臨床試験におけるAIの成長の機会と革新的な使用事例

AI技術は、実世界のデータの収集と分析、臨床試験の第I相と第II相のシームレスな組み合わせ、患者を中心とした新しいエンドポイントの開発など、臨床試験を変革するための基本的なイノベーションをもたらすものです。AIを活用することで、さまざまな入力から標準化、構造化、デジタル化されたデータ要素を作成することができ、AIを活用した試験デザインは、患者中心のデザインの作成を最適化・加速するため、患者の負担を大幅に減らし、成功の可能性を高め、修正回数を減らし、試験全体の効率性を向上させることが可能です。大手テクノロジープロバイダーと製薬スタートアップは共に、今後のより効果的な臨床試験の方向性を示しています。

当レポートでは、臨床試験におけるAI市場について調査し、市場の概要とともに、戦略的インペラティブ、成長の機会などを提供しています。

目次

戦略的インペラティブ

• 成長がますます困難になるのはなぜか
• 戦略的インペラティブ
• 臨床試験におけるAIに対する上位3つの戦略的インペラティブの影響
• 成長の機会が成長パイプラインエンジンを加速させる

成長機会分析

• 分析範囲
• 定義
• セグメンテーション
• 臨床試験の課題主要3項目
• 臨床試験におけるAIの価値提案
• 治験の成功にAIが不可欠な理由
• AI対応の臨床試験を通じた患者動向
• 成長促進要因
• 成長抑制要因
• 規制シナリオ- 臨床試験におけるAIの使用
• ベンダーエコシステム
• 臨床試験におけるAI-活躍企業
• 臨床試験におけるAI-採用のタイムラインと影響

使用事例-臨床試験デザイン

使用事例-患者の充実、募集、登録

使用事例-患者のモニタリング、医療アドヒアランス、および保持

使用事例-調査員とサイトの選択

注目すべき他の企業

• 注目すべき他の企業

成長の機会

• 成長の機会1-癌治験における患者の多様性を拡大するためのリモートリクルート
• 成長の機会2患者中心の臨床試験デザインにより、より良い保持とモニタリングを実現
• 成長の機会3-AIを統合したクラウドベースのSaaS配信モデル
• 添付資料一覧
• 免責事項

Integrating Real-world Insights into Intelligent Platforms to Enable Patient-centric Trial Design

As clinical pipelines globally witness a surge in novel complex therapies, the clinical trial industry demands new tools in predictive analytics to improve trial design, planning, and execution. Artificial intelligence is gaining large-scale recognition as support for decentralized trial designs, thus enabling patient-centric clinical trial designs. The rapid adoption of AI/ML algorithms and platforms to structure and utilize electronic health records (EHRs) allows the industry to tap into a vast, rich, and highly relevant data source that holds tremendous potential in improving the global clinical trial landscape.

Incorporating integrated AI-driven solutions in clinical trial design and patient retention will ease the go-to-market strategy for various CROs and pharma players as they will reduce costs, increase efficiency, and support the transition to decentralized trials by means of remote patient recruitment, management, as well as engagement through interactive platforms thus ensuring higher retention. Additionally, these platforms are highly beneficial in the selection of appropriate investigators and trial sites. Randomized control trials (RCTs) are another possible application for sponsors to leverage AI in analyzing vast site-level datasets for greater insight into trial design and implementation.

Leading CROs such as Syneos Health or IQVIA, as well as several pharmaceutical companies such as BMS, have successfully deployed AI-based platforms to support site selection and patient recruitment. Companies (including AstraZeneca and Novartis among others) are also applying AI in clinical trials to enable the optimization of different stages with the intent of reducing the overall trial timelines.

