The FDA Steps Up Pressure on Sponsors to Increase Diversity in Clinical Trials — How Decentralized Clinical Trials Can Help
Published: December 2022 by PCM Trials
The FDA has been advocating for increased diversity in clinical trials for decades, yet certain groups remain woefully underrepresented in many studies. But it appears we are at a turning point where talk about increasing diversity and inclusiveness is turning into action, and real change is afoot. This paper explores the reasons behind the shift and how decentralized clinical trial methods can enable sponsors and CROs to recruit and retain more diverse participants. Learn More
Published: October 2022 by Ethical
DSMBs, DMCs and Steering Committees have existed for a number of years. Regulatory guidance from both major agencies, the FDA and the EMA were issued to advise sponsors and investigators on the good use of such committees.
Abundant information can be found about when, why and how to set up and use DSMBs but we feel that there was still a need for regrouping all that information into this single integrated handbook. Learn More
Published: October 2022 by PCM Trials
If you’re like a growing number of sponsors and CROs, you already recognize the many benefits of conducting a hybrid or fully remote clinical trial. However, not all remote visit providers are the same. So how do you decide which one is right for your next trial? This whitepaper offers 10 questions to ask of prospective partners to ensure they have the capabilities and experience to meet your needs. Learn More
Published: September 2022 by Medable
According to a survey conducted by Florence Healthcare, 47% of research sites had adopted eConsent by December 2020, just 8 months after the WHO declared an official pandemic. By July 2021, 75% of research sites had either used it or were looking into it.
In conclusion — a decentralized consent process is here to stay.
Learn why Medable's Total eConsent offering is the industry-leading remote consent technology, and how it can reduce your enrolment timelines by 50%. Learn More
Published: August 2022 by WCG
Endpoint adjudication is nothing new. Sponsors often turn to endpoint adjudication committees (EACs) for large, complex studies, but they aren’t limited to large trials anymore. In recent years, we’ve seen a growing trend to leverage EACs in new ways. The goal, however, remains the same: to reduce bias and increase accuracy of clinical trials. In this paper, we will talk about factors to consider when determining the need for an adjudication committee. Learn More
Published: August 2022 by PCM Trials
Decentralized clinical trials became better understood after sponsors and CROs turned to them to rescue studies during the pandemic, but several misconceptions persist that are standing in the way of wider adoption of DCTs and the value they bring, including providing a more diverse range of participants access to potentially life-saving drugs.
This whitepaper lists five common concerns about DCTs and how a leading provider of mobile research services, PCM Trials, addresses them. Learn More
Published: July 2022 by WCG IRB
In this paper, we will talk about why it is important to collect information in clinical research studies about gender identity and sexual orientation and will discuss specific ideas for making studies inclusive of and respectful to the LGTBQIA+ community. Learn More
Published: June 2022 by eClinical Solutions
This whitepaper highlights why the industry is shifting from Risk-Based Monitoring (RBM) to Risk-Based Quality Management (RBQM), and how sponsors can build a scalable approach that protects trial participants, upholds study integrity, and increases operational efficiencies. Learn More
How Sponsors and CROs can Fully Benefit from the Permanent Shift to Decentralized Clinical Trials Brought About by the COVID-19 Pandemic
Published: June 2022 by PCM Trials
How can you benefit from the permanent shift to decentralized clinical trials brought about by the COVID-19 pandemic? Learn about all the benefits in our Lessons Learned guide today! Learn More
Published: May 2022 by Medable
Over 70% of potential research participants live >2 hours away from a research site, & patient drop-out rates can reach 30% depending on the therapeutic area. Download the white paper to discover how to optimise eConsent for maximum patient centricity. Learn More
Published: January 2022 by WCG
The good news is that diversity and equity programs are on the rise. They are urgently needed across healthcare initiatives – including clinical trials. How do we create trust, engage minority patients and reduce access barriers to medical care and the benefits of clinical trials? Learn More
Checklist for Selecting an Electronic Data Capture (EDC) System and CTMS that Your CRO Will Find Easy to Use
Published: April 2022 by Institute of Biostatistics and Analysis
The Institute of Biostatistics and Analysis' EDC Systems Guide will help you find the software that saves you time, money and nerves and that will maximally support your clinical studies. Learn the importance of well-designed EDC software and what features such a system should have to help you smoothly navigate through your clinical trials without unnecessary hiccups. Learn More
Published: April 2022 by WCG
The way that we conduct clinical research has been changing since the onset of the COVID-19 pandemic. What factors are contributing to study enrollment challenges for sites and sponsors? What solutions can we as an industry leverage to overcome those obstacles? As an industry, we are at an inflection point. We can’t keep doing things the way we’ve always done them; we must do better. Learn More
Published: March 2022 by WCG IRB
This paper examines the nature of decentralized clinical trials, potential benefits and risks of this new paradigm, and best practices for maintaining regulatory and Institutional Review Board (IRB) compliance. Learn More
Published: February 2022 by WCG IRB
Expanded access can appear to be a daunting endeavor, especially for those physicians not part of an institution or without an established relationship with an institutional review board. This paper will help provide guidance on starting the expanded access request process for those physicians who want to provide an expanded access option to their patient as quickly as possible. Learn More
Published: February 2022 by eClinical Solutions
Take a deeper look into the key components of preparing for the digitization of today’s clinical trials in this new guide. You will learn the necessary steps that organizations must take to embrace transformation processes that will help usher in a new way forward for clinical trials. Learn More
Published: November 2021 by Medable
Patient recruitment, retention, diversity, safety, and data collection & analysis are all factors driving the need for radical innovation in clinical drug development. This need has been made painfully apparent during the current COVID-19 pandemic.
