Cover Image
市場調查報告書

風險為基礎的監測:臨床實驗轉換期最佳化的遙控風險評估的投入

Risk-Based Monitoring: Inject Remote Risk Assessment to Optimize Clinical Trial Outcomes

出版商 Cutting Edge Information 商品編碼 320377
出版日期 內容資訊 英文 339 Pages
商品交期: 最快1-2個工作天內
價格
Back to Top
風險為基礎的監測:臨床實驗轉換期最佳化的遙控風險評估的投入 Risk-Based Monitoring: Inject Remote Risk Assessment to Optimize Clinical Trial Outcomes
出版日期: 2014年10月30日 內容資訊: 英文 339 Pages
簡介

本報告以風險為基礎的監測(RBM)為主題,提供實行的結構、人員編製作用增加,技術、熟練供應商的利用,及RBM支撐的架構等的相關分析,成功的建議彙整,為您概述為以下內容。

摘要整理

風險為基礎的監測:最大化CRA效率的遠程策略、技術的利用

  • 調查手法
  • 調查定義
  • 風險為基礎的監測:成功的五個建議

為了對應實行風險為基礎的監測的現有結構、人員編制的作用增加

  • 臨床操作的有效利用:提供主要風險為基礎的監測支援的對群組的重視
  • 為了一體化公司內部資源和公司外部資源,分配風險型、傳統監測的責任
  • 風險為基礎的監測:CRA的作用增加

由於風險為基礎的監測技術、經驗豐富的供應商影響臨床實驗預算

  • 風險為基礎的監測策略減少臨床實驗支出
  • 利用經驗豐富的研究合作夥伴幫助風險為基礎的監測配合措施
  • 技術的實行促進風險為基礎的監測方法
  • 風險為基礎的監測策略、技術的價值

開發架構以支持一連串的風險為基礎的監測方法

  • 風險為基礎的監測的一般性利用:各開發階段
  • 風險為基礎的監測的一般性利用:各治療領域
  • 偏好的監測類型:各開發階段
  • 風險為基礎的監測實驗的計劃和風險閾值的建立
  • 風險為基礎的監測流程的管理

風險為基礎的監測隊簡介

圖表清單

目錄
Product Code: PH205

Site monitoring schedules are a key consideration for life science companies' clinical trials. Regardless of clinical development phase or therapeutic area, the level of planned site visitation can potentially expedite or delay trial progress. Traditionally, trial sponsors visit clinical sites every four to eight weeks. In-person site visits help sponsors identify any issues that may arise, including protocol miscommunications and patient safety concerns. Historically, the more often companies conduct site visits, the more likely all clinically facing teams are to be up-to-date on trial challenges and the better positioned sponsors' clinical staff are to resolve them quickly.

The downside to in-person site monitoring strategies is that this practice may not always be the most efficient in terms of the return it generates. Despite companies' dedication to performing in-person visits to prevent data errors, Applied Clinical Trials estimates that in-person clinical site visits actually account for less than 3% of the data changes incurred post-monitoring visit. Moreover, this practice can be costly in terms of companies' limited budgetary and staffing resources. According to a recently published article in Perspectives in Clinical Research, clinical site monitoring accounts for up to 30% of companies' total clinical trial cost.

By comparison, remote risk-based monitoring (RBM) practices may present a viable alternative. In its recent position paper, the US Food and Drug Administration (FDA) highlighted that “a risk-based approach to monitoring does not suggest any less vigilance in oversight of clinical investigations.” When used in conjunction with inperson visits, off-site or RBM strategies may also help companies to reinforce good clinical practices (GCPs) without requiring teams to expend additional time or staffing resources.

Sponsors generally visit sites both prior to patient enrollment, as the first few patients are enrolled, and periodically as trials progress. All clinical trial parties - from sponsors to contract research organizations (CROs) to sites - benefit from early site visits. At least one site executive cautioned that companies that do not conduct inperson visits during trial ramp up risk collecting unusable data or data that, at the very least, is not in-line with sponsor or CRO expectations. At many companies, clinical research associates (CRAs) visit all sites with the same frequency - regardless of the number of patients each site actually enrolls. However, performing uniform in-person visits across all sites on a monthly basis may put a strain on lean clinical teams.

Over the years, CRAs - the prime role responsible for conducting companies' site visits - have become progressively overburdened. Surveyed companies' staff are routinely responsible for monitoring vast numbers of patients across multiple sites, particularly during late-stage trials. Depending on how far individual sites have progressed in terms of patient enrollment and adhering to schedules laid out in the trial protocol, sponsor visits can take anywhere from several hours to several days. These constraints on CRAs' time - and their subsequent impact on CRA burnout - have driven the pharmaceutical industry to pursue alternative means to monitor sites' progress. Ideally, these new monitoring techniques would consider site-specific data to reduce in-person visits to sites with little to no enrollment, while expanding visits to sites for which studies are progressing faster.

