Life is short, so sometimes, you just have to buy those shoes! While I was working as a Clinical Research Coordinator at the University of Colorado Anschutz Medical Campus, that’s what an oncology patient told me when I complemented her boots. I will call her Lara, as her boots reminded me of Lara Croft from the Tomb Raider video game series.
Lara had made the decision to enter a CGT clinical trial. In addition to the hefty protocol requirements, our university also required patients to live within 30 miles of the hospital for up to 6 weeks without the need of driving for up to 8 weeks post-infusion. A single infusion required over 56 key staff members from the apheresis team, inpatient, outpatient, research, dietetics, psychiatry, financials, etc., and I was responsible for coordinating them all to meet the study’s needs and university/ local/ state regulations.
There was a moment during a required 12-lead ECG collection where Lara started to cry. During her appointment with the oncologist while her husband and young children were on the phone, she had the realisation that the study might not work. I think cognitively, she understood her situation from the beginning but on an emotional level, it was the first time she wondered what it might mean for her children.
During the appointment, she asked me how old I was and whether I still felt I needed my mother. She discussed family and had me re-review aspects of the trial with her again. I reminded her that the study was voluntary. Lara decided to move forward with the study for her family and because it could help us understand her disease to treat others in a similar position. The trial only briefly demonstrated improvement. Within a year, Lara had passed away.
In July 2022, my own mother was diagnosed with cancer. Due to innovations in surgery, radiation, and therapy over approximately the last 30 years, my mother was able to receive a minimally invasive surgery, radiation and therapy that may not have been possible without work by clinical researchers. Currently, she has no evidence of disease.
I decided to write this article because my mother’s birthday happens to fall on World Cancer Day. Reflecting on my eight years at Colorado University, I’m reminded of the conversation I had with Lara and the question she asked. I will always need my mother in some form, though the way in which I need or relate to her changes as I age. Cancer could affect any one of us and at any moment. I have seen patients walk away with complete remissions or regain function they had lost from clinical trials even when they were initially told they only had months left. It’s those cases where spirited individuals passed away that drive me to continue this work and remind me how important this job is to those patients living with cancer. It is the reminder to keep going so everyone may see the same success clinical innovation has brought to my own family.
So, for my mom’s birthday, for Lara and for World Cancer Day, I think, I will get mom a pair of shoes.
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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 whitepaper
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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
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Personalising Digital Health
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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
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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
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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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Transfer of marketing authorisation
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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
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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
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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
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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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CMS Part D Price Negotiations: Is your drug on the list?
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Evidence Synthesis: A solution to sparse evidence, heterogeneous studies, and disconnected networks
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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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Strategies for commercialising oncology treatments for young adults
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