Approximately 25 years ago work began on a document intended to revolutionize and improve the efficiency of new drug development. The document, dubbed ICH E6, was intended to provide guidance for clinical trials conducted around the world. ICH E6 is quickly becoming a reality and sponsor companies need to be prepared for it.
- No CMOs Or CROs: A Unique Approach To Cell Therapy Development
- The Right Precision Medicine Partner Is Essential For Trials And Patients
- How One Biotech Is Taking An Innovative Approach To Alzheimer’s Disease
- Merck’s Efforts To Increase Patient Diversity
- A Drug Developer's First Experience With Decentralized Trials
- The Right Payment System Makes Bayer Healthcare A Sponsor of Choice
- 3 Steps To Address Diversity In Clinical Trials
These Are The Top Priorities & Challenges For New CDER Director Patrizia Cavazzoni, M.D.
Recently appointed to the permanent CDER director role, Dr. Cavazzoni’s appointment was not unexpected, as she was recruited to join the FDA in 2018 from a senior industry role and served as acting CDER director at the start of the agency’s pandemic response. Her experience suggests she will continue to evolve – rather than revolutionize – FDA’s drug review policies.
4 Imperatives For Updating Our Clinical Quality Systems Approach For 2022 Pharma
The clinical quality management systems approach developed 20 years ago is not sustainable in the today’s industry because we've seen dramatic industry changes in outsourcing, remote monitoring, the use of electronic systems in clinical research, and more. But how do we update our approach for 2022 pharma? This article examines 4 imperatives, including how to accomplish them.
3 Key Ways To Improve Patient & Physician Education On Clinical Trials
The success of clinical trials and the advancement of clinical research depend on the existence of a large, diverse, and motivated patient pool. Failure to educate, motivate, and engage patients to participate could have devastating effects. Here are 3 key ways to improve patient and physician education on participating in clinical trials.
The 6 Pillars Of Effectively Managing Up In Clinical Development
Managing up, regardless of title, can be a challenging skill to master from the onset. Laurie Halloran and Michelle Pratt of Halloran Consulting share their 6 key lessons that they've learned along their careers in clinical development. This article will help you manage your relationships with your colleagues in a more senior role, while also positioning yourself for success.
Diversity In Clinical Trials: 10 Strategies To Increase Minority Enrollment In Oncology Trials
Ethnicity, age, and sex can all impact safety and efficacy of any medication in people. Hence, diversity among clinical trial participants is critically important. This article shares 10 interventions to ensure participation of underserved groups to enhance diverse clinical recruitment.
Rare Diseases: How To Leverage Social Media For Patient Analysis
Due to insufficient sample sizes and a lack of granularity, traditional data analysis of rare diseases produces unreliable results. What can you do to learn more about patients with rare diseases? Leverage data from social media and other online sources! The internet offers a trove of public data waiting to be tapped into.
eClinical Systems Post-COVID: Have You Realized Your Digital Transformation?
When the pandemic started to impact our communities, what happened next exemplified the commitment and passion of TMF professionals, clinical researchers, and the pharmaceutical industry as a whole. Now, as the U.S. is in a summer characterized less by COVID and more by time spent with family and friends, are we willing to face COVID’s hard lessons?
How Clinical Trials Execs Adapted To The Pandemic’s Digital Demands
At the worst point during the pandemic, year-on-year enrollment of new patients globally was down 59% in April 2020. By August of 2020 (the last update published), the year-on-year impact was down only 20%. This article explores how clinical execs adapted to the pandemic's demands and offers two questions for introspection regarding patient recruitment going forward.
CLINICAL TRIAL WHITE PAPERS
Increasing Patient Engagement With The Clinical Research As A Care Option Model
It is estimated that as little as 3% of adults with cancer participate in clinical trials. At the same time, recent surveys have shown that up to 75% of patients say they are willing to participate in a clinical research study, indicating that many more people would take part in studies if given the opportunity. Clinical research as a care option, also known to the clinical trial industry as the CRAACO concept, offers a solution to the participation and awareness gap. This article explores the benefits of CRAACO for all stakeholders in healthcare, and outlines some of the steps necessary to turn this option into reality.
Clinical Trial Recruitment Practices: The Evolution Of Ethical Considerations10/16/2019
Recruitment practices for clinical trials have evolved significantly over the last few decades. Read this white paper to learn about the evolution of acceptable recruitment practices, and what IRB members typically look for when reviewing recruitment materials and practices.
ChromoReport Spring 2020: Machine Learning Predictive Models8/27/2020
Clinical operations staff need to have confidence in machine learning predictive models and be able to validate the accuracy of outcomes. By knowing which indicators have the most impact on these models, organizations can focus on those indicators to refine their models and learn from these insights, which can ultimately drive behavioral changes (i.e., less reliance on subjective decisions) to optimize business processes.
Single IRB Review For Multicenter Research: A Guide For Institutions1/27/2021
Single IRB review for multicenter research is now the norm in the US. Initiatives that are requiring harmonization between the FDA regulations and the Common Rule have made it clear that the federal agencies favor centralized review by a single IRB for multicenter research. Download this guide to find out about issues your institution should consider as the research community evolves into the new landscape of mandated centralized IRB review.
