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Helen Yeardley
There is an increasing demand from sponsors for technology and data-driven solutions to improve site selection, study start-up and patient recruitment.
With the explosion of data and improvements in analytical techniques, including emerging technologies that incorporate machine learning and artificial intelligence (AI), sponsors are also demanding greater transparency about how these processes are carried out. This article examines how effective these approaches have been and what the potential opportunities are going forward.
Data Driven Site Selection and Supporting Accelerated Start-up
Growth in available clinical trial investigators has declined over the past several years according to a recent study published by Tufts, making it especially important to have mechanisms in place to identify investigators and their affiliated institutions that have high enrolment potential.
The challenge facing sponsors and CROs is to develop tools that support site-selection and integrate multiple internal and external sources of site and investigator information, along with survey capabilities, to help select the right sites. The data sources involved have a diverse set of information types, ranging from site experience to start-up and enrolment performance, which are all factored into enrolment projections for a given study.
Delays in study start-up has been an industry issue for a long time now and there is a growing demand for outsourced technologies that could streamline these activities. Site identification and selection, based on the increasing availability of data, is a key area of demand. In response, several industry consortia have been formed to aggregate data and make it available for site selection decision making.
As the landscape evolves, it makes sense to adapt a strategy of using leading-edge tools to leverage the best of what is available in the marketplace for optimum results. Available systems can be used to target rate limiters in the start-up process, and their success is measured by a reduction in cycle times, without compromising quality.
With this combined strategy, you are likely to see a decrease in cycle time with increased transparency of the site selection process as well as from the enhanced tracking capabilities and improved visibility these technology and data-driven approaches provide. Furthermore, acceleration in regulatory collection as well as contracts/budgets negotiation, may contribute to overall faster start-up timelines.
Managing and Tracking Documents and Budget Negotiations
In regulatory document submission and contract and budget negotiations, it is advisable to capitalise on a central site activation management system, which should be used both for standardised and central tracking, as well as to share and exchange draft and final documents with key stakeholders globally.
The system can be used to track baseline, planned and actual dates for regulatory and ethics agency submissions/approvals. Furthermore, the system permits approved documents be directly exported from the final start-up package directly into the electronic trial master file (eTMF) for final filing.
Aligning Innovation with Processes
Part of the process of introducing new technology is to ensure that it is integrated into the workflow to improve efficiency, along with ensuring global compliance. The approach taken depends on how disruptive the technology is going to be. In some cases, you can just update existing procedures while others require the introduction of a new process. Regardless it is important to ensure that the process is fully aligned and complementary to the technology.
Site activation tools may manage various types of information from CTMS systems (including, but not limited to, investigator and organisation name, contact details, site number, pre-study visit date, site initiation visit date) and from the eTMF (e.g. document nomenclature).
The Promise of Evolving New Technologies
Improving the use of data analytics and technology would allow for an increased ability to re-use site information on multiple studies and reduce the time between site selection and initiation. In addition, it could support increased engagement and partnering with sites with known patient populations. Another great opportunity is in the promise of AI and machine learning.
With these technologies, we would be able to ask open-ended questions and develop greater insights from sites and patients about what it will take to successfully deliver a study. These insights can then be incorporated into the organisation’s operational strategy, creating the infrastructure for using data analytics and technology to improve site selection and study start-up processes.
Contact us to find out more about how ICON is overcoming the challenges in Study Start-Up with technology (One Search) and reducing time for clients.
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Digital Disruption
- 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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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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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
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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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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
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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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Accelerated early clinical manufacturing
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Cardiovascular Medical Devices
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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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Payers Perspectives on Digital Therapeutics
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Precision Medicine
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The Role of ICER as an HTA Organisation
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