Written by: Sanjay Vyas, EVP, India Country Head & Managing Director & SBU Head Clinical Trial Supplies & Logistics | Vince Santa Maria, Vice President CTS&L Production, Labeling and Depot Clinical Trial Supplies, and Logistics
The rise of clinical trial complexity has been well-documented but the impact on supply chain management is not well understood. Phase 3 clinical trials today generate three times more data than 10 years ago, reflecting steep increases in the number of protocol procedures, the division of patients into genetic subgroups and other changes in protocol design practices.1 Globalization and the rise of therapies with highly specific handling requirements have contributed to the rise in complexity.
Decentralized clinical trials (DCTs), adoption of which soared in response to COVID-19, further changed the landscape. Hybrid trials, including studies with direct-to-patient (DTP) logistics that ship investigational drugs to the homes of participants, are part of a set of solutions that are addressing persistent challenges faced by sponsors: notably, cutting the number of site visits per trial improves recruitment and retention by expanding the geographic scope and reduces the time patients spend traveling, an important consideration given around 70% of participants live at least two hours from their nearest study center.
Implications for logistics
The rise of hybrid trials is one of the factors disrupting an already-complex supply chain. The chain of custody has grown longer, and compliance and regulatory guidance now include depot-to-site shipments as well as clinical drug products and many other ancillary trial materials sent directly to patient homes. The scope of clinical supply management is changing, too, with studies now needing to ship ancillary supplies, devices and mHealth components such as sensors, tablets and phones.
All this is happening at a time when demand for clinical logistics services, be it for DCTs, fully site-based studies and everything in between, is rising quickly. According to a report by Grand View Research, the global clinical trial supply and logistics market is expected to reach $5.4 billion by 2028, expanding at a compound annual growth rate of 7.1% between now and the end of the forecast period.2
The growing geographic scope, number of supplies and pressures on the availability of supplies mean more qualified specialty partners are needed. Supply chain partners must be vetted and audited for regulatory compliance before they can deliver investigational medicinal products (IMP), while the logistics operation must also source, store and distribute the required ancillary supplies, as well as drug delivery and mHealth devices.
Patients, meanwhile, must be informed appropriately on how to use and store products properly, with added complexity arising if temperature-controlled distribution and storage processes are needed en route or at home. Home healthcare services provided by CROs can ensure patient compliance, through the role of home nurses, who train and help the patient understand the criticality of the service. Privacy laws require the security of remote data submissions and data but specific regulations can vary from country to country, necessitating the in-depth knowledge and regulatory expertise that a CRO partner can provide.
How a strong CRO partnership can help
To address the challenges, CRO solutions must integrate a range of patient-friendly service models to meet the needs for recruitment and trial performance for target populations, therapeutic indications and geography. A good CRO partner needs to excel across numerous variables to deliver truly patient-centric services, as well as efficiency and value to sponsors.
These solutions include a strong global footprint for storage of clinical supply materials and drug product, an ability to respond quickly to changing circumstances and sophisticated real-time tracking technology. CROs also need to rigorously apply standards and certifications to all products, bringing the same level of scrutiny to ancillary supplies and IMPs.
The most effective CROs have in-house knowledge across the entire clinical trial and logistics spectrum. Equipped with that knowledge, Parexel’s Clinical Trial Supplies & Logistics team ensures the right supplies get to the right sites and patients at the right time.
The level of knowledge and connections needed to manage problems that inevitably arise on occasion when running complex global logistics operations is exemplified by Parexel’s cross-border DTP service from Malaysia to Singapore.
Here, an oncology patient was unable to continue crossing the border for treatment because of pandemic restrictions. Parexel filed a full protocol deviation and worked with the regulatory agencies in Singapore and Malaysia, as well as with cross-border customs compliance officials, to secure all of the permissions to enable the patient’s treatment to continue. The changes were made possible by Parexel’s strong supply chain base and in-house trade compliance and regulatory teams.
Plan ahead to put the patient first
Proactive planning mitigates the unforeseen pitfalls encountered in all clinical trials. Details of planning strategies vary from trial to trial, but there are common elements. It is vital to involve supply chain stakeholders, across compliance and legal specialists, licensing experts or depot managers, in the creation of feasibility plans. Wide, early stakeholder engagement positions clinical trials to deliver on patient experience.
The importance of such engagement is illustrated by a global program of five studies that required standardized set-up alignment relating to data collection and equipment. A fast, adaptable start-up was necessary with over 330 sites and more than 1,300 patients. The sponsor’s resources and incumbent depot provider were insufficient for the country coverage and start-up speed required.
Parexel addressed the need by providing comprehensive management of ancillary supplies (devices, documentation), including sourcing of local materials where import regulations made central procurement infeasible. This involved management of multiple vendors, rental of devices and translation of documentation for 27 languages. Through collaboration and resource engagement, the Parexel logistics team enabled distribution of IMP and ancillary supplies for site initiation visits within 1.5 months and the sponsor was able to submit their results on time to the FDA for approval.
Underpinning everything, from the first planning meeting to the final communication with a trial participant, must be a patient-first mindset. Sponsors and CROs need to place themselves in the patient’s shoes and consider the cultural, geographical, emotional and financial barriers they may face such as the distance they live from trial sites and the need to fit studies around their jobs.
By integrating patient-friendly service models, CROs can deliver clinical trials that serve all stakeholders, ensuring positive experiences for participants while meeting the performance targets of sponsors. The operationalization of hybrid trials, and management of the logistical challenges they pose, is helping to achieve those outcomes by making clinical trials a more attractive proposition to patients.
Take a tour of a US pharmaceutical depot in the video by the Parexel Global Clinical Trial Supply Team.
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References
1. Tufts Center for the Study of Drug Development. Rising protocol design complexity is driving rapid growth in clinical trial data volume, according to. Tufts Center for the Study of Drug Development https://www.globenewswire.com/news-release/2021/01/12/2157143/0/en/Rising-Protocol-Design-Complexity-Is-Driving-Rapid-Growth-in-Clinical-Trial-Data-Volume-According-to-Tufts-Center-for-the-Study-of-Drug-Development.html (2021).
2. Grand View Research, Inc. Clinical Trial Supply And Logistics Market Size Worth $5.4 Billion By 2028: Grand View Research, Inc. PR Newswire https://www.prnewswire.co.uk/news-releases/clinical-trial-supply-and-logistics-market-size-worth-5-4-billion-by-2028-grand-view-research-inc--837928186.html (2021).