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
Simple SOP Updates Every Research Site Needs To Succeed At Remote Monitoring
Today’s crisis climate is creating a dichotomy in clinical research. As a result, sites are closing, medical facilities are enforcing access restrictions, and there are constant delays or stoppage of non-essential studies. On the other hand, this health crisis is highlighting the critical need for clinical research due to ongoing COVID-19 trials. As a result, clinical researchers are asking questions and seeking workarounds to continue operations in response to site-specific adjustments. One central issue has surfaced — how do we continue to maintain compliance when working from home?
Understanding New FDA Guidance For Pediatric Oncology Studies4/21/2020
The Research to Accelerate Cures and Equity (RACE) for Children Act requires that any original new drug or biologics license application submitted on or after August 18, 2020, for a new active ingredient must contain reports of molecularly targeted pediatric cancer investigations if the drug is directed at a molecular target that the FDA determines to be substantially relevant to the growth or progression of a pediatric cancer. Learn more about the changes in this article.
Developing A Data Strategy For Clinical Trials6/10/2021
Data is the most important asset that a pharmaceutical or biotechnology company has, and the number and complexity of sources of data in clinical trials is increasing all the time; at the same time, there is increasing pressure to deliver high quality data with accelerated timelines. This white paper describes a standardized approach to developing a data strategy that can be customized to a company’s current needs and can be adjusted as those needs change.
Practical Considerations Of A Successful RBQM Implementation11/22/2020
Advances in technology, such as electronic capture and storage of study data and documentation, have accommodated the growing reliance on RBQM for clinical trials. With any new technology, there are questions about implementation and best practices.
Increasing Patient Engagement With The Clinical Research As A Care Option Model6/30/2021
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.
The H1N1 Study: Conducting Public Health Research During A Pandemic4/7/2020
This article describes Rho’s involvement in a recent clinical trial that assessed the safety and immunogenicity of the 2009 H1N1 vaccine in adults and children (aged 12-79 years) with severe asthma.
CLINICAL TRIAL APP NOTES & CASE STUDIES
Blood Disorder Clinical Trials – Adapting To COVID-19 Challenges7/2/2021
The spread of COVID-19 has heightened the potential risk of infection for patients suffering from blood disorders. Hematologist Dr. Robert S. Negrin, a new member of Biorasi’s growing Scientific Advisory Board, weighs in on understanding and adapting to changes to blood disorder trials and treatment during the pandemic.
Spotlight On PNH: The Evolution Of Research And Treatment6/15/2021
Paroxysmal nocturnal hemoglobinuria (PNH) is defined as an acquired rare disease triggered by a rare mutation in bone marrow stem cells, with patients experiencing production of irregular blood cells. In terms of clinical studies, PNH’s uniqueness presents a number of operational challenges. In this article, Dr. Mehool Patel discusses innovations in the treatment of PNH, the diverse nature of this rare disease, as well as solutions for PNH clinical trial enrollment and availability.
Has EDC Kept Up With Changes In Clinical Trials?9/10/2020
Clinical trials have changed dramatically but electronic data capture systems haven’t necessary kept up. New platforms are helping support the volume and variety of data that results from incorporating virtual components into clinical trials.
An Excerpt from CRO Quality Benchmarking - Phase II-III 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 233 experienced Phase II/III outsourcers and nearly 700 service provider encounters – all helping to frame what you need to be in the driver’s seat.
Identifying The Decision-Makers At Your Customers’ Organizations6/29/2021
ISR was engaged by the Global Marketing Director at a Top 20 CDMO with the above question. The client had years of experience in marketing their brand to prospective customers but had recently begun to question the efficiency of their marketing spend. The client wanted to demonstrate to their company stakeholders that their marketing efforts were not only hitting the right targets, but that the language used in those efforts reflected their customers’ needs. Knowing this information would allow the client’s marketing department to move away from broad, product-based messaging focused on how good their services are, to messaging focused on how their services address their customers’ concerns.
The Time Is Now For Transformation In Clinical Data Collection7/1/2020
The latest platform for data collection and clinical trial management can help overcome barriers to implementing new data collection methods and digital strategies for clinical trials.
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.