Recently, RBM has emerged as one solution for trial sponsors to stay abreast of clinical trial progress across all enrolled sites, without necessarily requiring teams to visit each site on a monthly or quarterly basis. Although long used across academic trials and within CROs, RBM represents a new tactic for many dedicated pharma and device companies.

Likewise, the life sciences industry has developed multiple programs in support of RBM's more widespread use. Even before 2011, when the FDA and the European Medicines Agency (EMA) released position papers in support of risk-based monitoring, companies generally acknowledged the need to modify their existing clinical practices. In 2008, several organizations across the life sciences and research industries banded together to promote the Clinical Trials Transformation Initiative (CTTI).

Participating bodies include:

  • Government programs
  • Regulatory agencies
  • Pharmaceutical companies
  • Contract research organizations
  • Academic institutions

Under CTTI, companies developed programs with the primary goal of increasing clinical trials' quality and effectiveness. One of the main components of this strategy is a “quality by design” (QbD) approach. In this application, quality refers to companies' collective ability to assess products' benefit-risk while ensuring patient safety. Under this model, teams develop custom data, using predetermined risk measurement tools which ideally will deliver similar conclusions as those associated with “error-free” data.

More recently, another group, TransCelerate Biopharma - founded in 2012 by several pharma companies, including seven of Pharmaceutical Executive's rated Top 10 - developed an RBM framework for clinical trials of varying risk. In this paper, the group focuses on several key principles. These include:

  • Digitizing clinical trial data via electronic data capture or similar systems.
  • Centralizing data capturing systems to allow sponsors to monitor trial progress remotely.
  • Analyzing incoming data to identify trends and risk patterns.
  • Leveraging identified trends to establish targeted monitoring strategies and safeguard against identified risks.

The team's recent position paper has provided the springboard for many pharmaceutical companies' RBM strategies. However, many organizations are careful to adapt principles from this paper to their clinical structures and in-house capabilities. Although CTTI and TransCelerate are separate initiatives, the efforts of each organization continue to drive RBM support across the life sciences industry.

Broadly stated, implementing RBM means undertaking three key steps:

  • Analyzing applicable trial risks to build a risk profile that considers the types of errors that may occur and their relative impact on trial integrity.
  • Developing a plan that will merge traditional and risk-based monitoring approaches to map out the extent of data review and the frequency of site visits throughout trial duration.
  • Adjusting and catering established monitoring plans to individual site needs as the clinical trial progresses.

RBM encompasses a number of tactics that allow clinical teams to remotely track sites' progress once trials have begun to enroll patients and gather relevant data.

These strategies include:

  • Triggered Monitoring
  • Centralized Monitoring
  • Reduced Monitoring
  • Remote Monitoring

SAMPLE

Figure E.1:
Average Number of Months Prior to Trial Launch That Specific
RBM Tasks Are Completed: All Pharma and Device Companies

Table of Contents

Executive Summary

Risk-Based Monitoring: Use Remote Strategies and Technology to Maximize CRA Efficiency

  • Study Methodology
  • Study Definitions
  • Risk-Based Monitoring: Five Recommendations for Success

Broaden Existing Structure and Staffing Roles to Accommodate Risk-Based Monitoring Practices

  • Leverage Clinical Operations -Focused Groups to Provide Primary Risk-Based Monitoring Support
  • Distribute Risk-Based and Traditional Monitoring Responsibility to Merge In-House Capabilities with Outside Resources
  • Risk-Based Monitoring: The Expanded Role of CRAs

Impacting Clinical Trial Budgets via Risk-Based Monitoring Technology and Experienced Vendors

  • Decreasing Trial Spend Through Risk-B ased Monitoring Strategies
  • Leveraging Experienced Research Partners to Aid Risk-Based Monitoring Efforts
  • Implementing Technology to Drive Risk-Based Monitoring Approaches
  • The Value of Risk-Based Monitoring Strategies and Technology

Developing Frameworks to Support an Array of Risk-Based Monitoring Approaches

  • General Usage of Risk-Based Monitoring, by Development Phase
  • General Usage of Risk-Based Monitoring, by Therapeutic Area
  • Type of Monitoring Preferred, by Development Phase
  • Planning Risk-Based Monitoring Trials and Establishing Risk Thresholds
  • Managing Risk-Based Monitoring Processes

Risk-Based Monitoring Team Profiles

List of figures

Executive Summary

Risk-Based Monitoring: Use Remote Strategies and Technology to Maximize CRA Efficiency

Risk-Based Monitoring: Five Recommendations for Success

  • Figure E.1: Average Number of Months Prior to Trial Launch That Specific RBM Tasks Are Completed: All Pharma and Device Companies
  • Figure E.2: Average Number of Months Prior to Trial Launch That Specific RBM Tasks Are Completed: CROs and Academia
  • Figure E.3: Groups Involved in Risk-Based Monitoring Activities: All Pharmaceutical and Device Companies
  • Figure E.4: Groups Involved in Risk-Based Monitoring Activities: CROs
  • Figure E.5: Average Percentage Saved on Overall Trial Costs by Using RBM Strategies
  • Figure E.6: Percentage of Companies Using Specific Tools to Monitor Clinical Risk

