As we all strive to be more efficient while staying within budget, it is easy to forget who we’re really doing this all for. The patient. Improving patient centricity in clinical supply not only supports the patient by supporting the development of new medicines, but by focusing supply chain activities on the needs of the patient, we also benefit ourselves by encouraging patients to participate, and remain, in clinical trials.
We can all be cynical – ‘Patient-centricity is just a term coined by the marketing department to make us sound more attractive to our customers’. While we suspect there may be some truth in this, adoption of a patient-centric ethos can generate positive results for Sponsors, supply chain vendors, and patients alike. In this article we explore some of the ways in which patient-centricity can be improved in clinical trial supplies.
How can we make clinical trial supplies more patient-centric?
What drives behaviours and service levels in organizations? Obviously, we are in business, so we have to make enough to cover our costs and make a small profit. However, focussing only on dollars and cents can make us forget why we do what we do, and can negatively impact our team’s motivation. Too many companies make this mistake. What motivates staff more and encourages them to think about what they are doing? Lining the pockets of senior executives and shareholders or enriching the lives of patients…who one day could be them or their family members. There is no greater failure in clinical supplies than not delivering medicines to a patient on time in full.
Patient centricity should influence our decision-making. Some companies claim to be patient-centric but operate with bare-bones staff in key delivery areas to control costs and maximize margins. As a result, they are consistently late – directly impacting upon patients. This can be partially driven by Sponsors – everybody wants a same-day service, but nobody wants to pay for it. However – it is primarily driven by financial, not patient, considerations.
Measuring the right things, for the right reasons
Correct use of KPIs, and ensuring staff are aware of how we use them, is essential in driving patient-centric behaviours. We shouldn’t view KPIs as a measure to purely assess staff performance. Unfortunately, this is how many staff view them – if my KPIs are below target, the leadership team will think I am doing a bad job and I’ll be punished. While there is some truth in this, KPIs should alert leadership of areas of the business that are over-stretched and need either investment or process improvement.
Looking beyond the numbers in KPIs is also important. If we miss a KPI there could be a good reason for this. Was the expectation ever realistic in the first place, and do we need to re-set these? Where did the process break down that led to underperformance, and what can we do to address this?
Training beyond SOPs
Educate staff about the impact on patients of their decisions and actions. In our view this is often overlooked. If a shipment goes out late, concern is more focused on ‘the client will be unhappy’ or ‘my boss will be mad’ as opposed to ‘the patient may miss a treatment and reduce the effectiveness of their therapy’ or ‘the patient may have travelled a long way to the clinic to receive their medicine, which wasn’t there, so now they will be inconvenienced again’. We operate in a heavily regulated industry and staff training is often SOP-driven focused on the what and how we perform activities, as opposed to the why.
What can we focus on to be more Patient-Centric?
Pack design
Clinical packaging for solid dose forms often needs to accommodate multiple dose units, especially for double-blind, double-dummy clinical trials and those involving treating patients with a combination of treatments. To make complex dosage regimens easy to follow for
the patient (and to reduce downstream labelling and secondary packaging costs), pack designs often result in huge blister/wallet designs. When presented with one of these designs by their vendor, one of our industry colleagues asked if the vendor would also be providing
a suitcase for the patient to take the pack home from the clinic (we’re assuming this was a slight exaggeration). So why does this matter? As an industry, we do everything we can to protect patient privacy in terms of data protection. Doesn’t providing a patient with a package so large that it can’t be carried discreetly work against this? Anecdotally, we have heard of patients removing all dose units from large packages and transferring them to more discreet containers. Stability issues aside, what does this do to the dosage regimen our pack
design was intended to simplify. Poor adherence can reduce the effectiveness of a patient’s treatment.
Label Design
Regulations mandate minimum text that must be included on labels. However, if the package being labelled is small (e.g. we are currently supporting a trial in which the primary package is a 2 ml vial), how do we accommodate this text? Too often, this is achieved by reducing font size to the minimum allowed by regulators. Is this patient-centric? Many patients in clinical trials are elderly and may no longer have 20:20 vision – while reducing font size may meet regulatory requirements, does it support safe patient dosing if a patient can’t read the instructions on their medication? Strategies are available to improve this:
Booklet labels are used across the industry to maximize flexibility of inventory. Using booklet labels reduces the need for a country-specific pack for each country within the trial, which minimizes the number of individual packaging jobs, thus helping to reduce the impact of set up and release activities on timelines and costs. However, if a booklet includes 48-pages and a patient’s language is on page 37, is this patient centric? Given the benefits of booklet labels,
we believe their use will continue until a suitable alternative is developed (e.g. elabels), so instead of lengthy labels with minimum sized text, why not use design to improve their patient friendliness? Page numbering, content pages, clear and easily found country identifier on each page. Even with these additional design elements, we still see a high proportion of unopened booklet labels in our returns facilities.
