Ben Prabhu, Clinical Research Associate
On one of my work trips recently, I got into a conversation with a fellow traveler about our respective jobs. I told him something that I feel I have been saying a lot recently – working in clinical research has been the most fulfilled I’ve felt in my life. I have been privileged to work with both patients who want to help further medical advancement whether it works for them or not, and healthcare providers who believe in the ethos of constantly discovering newer and better ways to treat their patients. To know that I’m a critical link in making this happen is as strong a motivation as any to approach every day at my job as the most important day in someone else’s life.
As recently as a year ago, I was having a conversation with a cancer patient on one of my trials that I was a study coordinator for, when she stopped and showed me a picture of her teenage granddaughter. When the patient had been told by her physician that they had run out of standard treatment options for her, it was her granddaughter who had persuaded her to consider a clinical trial that she would be eligible for. The patient turned to me and said “thank you for all you do, because every extra second I get with my granddaughter is precious and you help make it happen”. While I knew that I only play a small role in the grand scheme of things, nothing else makes me feel prouder and happier to know that I work in an industry that by its nature is at the forefront of genuinely making a difference in someone’s life every day.
Amber Hallenborg, Senior Director, Corporate Development
I’ve been working within elements of research since university, starting with behavioural focus groups for at risk youth long before entering the clinical realm. It has been my honour to work at the site level, the academic level, the biotech level, and my very favourite, the CRO level. Regardless of role or organisation, it will always be rewarding to play any part in the incredibly complex process of seeing products become available to those who need them most. Working in clinical research means seeing hope for the future around every corner. To work in the industry means we trust the process needed to put forth the very best we can to all populations. Because I trust this process, I myself participated as a subject for the very first time for a covid vaccine trial in 2021. I am happy to be one of the many volunteers for a trial because, regardless of outcome, there is a reason for it all!
Shannon Jonietz, Project Manager, Project Delivery
Our family got to experience a clinical trial first hand when my dad was diagnosed with esophageal cancer in 2019. We were with him through every form, every exam, every treatment, every AE: everything. We are eternally grateful for the care he received in the trial he was on, and it gave him two years he would not have otherwise had before the cancer spread too far. As a Project Manager, I see the steps, but to live it has given me a greater appreciation for our teams, but also for the PIs and their staff and they care they give. This is not an experience I would wish on anyone, but it’s not one I would trade either.
Rebekah Nolan, Senior Clinical Research Associate
I was motivated to pursue a career in clinical research because my dad was a patient on a phase 3 trial that ultimately provided the data for abiraterone being approved for use in advanced prostate cancer.
Unfortunately, my dad died in 2014 and was not around to see me graduate and start my career, but I was inspired by the care he was given by the trial team and the hope that it gave him in fighting his disease.
I am now privileged to be involved in other clinical trials at the same site my dad attended for his care. I wish my dad was here so I could tell him about the important and life changing work that we do, but I am comforted by the knowledge that our research means that millions of other patients can be around with their families for longer.
Kim Pope, Project Associate, Project Administration
In September of 2014, my father was diagnosed with prostatic adenocarcinoma, Gleason pattern 4+3=7. The physician at the time recommended surgery and various treatment options. A friend of our family recommended for my Father to call Duke and ask about a clinical trial. My mother called for an appointment, and luckily they were able to get him scheduled. He went once a month for a year, and in 2015 was declared cancer free. His checkups after this point went from every 3 months, to every 6 months. He now only needs a yearly check-up. We are so incredibly grateful that he was able to participate in the clinical trial at Duke. I will always take pride in my work, because I know that what we do makes such a positive difference in so many lives.
Agustina Mazza, Senior Quality Process Specialist
Last July 2021 my 7-year-old daughter Ana was diagnosed with Type 1 Diabetes. I missed all the signs, which led her to being severely decompensated and went into diabetic ketoacidosis. She had to be admitted to the ICU for a few days and then she spent another 2 weeks in the hospital. It was the scariest moment of my life. And in the middle of my husband and I digesting that our daughter would now live with a chronic disease, requiring insulin for life, trying to understand all the changes that we were going to go through, trying to think how to explain all of this to her, the words of one of the many doctors that came in and out of our room touched my heart. He said “she’s only 7 years old, and research in Diabetes keeps making breakthroughs as we speak, so maybe by the time she’s in her 20s or 30s we will have a cure for this disease”. And in that moment I understood the true importance of the work that we do, and felt a bit of proud of having worked at ICON for the past 14 years. Although my work is merely administrative and has no impact on the science, I like to think that I’m contributing at least a little to make clinical trials move further while I keep my faith in that one day I’m going to see the cure for my daughter’s disease.
Linsey Barone, Client Relations Manager
I enrolled my 11-year-old son, Layne, born with a rare genetic disorder called Prader-Willi Syndrome, into a clinical trial in October of 2019.
Our world is filled with uncertainty, but this clinical trial gives us hope – hope for a better life, hope for a better future.
