Clinical Leader - Clinical Trials, CRO, Contract Research, eClinical

AstraZeneca Goes All-In On Biomarker Testing & Education

Recent breakthroughs in precision medicine are revolutionizing cancer care and biomarkers are a key part of the puzzle. Scientific data has been generated that will help researchers understand the biology of cancer and more specifically, tumor profiles at the molecular level. Despite immense scientific advancements in recent years, biomarker testing is not always the standard of care for most people living with cancer. AstraZeneca hopes to change that.

GUEST COLUMNISTS

Decentralized Trials: Trends & Technology Propelling Home Healthcare Services
Moving some trial site activities into patients’ homes has been shown to increase recruitment by 60% or more, and it typically maintains patient retention at over 90%. This article delves into research regarding trends and technology enabling decentralized trials.
How To Increase Patient Diversity: LLS Brings Clinical Trials To Underrepresented Communities
Racial and ethnic minorities, rural residents, and people with lower socioeconomic status are overwhelmingly underrepresented in clinical trials. The Leukemia & Lymphoma Society (LLS) has launched a first-of-its-kind research grant program to help move the needle on this long-standing problem.
The 3-Step Approach To Unlock The Power of Historical Trial Data
While the biopharmaceutical industry has made significant strides in the sharing and use of external trial data to help bring medications to patients faster, many organizations can find it difficult to make sharing and using this data routine. How do we build on new momentum to continue and accelerate the use of historical trial data to transform R&D in the future?
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.
Best Practices For Designing And Running Clinical Trials For Patients With Rare Diseases
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.
How Clinical Execs Can Embrace Technology (& How To Find Activated Patients Who Do, Too)
How can we make the clinical trial process more efficient and effective? By embracing technology (for example, AI and machine learning) and finding patients who embrace technology, too. The former deputy chief medical officer for the American Cancer Society shares his thoughts.
How to Optimize Success in Clinical Trials of Antidepressants
In order to bring promising therapies safely, effectively, and expediently to the millions of individuals who suffer from major depressive disorder, we need to reevaluate learnings from the past few decades to overcome the challenges in design and conduct of clinical trials for antidepressant drugs.
Diverse Patient Populations In Clinical Research: 3 Steps For Success
While the clinical trials industry has made incredible strides raising awareness among the broader general population, as we’ve witnessed firsthand amid the ongoing COVID-19 pandemic, there remains a persistent lack of representation in clinical research among diverse communities. How do we address this?

CLINICAL TRIAL WHITE PAPERS

Ensuring Compliance With Part 11: A Site’s Perspective
As more sites are looking to implement technology to go paperless, improve standardization, and provide secure access to essential documents, site staff ’s experience with ensuring compliance with 21 CFR 11 (Part 11) of the Code of Federal Regulations—focusing on the U.S. Food and Drug Administration’s (FDA’s) standards for electronic records and electronic signatures — may be limited. Balancing the need to maximize efficiency and ensure compliance presents a challenge, but with the right resources, the challenge is an achievable one. Gaining a better understanding of the purpose, scope, and components of Part 11 will help sites achieve their compliance goals.

The Electronic Trial Master File: Study Item And Placeholder Analysis
5/21/2021

Electronic trial master file (eTMF) systems are proving to be effective in planning, managing, monitoring, and maintaining inspection-readiness and compliance. This paper explores the use of planning wizards and how placeholder creation promotes study completeness, timely document uploading, and reduced rates of quality control failures. These features can ease workloads while providing the transparency needed for inspections and audits.
COVID-19 Vaccine Development: Building On A Legacy Of Innovation
3/31/2021

The SARS-CoV-2 virus at the center of the COVID-19 pandemic may be novel, but the coordinated research and development efforts to create a vaccine for it are not entirely so. They borrow from experiences derived from more than 50 years of successful vaccine development programs. Read Worldwide’s take on the history of medicine and the development of the coronavirus vaccine.
The H1N1 Study: Conducting Public Health Research During A Pandemic
4/7/2020

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.
ALS Studies And Lessons Learned From COVID-19
2/2/2021

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.
Risk Based Quality Management (RBQM) - A Collaborative Approach To Holistic Clinical Trial Oversight
11/25/2019

Developing, executing, and overseeing clinical trials is a complex process. This paper shares perspectives that will assist sponsor organizations in the creation of a RBQM system in partnership with their CROs and vendors. When a shared, proactive plan is established, sponsors and CROs/vendors can then tailor their oversight strategy to support improved quality and safety of clinical trial execution.

More Clinical Trial White Papers

CLINICAL TRIAL APP NOTES & CASE STUDIES

Cleaning Up Patient Data … Quickly
3/2/2020

A sponsor needed to deliver data so a go-/no-go decision could be made at a major internal meeting that couldn’t be rescheduled. The problems stemmed, in part, from a failure to communicate between a large, somewhat impersonal CRO and a small sponsor that was used to close personal relationships and more or less constant interaction with the team managing its studies. We picked up the project in March 2013 and completed data lock by the end of September.
Midlantic Urology Associates Introduces Added Convenience For Patients With Rideshare Program
7/15/2019

Midlantic Urology Associates had been employing a single driver for all participant pick-ups. This proved to be inefficient and unsustainable, so they began utilizing taxis. This alternative was costly and unreliable – there had to be a better way. ClinCard’s integration with Lyft has not only improved the experience for patients and study coordinators but has also helped with recruitment as new patients are enrolling in the study as a result of this added convenience.
A Global Observational Registry Of Adult Patients With Homozygous Familial Hypercholesterolemia (HoFH)
8/5/2020

Clinical development service provider efficiently and strategically manages a global rare disease registry with rolling start-up, including mandated annual data collection and reporting.
Groundbreaking Work Leads To First Gene Therapy Ever Approved In Europe
1/14/2021

Veristat was brought in to create and manage a full development program for a gene therapy for a very rare inherited disorder. The work involved charting the course in completely uncharted waters – our team had to create industry best practices that didn’t exist before, anywhere. With no classic route to market, Veristat’s experts wrote the map on patient recruitment, regulatory and health agency engagement, natural history studies and the Central Site Model.
Phase III Rare Disease Rescue
1/2/2020

A small biotech with limited internal capacity outsourced a phase III clinical program in patients with Necrotizing Soft Tissue Infections. After nearly 16 months, patient enrollment was still a major challenge, the study was over budget and CRO staff turnover on the project was extremely high. Catalyst provided a blinded and unblinded monitoring team that reported into the Sponsor’s CTM using Catalyst’s SOPs allowing the Sponsor to retain control of their program.
A High Unmet Need That No One Wanted To Talk About
3/2/2020

What do you do when patients are too embarrassed to talk about what’s wrong with them? Recruiting “hidden” patient groups for rare disease studies is always challenging, and flexibility is the only constant.

More Clinical Trial App Notes & Case Studies

NEWSLETTER ARCHIVE

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COVID-19 AND YOUR CLINICAL TRIALS

More COVID-19

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.

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.
Best Practices For Designing And Running Clinical Trials For Patients With Rare Diseases

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.
FDA’s 2021 Focus Areas Of Regulatory Science: 5 Trends To Watch

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

Turning Point In U.S. History: Our Chance To Do Better With Clinical Trials

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.
Addressing Disparities And The Democratization Of Clinical Trials

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.
Let’s Tackle The Hidden Real-World Reasons For Poor Clinical Trial Diversity

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.