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Decentralised and hybrid trials
The patient perspective
What does the patient want?
Listening to the patient
Decentralised and hybrid trials are widely discussed in the pharmaceutical industry and are already being deployed on some clinical studies. There are organisations that are convinced that it is the next big step in making clinical research more patient-centric and that this will have a significant impact on the ongoing challenge of patient recruitment. But what does the patient think?
ICON conducted a survey through its Global Site Network to get the patient view and find out whether bringing the trial to the patient could make a difference in accessing more patients. We explored perceptions and preferences around what makes it easier for patients to participate in clinical trials and to determine whether industry perception was reality.
The majority of patients indicated hybrid or no preference on where clinical trial test are taken
Key insights
- Patients want options. Decentralised trials are attractive to some but not all patients in the survey. Hybrid trials are more likely to be of interest because the attachment with the healthcare professional and the support they provide remains intact.
- The patient relationship with site staff is important. In fact, since all of the patients involved in this study were connected with a site, whether that was through participation in a trial or just screening, this may have had an impact on how patients surveyed responded to some questions.
- Although patients are open to the idea of virtual trials with video calls, they still prefer face-to-face interaction for some or all visits.
- While decentralised trials are appealing to some, travelling to a site is not a major barrier to all. Patients are willing to travel in order to have the opportunity to participate in a clinical trial.
- Patients prefer non-paper options for diaries, but the option of devices needs to be available for those who do not want to use their own or do not have them.
- Differences are not as pronounced in therapeutic areas as might be predicted. However, there were some therapeutic areas that showed more enthusiasm for decentralised or hybrid trials. For example respondents with Dermatology conditions consistently demonstrated a tendency to prefer or be open to remote options and had the highest preference to use their own smart phone. Neurology patients showed similar tendencies.
- Age considerations cannot be taken for granted. When looking further at the data within specific age groups, the 18–24-year-old group tended to prefer on-site, face-to-face interaction while the 25–34-year-old group was the most open to remote visits and activities, with a steady decline thereafter with increasing age.
- The provision of free services for coordinating travel arrangements or other logistics was important for all age groups in making them more likely to consider participation in a clinical trial.
Summary of findings
The numbers behind the insights
Conclusion
- The industry, sponsors and sites need to connect and align with the patient needs if they really want to improve the patient experience and make the clinical trial truly patient-centric.
- The patient perspective on clinical trial participation may differ from what is generally expected at an industry level. We need to ask the patients what they want, provide choices for them, and move at their pace. Moving too quickly, increasing the challenges and complexities of participation may mean slower adoption in the long run.
Contact us today for more information on this survey, our patient insight program or to discuss our decentralised and hybrid services.
Decentralised & Hybrid Trial Insights
ICON's Decentralised & Hybrid clinical trial experts provide analysis including whitepapers, blogs and contributions to media and industry conversations relating to all aspects of decentralisation in clinical trials.
In this section
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Digital Disruption
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Digital Disruption whitepaper
- 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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Digital Disruption whitepaper
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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
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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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