We can no longer ‘do the same thing and expect a different result’; it’s time to take giant steps forward. This White Paper outlines the methods Sponsors, Sites & CROs can adopt to digitally transform their protocols for improved scientific outcomes. Learn More
Published: November 2021 by MRN
Supporting patients and sites is the goal of decentralized solutions in clinical trials – increasing recruitment and retention for sites and making participation less burdensome for patients and families.
This free whitepaper, Decentralized Clinical Trials- how to deliver the complex efficiently, will give you an inside view into key questions and considerations stakeholders need to be asking when developing decentralized visits that will result in efficient and safe delivery for patients. Learn More
Published: November 2021 by WCG
The cost of developing drugs continues to escalate. Estimates vary, but the Tufts Center for the Study of Drug Development estimated the out of pocket pre-tax costs to be $1.4 billion per approved new product in 2013 dollars. It is not unreasonable to assume that this has continued to rise over the intervening years. In view of these rising costs it is more crucial than ever before that Sponsor companies try to mitigate against failure and delay in their drug developments.
In this whitepaper, WCG explore aspects of immunology clinical trials that deserve particular focus in order to provide the greatest opportunity for success. Learn More
Published: October 2021 by Ethical GmbH
Improper Protocol Deviation management is costing the clinical trial industry millions of dollars per year. This represents substantial safety and quality risks that add new additional burdens for clinical teams all over the world. This Handbook (30 pages) explains the overall Protocol Deviations assessment process, lists the involved parties and describes the various methods/actions provisioned by regulations. We also discuss tools and procedures that may alleviate the burden and improve the outcome of Protocol Deviations management. Learn More
More Than Good Intentions: Diversity, Equity & Inclusion Requires a Program-Level, Strategic Framework
Published: September 2021 by WCG
Sponsors understand the importance of diversity, equity and inclusion (DE&I) efforts and have begun to implement them in their trials, but diversity in clinical trials has yet to be achieved.
To address this gap between aspiration and execution, sponsors — as well as sites and CROs — must recognize that DE&I is not merely another project. Neither is it a series of tactics. It is a systemic, top down transformation that must be managed strategically at the program level. The DE&I strategy must be communicated and implemented across your trial sites, including referral sites. It needs to extend into the nearby community-based sources of potential patients. Most importantly, no one can execute a diversity strategy alone.Learn More
Published: September 2021 by Medidata
While the use of medical imaging in clinical trials is rapidly increasing, the wave of M&A activity across key imaging players has created confusion for clinical trial stakeholders. This guide provides eight parameters sponsors, sites, and CROs should focus on to avoid the pitfalls in this disrupted landscape and ensure an optimal imaging strategy for your trials. Learn More
Published: August 2021 by WCG
In a recent WCG webinar, Steven Beales, Senior Vice President, Scientific and Regulatory at WCG, facilitated a conversation with FDA leaders, Robert Temple, the Deputy Director of CDER, and Jacqueline Corrigan-Curay, the Director of the Office of Medical Policy. They discussed overreporting SUSARs and the impact on patient safety. This whitepaper is based largely, but not solely, on that conversation. Learn More
Published: July 2021 by Medidata
The rising complexity of clinical trials and pressures resulting from the COVID-19 pandemic have forced sites, sponsors, and clinical research organizations (CROs) to adopt remote and risk-based approaches for clinical trial execution. With the increasing prevalence of decentralized clinical trials, the industry is now poised to fully embrace and implement risk-based quality management (RBQM) approaches to trial execution and oversight.
