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

How COVID-19 Will Change Clinical Trials And End The Patient Recruitment Challenge

Clinical technologies are evolving and promise to change how studies are conducted. Still, change takes time. Most companies do not rush out to embrace every new technology that comes along. The COVID-19 pandemic may be changing that.

GUEST COLUMNISTS

Can Virtual Trials Maintain Their Momentum After COVID?
Prior to COVID-19, there were many discussions about how it might be possible to conduct virtual trials, using technology and innovative measures. Now that the pandemic has forced many trials into virtual settings, what will it take for the industry to fully implement a virtual approach beyond the pandemic?
9 Factors For Driving Inclusivity & Patient Centricity In A Transformed Clinical Trials Landscape
Patient-centricity, quality, and inclusion are not natural consequences of the shift to virtual clinical trials. To be intentional with the design, we must start with articulating and understanding the full contexts of patients’ lives, medical and beyond.
What Is Your AI Road Map To Revolutionize Drug Development?
When it comes to artificial intelligence (AI), many organizations do not know where to start or waste their energy going in many directions without a clear vision. This article will share insights on how to pragmatically initiate an AI journey using the evolution of clinical data management as an example.
How FDA Is Helping Advance Clinical Trial Diversity
An update from the FDA Office of Minority Health and Health Equity on its efforts to address health disparities and health equity — and ultimately strengthen the agency’s ability to respond to minority health concerns.
How Storyboarding Can Bring Clarity To Regulatory Inspection Readiness & Facilitation
Developing storyboards for regulatory inspection readiness and facilitation is a growing trend, yet the tool is shrouded in mystery for many pharma industry professionals. (Downloadable storyboard template included.)
Discovering & Motivating Talent In The Life Sciences: Redefining “Other Duties & Responsibilities”
How do we attract the right kind of talent to a role within our organizations? How do we take the same innovative approaches in our talent acquisition processes that we put into our products? One answer can be found in an often-overlooked bullet point in a common job description: “other duties and responsibilities as required.”
4 Best Practices That Kept A Biotech’s Clinical Trial Moving In The COVID-19 Era
The timely enrollment and progression of clinical trials is critical for a pre-commercial biotech company, as delays can keep treatments from getting to patients and cost an organization significant money and reputation. When you throw in a worldwide pandemic, it’s a whole new ball game.
Can CROs Rise To The Patient Access & Recruitment Challenge?
You have a human condition to improve and a protocol to follow. All smooth sailing from here, right? Indeed, even the most well-planned clinical trial is dead in the water if the needed patients are not accessible or willing to participate.

CLINICAL TRIAL WHITE PAPERS

Driving Product Development And Finding The Fast Track In Early-Phase Oncology Programs
Explore the many aspects a company must consider in planning and executing an early-phase oncology trial of this hypothetical compound, from performing a regulatory gap analysis and developing a target product profile to identifying the right patients and selecting efficacy endpoints.

Basket Clinical Trial Designs: The Key To Testing Innovative Therapies Is Innovation In Study Design And Conduct
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.
ePRO And Agile Methodology: A Winning End-to-End Solution For Oncology Studies
In oncology clinical research, patient reported outcomes (PRO) have historically been collected on paper. This white paper describes a unique, agile ePRO deployment methodology used by a global clinical trial technology company, discusses the benefits of using ePRO in oncology trials, and explains why this agile process is beneficial for oncology trials.
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?
Mitigating Inherent Risks In Global Sample Processing
The global demand for specialized sample processing has grown dramatically however despite the rising need, research teams continue to struggle to obtain high-quality laboratory support services to perform sample processing. Learn how innovative flow cytometry fast turnaround and monitored, specialized processing can help safeguard samples.
Maximizing Success In Early Stage Oncology Trials: Considerations And Strategies In The Era Of Molecularly Targeted Agents
Making a meaningful impact on the survival and quality of life of patients with cancer remains a significant challenge. This white paper discusses considerations and strategies for maximizing the likelihood of success in early phase oncology trials and developing significantly improved therapeutics for patients.

