The projected growth of the clinical research industry demands that the workforce keep pace with the workload — and it must be diverse and research-ready. What’s at stake? Nothing more than the risk of delaying approvals of new treatments for patients who need them.
- 5 Trends Across Employee And Clinical Trial Recruitment
- What Astellas Has Learned About Decentralized Trials
- Trusting Digital Health Technologies: Why Global Standards Are A Must
- Portage Biotech Creates A New Drug Development Model
- A 3-Point Strategy For Training Part-Time GCP Consultants
- How To Make Trials More Successful With Medical Monitors
- LATAM’s Regulatory Framework For Medtech Early Feasibility Studies
GUEST COLUMNISTS
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![Senoir-Couple-Homecare-Visit-GettyImages-1375404465]( "How — And Why — To Embrace Intersectionality In Clinical Trials")
How — And Why — To Embrace Intersectionality In Clinical TrialsIntersectionality is the framework for how a person’s relationships, identities, interactions, and interdependencies can create different advantages and disadvantages. In order to fully embrace intersectionality and make meaningful impacts in clinical trial recruitment of diverse populations, the entire journey of the patient must be realized — every step of the way.
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![GettyImages-1332002332-network-technology-data-4g-5g-cellular-connectivity]( "Survey Reveals High Levels Of CTIS Adoption In Europe")
Survey Reveals High Levels Of CTIS Adoption In EuropeEarly feedback from users of the EMA’s new centralized clinical trials information system (CTIS) is broadly positive, according to a survey of 400 U.S. and European life science leaders. CTIS use isn’t mandatory until after the end of January 2023, but industry uptake has already been strong.
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![Law book with a gavel - 2022 GettyImages-1355117041]( "India’s New Drugs, Medical Devices, And Cosmetics Draft Bill 2022")
India’s New Drugs, Medical Devices, And Cosmetics Draft Bill 2022To accommodate changing requirements and encourage the adoption of new technology, India’s Ministry of Health and Family Welfare released a draft bill in July 2022 to replace the existing Drugs and Cosmetics Act 1940. What are the major areas of change and how much of an impact will there be?
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![Female-doctor-at-office-GettyImages-1367408214]( "Key Learnings To Optimize Clinical Trials During COVID-19")
Key Learnings To Optimize Clinical Trials During COVID-19Designing and conducting trials during the COVID-19 global pandemic forced clinical teams to be creative, to explore the use of technology, and to design a trial that meets the participants where they are — without compromising outcomes.
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![Idea-GettyImages-1364280438]( "Key Insights From The 2022 PDA/FDA Joint Regulatory Conference")
Key Insights From The 2022 PDA/FDA Joint Regulatory ConferenceKey focus of this article is spent on thoughts shared by the FDA speakers, including the importance of a quality infrastructure, sustainable compliance, data integrity, and more.
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![GettyImages-1321906152]( "How To Implement Patient-Focused COAs")
How To Implement Patient-Focused COAsDrug developers often talk about “patient centricity,” but most find it challenging to prioritize a patient-centric research approach in the earlier phases of drug development. A good place to start is by collectively measuring what matters most to patients — and COAs help get us there.
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![Speech-Bubbles-GettyImages-1370624040]( "How To Optimize Returns On Plain Language Summaries")
How To Optimize Returns On Plain Language SummariesThe EMA now requires Plain Language Summaries (PLS) for clinical trials with sites in the EU. The FDA has no current regulations for PLS, but they fit into recent guidance documents. PLS meet the needs of trial participants, their families, and patient advocacy groups, among others. Optimize your PLS with these tips.
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![GettyImages-1199119631]( "RWE & Advanced Diagnostics Propel Better Patient Outcomes")
RWE & Advanced Diagnostics Propel Better Patient OutcomesNotable diagnostic advancements in data science and the scientific community’s ability to use analytic tools are playing an essential role in improving patient outcomes.
CLINICAL TRIAL WHITE PAPERS
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![Global Medicine GettyImages-121380309]( "Regulatory Strategy Considerations For Working With The FDA Vs. The EMA")
Regulatory Strategy Considerations For Working With The FDA Vs. The EMAThis guide explores the regulatory strategy considerations sponsors should bear in mind when working with global regulation agencies, with a focus on the development of drug and biologic products.
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2020 Completed Trials: A Bumpy Road for Industry-Sponsored Clinical Studies9/27/2021
The COVID-19 pandemic created delays for trials that were planned for completion in 2020 and directly contributed towards trial terminations. Despite this, more diseases, and more indications outside of oncology, achieved at least 25 successful trials. Read the full report.
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Considerations Regarding Noninferiority: A Case Study In Multiple Sclerosis9/22/2021
To illustrate the seven key elements that should be considered before selecting an NI study design, this paper presents a case study examining the potential use of an NI design in a study involving relapsing remitting multiple sclerosis (RRMS).
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Long-Term Follow-Up For Gene Therapies — Innovative, Patient-Centered Approaches11/18/2021
Find out how long-term follow-up (LTFU) studies for gene therapies present unique challenges, and highlight important considerations for different kinds of sponsors, including biotech and emerging biopharma.