Broaden Existing Structure and Staffing Roles to Accommodate Risk-Based Monitoring Practices

Leverage Clinical Operations -Focused Groups to Provide Primary Risk-Based Monitoring Support

  • Figure 1.1: Group with Primary Risk-Based Monitoring Responsibility: Pharmaceutical and Device Companies
  • Figure 1.2: Small Company B: Structure of Risk-Based Monitoring Strategy Management
  • Figure 1.3: Groups Involved in Risk-Based Monitoring Activities: All Pharmaceutical and Device Companies
  • Figure 1.4: Groups Involved in Risk-Based Monitoring Activities: Top 10 Companies
  • Figure 1.5: Groups Involved in Risk-Based Monitoring Activities: Top 50 Companies
  • Figure 1.6: Groups Involved in Risk-Based Monitoring Activities: Small Companies
  • Figure 1.7: Groups Involved in Risk-Based Monitoring Activities: Device Companies
  • Figure 1.8: Groups Involved in Risk-Based Monitoring Activities: CROs
  • Figure 1.9: Group with Primary Risk-Based Monitoring Responsibility: CROs
  • Figure 1.10: Groups Involved in Risk-Based Monitoring Activities: Academia
  • Figure 1.11: Group with Primary Risk-Based Monitoring Responsibility: Academia
  • Figure 1.12: Groups Involved in Risk-Based Monitoring Activities: Pharmaceutical and Device Companies (US and Canadian Teams)
  • Figure 1.13: Groups Involved in Risk-Based Monitoring Activities: Pharmaceutical and Device Companies (EU Teams)
  • Figure 1.14: Groups Involved in Risk-Based Monitoring Activities: Pharmaceutical and Device Companies (Asian Teams)
  • Figure 1.15: Groups Involved in Risk-Based Monitoring Activities: CROs (US)
  • Figure 1.16: Groups Involved in Risk-Based Monitoring Activities: CROs (Asia and EU)
  • Figure 1.17: Groups Involved in Risk-Based Monitoring Activities: Academia (EU)
  • Figure 1.18: Groups Involved in Risk-Based Monitoring Activities: Academia (US)

Distribute Risk-Based and Traditional Monitoring Responsibility to Merge In-House Capabilities with Outside Resources

  • Figure 1.19: Dedicated Risk Assessment Teams' Staffing: Top 10 and Top 50 Companies
  • Figure 1.21: Top 20 Company A: Contract Staffing Organization
  • Figure 1.20: Dedicated Risk Assessment Teams' Staffing: Small and Device Companies
  • Figure 1.23: Dedicated Risk Assessment Teams' Staffing: Academia
  • Figure 1.22: Dedicated Risk Assessment Teams' Staffing: CROs
  • Figure 1.24: Percentage of CRA Responsibility Outsourced: Top 10 and Top 50 Companies
  • Figure 1.25: Percentage of CRA Responsibility Outsourced: Small and Device Companies
  • Figure 1.26: Percentage of CRA Responsibility Outsourced: CROs
  • Figure 1.27: Percentage of Data Management Responsibility Outsourced: Top 10 and Top 50 Companies
  • Figure 1.28: Percentage of Data Management Responsibility Outsourced: Small and Device Companies
  • Figure 1.29: Percentage of Data Management Responsibility Outsourced: CROs
  • Figure 1.30: Percentage of Statistician Responsibility Outsourced: Top 10 and Top 50 Companies
  • Figure 1.31: Percentage of Statistician Responsibility Outsourced: Small and Device Companies
  • Figure 1.32: Percentage of Statistician Responsibility Outsourced: CROs
  • Figure 1.33: Percentage of Drug Safety Responsibility Outsourced: Top 10 and Top 50 Companies
  • Figure 1.34: Percentage of Drug Safety Responsibility Outsourced: Small and Device Companies
  • Figure 1.35: Percentage of Drug Safety Responsibility Outsourced: CROs

