Clinical supplies & logistics
all very well saying ‘you can access it,’ but not everyone can if it’s too far away.” If the treatment centre or trial is in a remote location, many patients who could benefit will inevitably be excluded. This underscores the importance of designing programmes that are not only inclusive but also practically accessible, ensuring the promise of EAPs translates into real-world benefits. To define the programme’s objectives, pharmaceutical companies need to consider what can be learned from EAPs and how that information can be used. “It’s amazing how much information is captured in this drug development journey and how much of it just gets filed away and nobody thinks about it,” adds Upadhyaya. Asking the right questions and engaging with the right stakeholders is important, but the mechanism for collecting data and evidence is essential for making the programmes as efficient and streamlined as possible, while ensuring that no valuable information is lost. With the magnitude of data already available, Upadhyaya stresses that there is no need to “reinvent the wheel” but to build on existing systems where data is already being captured. “Rather than say ‘here’s another tool or another app,’ we can build on something they’re familiar with and don’t need to log in and remember another password,” she explains. “From a practical perspective, we know how frustrating it is to go from one website to another.”
Revisiting the drawing board to identify the key objectives and goals for EAPs is critical to ensuring that the programmes offer value for all stakeholders and create the best access programme for patients. “My biggest frustration is that there is a lot of stuff that goes on in pharma that they have done for years without thinking about the value that it adds to the overall opportunity of access,” Upadhyaya continues. However, despite spending money on resources, the information gathered is often not used and just adds to the cost of the product. “If we didn’t need to do it, one, why did we waste everyone’s time, effort, and energy? And two, if we didn’t do it, we wouldn’t need to add that cost onto the price of this really expensive drug.” To avoid this unnecessary cost, companies need to collaborate with their shareholders to identify needless costs and exercises. It is not enough to tick a box, Upadhyaya explains; companies need to listen to what is being said and take it on board to help improve their EAPs.
Authentic and accurate insight Looking ahead, EAPs are likely to become more integral to the development of new treatments. To capitalise on this, programmes need to become more flexible to be accessible to everyone. Incorporating digital health technologies and data collection tools is one way Upadhyaya suggests could enhance patient access and streamline programme administration.
Clinical Trials Insight /
www.worldpharmaceuticals.net
This could include the use of mobile apps for remote monitoring, telemedicine consultations, and digital platforms for data submissions and analysis. One example Upadhyaya uses to demonstrate the possible benefits of using digital solutions is the ability to capture real-time experiences of patients. During a clinical trial, many factors could influence a patient’s participation in some tests, especially with children, who may be coerced or bribed to engage in activities they might not usually undertake. This can lead to outcomes that might not be seen as credible or unbiased. However, remote monitoring, such as a wearable device, allows clinicians to observe and record physical activity in a natural setting free from these biases. This approach provides a more authentic and accurate insight into patient behaviour, enabling the collection of valuable and reliable data.
“My biggest frustration is that there is a lot of stuff that goes on in pharma that they have done for years without thinking about the value that it adds to the overall opportunity of access.”
Moreover, Upadhyaya notes that digital monitoring tools often yield positive unintended consequences. For instance, she recounts a case where a company involved in real-world evidence collection discovered that the therapy significantly reduced infections and emergency admissions among children. This unexpected finding indicated that the therapy not only improved health but also decreased the need for antibiotics and inpatient stays, leading to substantial cost savings and better overall patient care. “This is an underutilised opportunity,” Upadhyaya emphasises. By incorporating digital health technologies into clinical trials and patient care, companies can uncover additional benefits that extend beyond their original objectives, thereby enhancing patient outcomes and contributing to a more efficient healthcare system. Ultimately, the future of expanded access programmes holds the promise of improved patient outcomes, accelerated medical innovation, and enhanced collaboration across the entire healthcare ecosystem. However, in order to truly capitalise on these opportunities, it is imperative that these programmes are designed to maximise their benefits for all of the stakeholders. By addressing current challenges, such as clear objectives and using data effectively, while embracing new opportunities that digital health technologies can offer, EAPs can become more effective and inclusive of the needs and contributions of all stakeholders. ●
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