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eCOA Training: How Can We Improve The Sites’ And Patients’ Experience?11/4/2021
In this white paper, read how training opportunities can be developed to better support personnel, how patients can be supported through understanding ePRO completion and the value of the data, and how sites and patients can be efficiently trained to keep engagement levels the same in a post-COVID world.
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How Real-Time Visibility Requirements Reduces Risk In eClinical Supply Chain Management9/26/2022
Data integrity is a massive concern for sponsors of clinical trials. This paper explores the real-time visibility requirements for an eClinical Supply Chain Management platform.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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What’s Needed: An Alternative Approach To Clinical Trial Management10/20/2021
RBQM is a more substantial undertaking, requiring quality, reliability, and interpretability. Regulators want to see clinical trials implementing this approach. Yet, sponsors and contract research organizations (CROs) are finding it challenging. It doesn’t have to be.
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Trial Tokenization And Linking To Real World Data: Extending The Effectiveness And Safety Analysis Of A New Focal Seizure Treatment8/12/2021
Recently, a biopharmaceutical company completed at 36 week Phase IV study of 175 patients across 40 trial sites to evaluate the effectiveness and safety of a recently approved anti-seizure medication as adjunctive therapy in focal seizure. Read the available case study to find out more.
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Streamlining Regulatory Submissions For A Novel Advanced Therapy Medicinal Product Trial10/28/2021
The European regulatory landscape for advanced therapy medicinal products (ATMPs) is complex, and the approval pathway depends on product classification. This case study describes how product classification may not always be clear-cut, given the proliferation of novel approaches to ATMP development.
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WebCOA Back-Up, The Best Balance For Data Quality, Ease-Of-Use, And Cost For Your Clinical Studies12/6/2021
Explore 7 reasons to choose a web-based back-up solution for your eCOA studies.
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Elevating Effective Outcomes With Companion Diagnostics3/22/2021
Companion diagnostics (CDx) is a keystone for pharma to create more precise drug therapies as personalized medicine accelerates. Here’s why a CDxcentral laboratory partner is necessary.
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Expanding Flexibility Of eCOA Data Collection With Controlled Interview Mode1/31/2022
By allowing the collection of ePROs by trained personnel during a remote interview, discover how the interview mode constitutes an additional data entry mode when clinical trial participants cannot go to the study site for a scheduled visit.
NEWSLETTER ARCHIVE
- 12.02.22 -- How To Make Trials More Successful With Medical Monitors
- 12.02.22 -- Partners Ready To Help With Your Study Startup Process
- 12.01.22 -- A 3-Point Strategy For Training Part-Time GCP Consultants
- 12.01.22 -- The Key To A Successful Decentralized Model
- 11.30.22 -- Unexpected Results: What I Learned During 12 Site Audits In Africa
CLINICAL LEADER CONTENT COLLECTIONS
The articles in this e-book all relate to the challenge of CRO selection. We hope you enjoy them and learn from the insights contained in them.
More Content CollectionsFOCUS ON PATIENTS
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![GettyImages-1321906152]( "How To Implement Patient-Focused COAs")
Drug developers often talk about “patient centricity,” but most find it challenging to prioritize a patient-centric research approach in the earlier phases of drug development. A good place to start is by collectively measuring what matters most to patients — and COAs help get us there.
-
![Speech-Bubbles-GettyImages-1370624040]( "How To Optimize Returns On Plain Language Summaries")
The EMA now requires Plain Language Summaries (PLS) for clinical trials with sites in the EU. The FDA has no current regulations for PLS, but they fit into recent guidance documents. PLS meet the needs of trial participants, their families, and patient advocacy groups, among others. Optimize your PLS with these tips.
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![Doctor-patient-GettyImages-1345513639]( "5 Ways To Expand Racial & Ethnic Diversity In Clinical Trials")
Between 2000 and 2020, nearly 80% of clinical trial participants were white. The underrepresentation of diverse racial and ethnic groups is not new, but we must do more to address disparities. Here are five strategies for action.
EMBRACING DIVERSITY & INCLUSION
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![IMG_9052]( "A Firsthand Experience In Africa — Better Than Expected")
Except for South Africa, sub-Saharan African countries are still largely underrepresented in the global clinical study map. Hesitation to conduct clinical studies in Africa may be partly a result of assumed poor infrastructure, missing regulations, and inexperienced researchers. But is it truly so? Or is our thinking stuck somewhere in the past?
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![Retention-Marketing-GettyImages-1331999115]( "5 Trends Across Employee And Clinical Trial Recruitment")
Whether in the world of employment or clinical trials recruitment, if recruits can’t find what they’re looking for from you, they will find it from someone else or fail to engage entirely. Explore five trends crucial to successful employee and trial participant recruitment.
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![GettyImages-511457590]( "LATAM’s Regulatory Framework For Medtech Early Feasibility Studies")
Latin America is a compelling region to conduct medtech early feasibility studies due to its ethnically diverse population, its high rate of urbanization, and more. Here, the author spotlights Colombia, Brazil, and Mexico as the hotspots for medtech feasibility studies in Latin America.