Risk-Based Monitoring: The Expanded Role of CRAs

  • Figure 1.36: Patients per CRA: Top 10 and Top 50 Companies
  • Figure 1.37: Patients per CRA: Small and Device Companies
  • Figure 1.38: Patients per CRA: CROs
  • Figure 1.39: Patients per CRA: Academia
  • Figure 1.40: Average Number of Patients per Site: Top 10 and Top 50 Companies
  • Figure 1.41: Average Number of Patients per Site: Small and Device Companies
  • Figure 1.42: Average Number of Patients per Site: CROs
  • Figure 1.43: Patients per Data Manager: Top 10 and Top 50 Companies
  • Figure 1.44: Patients per Data Manager: Small and Device Companies
  • Figure 1.45: Patients per Data Manager: CROs
  • Figure 1.46: Patients per Data Manager: Academia
  • Figure 1.47: Patients per Statistician: Top 10 Companies
  • Figure 1.48: Patients per Statistician: Small and Device Companies
  • Figure 1.49: Patients per Statistician: CROs
  • Figure 1.50: Patients per Drug Safety FTE: Top 10 Companies
  • Figure 1.51: Patients per Drug Safety FTE: Small and Device Companies
  • Figure 1.52: Patients per Drug Safety FTE: CROs
  • Figure 1.53: Pharmaceutical and Device Companies' Average Number of Sites per CRA for Phase 1 Trials
  • Figure 1.54: CROs' Average Number of Sites per CRA for Phase 1 Trials
  • Figure 1.55: Pharmaceutical and Device Companies' Average Number of Sites per CRA for Phase 2 Trials
  • Figure 1.56: CROs' Average Number of Sites per CRA for Phase 2 Trials
  • Figure 1.57: Pharmaceutical and Device Companies' Average Number of Sites per CRA for Phase 3 Trials
  • Figure 1.58: CROs' Average Number of Sites per CRA for Phase 3 Trials
  • Figure 1.59: Pharmaceutical and Device Companies' Average Number of Sites per CRA for Phase 4 Trials
  • Figure 1.60: CROs' Average Number of Sites per CRA for Phase 4 Trials
  • Figure 1.61: Pharmaceutical and Device Companies' Average Number of Site Visits per Month for Phase 1 Trials
  • Figure 1.62: CROs' Average Number of Site Visits per Month for Phase 1 Trials
  • Figure 1.63: Pharmaceutical and Device Companies' Average Number of Site Visits per Month for Phase 2 Trials
  • Figure 1.64: CROs' Average Number of Site Visits per Month for Phase 2 Trials
  • Figure 1.65: Pharmaceutical and Device Companies' Average Number of Site Visits per Month for Phase 3 Trials
  • Figure 1.66: CROs' Average Number of Site Visits per Month for Phase 3 Trials
  • Figure 1.67: Pharmaceutical and Device Companies' Average Number of Site Visits per Month for Phase 4 Trials
  • Figure 1.68: CROs' Average Number of Site Visits per Month for Phase 4 Trials

Impacting Clinical Trial Budgets via Risk-Based Monitoring Technology and Experienced Vendors

Decreasing Trial Spend Through Risk-Based Monitoring Strategies

  • Figure 2.1: Percentage Saved on Overall Trial Costs by Using RBM Strategies: Top 10 and Top 50 Companies
  • Figure 2.2: Percentage Saved on Overall Trial Costs by Using RBM Strategies: Small and Device Companies
  • Figure 2.3: Percentage Saved on Overall Trial Costs by Using RBM Strategies: CROs and Academia
  • Figure 2.4: Percentage Saved on Overall Trial Costs by Using RBM Strategies: US Teams
  • Figure 2.5: Percentage Saved on Overall Trial Costs by Using RBM Strategies: EU Teams
  • Figure 2.6: Percentage Saved on Overall Trial Costs by Using RBM Strategies: Asian Teams
  • Figure 2.7: Traditional v. RBM Trial Costs per CRA, by Development Phase
  • Figure 2.8: Traditional v. RBM Trial Costs per CRA, by Development Phase: CRO Company 16

Leveraging Experienced Research Partners to Aid Risk-Based Monitoring Efforts

  • Figure 2.9: On-site v. Off-Site Costs in RBM Trials: Top 10
  • Figure 2.10: On-site v. Off-Site Costs in RBM Trials: Small and Device
  • Figure 2.11: On-site v. Off-Site Costs in RBM Trials: CROs
  • Figure 2.12: On-site v. Off-Site Costs in RBM Trials: US
  • Figure 2.13: On-site v. Off-Site Costs in RBM Trials: EU
  • Figure 2.14: On-site v. Off-Site Costs in RBM Trials: Asia

