Medpace experts discuss how to overcome oncology recruitment challenges for clinical trials for specific populations, indications, and challenging studies.
Identifying High Performing Sites and Engaging PatientsMedpace
One of the biggest challenges facing any clinical trial is how to identify the sites with the greatest potential to engage and retain patients. Applying decades of experience to the topic, Medpace experts will share considerations, lessons-learned and best practices for developing patient recruitment strategies to put you on the path for optimal success.
The RACE for Children Act Will Change the Landscape for Pediatric Cancer Rese...Medpace
In this webinar, we explore the regulatory implications of the RACE for Children Act and what this law means for your development program, particularly with navigating the change in requirements for pediatric oncology trials. Furthermore, we explore the challenges of executing oncology trials in pediatric populations and offer insight into design and operational aspects to seamlessly execute these studies as part of your clinical development plan
Challenges and Considerations in Designing and Conducting Immuno-Oncology Cli...Medpace
Given the accelerating pace of immuno-oncology clinical research, awareness of the specific challenges and considerations in designing and conducting successful trials for these new agents is critical.
Emerging diagnostic technologies proving the clinical application through g...Lyssa Friedman
Next Generation Sequencing is an exciting new technology for diagnostics companies. But is it right for all products and for all companies? This presentation was delivered via Webinar for a IVD audience for Q1 Productions, March 25, 2014.
Wielding the Double-Edge Sword of Cardiac Biomarkers in Clinical Trials: A Di...Medpace
Learn best practices for utilizing cardiac biomarkers across various components of a clinical trial from Dr. James Januzzi, a leading expert in cardiovascular biomarkers.
Identifying High Performing Sites and Engaging PatientsMedpace
One of the biggest challenges facing any clinical trial is how to identify the sites with the greatest potential to engage and retain patients. Applying decades of experience to the topic, Medpace experts will share considerations, lessons-learned and best practices for developing patient recruitment strategies to put you on the path for optimal success.
The RACE for Children Act Will Change the Landscape for Pediatric Cancer Rese...Medpace
In this webinar, we explore the regulatory implications of the RACE for Children Act and what this law means for your development program, particularly with navigating the change in requirements for pediatric oncology trials. Furthermore, we explore the challenges of executing oncology trials in pediatric populations and offer insight into design and operational aspects to seamlessly execute these studies as part of your clinical development plan
Challenges and Considerations in Designing and Conducting Immuno-Oncology Cli...Medpace
Given the accelerating pace of immuno-oncology clinical research, awareness of the specific challenges and considerations in designing and conducting successful trials for these new agents is critical.
Emerging diagnostic technologies proving the clinical application through g...Lyssa Friedman
Next Generation Sequencing is an exciting new technology for diagnostics companies. But is it right for all products and for all companies? This presentation was delivered via Webinar for a IVD audience for Q1 Productions, March 25, 2014.
Wielding the Double-Edge Sword of Cardiac Biomarkers in Clinical Trials: A Di...Medpace
Learn best practices for utilizing cardiac biomarkers across various components of a clinical trial from Dr. James Januzzi, a leading expert in cardiovascular biomarkers.
The Business of Genomic Testing by James CrawfordKnome_Inc
View this webinar at: http://www.knome.com/webinar-business-of-genomic-testing. This presentation discusses the findings of a College of American Pathologists survey of “early adopters” of NGS recently published in "Genetics in Medicine". The study objective was to identify the reasons for health systems to bring next-generation sequencing into their clinical laboratories and to understand the process by which such decisions were made. A standardized open-ended interview was conducted with the laboratory medical directors and/or department of pathology chairs of 13 different academic institutions in 10 different states.
Improving Inclusion/Exclusion Criteria for Clinical TrialsBrook White, PMP
Adherence to inclusion and exclusion criteria is essential to the successful execution of a clinical trial. Deviations from these criteria must be avoided because they can jeopardize scientific integrity, regulatory acceptability, or the safety of subjects in the study. This presentation provides suggestions and advice on formulating inclusion and exclusion criteria to enhance the quality of subject selection, minimize protocol violations, and avoid protocol amendments.
Our main involvement with your clinical research recruitment program concludes with processing the responses to your mailer. As our staff members direct the respondents to your site, you can begin conducting final interviews to complete the clinical trial recruitment process.