This white paper outlines the current state of RBQM in virtualizing clinical oversight, and the value that adopting these approaches brings to sponsors, CROs, sites, and ultimately patients.. Learn More
Published: July 2021 by Medidata Acorn AI
What if researchers didn’t need to recruit a control group and could offer the experimental treatment to everyone who agreed to be in the study? In this white paper — developed in partnership with MIT Technology Review — you’ll learn how biotechnology companies are leveraging Medidata’s detailed information from 23,000+ trials and 7 million patients to create external control arms and accelerate the clinical trial process. Learn More
Published: May 2021 by WCG
Whether the focus is endpoint adjudication, aggregate data monitoring or safety assessment, the clinical and device development industry clearly understands the value of establishing expert scientific committees to provide oversight on study data. These expert committee assessments provide validation on clinical data as additional support for regulatory submissions and commercial strategy. What is less well understood, however, is the importance of independent expertise. Without independent expertise, sponsors risk biased decision-making, conflicts of interest, potential clinical delays and squandered resources that could otherwise be avoided. Learn More
Published: May 2021 by Veeva
Investing in data standards plays a huge role in improving the quality of clinical studies. But often, people don’t use the standards correctly, there are too many variations, or the standards keep changing, preventing you from running efficient trials.
Learn how to develop a standards program that has your full team’s buy-in and improves the efficiency and quality of your clinical trials. Learn More
Published: May 2021 by eClinical Solutions
Take a deeper look into the current state of data sources, organization, and analytics in this new whitepaper. You will learn about their impact and the opportunities that exist to accelerate decentralized and digital trials. The paper includes insights on how 149 life science organizations are managing drug development data volume and diversity, existing challenges that impact clinical performance and efficiency, and the opportunities to accelerate digital transformation leveraging technology platforms and new processes. Learn More
Published: April 2021 by WCG
The clinical trial environment faced a massive disruption in the wake of COVID-19, the scope of which was both unprecedented and incalculable. Clinical trial operators were in triage mode. There was no tested playbook for a pandemic, no standard operating procedure. And almost everything depended on sites. So how will clinical trial stakeholders continue to adapt in a (post-) pandemic world? Learn More
Published: April 2021 by WCG
Complex challenges provide ample incentives to re-imagine the traditional business model – rising costs, shifting resources, increased pressure and “new normal” virtual settings. Motivated clinical research leaders want increased focus on patient care along with faster study starts, more patient access to trials and better performance while reducing costs and staffing burdens. Our recent webinar discussed industry trends as well as obstacles and new, practical approaches to achieving success. Learn More
Published: April 2021 by Egnyte
For high-growth institutions with limited resources and bandwidth, the question arises: what should you do to comply with international and regional data privacy regulations?
Determine your best approach to data privacy with this whitepaper from Egnyte. Learn More
Published: March 2021 by Agatha, Inc.
Electronic systems for managing clinical study documentation first emerged in the 1990s and have evolved through several generations. Today, we have entered the fourth-generation of the eTMF system. This guide walks through the changes over four generations and aims to help clinops professionals understand what constitutes a 4G eTMF, how to compare alternative systems, and offers tips to put one into production quickly. Learn More
Published: Mach 2021 by Ethical GmbH
A complete guide to creation and management of the Endpoint Adjudication Charters. Endpoint adjudication charters are a key element for the setup of quality Adjudication procedures and have been developed in various formats. We at Ethical have performed a thorough review of dozens of endpoint adjudication charters in order to build the present guide. Learn More
Published: February 2021 by Acorn AI™
This white paper discusses the concept of the Synthetic Control Arm® (SCA®), which is a type of external control that is generated using patient-level data from patients external to the trial. SCA® is designed to improve the interpretation of uncontrolled trials and enable better product development decisions. A series of case studies are provided to highlight the different ways a SCA® has been used. Learn More
Published: February 2021 by Medidata
COVID-19 has highlighted bottlenecks and obstacles to data capture, monitoring, and management.
The new paradigm of remote visits and virtual trials, the growing pressure to leverage an expanding set of research, clinical, operational and real-world data, and the shift to risk-based monitoring demand new data management strategies.
