What are the 3 biggest elements shaping clinical development today?

1 - Incorporating the patient perspective in planning clinical development programs

In the past, clinical studies were designed based on what physicians told us, what the guidelines dictated and what we knew about specific indications and diseases from the scientific literature. The patient voice was not really heard or came late in the process.

Now, by interacting more with patients through different associations, patient groups and opinions expressed on social media, patients’ perspectives are being incorporated from the very beginning of the development process. These tools are being used to understand the patients’ experience - how they perceive their illness and what aspects of their care are most important to them – and to gauge their concerns. Studies are then designed to address these issues.

This is also important for the health authorities reviewing dossiers on new drug applications and the payers funding them, because they want to know these treatments address true medical needs. For example, maybe we can improve the score on a clinical scale by three points, but what does this mean for the patient in real and practical terms? Does it mean that he is able to drink a cup of coffee without spilling it, as Arthur, who has Huntington’s Disease, wants to do.

Mapping improvements to patients’ needs is the goal and the reason for increased patient interaction.

2 - Innovative study designs

There is a transition from the traditional, conservative design approach, which involved distinct and separate phases—e.g. phase 1, pause to analyze data, phase 2, pause again, and so on. The current trend is to gather more information upfront, allowing early decisions to be made on whether to continue or redirect resources elsewhere.

This shift necessitates a new strategy for what is measured and how frequently the data is reviewed. It involves designing studies to progress seamlessly, with pre-specified adjustments based on ongoing observations. A component in this process could be frequent prespecified “interim looks”, where the data is reviewed at specific milestones and the study adjusted accordingly. Although this method is more complex, it can potentially shorten development programs significantly and increase their likelihood of success bringing medications to patients much sooner.

3 - Rise of technology in clinical research and drug development

Technology is advancing at an incredible pace, and it makes sense to harness it to improve the way we develop new medications. There are several ways technology is helping to make clinical studies more accurate and also more efficient.

For example, utilizing body sensors to monitor symptoms instead of relying on subjective scales can significantly reduce statistical noise. This approach allows for smaller and quicker studies, as fewer patients are needed to gather accurate data.

Remote monitoring is also enhancing efficiency by reducing the burden on study participants and enabling researchers to reach the most relevant patients, regardless of their location.

Furthermore, the growing importance of AI is evident as it may allow the future use of virtual patients and digital twins designed from medical records as a control group in studies, eliminating, in theory, the need for traditional placebo arms.

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Find out more:

• 3 Trends I’m Watching in Global Manufacturing and Supply: Teva’s VP for External Manufacturing & Supply Operations Dan Pritchett reveals new moves in the sector
• How can we use AI to make medicines more efficiently? Teva’s Chief Medical Officer Eric Hughes explains
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