As a Client Relationship Manager here at ICON plc, I get to experience clinical trials in a whole new light. We are impacting lives every day, and to be a part of something so significant and so powerful is a really great feeling.
Catherine Bliss, Associate Director, Resource Management
When I started working for PRA in 2007 as a Project Associate working on three prominent Multiple Sclerosis (MS) trials, I had no idea that 14 years later I would be diagnosed with MS and one of the treatments I would be offered would be the drug I worked on years before.
I remember so clearly packing up site supplies – vision charts and 9-hole peg tests to send to Neurologists – and reading the protocols. We would hear testimonials of patients who had been positively impacted by the drug, and it really opened my eyes to the disease. At the time there were very few treatment options available for these patients and their future was plagued with uncertainty about their mobility and problems to come.
Today, I have so much hope for my future and am blessed that I work in the industry that has given hope to me and so many others. I have access to so many treatment options. Medical advice and support have improved so much in the last 14 years, and I am very proud that I played a small part in taking control of my own destiny. I thank all of you who are currently working on MS trials, as the work you do today may be a treatment for me in the future.
I thank all of you working in clinical research, as the work we are all doing today is helping a friend, a family member, a human being tomorrow.
Do not forget or minimize the impact you are making, because my example has really given me the best chance for my future and I am sure you are doing the same for the world.
Robyn Vancil, DOCS Operations Manager
Remi is my dark chocolate English Labrador Retriever who will be 16 years old, and Layla Grace is my almost 11-year-old yellow Labrador Retriever. They think that I am their real mom, so please don’t tell them that they are adopted.
In the summer of 2021, a very large tumor appeared on Layla’s back right leg. I got three opinions after learning it was cancer. I also learned it would take a long time to get an appointment with a pet oncologist. The pet oncologist would need to advise if Layla could under-go the surgery for the tumor to be removed if the cancer did not spread to her lungs.
After a ton of stress and sadness, I was sitting at my desk one day and a light bulb went off – Why not search for clinical trials that will help Layla, help medical research and give her a better quality of life? After all, this is the industry that I work in and love.
I found a clinical trial called STING agonists at the University of Pennsylvania. The day my vet sent the oncology results, I received a call to have Layla evaluated to see if she could be a participant in the trial. While STING was already active in humans, Layla turned out to be the seventh dog to be admitted to the trial. STING is a clinical trial drug that is injected twice to find, detect and kill cancer. Layla had two one-night visits and I received consistent updates from the PI and study coordinator. They literally laid with her to monitor her closely. The updates, paperwork, communication and care she received was astounding.
Since they removed the tumor, they also had to remove her back right leg – she would become a tripod. This was common in dogs, and it wasn’t as emotional or mentally consuming as it is in humans. I received a call on my birthday, September 9, 2021, that Layla was cancer free. I saved close to $15,000, had peace of mind and added years to her life: PRICELESS.
Layla is thriving and does fantastic on a daily basis, although, she may not be able to chase bunnies anymore.
Louisa Roberts, VP, Corporate Development & Strategic Partnerships
Like many people, I have been geographically separated from my family during COVID, relying on Zoom and WhatsApp to stay connected. I was surprised to find another point of connection when my parents enrolled in a large COVID tracking decentralised clinical trial in the UK (with no encouragement or consultation from me!). My mum and dad are in their 70s and 80s, respectively, and responded eagerly to the invitation they received in the mail (a good reminder digital recruitment is not for everyone). They wanted to help, but with many weeks of lockdown/ isolation in Scotland, the weekly phlebotomist visits helped them, and became something they looked forward to. Colleagues and sponsors frequently speak the importance of listening to patient experience, and it was extra powerful hearing it from my mum. The relationship they formed with the phlebotomist was deep, and a great reminder of the power of human connection, that clinical research is clinical CARE. As COVID continued, the protocol was amended so that patients could take blood themselves with a needle capillary, but this did not work for my dad. He was unable to draw blood from his finger, and after many failed attempts was genuinely disappointed. This serves as a good reminder that pushing more tasks to patients doesn’t make it easier for all. For my mum, her one frustration is that she cannot figure out how to use the vouchers that they received for participation. It was not their motivation to take part but she feels like she has failed in some way, and I have to say trying to deal with computers and voucher codes from 5,000 miles away is frustrating for me too. Sharing in their experience has been really special both personally and professionally, they have enhanced my understanding on how new models of research, and even small details, impact patient experience.