Patient recruitment & retention is highlighted as the key factor in ensuring study success, the area of patient retention in clinical trials is often overlooked. Retention of patients throughout the life of a clinical trial is however extremely vital from scientific as well as economic point of view. Poor recruitment & retention negatively impacts on the overall evaluable data for regulatory submissions. Dropped participants must be replaced which incurs further expenditures and time delays. Subject dropout rates are estimated to range from 15-40% of enrolled participants in clinical trials.
The Business of Genomic Testing by James CrawfordKnome_Inc
View this webinar at: http://www.knome.com/webinar-business-of-genomic-testing. This presentation discusses the findings of a College of American Pathologists survey of “early adopters” of NGS recently published in "Genetics in Medicine". The study objective was to identify the reasons for health systems to bring next-generation sequencing into their clinical laboratories and to understand the process by which such decisions were made. A standardized open-ended interview was conducted with the laboratory medical directors and/or department of pathology chairs of 13 different academic institutions in 10 different states.
Improving Inclusion/Exclusion Criteria for Clinical TrialsBrook White, PMP
Adherence to inclusion and exclusion criteria is essential to the successful execution of a clinical trial. Deviations from these criteria must be avoided because they can jeopardize scientific integrity, regulatory acceptability, or the safety of subjects in the study. This presentation provides suggestions and advice on formulating inclusion and exclusion criteria to enhance the quality of subject selection, minimize protocol violations, and avoid protocol amendments.
Our main involvement with your clinical research recruitment program concludes with processing the responses to your mailer. As our staff members direct the respondents to your site, you can begin conducting final interviews to complete the clinical trial recruitment process.
Patient recruitment & retention is highlighted as the key factor in ensuring study success, the area of patient retention in clinical trials is often overlooked. Retention of patients throughout the life of a clinical trial is however extremely vital from scientific as well as economic point of view. Poor recruitment & retention negatively impacts on the overall evaluable data for regulatory submissions. Dropped participants must be replaced which incurs further expenditures and time delays. Subject dropout rates are estimated to range from 15-40% of enrolled participants in clinical trials.
SHARE Webinar: Why Should I Join a Clinical Trial with Dr. Hershmanbkling
Dr. Dawn L. Hershman of the Herbert Irving Comprehensive Cancer Center at Columbia University presented the basics of clinical trials and emphasized how important it is for more patients to participate in them. She also discussed trials currently available for early stage and metastatic breast cancers. The webinar was presented on June 25, 2014. To hear the webinar, visit www.sharecancersupport.org/hershman
How evidence affects clinical practice in egyptWafaa Benjamin
Evidence based medicine is the gold standard for clinical care.
It implies the integration of best research evidence with clinical expertise and patient values.
There is still a wide gap between availability of evidence and its incorporation into routine practice in our country.
Barriers to implementation could be personal, social, institutional, financial and legal barriers.
True practice of evidence based care can only occur where evidence based decisions coincide with patients’ beliefs and clinicians’ preferences.
Continuing medical education programs should be set with integrating evidence based medicine teaching and learning within clinical training.
The importance of presence of local national guidelines which need to take into account variation in expertise, resources and patient preferences across our geographical and cultural contexts .
Customisation of a guideline to meet the local needs of a target patient population is critical to successful implementation.
We can aid decision making from the pre-clinical to the clinical setting, supporting line of sight to the clinic, by identifying and translating crucial biomarker approaches into the real world.
Connecting the Dots for Fast-Track Approval for Rare Disease and Orphan DrugMedpace
Managing a rare disease or orphan drug clinical trial has several challenges. Be prepared to understand and take away real world tactical lessons to expedite these studies:
•What are the new promising techniques in clinical studies for Rare Disease research? How are the innovative areas of adaptive strategies and translational medicine being employed?
• How do patient registries and natural history studies provide insights and patients for these studies?
• What quality of life issues play into patient retention in these studies?
• How can regulatory challenges from submissions to drug approvals be met using integrated global knowledge and systems to keep a project on track?
A thoughtful presentation on participation in clinical trials from the Thomas Jefferson University team at the 2017 CURE OM Patient & Caregiver Symposium.
