Start with the end in mind: Planning your clinical trial strategy early on

| by Tamsyn Frost

It has become more important than ever to start thinking and talking about your drug development plan as early as possible.

From more complicated protocols and adaptive design to electronic data capture and electronic patient reported outcomes – new technologies are creating opportunities but also adding to the complexity of a clinical trial design. That means you need to be checking with the regulators to ensure they’ll accept what you’re doing, and that the design and endpoints you’ve selected are appropriate, especially when it comes to more innovative products where there may not be specific guidelines.

From computer modelling to QbD: Be prepared

We’re seeing more examples of alternative approaches to non-clinical studies gain traction with regulators, for example, computer modelling and simulation-based study designs; however, it’s still important to bring regulators in early on.

Even before you’re ready to have those conversations externally, you should be sitting down with your team, and possibly regulatory partners, to plan with the end objective in mind. Ask yourself questions about your planned development process. For example, are there ways you can really streamline this process and build more efficiency by introducing quality by design concepts to manufacturing processes or computer modelling approaches that use real-world data and artificial intelligence?

Bringing in your vendors

Unfortunately, many companies don’t select a vendor until after the protocol design has been finalised. That’s too late. Your vendor needs to have input into your protocol design or you risk forcing your partners into trying to implement sub-optimal processes and approaches. It’s worth remembering that vendors bring with them expertise and advanced capacities that you should take advantage of during protocol design. To get the best out of vendors, involve them as soon as there is a clear understanding of the protocol objectives.

In addition, you need to be bringing in other key stakeholders, including patients, early on. What we’re seeing is the more involved your patients are, the better your recruitment process.

A key role that many small companies don’t consider when planning trials in Europe is the legal representative. Yet this is an integral role under the new Clinical Trial Regulation (CTR) because it is the legal representative who is responsible for your compliance with CTR obligations. Crucially, your legal representative should be independent of your clinical research organisation (CRO) to avoid any potential conflicts of interest.

Don’t leave it too late

Engaging your legal representative early will not only prepare you for requirements that could become stumbling blocks if left too late but can help you avoid delays to your clinical trial application (CTA) submission. As the legal representative takes responsibility for the compliance of the study they need to conduct an assessment of the sponsor’s quality and compliance systems before agreeing to take on such an onerous role. Even if your QMS is in good shape and your company is familiar with CTR and all the new requirements you need to start discussions with your legal ideally 3 months before you are considering submitting your CTA in the EU to avoid any delays.

Your EU legal representative will look at your quality management system and, based on their knowledge of what is required, help you to ensure it’s in order. They will chat to your team and work through what to expect or identify gaps in your standard operating procedures, and how overall compliance is achieved by your QMS. Allowing the time for those conversations and checks and balances will be a lot more impactful and beneficial to you as you prepare for your clinical trials. It will also help you to avoid unnecessary delays and costs such as in making contract amendments should it become apparent that a particular responsibility has not been properly considered or documented when defining roles and responsibilities of a vendor. Even if you have conducted clinical trials in other regions, the EU landscape is very different, so it’s essential to bring strategic and operational thinking into your team as early as possible to give you the best chance of success

“Engaging your legal representative early will prepare you for requirements that could become stumbling blocks if left too late.”