Real-World Data Powers Advancements In Cancer R&D12/2/2020
Innovation in the area of oncology has taken off at a historic pace. Private industry and the FDA are relying more on big data, specifically multi-source, point-of-care, real-world data (RWD) to power clinical and economic real-world evidence (RWE) outcomes. We are experiencing more powerful, streamlined ways to bring innovations and advances to patients who need them at the point of care.
Challenges In Medication Development For Addictions2/12/2020
There is a significant unmet need for medications for addictions, chronic, relapsing disorders that lead to biological and behavioral changes that can have harmful medical and psychological consequences. This paper presents an overview of the medications that have been developed for addictive disorders, the study endpoints that have been used for market approval, and the challenges companies may face when developing medications for addictive disorders.
CLINICAL TRIAL APP NOTES & CASE STUDIES
Toolbox Medical Relies On WCG IRB’s Prompt, Personalized Expertise In An Unsettled Environment4/20/2021
During the last year, Toolbox Medical, Inc. has been exceptionally busy, helping clients develop COVID-19-related products. In fact, they launched at least six studies in January 2021 alone. As Toolbox’s client base and workload grows, it relies heavily on its long-time IRB partner, WCG IRB.
Home Health Nurse Network Ensures Patient Care Continuity During The COVID-19 Pandemic9/10/2020
Due to primary provider office closures, patients were unable to schedule their in-office subcutaneous injections required every six months. The client turned to UBC to design, structure and operationalize a program using our nationwide network of registered nurses, which would transition in-office visits to a supportive and effective in-home setting.
How Your Long-Term Data Strategy Can Increase The Value Of Your Clinical Asset5/17/2021
The moment you decide that a clinical program needs to be conducted, stand back and think about the end of the program. How are you going to collect and assemble the consolidated clinical trial data so that it meets or exceeds the expectations of your eventual customer - a regulator, prospective licensing partner or investor? This article looks at the answer to this question by comparing outsourcing models and making some practical suggestions regarding CRO partner utilization and strategy.
Global Pharma Company Dramatically Improves Collaboration, Communication, And Compliance In Trials10/9/2020
A Top 5 global pharmaceutical company wanted to help sites do everyday tasks more efficiently, making it easier for site staff to adhere to the protocol and deliver high-quality data. After evaluations and pilots, the company deployed IQVIA Technologies’ Investigator Site Portal (formerly DrugDev) in a 4-phase approach that delivered benefits each step of the way.
An Excerpt From CRO Quality Benchmarking - Phase I Service Providers, 12th Edition7/2/2020
Which provider is best to conduct a given trial? Who will perform the best? This report includes insights from 190 experienced Phase I outsourcers and more than 600 service provider encounters – all helping to frame what you need to be in the driver’s seat.
Tips To Overcoming Sponsor Resistance When Adopting An eRegulatory System9/28/2020
While electronic document management is becoming more mainstream, it’s still considered uncharted territory for some research sites. The transition is often approached with trepidation, fear, and questions. Over the past several years, we have helped many sites move towards a paperless environment. And in our experience, we’ve found sponsor pushback to be a common concern. To that end, we are offering a few tips to ease the apprehension.
CLINICAL LEADER CONTENT COLLECTIONS
Many in the industry believe AI will be a game changer in drug development. Imagine a future where researchers can identify available patients, their location, the best sites and CROs to partner with, and the probability of success of trials before they even begin. Our latest e-book from Clinical Leader explores the promise of AI.More Content Collections
FOCUS ON PATIENTS
2 Key Ways To Improve Patient Recruitment Of Minorities In Clinical Trials – A Participant’s Perspective
John A. Reaves was compelled to participate in clinical trials for a COVID-19 vaccine. In this article, he discusses his experience and provides two recommendations, including potential strategies for accomplishing them, for how the industry can improve recruitment of minorities for clinical trials.
As an industry, we are constantly searching for ways to improve the drug development process – particularly in the rare disease space. One way to improve on running your rare disease clinical trial is to foster collaborative partnerships with patient advocacy organizations and to stay connected to patients throughout the trial. Here's how to do that.
The FDA recognized that a new approach was required to keep pace with the rapid evolution of science and technology driving drug development, and it released the report Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS) early in 2021 to identify and communicate areas requiring continued targeted investment. These five key elements deserve our attention.
EMBRACING DIVERSITY & INCLUSION
We are at the beginning of important conversations. Conversations that need to happen so we can definitively address the health disparities that continue to impact outcomes among ethnic and racial groups in the United States.
Advancements of the protocols, tools, and technologies that were highly leveraged during the COVID-19 pandemic are the key to breaking down the barriers that perpetuate clinical trial disparities.
To achieve better outcomes and health equity for historically underserved populations, we must address the not widely acknowledged, hidden, real-world reasons for such poor diversity in clinical trials. Here, we will pull back the covers on the issues we must tackle to improve diversity in trials.