Insights from the 2024 ISCR Annual Conference: India’s evolving clinical research arena
ICON, an Accredited Member Organisation of the Indian Society for Clinical Research (ISCR), recently participated in the 17th annual ISCR conference, held February 1-3 in Hyderabad, India. This conference serves as a pivotal forum for professionals engaged in clinical research activities across India, fostering knowledge exchange and learning opportunities to further drive industry progress. With over 1,800 delegates representing major international and national pharma companies, global CROs and technology companies, the event showcased the extensive capabilities of all clinical research domains in India.
Transforming clinical research: The conference theme
The central theme of this year’s conference was "Transformation in clinical research for better patient outcomes." Spanning six major tracks, including Clinical Operations, Regulatory Affairs, Biostatistics and Programming, Clinical Data Management, Pharmacovigilance, Real-World Evidence (RWE) and Health Outcome Economic Research (HOER), the event explored various facets of this transformation. Discussions ranged from decentralised clinical trials to the impact of technology on the clinical research landscape.
Focus on Clinical Data Management and Biostatistics and Programming
Of particular interest were the sessions within the Clinical Data Management and Biostatistics and Programming tracks. These sessions delved into the digital transformation and automation in clinical data management, and biostatistics and programming, emphasising its role in accelerating clinical research and enhancing patient outcomes.
ICON’s industry-leading insights
ICON, with our extensive experience in digital transformation, data management, and biostatistics and programming, shared valuable insights during the conference. Our subject matter experts and thought leaders presented on topics of special interest, including:
Digital transformation and clinical data management:
Kedar Deshmukh, Director, Clinical Data Science
Panel discussion: Digital health technologies (DHT) and decentralised clinical trials’ impact on patient outcomes
The potential of digital health technologies (DHT) extends beyond exploratory outcomes, particularly in driving digital endpoints. There is a pressing need for clearly defined primary and secondary digital endpoints, especially in neurology and cardiovascular therapeutic areas. Evidence is mounting that wearable sensors offer significant potential for gathering continuous, high-frequency and detailed endpoint data, providing a comprehensive view for improved clinical evaluation. However, wearable sensors face challenges in patient authentication and data accuracy, leading to regulatory hurdles in accepting digital endpoints.
Clinical data management must collaborate with clinical data systems technology to develop advanced algorithms that ensure patient authentication and identify data patterns that may arise from improper use, external influences causing false positives or false negatives, or simply missing data due to synchronisation issues.
Emerging roles such as decentralised clinical trial (DCT) experts, DHT leads and concierge service leads play a crucial role in implementing patient-facing technologies with trial subjects and enhancing compliance and retention.
Shalima James, Clinical Data Science Lead
Demystifying the clinical data science puzzle
Clinical Data Science is an emerging field within clinical research that demands multidisciplinary expertise. The necessity for comprehensive and standardised data is paramount. Data quality now encompasses more than just the quality of Electronic Data Capture (EDC) source data or reconciliations; it also involves the quality of data ingestion and the review of data patterns.
The development of validated AI models is essential to establish trust among clinicians. Collaboration between data scientists and clinicians is crucial. Both parties must understand each other's expertise and collaborate to define research questions, validate insights and implement data-driven interventions.
Suvarchala Nidhanapati, Senior Clinical Data Science Lead
Evolution of clinical data review and roles to enhance subject safety outcomes
Technological advancements have significantly transformed data review methodologies, leading to the emergence of diverse roles and responsibilities. According to the ICH GCP E6 R2 guidelines, data science plays a pivotal role in this transformation process. New roles, such as data scientists, have evolved by amalgamating traditional data management responsibilities with expertise in data science. These professionals have contributed significantly to the development of innovative approaches for safety data review.
Real-time data review for safety and vendor data has enabled the early identification of potential risks, thereby enhancing safety measures and reducing the time required for critical data analysis.
Biostatistics and Programming:
Smitha Nalam, Director, Statistical Programming
Panel discussion: Are new technologies (AI/ML/IOT) a threat or blessing for Biostatisticians and Statistical Programmers?
This discussion around the shifting innovation in artificial intelligence (AI) and machine learning (ML) in Biostatistics and Programming shed light on how individuals with domain expertise can easily adapt into newer roles. The panellists shared new ideas and techniques for innovative data sources and, reminiscent of complex data standardisation, the exploration of new technologies in analysis and statistics that could help bring solutions to patients faster and meet unmet medical needs.
Supratik Chakravarthy, Principal Biostatistician
Picture perfect: Exploring distinctive visualisation techniques in clinical trials
Effective data visualisation techniques play a crucial role in transforming complex data into understandable visual representations, facilitating the faster and more effective identification of patterns, trends and anomalies. We explored examples of unique visualisation techniques based on different types of data scenarios and discussed the importance of these advancements for expanding medical knowledge and improving patient outcomes.
Conclusion
The ISCR conference served as a catalyst for fostering collaboration and innovation in India's clinical research landscape. The event spotlighted India’s remarkable surge in clinical research activities, highlighting collaborative efforts among government bodies, pharmaceutical companies and research institutions. We are proud to have contributed to this event and remain committed to advancing the field amidst its evolving landscape.
Contact us for further insights or to discover how ICON can support your clinical data management and biostatistics needs. We look forward to partnering with you on your journey toward better patient outcomes.
Authors:
Kedar Deshmukh
Smitha Nalam