Return, Accountability and Destruction of IMPs for Clinical Trials

A clinical trial demands meticulous planning. From patient recruitment to comparator sourcing, the process involves a carefully coordinated schedule that addresses legal requirements, strict regulations, transportation, and safe storage of medicinal products, among other critical tasks.

But what happens at the end of a trial? This can often present its own set of challenges, particularly regarding management of unused investigational medical products (IMPs). For proper accountability, the return and destruction of these must be conducted with the same rigour as the trial itself.

In this article we will explore the critical process of managing unused IMPs at the end of the clinical trial.Managing Unused Investigational Medical Products

Managing unused IMPs requires strict management. The process includes accurate record keeping, maintaining inventory control, implementing patient return procedures and executing proper destruction methods. All these steps must align with environmental and safety regulations to prevent any non-compliance issues.

• Accurate record-keeping begins as soon as the IMPs are received. Detailed records must be maintained until their final disposition. This includes documenting quantities, batch numbers, expiration dates and storage conditions. This ensures traceability and accountability of the products throughout the trial.
  
  
• Inventory management systems track the movement of products, highlighting any inconsistencies. This is a vital step to prevent either shortages or overstocking, both of which can lead to significant issues. Shortages can affect the continuity of the trial and data integrity and overstocking can result in storage problems or having much needed, budget tied up in stock.
  
  
• Patient return procedures with strict protocols must be in place in order for patients to return unused or partially used medications. In some instances, it may be necessary to arrange for IMP return collections if a patient is unable to travel or has transportation difficulties. Such procedures ensure that all IMPs are accounted for and properly handled reducing the risk of unauthorised use or accidental exposure.
  
  
• Proper destruction methods must be used to destroy expired or unusable IMPs that comply with environmental and safety regulations. This involves secure disposal processes that prevent contamination and adhere to legal standards.
  
  
• A certificate of destruction is crucial when disposing of investigational medical products from clinical trials to ensure compliance with regulatory standards. This document serves as legal evidence that pharmaceutical waste has been handled and disposed of correctly, mitigating the risks of environmental contamination and legal repercussions. Without it, facilities face significant fines and liabilities, emphasising the necessity of a comprehensive and compliant waste management system.
  
  
• Compliance with Good clinical Practice (GCP) guidelines and regulatory requirements is paramount in IMP handling. Severe consequences, including data integrity issues, regulatory sanctions and potential harm to patients may result if legal requirements are not met. Ensuring compliance throughout the IMP management process safeguards the trial’s integrity and validity whilst protecting public health.

Planning for Success

Whilst returns, destruction and accountability takes place at the end of a clinical trial, planning for this, should start as soon as a project is given the go-ahead. Clear communication and collaboration between sponsors and investigators, CROs and clinical trial supply chain providers is essential. Establishing proper Standard Operating Procedures (SOPs) ensures consistent and compliant handling of IMPs, from receipt to destruction.

Emerging trends and best practices in IMP management offer new solutions and improvements. Advanced technology, such as real-time IMP tracking and inventory management systems enhance efficiency and accuracy.

Going forward, best practice disposal methods move towards protecting our planet and sustainable disposal options represents a commitment to environmental responsibility. Ethical considerations such as minimising waste and ensuring patient safety underscore the importance of responsible IMP management.

Work with Oximio

At Oximio, we have been providing clinical trial supply chain solutions across the globe for over 20 years. Embracing best practices, adhering to legal requirements and adopting an environmentally friendly approach, our return management service include:

• Provision of sharp-bins, cardboard boxes
• Dedicated quarantine storage
• Recollection of the clinical supplies from investigational sites
• Product disposal
• Certificate of Destruction
• Full accountability up to kit level
• Re-export of study equipment

For further information, why not contact us today. We’d be delighted to talk to you.

Further reading: Clinical Trial Packaging: Safeguarding Products, Patients, and the Planet