Avoiding Common Pitfalls in Cell and Gene Therapy TrialsMedpace
Our experts will dive into case studies explaining the issues that arose with past projects, and how these studies got back on track. The knowledge gained from these experiences accelerate CGT development by avoiding potential pitfalls and getting ahead of regulatory and operational issues. Our team will walk you through the delays associated with these pitfalls and how to avoid them.
Considerations for the Next Wave of COVID-19 DevelopmentMedpace
What did we learn from the first wave of COVID-specific studies that can be applied to those studies that will follow? Medpace has gathered some of its medical and operational team experts who have been on the front-line in designing and conducting trials for SARS-CoV-2 to answer some frequently asked questions, trends they see emerging and considerations for future development.
COVID-19 Product Development and Clinical Trials: Considerations from Europea...Medpace
Join experts from Medpace’s regulatory and operational teams in this webinar as they provide insights and considerations on how to accelerate product development for COVID-19 during different stages
Part 3: Rare Disease Clinical Development – Strategies for Ensuring Endpoint ...Medpace
n this free webinar, Medpace partners with Michelle Eagle of ATOM International, a provider of CE training for clinical trials across the world, to discuss approaches and steps that can be taken to ensure quality and integrity.
Getting Ahead of the Evolving Landscape in RadiopharmaceuticalsMedpace
In this webinar devoted to radiopharmaceuticals, the featured speakers will explore the scientific, operational and regulatory considerations for radiopharmaceuticals. With a focus on oncology, they will discuss the current regulatory landscape and how this impacts overall development programs. The speakers will explore the challenges of conducting radiopharmaceutical trials, offering insights into trial start-up, site selection and operational aspects to seamlessly execute these studies as part of clinical development plans.
Challenges and Considerations in Clinical Development of "Targeted Therapies"...Medpace
In this webinar, Medpace experts discuss key clinical, operational and laboratory considerations, lessons-learned, and best practices for accelerating the global development of safe and effective targeted therapeutics, using acute myeloid leukemia (AML) to highlight the complexities.
What Happens After Your Device is Approved? Collecting Data in the Real WorldMedpace
In this workshop, Medpace will discuss key considerations for generating real-world evidence and how to apply critical insights in order to drive late-stage clinical research. To listen to this presentation, visit https://vimeo.com/168768256
Latin America: Challenges & Opportunities in Clinical ResearchMedpace
With an established regulatory environment and a strong healthcare infrastructure, Latin America continues to grow as an advantageous landscape for conducting clinical research. Join Medpace experts Anibal Calmaggi, MD, Senior Medical Director, Infectious Diseases and Vaccines, and Wanda Dobrzanski, MD, Director Clinical Operations, Pediatric infectious diseases and Pharmaceutical medicine specialist, as they share their collective 36 years of experience in designing and managing clinical research in Latin America.
This presentation discusses:
• Advantages and benefits of running trials in Latin America
• Challenges and strategies for addressing them
• Required procedures and processes
• An in-depth look at the most significant Latin American countries for conducting clinical research
Precision Medicine: Opportunities and Challenges for Clinical TrialsMedpace
The momentum and muscle behind "finding the right drug for the right patient at the right dose" has further escalated with President Barack Obama’s announcement of a $215 million dollar Precision Medicine Initiative earlier this year. In this webinar, Dr. Frank Smith will explore advances in precision medicine and how it is affecting clinical research. As a pediatric hematologist/oncologist, he will use his extensive clinical and research background as a backdrop for the discussion.
Topics will include:
The evolution of "personalized medicine" to "precision medicine"
How state-of-the-art molecular biology is creating new diagnostic and prognostic strategies
How these new strategies are helping inform the design of clinical trials
Case study: How precision medicine is improving clinical trials in hematology and oncology
Clinical Trials Conduct and Protocol Compliance in AsiaMedpace
This presentation focuses on health issues in Asia Pacific (specifically China), clinical trial challenges - operational and regulatory, and key considerations when conducting trials within this region.
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Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?