So, what is the alternative? The industry has developed demand-led packaging strategies. By delaying labelling and kitting primary packs until an actual patient need has been identified (e.g. an order to ship to a clinical site is received), demand-led strategies allow clinical supplies to be labelled with single panel labels in the patient’s own language, eliminating the need for booklet labels. This approach can be expensive and can increase order-to-ship lead times, in addition to creating extra workload and potential bottlenecks in QA/QP teams. Each time an order is received, material needs to be picked, packaging rooms set up, labels and materials checked, batch records generated/printed/reviewed, product released and rooms cleared. The industry has invested in streamlining some of these activities, but it is not possible to remove them all and remain compliant. As a result, while demand-led is a patient-centric approach, it’s adoption has been limited.
Label placement
While this benefits the site directly (easier to find the right kit when they receive an order), by reducing the risk of error at site, choosing the best position for a label on a clinical supply kit is patient-centric.
When we are designing patient kits, how often do we see designs like the one below? Where should we place our label? More often than not, we will use the largest surface – the top of the kit.
However, how are kits going to be stored at the clinical site? It is highly likely that they will be stacked on a shelf. If a site receives an order for a specific kit, labels are hidden, so the only way to find a specific kit is to remove them one-by-one until the correct numbered kit is located.
To improve the ease of finding the right kit, site staff may be tempted to add their own labels to the visible surface of the box, or may even hand write kit IDs onto the pack itself. However, when we consider all of the steps we take in our packaging facilities to minimize the risk of error – controlled issue of labels, multiple checks – does this undo all of our good work? The picture below shows a real-life example of what can happen at clinical sites.
Thinking of how kits will be stored and retrieved at clinical sites, and designing them accordingly, can help avoid risks introduced if sites have to implement their own processes.
Other patient-centric strategies
Home delivery (direct-to-patient supply)
Not all patients live close to their clinical trial site. Travelling to sites to collect medication places an extra burden on the patient, and may discourage continued participation in a clinical trial. Delivering medication directly to the patient may eliminate this. In an ISPE report in 2013, 80% of patients reported that they would find home delivery of medication ‘helpful’.
While not suitable for all medications (for example, this approach may not work for therapies that need close medical supervision, or which have complex reconstitution processes that need to be supported by a pharmacy), direct-to-patient strategies have been growing in popularity. The COVID-19 pandemic, during which patients could not travel to clinics, forced the industry and regulators to look more closely at this approach. Adoption is increasing, although our observation is that it has slowed somewhat since the pandemic ended.
Direct-to-patient does not come without additional work and costs. For example, patient data (name and address) is now visible to a wider audience. How will privacy be protected? Also, a single shipment to a clinical site could support the needs of multiple patients. If home delivery is used, these same patients now require multiple shipments…all of which cost money. As with all of the suggestions included in this paper it is important to consider the cost:benefit ratio of this strategy.
Patient counselling and support materials
While outside of the remit of our services, enhanced support for patients through the clinical site or through standalone service providers can enhance compliance with trial protocols, reduce drop out rates and improve patient safety.
Patient support materials (e.g. leaflets, apps, websites) are used widely for commercial products. While we have not seen any examples of these in clinical trials, it is an area we have explored ourselves as a means to improve patient engagement, and as a result of this,
improve patient retention in clinical trials.
Conclusion
There is a wide array of approaches that can be used in clinical supplies to enhance patient centricity. Some of these can increase costs, others just need us to apply a little more thought to what we are doing. However, even if selecting a particular strategy increases our clinical supply costs, how does this stack up against the cost of delayed trial completion due to poor enrolment or retention rates? To us, patient centricity goes beyond these economic arguments. Protecting patient safety and helping them to take their medication correctly, so it has the maximum chance of success, is just the right thing to do.
About the author
Rhys Evans is the Senior Vice President of Global Operations at RxSource. He joined the company 5 years ago and has over 12 years of experience within the industry.
Last quarter alone, we were able to positively impact the lives of 44,500 patients. Our goal is to improve the lives of 10 million patients in 10 years. Contact us today to learn more about how we can work together to make a meaningful impact.
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