AI technologies bring fundamental innovations for transforming clinical trials, such as collecting and analyzing real-world data, seamlessly combining phases I and II of clinical trials, and developing novel patient-centered endpoints. AI can be leveraged to create standardized, structured, and digital data elements from a range of inputs, and as AI-enabled study design helps optimize and accelerate the creation of patient-centric designs, it significantly reduces patient burden, increases the likelihood of success, decreases the number of amendments, and improves the overall efficiency of trials. Together, big technology providers and pharmaceutical start-ups are setting the course for more effective clinical trials in the future.

Key Issues Addressed:

• What are the key trends impacting the clinical trial industry in terms of technology implementation?

• What are the various application areas for AI in terms of execution of clinical trials?

• Who are some of the key industry stakeholders building cutting-edge AI enabled platforms?

• What are the industry drivers and barriers impacting the AI enabled clinical trial industry?

• What are the key strategies global stakeholders are taking to better serve customers while ensuring growth?

• What are the key growth opportunities going forward and call to action for CROs, sponsors and technology participants in the ecosystem?

Table of Contents

Strategic Imperatives

• Why Is It Increasingly Difficult to Grow?
• The Strategic Imperative 8™
• The Impact of the Top 3 Strategic Imperatives on Artificial Intelligence (AI) in the Clinical Trials Industry
• Growth Opportunities Fuel the Growth Pipeline Engine™

Growth Opportunity Analysis

• Scope of Analysis
• Definitions
• Segmentation
• The Top 3 Clinical Trial Challenges
• The AI Value Proposition in Clinical Trials
• Why AI Is Critical for Trial Success
• The Patient Journey Through AI-enabled Clinical Trials
• Growth Drivers
• Growth Restraints
• Regulatory Scenario-AI Use in Clinical Trials
• Vendor Ecosystem
• AI in Clinical Trials-Companies-to-Action (C2A) Targets
• AI in Clinical Trials-Adoption Timeline and Impact

Use Case-Clinical Trial Design

• AI Applications in Clinical Trial Design
• Vendor Spotlight-Owkin
• Industry Use Case and Analyst Perspective
• Vendor Spotlight-ConcertAI
• Industry Use Case and Analyst Perspective
• Other AI Vendors in Clinical Trial Design

Use Case-Patient Enrichment, Recruitment, and Enrollment

• AI Application in Patient Enrichment, Recruitment, and Enrollment
• Vendor Spotlight-Unlearn
• Industry Use Case and Analyst Perspective
• Vendor Spotlight-TrialWire
• Analyst Perspective
• Other AI Vendors for Patient Enrichment, Recruitment, and Enrollment

Use Case-Patient Monitoring, Medical Adherence, and Retention

• AI Application in Patient Monitoring, Adherence, and Retention
• Vendor Spotlight-AiCure
• Industry Use Case and Analyst Perspective
• Vendor Spotlight-AWS
• Industry Use Case and Analyst Perspective
• Other AI Vendors for Patient Monitoring, Adherence, and Retention

Use Case-Investigator and Site Selection

• AI Applications in Investigator and Site Selection
• Vendor Spotlight-Medidata AcornAI
• Industry Use Case and Analyst Perspective
• Vendor Spotlight-Deep 6 AI
• Industry Use Case and Analyst Perspective
• Other AI Vendors for Investigator and Site Selection

Other Companies to Watch

• Other Companies to Watch
• Other Companies to Watch (continued)

Growth Opportunity Universe

• Growth Opportunity 1-Remote Recruitment to Expand Patient Diversity for Cancer Trials
• Growth Opportunity 1-Remote Recruitment to Expand Patient Diversity for Cancer Trials (continued)
• Growth Opportunity 2-Patient-centric Clinical Trial Design for Better Retention and Monitoring
• Growth Opportunity 2-Patient-centric Clinical Trial Design for Better Retention and Monitoring (continued)
• Growth Opportunity 3-AI-integrated Cloud-based SaaS Delivery Models
• Growth Opportunity 3-AI-integrated Cloud-based SaaS Delivery Models (continued)
• List of Exhibits
• Legal Disclaimer