In this section
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Digital Disruption
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Clinical strategies to optimise SaMD for treating mental health
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Digital Disruption: Surveying the industry's evolving landscape
- AI and clinical trials
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Clinical trial data anonymisation and data sharing
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Clinical Trial Tokenisation
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Closing the evidence gap: The value of digital health technologies in supporting drug reimbursement decisions
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Digital disruption in biopharma
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Disruptive Innovation
- Remote Patient Monitoring
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Personalising Digital Health
- Real World Data
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The triad of trust: Navigating real-world healthcare data integration
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Clinical strategies to optimise SaMD for treating mental health
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Patient Centricity
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Agile Clinical Monitoring
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Capturing the voice of the patient in clinical trials
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Charting the Managed Access Program Landscape
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Developing Nurse-Centric Medical Communications
- Diversity and inclusion in clinical trials
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Exploring the patient perspective from different angles
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Patient safety and pharmacovigilance
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A guide to safety data migrations
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Taking safety reporting to the next level with automation
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Outsourced Pharmacovigilance Affiliate Solution
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The evolution of the Pharmacovigilance System Master File: Benefits, challenges, and opportunities
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Sponsor and CRO pharmacovigilance and safety alliances
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Understanding the Periodic Benefit-Risk Evaluation Report
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A guide to safety data migrations
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Patient voice survey
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Patient Voice Survey - Decentralised and Hybrid Trials
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Reimagining Patient-Centricity with the Internet of Medical Things (IoMT)
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Using longitudinal qualitative research to capture the patient voice
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Agile Clinical Monitoring
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Regulatory Intelligence
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An innovative approach to rare disease clinical development
- EU Clinical Trials Regulation
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Using innovative tools and lean writing processes to accelerate regulatory document writing
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Current overview of data sharing within clinical trial transparency
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Global Agency Meetings: A collaborative approach to drug development
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Keeping the end in mind: key considerations for creating plain language summaries
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Navigating orphan drug development from early phase to marketing authorisation
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Procedural and regulatory know-how for China biotechs in the EU
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RACE for Children Act
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Early engagement and regulatory considerations for biotech
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Regulatory Intelligence Newsletter
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Requirements & strategy considerations within clinical trial transparency
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Spotlight on regulatory reforms in China
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Demystifying EU CTR, MDR and IVDR
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Transfer of marketing authorisation
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An innovative approach to rare disease clinical development
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Therapeutics insights
- Endocrine and Metabolic Disorders
- Cardiovascular
- Cell and Gene Therapies
- Central Nervous System
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Glycomics
- Infectious Diseases
- NASH
- Oncology
- Paediatrics
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Respiratory
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Rare and orphan diseases
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Advanced therapies for rare diseases
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Cross-border enrollment of rare disease patients
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Crossing the finish line: Why effective participation support strategy is critical to trial efficiency and success in rare diseases
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Diversity, equity and inclusion in rare disease clinical trials
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Identify and mitigate risks to rare disease clinical programmes
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Leveraging historical data for use in rare disease trials
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Natural history studies to improve drug development in rare diseases
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Patient Centricity in Orphan Drug Development
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The key to remarkable rare disease registries
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Therapeutic spotlight: Precision medicine considerations in rare diseases
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Advanced therapies for rare diseases
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Transforming Trials
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Accelerating biotech innovation from discovery to commercialisation
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Ensuring the validity of clinical outcomes assessment (COA) data: The value of rater training
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Linguistic validation of Clinical Outcomes Assessments
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Optimising biotech funding
- Adaptive clinical trials
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Best practices to increase engagement with medical and scientific poster content
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Decentralised clinical trials
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Biopharma perspective: the promise of decentralised models and diversity in clinical trials
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Decentralised and Hybrid clinical trials
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Practical considerations in transitioning to hybrid or decentralised clinical trials
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Navigating the regulatory labyrinth of technology in decentralised clinical trials
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Biopharma perspective: the promise of decentralised models and diversity in clinical trials
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eCOA implementation
- Blended solutions insights
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Implications of COVID-19 on statistical design and analyses of clinical studies
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Improving pharma R&D efficiency
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Increasing Complexity and Declining ROI in Drug Development
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Innovation in Clinical Trial Methodologies
- Partnership insights
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Risk Based Quality Management
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Transforming the R&D Model to Sustain Growth
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Accelerating biotech innovation from discovery to commercialisation
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Value Based Healthcare
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Strategies for commercialising oncology treatments for young adults
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US payers and PROs
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Accelerated early clinical manufacturing
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Cardiovascular Medical Devices
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CMS Part D Price Negotiations: Is your drug on the list?
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COVID-19 navigating global market access
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Ensuring scientific rigor in external control arms
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Evidence Synthesis: A solution to sparse evidence, heterogeneous studies, and disconnected networks
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Global Outcomes Benchmarking
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Health technology assessment
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Perspectives from US payers
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ICER’s impact on payer decision making
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Making Sense of the Biosimilars Market
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Medical communications in early phase product development
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Navigating the Challenges and Opportunities of Value Based Healthcare
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Payer Reliance on ICER and Perceptions on Value Based Pricing
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Payers Perspectives on Digital Therapeutics
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Precision Medicine
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RWE Generation Cross Sectional Studies and Medical Chart Review
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Survey results: How to engage healthcare decision-makers
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The affordability hurdle for gene therapies
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The Role of ICER as an HTA Organisation
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Strategies for commercialising oncology treatments for young adults
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Blog
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Videos
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Webinar Channel