Download the guide to consolidate and manage study data for validity and reliability, understand the impact of your technology choices, and identify processes to ensure drug and device safety and efficacy. Learn More
Published: December 2020 by WCG
Looking ahead to 2021, we have a new outlook on how we can conduct clinical research with a new-found capacity for flexibility, collaboration, and a focus on the importance of both patient-centric research practices and diversity. In our 2021 prospectus, 23 industry experts from WCG share the important shifts, trends, regulations, and priorities that will inform clinical trial development in 2021 and beyond. Learn More
Published: Dcember 2020 by Medidata
Medidata surveyed life science CTOs about how they perceive and choose clinical trial tech platforms. Discover why the benefits of unified platforms—cross-application data reporting, connected workflows, simplified virtualization, and reduced costs—appeal to CTOs, and learn about the future of technology for clinical development. Learn More
Published: November 2020 by ICON plc
The manifestations and effects of Traumatic Brain Injury (TBI) are varied and impact diverse populations — it is estimated that 69 million individuals suffer TBI each year. A better understanding of how TBI manifests, can lead to better identification of biomarkers, and the development of prevention and treatment strategies. Learn how digital health technologies are shaping the future of TBI clinical research. Learn More
Published: October 2020 by LMK Clinical Research Consulting
Society evolves with technology, and the clinical research industry is no different; it uses technology to develop new tools and treatments to advance medical care. Many clinical research companies have transferred from paper-based trial master files (TMFs) and manual logs to electronic systems and eTMFs. These systems are utilized to assist in keeping documentation compliant and organized. Though these systems make it easier to classify and preserve documentation, they also require a lot of time and effort to ensure proper controls and maintenance. Due to the lack of resources, training and quality control, operating regulatory compliant electronic systems has become an industry-wide issue. Learn More
Published: September 2020 by Florence
How clinical operations leaders leverage remote site access technology to enable remote monitoring, start-up, management, and SDR/V. This guide will show you best practices, how-tos, and insights for implementing your own remote site access strategy: what is the eISF and how does it enable remote site access, how you can select a platform that will work for you and your sites, how to maximize the benefits, and how to get your study sites on board. Learn More
Published: August 2020 by Clincierge
Rare disease sponsors face an uphill battle when it comes to patient recruitment and retention during the COVID-19 Pandemic. Clincierge improves clinical trial outcomes by providing safe and patient-centric, strategic travel solutions to reduce barriers to trial participation. Learn more about the challenges rare-disease patients face and how Clincierge coordinates reliable patient support solutions, which can transform a patient’s experience and improve clinical trials. Learn More
Published: August 2020 by Medidata
This six (6) part white paper dives into the challenges that biopharmaceutical sponsors face and presents a variety of solutions capable of streamlining the process to speed delivery of rare disease treatments to the market. Learn More
Published: May 2020 by Oracle Health Sciences
This white paper defines CRO oversight, describes the importance of relationship building among stakeholders, and takes a look at innovative solutions for streamlining study startup a notorious bottleneck and a critical step toward managing study statuses in real-time. Learn More
Published: March 2020 by WCG
Uncertainty over the future impact and implications of COVID-19 continues to exacerbate the preexisting issue of under-resourced sites.
Overwhelmed and lacking proper bandwidth, many sites may not have the appropriate infrastructure to adapt to this everchanging situation. Strategically placed remote site and patient support can ease that burden by carrying out a customized support plan tailored to the unique needs of each study site. Whether offering remote support in any type of trial or ensuring safe proper procedures on-site, WCG's remote site staff can work within any study team to ease the burdens that threaten to keep new therapies from reaching patients. Learn More
Published: February 2020 by The Avoca Group
So often, inspections are a major source of stress in the clinical trial environment. This is especially true when processes involved in preparing for an inspection are reactive. But, it doesn’t have to be that way. Using industry-leading practices and resources enables a proactive approach to mitigate — or even eliminate — the pain points associated with preparing for inspections. Learn More
Published: October 2019 by WCG
The number of drug products under development that incorporate recombinant or synthetic DNA or RNA, viral vectors, and/or genetically-modified organisms (“GMOs”) continues to grow rapidly, and several such products have received marketing approval from the FDA. This paper focuses on important points to consider when planning to initiate clinical trials with these products at sites inside or outside the USA, if the research is subject to rules and regulations of the FDA and/or the National Institutes of Health (NIH) of the United States. In particular, we focus on the roles of Institutional Biosafety Committees (IBCs) and Institutional Review Boards (IRBs) in approving and facilitating study startup. Learn More
Advances in Oncology Extend Lives, but Lead to New Safety Considerations for Sponsors and Investigators
Published: October 2019 by WCG
From cardiovascular adverse events to complex dosing regimens, oncology trials present unique safety-related considerations. Left unaddressed, they could undermine a trial or put patient safety at risk. In this paper, we discuss some of those issues and how sponsors can best address them. Learn More
Published: May 2019 by WCG
Patient voice isn’t an accessory; it’s foundational. Patients are key to clinical trials, and relegating them to mere “subjects” diminishes their value. Including the patient voice in study design and development can make an enormous difference in recruitment, enrollment, and retention. Doing so also pleases regulators, who are increasingly putting a premium on patient-focused drug development. It doesn’t have to be difficult, but getting it wrong — or not doing it at all — can undermine a trial. Learn More
Something Has to Give: The Current Unsustainable Approach to Safety Reporting Puts Trials and Patients at Risk
Published: May 2019 by WCG
Safety reporting may be the most inefficient aspect of clinical trials today. It’s also among the most expensive, costing sponsors more than $700 million per year. Most are not receiving the best value for their investment, and some don’t even know how much they are spending. Automation has helped resolve some of the challenges, but it has created just as many. The system needs a complete overhaul. It can be done, but it requires the willing to invest in change. Learn More