More Clinical Trial White Papers

CLINICAL TRIAL APP NOTES & CASE STUDIES

A Multiple Sclerosis Clinical Trial Collaboration
Managing multiple outcome measures and rapid patient recruitment for Phase IIB clinical trial on targeting relapse-remitting Multiple Sclerosis
Regulatory Inspection SOP Checklist: How to Prepare for an Inspection
A best practice for inspection preparation is a standard operating procedure (SOP) that codifies the roles, procedures, and training your organization will enact in preparation for an announced inspection.
Adopting Label Change Best Practice To Promote Clarity And Compliance
Globalized clinical trials are quickly becoming a pre-requisite for success. Read Almac’s latest case study to learn how one sponsor was able to extend its trial into new countries without risking labelling non-compliance, which enabled them to continue on their mission to improve the health outcomes for millions of patients.
FDA Inspections Need Not Be Stressful
As a stakeholder in a research facility the prospect of an inspection by the US Food and Drug Administration (FDA) may elevate your blood pressure and induce feelings of panic. But according to Dr. Harvey Arbit, "the FDA inspection process should go quite smoothly if you're doing everything right." Still nervous? Don't be.
Fast Track To Flexible Clinical Trials
So, about that clinical trial running right now. In several countries. Clinical setting required. Hmm. We at ISR are speculating that sponsors are shopping around for providers who can adapt, and adapt quickly, to current times. We know that outsourcing is already a challenging undertaking – which CRO is best-suited to conduct a given trial? Who will perform the best? These are loaded questions in normal times, and we provide the reliable data needed to tackle them. Every year we survey hundreds of clinical development outsourcers to share their perspectives and experiences regarding CRO selection and performance evaluation. Did we have the foresight to ask about trial adaptability in the face of a global pandemic? Unfortunately, no, but some findings suggest change is coming.
Solution For Independent Data Monitoring Committee Services
Client turns to this CRO when they needed a team experienced with the full range of IDMC activities to provide a seamless solution.

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NEWSLETTER ARCHIVE

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COVID-19 AND YOUR CLINICAL TRIALS

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CLINICAL LEADER CONTENT COLLECTIONS

In this eBook, we take a close look at Real World Evidence. What is it, how is it being used, why all the hype over it, and how the use of RWE is bringing together the worlds of pharma R&D and healthcare. But more importantly, how can we best tap into the data we have available to us today to improve clinical studies and healthcare in the future. Our experts include executives from Bristol-Myers Squibb, Pfizer, the University of Southern California, and Harvard Medical School.

FOCUS ON PATIENTS

9 Factors For Driving Inclusivity & Patient Centricity In A Transformed Clinical Trials Landscape
Patient-centricity, quality, and inclusion are not natural consequences of the shift to virtual clinical trials. To be intentional with the design, we must start with articulating and understanding the full contexts of patients’ lives, medical and beyond.
4 Best Practices That Kept A Biotech’s Clinical Trial Moving In The COVID-19 Era
The timely enrollment and progression of clinical trials is critical for a pre-commercial biotech company, as delays can keep treatments from getting to patients and cost an organization significant money and reputation. When you throw in a worldwide pandemic, it’s a whole new ball game.
Unpacking FDA’s New Guidance On Collecting Patient Experience Data
The FDA recently released one of what is to be four new guidances providing a general overview of patient-focused drug development. This article summarizes each component of "Guidance 1: Collecting Comprehensive and Representative Input" and details how the guidance may impact sponsors of clinical trials.

EMBRACING DIVERSITY & INCLUSION

9 Factors For Driving Inclusivity & Patient Centricity In A Transformed Clinical Trials Landscape
Patient-centricity, quality, and inclusion are not natural consequences of the shift to virtual clinical trials. To be intentional with the design, we must start with articulating and understanding the full contexts of patients’ lives, medical and beyond.
How FDA Is Helping Advance Clinical Trial Diversity
An update from the FDA Office of Minority Health and Health Equity on its efforts to address health disparities and health equity — and ultimately strengthen the agency’s ability to respond to minority health concerns.
How Can We Begin To Solve Unconscious Systemic Bias In Clinical Trials?
Halting disparities in clinical trials during the time of COVID-19 will take eradicating unconscious bias, building trust in diverse communities, dispelling long-held myths, constructing relationships, and educating patients, family members, and physicians.