Implementing Technology to Drive Risk-Based Monitoring Approaches

  • Figure 2.15: Percentage of Companies Using Specific Tools to Monitor Clinical Risk: All Companies
  • Figure 2.16: Percentage of Companies Using Specific Tools to Monitor Clinical Risk: Top 10 and Top 50 Companies
  • Figure 2.17: Percentage of Companies Using Specific Tools to Monitor Clinical Risk: Small and Device Companies
  • Figure 2.18: Percentage of Companies Using Specific Tools to Monitor Clinical Risk: CROs and Academia
  • Figure 2.19: Percentage of Companies Using Specific Tools to Monitor Clinical Risk: US Teams
  • Figure 2.20: Percentage of Companies Using Specific Tools to Monitor Clinical Risk: EU Teams
  • Figure 2.21: Percentage of Companies Using Specific Tools to Monitor Clinical Risk: Asian Teams
  • Figure 2.22: Annual Cost of Maintaining Electronic Data Capture (EDC) Systems, by Company
  • Figure 2.23: Annual Cost of Maintaining Electronic Data Capture (EDC) Systems, by Region
  • Figure 2.24: Annual Cost of Maintaining Safety Systems, by Company
  • Figure 2.25: Annual Cost of Maintaining Safety Systems, by Region
  • Figure 2.26: Annual Cost of Maintaining Central Laboratory Systems, by Company
  • Figure 2.27: Annual Cost of Maintaining Central Laboratory Systems, by Region
  • Figure 2.28: Annual Cost of Maintaining Clinical Trial Management Systems (CTMS), by Company
  • Figure 2.29: Annual Cost of Maintaining Clinical Trial Management Systems (CTMS), by Region
  • Figure 2.30: Number of Trial Management Platforms Used: All Companies
  • Figure 2.31: Percentage of Companies Currently Using Specific Trial Management Systems: All Companies
  • Figure 2.32: Percentage of Companies Currently Using Specific Trial Management Systems: Top 10 and Top 50 Companies
  • Figure 2.33: Percentage of Companies Currently Using Specific Trial Management Systems: Small and Device Companies
  • Figure 2.34: Percentage of Companies Currently Using Specific Trial Management Systems: CROs
  • Figure 2.35: Percentage of Companies Currently Using Specific Trial Management Systems: US Teams
  • Figure 2.36: Percentage of Companies Currently Using Specific Trial Management Systems: EU Teams
  • Figure 2.37: Percentage of Companies Currently Using Specific Trial Management Systems: Asian Teams
  • Figure 2.38: Rating of Clinical Trial Management System Attributes: All Companies
  • Figure 2.39: Rating of Clinical Trial Management System Attributes: Top 10 and Top 50 Companies
  • Figure 2.40: Rating of Clinical Trial Management System Attributes: Small and Device Companies
  • Figure 2.41: Rating of Clinical Trial Management System Attributes: CROs
  • Figure 2.42: Rating of Clinical Trial Management System Attributes: US Teams
  • Figure 2.43: Rating of Clinical Trial Management System Attributes: EU Teams
  • Figure 2.44: Rating of Clinical Trial Management System Attributes: Asian Teams
  • Figure 2.45: Perceived Influence of Specific Factors in Adopting Centralized Risk-Based Monitoring Platforms: All Companies
  • Figure 2.46: Perceived Influence of Specific Factors in Adopting Centralized Risk-Based Monitoring Platforms: Top 10 and Top 50 Companies
  • Figure 2.47: Perceived Influence of Specific Factors in Adopting Centralized Risk-Based Monitoring Platforms: Small and Device Companies
  • Figure 2.48: Perceived Influence of Specific Factors in Adopting Centralized Risk-Based Monitoring Platforms: CROs and Academia
  • Figure 2.49: Perceived Influence of Specific Factors in Adopting Centralized Risk-Based Monitoring Platforms: US Teams
  • Figure 2.50: Perceived Influence of Specific Factors in Adopting Centralized Risk-Based Monitoring Platforms: EU Teams
  • Figure 2.51: Perceived Influence of Specific Factors in Adopting Centralized Risk-Based Monitoring Platforms: Asian Teams
  • Figure 2.52: Number of KPIs Tracking in Remote Monitoring Systems: All Companies
  • Figure 2.53: Percentage of Companies Tracking Specific KPIs in Remote Monitoring Systems: All Companies
  • Figure 2.54: Percentage of Companies Tracking Specific KPIs in Remote Monitoring Systems: Top 10 and Top 50 Companies
  • Figure 2.55: Percentage of Companies Tracking Specific KPIs in Remote Monitoring Systems: Small and Device Companies
  • Figure 2.56: Percentage of Companies Tracking Specific KPIs in Remote Monitoring Systems: CROs and Academia
  • Figure 2.57: Percentage of Companies Tracking Specific KPIs in Remote Monitoring Systems: US Teams
  • Figure 2.58: Percentage of Companies Tracking Specific KPIs in Remote Monitoring Systems: EU Teams
  • Figure 2.59: Percentage of Companies Tracking Specific KPIs in Remote Monitoring Systems: Asian Teams
  • Figure 2.60: Frequency of Clinical Trial Management System Report Generation for Specific Topics: All Companies
  • Figure 2.61: Frequency of Clinical Trial Management System Report Generation for Specific Topics: Top 10 and Top 50 Companies
  • Figure 2.62: Frequency of Clinical Trial Management System Report Generation for Specific Topics: Small and Device Companies
  • Figure 2.63: Frequency of Clinical Trial Management System Report Generation for Specific Topics: CROs and Academia
  • Figure 2.64: Frequency of Clinical Trial Management System Report Generation for Specific Topics: US Teams
  • Figure 2.65: Frequency of Clinical Trial Management System Report Generation for Specific Topics: EU Teams
  • Figure 2.66: Frequency of Clinical Trial Management System Report Generation for Specific Topics: Asian Teams
  • Figure 2.67: Percentage of Companies Using Specific External Platforms To Assist RBM Activities: All Companies
  • Figure 2.68: Percentage of Companies Using Specific External Platforms to Assist RBM Activities: Top 10 and Top 50 Companies
  • Figure 2.69: Percentage of Companies Using Specific External Platforms to Assist RBM Activities: Small and Device Companies
  • Figure 2.70: Percentage of Companies Using Specific External Platforms to Assist RBM Activities: CROs and Academia
  • Figure 2.71: Percentage of Companies Using Specific External Platforms to Assist RBM Activities: US Teams
  • Figure 2.72: Percentage of Companies Using Specific External Platforms to Assist RBM Activities: EU Teams
  • Figure 2.73: Percentage of Companies Using Specific External Platforms To Assist RBM Activities: Asian Teams

