So, just what is a clinical trial? A clinical trial (clinical study or research study) determines whether a new drug or treatment will work on a disease and be of benefit to patients. Trials allow doctors and researchers to gain information on the benefits, side effects and possible applications of new drugs, as well as different combinations, doses and new indications of existing drugs.
All clinical trials are based on a set of rules – protocol. This protocol describes what type and how many people may participate in the trial, the schedule of tests, procedures, medications and dosages and the length of the study. During a clinical trial, participants are seen regularly by the research staff (doctors) to monitor their health and to determine the safety and effectiveness of their treatment.
Clinical trials have four distinct research phases, progressing from relatively simple studies involving small numbers of participants to later stages, typically large-scale international studies generating vast amounts of data from a diverse population of participants.
The role of the supply chain in clinical trials – The supply of clinical trials is a specialist operation distinct in its quality and accuracy demands, even when compared with its commercial pharmaceutical counterpart. It involves five major stages: trial planning (units, label preparation and component/comparator procurement, blinding design – the process by which the identity of the trial drugs is concealed); clinical lot manufacture, blinding, drug packaging and labelling; storage, shipping and distribution; dispensing; and uplifts, reconciliation and destruction.
Clinical trials are becoming more complex as studies globalise and larger patient numbers are required to satisfy regulatory standards. Successfully co-ordinating patient screening, enrolment, randomisation, study-drug distribution and inventory management is more challenging than ever. As competition to speed up the drug development process intensifies, innovative ways to increase supply chain efficiency are key.
Analysis suggests that a Phase III study can cost as much as E25-E30 million over five years. Additionally, it has been estimated that up to 70 per cent of clinical material produced is never used due to inefficiency in inventory control and information. This largely arises due to uncertainty surrounding the initiation and progress of clinical trials; companies must make assumptions about key parameters: study start dates; locations; treatment duration; anticipated rates of patient enrolment; packaging design; drug dosage; sourcing; and blinding and packaging of the required drugs.
Contingency levels raised
Contingency levels raised by each partner in the supply chain can often lead to inventory requirements expanding to provide sufficient medication for patients recruited to the trial.
When assessing the vast savings possible in time and money by reducing drug waste and allowing trial sponsors to get the drug to market quicker, the role of a supply chain specialist and centralised drug distribution offers clear benefits.
Matching information flow to inventory in real-time is crucial. As a result, investment in systems validation and design, specifically for the demands of clinical trials logistics, is key for the provider to ensure compliance with regulatory requirements.
Legislation as a driver of change – Historically, most pharmaceutical companies have viewed clinical trials supply simply as a ‘cottage industry’ within the development function. Treated informally, it has attracted relatively little senior management attention. However, clinical trials supply is fast becoming a major item on the management agenda, particularly in light of recent changes in European regulation. It is essential that the changes in Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP), driven by Annex 13 to the European Commission Directive 91/356/EEC (regarding the manufacture of investigational Medicinal Products) and Directive 2001/20/EC (relating to GCP and the conduct of clinical trials on medicinal product for human use) are recognised by the supply chain industry.
Unique array of challenges
These changes, written into European member states’ law, are brought into effect as of 1 May 2004 and recognise clinical trials supply as a specialist operation facing a unique array of challenges impacting on the distribution landscape for investigational medicinal products within Europe. The increased focus on quality is driving logistics providers to develop new facilities, purpose-built clinical trials cells for example, within their existing pharmaceutical infrastructures.
State-of-the-art clinical trials storage areas should encompass technology to deliver a monitored and controlled environment to ISO 14644 Class 100,000 (Class 8) and feature dedicated capacity for ambient, chilled and frozen temperature ranges. Leading logistics providers may also provide clean room facilities ensuring other value added services such as packing and rework are available.
As developments in clinical trials distribution gather pace, logistics providers that offer international export specialism can create further value by offering complete clinical supply chain management throughout Europe and across the globe. This allows pharmaceutical companies to focus on their core research and development process.
Key features of clinical trials logistics include: centralising clinical warehouse inventories; application of import/export procedures for the movement of drugs into and out of the European Union; tracking drugs issued to individual investigators; managing expiration dates; small-scale supplies packaging; re-labelling according to local country requirements; qualified person release of pharmaceutical stock into circulation; drug storage and site delivery services; loading initial stock to trial centres; re-supply to centres; returns handling; reconciliation and certified destruction at the end of the study.
Advanced technology and supply chain visibility – An integrated IT platform for clinical trials enhances process visibility and operational control for raw materials, intermediates and patient packs throughout their logistics lifecycle. Web-enabled systems based on the foundations of material requirements planning, warehouse and freight/export document management, e-commerce and financial planning offer unparalleled levels of reporting and control over inventory and works order processing.
This increasing importance and complexity of successfully managing clinical trials has resulted in the emergence of a specialised niche in the pharmaceutical contract services industry, developed to meet the critical attributes of speed and accuracy. Investment in the enhancement of clinical trials logistics is vital if supply chain companies are to match the requirements of existing and prospective customers with leading-edge capabilities that meet the latest regulatory standards.
Chris Tierney is clinical trials development manager in Exel’s Healthcare sector and can be contacted at firstname.lastname@example.org.
- Clinical trials are becoming more complex as studies globalise and larger patient numbers are required to satisfy regulatory standards.
- Analysis suggests that a Phase III study can cost as much as E25-E30 million over five years. Additionally, it has been estimated that up to 70 per cent of clinical material produced is never used due to inefficiency in inventory control and information.
- Matching information flow to inventory in real-time is crucial. As a result, investment in systems validation and design, specifically for the demands of clinical trials logistics, is key for the provider to ensure compliance with regulatory requirements.