Webinar: Oncology Trial Recruitment: Challenging Indications and Challenging Studies
1. CLICK TO EDIT
TITLE
Click to edit subtitle
[Insert Sponsor logo or delete]
Clinical Operations – ask the Design Assistant for assistance inserting
Oncology Trial
Recruitment:
Challenging Indications
and Challenging Studies
Presented by:
Lyon Gleich, MD
Vice President of Medical Affairs
Jennifer Cutter, PhD
Director of Clinical Trial Management
Ross Ezzati, MBA
Director of Clinical Trial Management
2. Challenging Indications,
Challenging Studies
2 Physician Led | Therapeutically Focused
o Oncology field with continued changes in drug
development
Immuno-oncology
Targeted Agents, Antibodies
ADCs (Antibody Drug Conjugates)
Biosimilars
o Fast Track, Sub-Part H, Breakthrough
o Basket trials to extra-specific targeted populations
o Genetically targeted studies
o Protocol, country, and site selection
3. The Oncology Protocol
3 Physician Led | Therapeutically Focused
o Regulatory considerations coupled with safety
and activity can dictate the target population
Define indication and target label early in
development and modify as needed
Initiate any companion diagnostics early
o Phase 1 design is crucial
Adaptive design can limit low dose exposure of
subjects
Defining the MTD, RP2D, justification of the
regimen, safety profile
Can be used, particularly through expansions, to
select populations for Phase 2 and registration
4. The Oncology Protocol
4 Physician Led | Therapeutically Focused
o Phase 2/3 – registrational trials
o Depending on specifity of indication, may be possible
to have a single arm Phase 2 as registrational trial if
unmet need and clear benefits can be demonstrated
Leads often to trials in very specific subpopulations with
potential recruitment challenges
• Many sites for few patients at each site
o If a randomized design required, Phase 2 often best
performed first to be sure of activity and powering of
the larger Phase 3
o Trial design should aim to broaden the population
within reason and consider the burden on subjects
and sites to support recruitment
In later phases avoid intensive PK and unneeded study
visits in later phases
5. Country and Site Selection
5 Physician Led | Therapeutically Focused
o If the oncologic indication is ubiquitous, considerations
can be driven by regulatory goals, patient availability,
and competitive environment
o If the oncologic indication is known to have
geographic “hotspots,” those areas must be targeted
o Genetic testing requirements and sample
shipments/testing may influence options for some
programs
o If failure of prior therapies required, an assessment if
other regions have the same SOC
Similarly if SOC comparators are used or any
background therapy, must be consistent across study
6. Country and Site Selection
6 Physician Led | Therapeutically Focused
o Consider if program will be US only or involve other regions
(or even not involve the US)
o In US, can target large academic centers or community
centers or both
o Western Europe in general with similar disease rates and
recruitment potential
Excellent large centers and high quality
o Eastern Europe can add significant recruitment potential;
may need closer monitoring
o Asia Pacific – developed countries similar to Western
Europe; developing countries have less competition, but
SOC may be a concern
China has large potential but start-up hurdles
o Latin America – recruitment potential, but start-up hurdles
7. Recruitment – The Sites
7 Physician Led | Therapeutically Focused
o Only a small minority of oncology patients participate in
clinical trials
o Early involvement of PIs
Protocol review, Committee participation
o Training of site staff
Instill excitement about the science and drug potential
o Communicate findings/issues with the sites
Positives and negatives to keep engagement
o Keep the sites engaged in the development
Work with sites to fully engage their regional referral networks
o Financial support for site efforts
o Recruitment supports
PI/CRC teleconferences, Newsletters, Signage/Pamphlets,
Brochures, Bring successful site practices to laggards
8. Recruitment – The Patients
8 Physician Led | Therapeutically Focused
o Patient outreach
Advocacy groups
Trial websites
Disease websites
• May need to create a disease specific website
Clinicaltrials.gov
Twitter and electronic outreach; site websites
o If genetic testing required, consider the testing
separate from the parent protocol so patients can
consider the trial earlier
o Travel and caregiver support
o Patient education on the disease, drug, and the
procedures
9. CLICK TO EDIT
TITLE
Click to edit subtitle
[Insert Sponsor logo or delete]
Clinical Operations – ask the Design Assistant for assistance inserting
Oncology Trial
Recruitment:
Challenging Indications
and Challenging Studies
Presented by:
Lyon Gleich, MD
Vice President of Medical Affairs
Jennifer Cutter, PhD
Director of Clinical Trial Management
Ross Ezzati, MBA
Director of Clinical Trial Management
Questions?
Thank You