The Value of Risk-Based Monitoring Strategies and Technology

Developing Frameworks to Support an Array of Risk-Based Monitoring Approaches

General Usage of Risk-Based Monitoring, by Development Phase

  • Figure 3.1: Use of RBM, by Phase: All Pharmaceutical and Device Companies
  • Figure 3.2: Use of RBM, by Phase: Top 10 Companies
  • Figure 3.3: Use of RBM, by Phase: Top 50 Companies
  • Figure 3.4: Use of RBM, by Phase: Small Companies
  • Figure 3.5: Use of RBM, by Phase: Device Companies
  • Figure 3.6: Use of RBM, by Phase: CROs
  • Figure 3.7: Use of RBM, by Phase: Academia
  • Figure 3.8: Use of RBM, by Phase: All Pharmaceutical and Device Companies with Dedicated Risk-Based Monitoring Teams
  • Figure 3.9: Use of RBM, by Phase: All Pharmaceutical and Device Companies Without Dedicated Risk-Based Monitoring Teams
  • Figure 3.10: Use of RBM, by Phase: Top 10 Companies with Dedicated Risk-Based Monitoring Teams
  • Figure 3.11: Use of RBM, by Phase: Top 10 Companies Without Dedicated Risk-Based Monitoring Teams
  • Figure 3.12: Use of RBM, by Phase: Top 50 Companies with Dedicated Risk-Based Monitoring Teams
  • Figure 3.13: Use of RBM, by Phase: Top 50 Companies Without Dedicated Risk-Based Monitoring Teams
  • Figure 3.14: Use of RBM, by Phase: Small Companies with Dedicated Risk-Based Monitoring Teams
  • Figure 3.15: Use of RBM, by Phase: Small Companies Without Dedicated Risk-Based Monitoring Teams
  • Figure 3.16: Use of RBM, by Phase: Device Companies with Dedicated Risk-Based Monitoring Teams
  • Figure 3.17: Use of RBM, by Phase: Device Companies Without Dedicated Risk-Based Monitoring Teams
  • Figure 3.18: Use of RBM, by Phase: All Pharmaceutical and Device Companies (US and Canadian Teams)
  • Figure 3.19: Use of RBM, by Phase: All Pharmaceutical and Device Companies (EU Teams)
  • Figure 3.20: Use of RBM, by Phase: All Pharmaceutical and Device Companies (Asian Teams)
  • Figure 3.21: Use of RBM, by Phase: Top 10 and Top 50 Companies (US Teams)
  • Figure 3.22: Use of RBM, by Phase: Top 10 and Top 50 Companies (EU Teams)
  • Figure 3.23: Use of RBM, by Phase: Top 10 and Top 50 Companies (Asian Teams)
  • Figure 3.24: Use of RBM, by Phase: Small Companies (US and Canadian Teams)
  • Figure 3.25: Use of RBM, by Phase: Small Companies (EU Teams)
  • Figure 3.26: Use of RBM, by Phase: Small Companies (Asian Teams)
  • Figure 3.27: Use of RBM, by Phase: Device Companies (US Teams)
  • Figure 3.28: Use of RBM, by Phase: Device Companies (EU Teams)
  • Figure 3.29: Use of RBM, by Phase: CROs (US Teams)
  • Figure 3.30: Use of RBM, by Phase: CROs (EU Teams)

General Usage of Risk-Based Monitoring, by Therapeutic Area

  • Figure 3.31: Use of RBM, by Therapeutic Area: All Pharmaceutical and Device Companies
  • Figure 3.32: Use of RBM, by Therapeutic Area: Top 10 Companies
  • Figure 3.33: Use of RBM, by Therapeutic Area: Top 50 Companies
  • Figure 3.34: Use of RBM, by Therapeutic Area: Small Companies
  • Figure 3.35: Use of RBM, by Therapeutic Area: Device Companies
  • Figure 3.36: Use of RBM, by Therapeutic Area: CROs
  • Figure 3.37: Use of RBM, by Therapeutic Area: Academia

