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
What Your Clinical Study Design Reveals About Your Clinical Packaging Needs
Securing a stable supply chain to deal with the uncertainties of clinical trials is critical. One misstep can have a profound impact not only on the cost and time of your trial but also on its overall success. To ensure the timely delivery of the necessary supplies, a sponsor must have a strong clinical packaging strategy that takes into account the most important details of its clinical study design.
ALS Studies And Lessons Learned From COVID-192/2/2021
For ALS trial sponsors and CROs alike, the need to protect the health of study participants, the study team, on-site health care professionals, and the broader community in which the trial centers are located is of paramount importance. The question is, how to ensure this protection and conduct the trial? The answers lie in preemptive mitigation and adaptive processes that can be implemented flexibly as conditions evolve.
How “Future-Proof” Is Your Digital Biomarker Data?3/5/2021
This white paper provides a comprehensive overview of wearable sensor data processing frameworks, traditional and emerging analytic methods, and how clinical trial sponsors will maximize their investment and ensure the long-term value of their digital biomarker data by selecting a wearable technology platform that collects and provides access to raw, “future-proof” source data.
Overcoming Clinical Trial Patient Recruitment And Retention Challenges5/26/2021
Clinical trial patients face more burdens today than ever before but calculated, compassionate use of technology can ease participation for patients and their families, improving study recruitment and retention.
Basket Clinical Trial Designs: The Key To Testing Innovative Therapies Is Innovation In Study Design And Conduct3/4/2020
As the science behind therapeutic interventions has deepened and grown, the clinical trial designs through which those interventions can be best tested have evolved as well. To study therapies directed against specific abnormalities, in cancer for example, it may make sense to include anyone with the target abnormality in the trial population, regardless of the location of their cancer.
Pharmacy Services In A Phase I Clinical Research Unit7/20/2020
This white paper discusses the role of the pharmacy in a modern day Phase I clinical research unit and its role in understanding the safety and pharmacology of a drug before Phase II can begin.
CLINICAL TRIAL APP NOTES & CASE STUDIES
How Did Medrio Achieve FPI In Seven Days?6/2/2021
With an industry average of 12 weeks, it’s incredible that we enabled Cytovale, Inc. to achieve their first patient in (FPI) in just seven days. In a time where speed is of the utmost importance, Medrio supported Study Builders, LLC to build the study and Cytovale to begin enrolling patients in the study in just seven days. The Cytovale technology will allow patients with sepsis to be identified earlier in their hospital stay.
Keep It Simple: The Top 5 Steps For Successful Protocol Design4/21/2021
Starting clinical trials in the right direction begins with a well-designed study protocol – the more comprehensive, the better. In this article we discuss some of the more “common sense” best practices to consider during the protocol design process with Dr. Robert Wilkins, former PI and Founder of QPS Consulting.
Parallelization: Imperative To The Compression Of Clinical Trial Cycle Times4/14/2021
Study startup, the activities involved at the outset of clinical trials, remains highly inefficient and prone to bottlenecks and errors. Clinical trials that get off to a good start are more likely to execute well and finish on-time and on-budget – study startup is the Achilles heel of clinical trials. With unrelenting pressures to rein in budgets and cycle times the application of project management techniques to study startup holds the key to optimizing operational efficiencies and compressing timelines. The parallelization technique which represents the greatest opportunity to realize efficiency gains that are reproducible across all studies, and not just on an as-needed basis.
Advanced Clinical Achieves A Strategic Advantage With Veeva Vault eTMF3/6/2020
Contract research organization Advanced Clinical leverages Veeva Vault eTMF to run faster, higher-quality trials for study partners.
Expanded Access For Delivery Of Treatment To Patients With Acute Adenovirus Infections Through A Named Patient Program11/25/2019
For sponsors, there are numerous operational logistics and regulatory approvals required in order to provide access to their medications through an EAP or CUP. In this case study, UBC deploys a global Expanded Access Program (EAP) to ease the burden on the sponsor and rapidly provide treatment to patients.
Leading Biotech Company Reduces Time, Cost, And Risk With Medidata’s Site Cloud7/4/2020
A leading biotech company with a strong commitment to developing and delivering innovative therapies for patients struggled to find a better way of sharing data once each clinical trial was completed. The answer was in an end-to-end solution to streamline and simplify the EOS media process.
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.