Risk Mitigation in Clinical Trials: Centralized Procurement for Global Decentralized Trials
Global decentralized clinical trials have become increasingly common in the field of clinical research due to their potential to improve patient access, diversity, and cost-efficiency. However, not using a centralized procurement approach for these trials can introduce a myriad of risks that may compromise the quality and success of the research. In this blog piece, we will delve into the risks associated with decentralized procurement and explore how sponsors and contract research organizations (CROs) can prioritize risk mitigation in clinical trials. Furthermore, we will highlight the numerous benefits of adopting centralized procurement in the context of global decentralized clinical trials (DCTs).
Short Cuts
Risks of Not Using a Centralized Procurement Approach
1. Increased Costs:
When each site in a global decentralized trial is responsible for procuring its own supplies, it can lead to duplication of effort and higher costs. Negotiating separate contracts with suppliers and dealing with different pricing structures can inflate the trial’s overall expenses.
2. Inconsistency of Supplies
Without centralized procurement, the quality and availability of supplies may vary from site to site. This inconsistency can challenge the trial’s goal of ensuring uniform treatment for all participants.
3. Delays in Trial Progress
Delays in receiving supplies, a common consequence of decentralized procurement, can hinder the trial’s initiation and progress. DCTs often rely on quick turnaround times to ensure participants receive timely treatment.
4. Increased Regulatory and Import Complexity
Managing procurement for a global decentralized trial with multiple sites can be highly complex. Factors like differing regulatory requirements, shipping costs, and currency exchange rates can complicate the process.
5. Increased Risk of Error
Multiple decentralized procurement processes can lead to errors, potentially resulting in participants receiving the wrong treatment or supplies becoming contaminated or expired.
6. Ethical and Regulatory Violations
Without a centralized approach, the risk of conflicts of interest and supplies being diverted for commercial purposes, rather than being used exclusively for the trial, increases. This poses ethical and regulatory challenges.
Centralized Procurement Benefits: A Risk-Mitigating Solution
A centralized procurement approach offers several key benefits that help mitigate risks in global decentralized trials:
Eliminates Duplication of Effort:
Centralized procurement streamlines the negotiation and contracting process, reducing time and costs associated with individual site procurement efforts.
Ensures Consistency of Supplies:
Working with a single supplier or group of suppliers helps maintain consistent, high-quality supplies across all trial sites.
Reduces the Risk of Delays:
Centralization provides better control over the supply chain, enabling early identification and resolution of potential delays.
Simplifies the Procurement Process:
A centralized approach simplifies procurement, allowing sponsors and CROs to allocate resources efficiently.
Improves Visibility into the Supply Chain:
Centralized procurement enhances supply chain visibility, facilitating early issue detection and resolution.
Reduces the Risk of Ethical Violations:
Centralization helps mitigate conflicts of interest and unauthorized diversion of supplies.
Mitigating Risks with Centralized Procurement:
Specific Steps for DCTs
In decentralized trials, sponsors and CROs can take additional steps to enhance efficiency and minimize risks:
Use Just-in-Time (JIT) Delivery: Adopt a JIT delivery model to reduce stockpiling of supplies, which can lower costs and prevent supply expiration or damage.
Employ Straight-to-Site (STS) Delivery: Deliver supplies directly to participants’ locations, improving convenience and reducing the risk of loss or theft.
Utilize Technology-Enabled Solutions: Implement technology-driven supply chain management solutions to automate and streamline the procurement process, reducing errors and enhancing visibility.
By following these tips, sponsors and CROs can mitigate the risks associated with procurement for DCTs and ensure that their trials are successful.
Embracing Centralized Procurement:
A Prescription for Success in Decentralized Trials
Global DCTs offer numerous advantages, but decentralized procurement poses significant risks that can undermine the success and integrity of research. By adopting a centralized procurement approach, sponsors and CROs can enhance efficiency, maintain quality, and reduce risks. It ensures that all participants receive consistent, high-quality treatment, thereby upholding the ethical and scientific standards of clinical research.
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