Type of Monitoring Preferred, by Development Phase

  • Figure 3.38: Type of RBM Used, by Development Phase: All Pharmaceutical and Device Companies
  • Figure 3.39: Type of RBM Used, by Development Phase: Top 10 and Top 50 Companies
  • Figure 3.40: Type of RBM Used, by Development Phase: Small Companies
  • Figure 3.41: Type of RBM Used, by Development Phase: Device Companies
  • Figure 3.42: Type of RBM Used, by Development Phase: CROs
  • Figure 3.43: Type of RBM Used, by Development Phase: All Pharmaceutical and Device Companies with Dedicated Risk-Based Monitoring Teams
  • Figure 3.44: Type of RBM Used, by Development Phase: All Pharmaceutical and Device Companies Without Dedicated Risk-Based Monitoring Teams
  • Figure 3.45: Type of RBM Used, by Development Phase: All Pharmaceutical and Device Companies (US Teams)
  • Figure 3.46: Type of RBM Used, by Development Phase: All Pharmaceutical and Device Companies (Asian Teams)
  • Figure 3.47: Type of RBM Used, by Development Phase: All Pharmaceutical and Device Companies (EU Teams)
  • Figure 3.48: Type of RBM Used, by Development Phase: CROs (US Teams)
  • Figure 3.49: Type of RBM Used, by Development Phase: CROs (EU Teams)
  • Figure 3.50: Source Data Verification (SDV) at a Glance

Planning Risk-Based Monitoring Trials and Establishing Risk Thresholds

  • Figure 3.51: Average Number of Months Prior to Trial Launch That Specific RBM Tasks Are Completed: All Pharmaceutical and Device Companies
  • Figure 3.52: Average Number of Months Prior to Trial Launch That Specific RBM Tasks Are Completed: CROs and Academia
  • Figure 3.53: Number of Months Prior to Trial Launch That Teams Begin Developing RBM Plans: All Pharmaceutical and Device Companies
  • Figure 3.54: Number of Months Prior to Trial Launch That Teams Begin Developing RBM Plans: All Pharmaceutical and Device Companies, by Region
  • Figure 3.55: Number of Months Prior to Trial Launch That Teams Gather Risk Identification Information: All Pharmaceutical and Device Companies
  • Figure 3.56: Number of Months Prior to Trial Launch That Teams Gather Risk Identification Information: All Pharmaceutical and Device Companies, by Region
  • Figure 3.57: Number of Months Prior to Trial Launch That Teams Establish a Monitoring Plan: All Pharmaceutical and Device Companies
  • Figure 3.58: Number of Months Prior to Trial Launch That Teams Establish a Monitoring Plan: All Pharmaceutical and Device Companies, by Region
  • Figure 3.59: Number of Months Prior to Trial Launch That Teams Define Critical Data and Processes: All Pharmaceutical and Device Companies
  • Figure 3.60: Number of Months Prior to Trial Launch That Teams Define Critical Data and Processes: All Pharmaceutical and Device Companies, by Region
  • Figure 3.61: Number of Months Prior to Trial Launch That Teams Complete Risk Assessments: All Pharmaceutical and Device Companies
  • Figure 3.62: Number of Months Prior to Trial Launch That Teams Complete Risk Assessments: All Pharmaceutical and Device Companies, by Region
  • Figure 3.63: Number of Months Prior to Trial Launch That Teams Develop Quality and Risk Management Plans: All Pharmaceutical and Device Companies
  • Figure 3.64: Number of Months Prior to Trial Launch That Teams Develop Quality and Risk Management Plans: All Pharmaceutical and Device Companies, by Region
  • Figure 3.65: Number of Months Prior to Trial Launch That Teams Begin Developing RBM Plans: CROs and Academic Trials
  • Figure 3.66: Number of Months Prior to Trial Launch That Teams Gather Risk Identification Information: CROs and Academic Trials
  • Figure 3.67: Number of Months Prior to Trial Launch That Teams Define Critical Data and Processes: CROs and Academic Trials
  • Figure 3.68: Number of Months Prior to Trial Launch That Teams Complete Risk Assessments: CROs and Academic Trials
  • Figure 3.69: Number of Months Prior to Trial Launch That Teams Establish a Monitoring Plan: CROs and Academic Trials
  • Figure 3.70: Number of Months Prior to Trial Launch That Teams Develop Quality and Risk Management Plan: CROs and Academic Trials
  • Figure 3.71: Risk-Based Monitoring Planning Process: Top 50 Company D
  • Figure 3.72: Examples of Risk Categories and Risk Indicators: Company D
  • Figure 3.73: Perceived Impact Ratings of Specific Factors on RBM Plan Development: All Pharmaceutical and Device Companies
  • Figure 3.74: Perceived Impact Ratings of Specific Factors on RBM Plan Development: Top 10 and Top 50 Companies
  • Figure 3.75: Perceived Impact Ratings of Specific Factors on RBM Plan Development: Small and Device Companies
  • Figure 3.76: Perceived Impact Ratings of Specific Factors on RBM Plan Development: US Teams
  • Figure 3.77: Perceived Impact Ratings of Specific Factors on RBM Plan Development: EU Teams
  • Figure 3.78: Perceived Impact Ratings of Specific Factors on RBM Plan Development: Asian Teams
  • Figure 3.79: Perceived Impact Ratings of Specific Factors on RBM Plan Development: CROs and Academia
  • Figure 3.80: Sponsor Site Management: A Targeted Approach
  • Figure 3.81: Data Used to Build Risk-Threshold Parameters: All Pharmaceutical and Device Companies
  • Figure 3.82: Data Used to Build Risk-Threshold Parameters: Top 10 and Top 50 Companies
  • Figure 3.83: Data Used to Build Risk-Threshold Parameters: Small and Device Companies
  • Figure 3.84: Data Used to Build Risk-Threshold Parameters: US Teams
  • Figure 3.85: Data Used to Build Risk-Threshold Parameters: EU Teams
  • Figure 3.86: Data Used to Build Risk-Threshold Parameters: Asian Teams
  • Figure 3.87: Data Used to Build Risk-Threshold Parameters: CROs and Academia

