsors in their selection of service providers to internally assess your lab’s capabilities in these areas. More.

Focus On Patients
Shared Decision Making And Its Impact On Clinical Trial Consideration
By Marla Clayman (American Institutes for Research), Nisith Kumar (Pfizer), Mary Murray (Bristol-Myers Squibb), Wilson Mok (Merck), and TJ Sharpe (patient advisor)

Patient participation forms the backbone of clinical research. Surveys reveal that up to 80 percent of patients say they are “somewhat or very willing” to join a clinical trial, yet enrollment levels remain low. For example, only 8 percent of cancer patients ever enroll in a clinical trial, despite substantial resources and efforts being invested in clinical trial advertising, transportation support, and other recruitment and retention activities.

Putting Patients First In Clinical Trial Designs: A Multifaceted Approach
By Gwen Nichols, M.D., chief medical officer, The Leukemia & Lymphoma Society

Patient enrollment is critical to the success of a clinical trial, yet clinical trial designs are not always conducive to the participation of cancer patients. According to a study by Dr. Joseph Unger and colleagues at Fred Hutchinson Cancer Research Center, more than half (55.6 percent) of all cancer patients do not participate in trials because no appropriate trial is available for the patient’s cancer type and stage at the center where they are being treated. Furthermore, when a trial was available, an additional 21.5 percent were ineligible due to exclusion criteria.

Industry Insights
The Importance Of Proactive Clinical Returns Planning
Article | A Q&A with Dianne Coughlan and Rognvald Lamb, Catalent

Accurate and timely delivery of clinical trial supplies helps to ensure that a study’s timeline stays on track. Sponsors often focus on up-front planning to ensure sites are prepared to reach clinical milestones but ignore the logistical challenges of reconciling and destroying clinical returns. This article breaks down how to effectively manage the clinical supply returns process and how to design a more holistic strategy.

Female Sexual Dysfunction Challenges In Clinical Trials
Article | By Kristen Snipes, Health Decisions Inc.

With only two FDA-approved HSDD therapies, and treatment demand for female sexual dysfunction on the rise, we expect an increase in clinical research initiatives. Given the complex nature of feminine sexuality — not to mention the female reproductive system — many challenges can impact patient care.

Industrializing OPEX In Clinical Trials
Article | By Jinu Jose, Cenduit LLC

Highly variable demand cycles, further de-risking of the business, and increasingly inexperienced interactive response technology (IRT) stakeholders are a few of the crucial, data-driven challenges facing studies. Learn how industrializing OPEX drives quality patient outcomes and provides a means for continuous improvement.

Long-Term Follow-Up Studies Go Virtual
Article | By Robin Douglas, IQVIA Virtual Trials

Long-term follow-up studies can be expensive and time-consuming for investigators, sponsors, and patients. Read how virtual models can improve patient retention in long-term follow-up studies, cutting the time, cost, and burden for patients and investigators.

Decision-Making Responsibilities When Outsourcing Late-Phase Studies
Article | By Kate Hammeke, ISR Reports

A look at which departments at sponsor organizations are involved in the decision-making process and how much decision-making responsibility each department has for outsourcing various late-phase study activities.

Cellular Therapy Studies: 7 Common Challenges
Case Study | By Heather Kopetskie and Kristen Mason, Rho

Cellular therapy is a form of treatment where patients are injected with cellular material. Different types of cells can be utilized, such as stem cells (e.g., mesenchymal stem cells) and cells from the immune system (e.g., T cells (Tregs)) from either the patient or a donor.

Clinical Supplies For Biosimilar Trials: What To Consider
Article | Thermo Fisher Scientific

A quick glance at the pharmaceutical industry news may indicate the golden age of biosimilars is just around the corner. Approved biosimilars could account for more than $20 billion in revenue and save EU and U.S. health systems more than $56 billion by the end of 2020, two recent reports concluded.

Veeva 2019 Unified Clinical Operations Survey: Annual CRO Report
White Paper | Veeva Systems, Inc.

This global research examines the drivers, barriers, and benefits of a unified clinical operating model from a CRO perspective. Findings show CROs are leading the adoption of modern clinical applications to increase efficiency, enhance collaboration, and improve trial performance.

Why Adopt eSource For Your Next Clinical Trial?
Infographic | Medrio

By eliminating paper and enabling remote monitoring, eSource reduces costs and resource dependence, enabling you to work faster and increase your trial volume.

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