Managing Risk-Based Monitoring Processes

  • Figure 3.88: Frequency with Which All Pharmaceutical and Device Companies Adjust Their Risk Threshold During a Clinical Trial, by Company Type
  • Figure 3.89: Frequency with Which CROs Adjust Their Risk Threshold During a Clinical Trial
  • Figure 3.90: Frequency with Which All Pharmaceutical and Device Companies Evaluate Risk During a Clinical Trial, by Company Type
  • Figure 3.91: Frequency with Which CROs Evaluate Risk During a Clinical Trial
  • Figure 3.92: Factors That Influence Risk-Based Monitoring Activities: All Pharmaceutical and Device Companies
  • Figure 3.93: Factors That Influence Risk-Based Monitoring Activities: Top 10 and Top 50 Companies
  • Figure 3.94: Factors That Influence Risk-Based Monitoring Activities: Small Companies
  • Figure 3.95: Factors That Influence Risk-Based Monitoring Activities: Device Companies
  • Figure 3.96: Factors That Influence Risk-Based Monitoring Activities: CROs

Risk-Based Monitoring Team Profiles

  • Figure 4.1: Company 1: Risk-Based Monitoring Background
  • Figure 4.2: Company 1: CRA Metrics
  • Figure 4.3: Company 1: Trial Site Metrics
  • Figure 4.4: Company 1: Phase 3 Trial Staffing Data
  • Figure 4.5: Company 2: Risk-Based Monitoring Background
  • Figure 4.6: Company 2: CRA Metrics
  • Figure 4.7: Company 2: Trial Site Metrics
  • Figure 4.8: Company 2: Phase 3 Trial Staffing Data
  • Figure 4.9: Company 5: Risk-Based Monitoring Background
  • Figure 4.10: Company 5: CRA Metrics
  • Figure 4.11: Company 5: Trial Site Metrics
  • Figure 4.12: Company 5: Phase 3 Trial Staffing Data
  • Figure 4.13: Company 7: Risk-Based Monitoring Background
  • Figure 4.14: Company 7: CRA Metrics
  • Figure 4.15: Company 7: Trial Site Metrics
  • Figure 4.16: Company 7: Phase 3 Trial Staffing Data
  • Figure 4.17: Company 8: Risk-Based Monitoring Background
  • Figure 4.18: Company 8: CRA Metrics
  • Figure 4.19: Company 8: Trial Site Metrics
  • Figure 4.20: Company 8: Phase 2 Trial Staffing Data
  • Figure 4.21: Company 10: Risk-Based Monitoring Background
  • Figure 4.22: Company 10: CRA Metrics
  • Figure 4.23: Company 10: Trial Site Metrics
  • Figure 4.24: Company 10: Phase 1 Trial Staffing Data
  • Figure 4.25: Company 12: Risk-Based Monitoring Background
  • Figure 4.26: Company 12: CRA Metrics
  • Figure 4.27: Company 12: Trial Site Metrics
  • Figure 4.28: Company 12: Phase 3 Trial Staffing Data
  • Figure 4.29: Company 14: Risk-Based Monitoring Background
  • Figure 4.30: Company 14: CRA Metrics
  • Figure 4.31: Company 14: Trial Site Metrics
  • Figure 4.32: Company 14: Phase 4 Trial Staffing Data
  • Figure 4.33: Company 15: Risk-Based Monitoring Background
  • Figure 4.34: Company 15: CRA Metrics
  • Figure 4.35: Company 15: Trial Site Metrics
  • Figure 4.36: Company 15: Phase 4 Trial Staffing Data
  • Figure 4.37: Company 16: Risk-Based Monitoring Background
  • Figure 4.38: Company 16: CRA Metrics
  • Figure 4.39: Company 16: Trial Site Metrics
  • Figure 4.40: Company 16: Phase 3 Trial Staffing Data
  • Figure 4.41: Company 17: Risk-Based Monitoring Background
  • Figure 4.42: Company 17: Trial Site Metrics
  • Figure 4.43: Company 20: Risk-Based Monitoring Background
  • Figure 4.44: Company 20: CRA Metrics
  • Figure 4.45: Company 20: Trial Site Metrics
  • Figure 4.46: Company 20: Phase 3 Trial Staffing Data
  • Figure 4.47: Company 24: Risk-Based Monitoring Background
  • Figure 4.48: Company 24: CRA Metrics
  • Figure 4.49: Company 24: Trial Site Metrics
  • Figure 4.50: Company 24: Phase 2 Trial Staffing Data
Back to Top