Clinical trials: is staying local the best plan?

In today’s world, buying local is a positive in many aspects of life, but does that translate to clinical trials? Where do you start in trying to figure out the best place to go? Let’s face it, clinical research is a global industry, so the choice is broad. To decide whether to stay local or look further afield, there are a number of factors, both strategic and operational, to consider.

1. The study’s purpose

   1. Is it to get regulatory approval/clearance in a particular geographic area? If so, is the population of that region well-represented in other locations, or is it unique to that geographic area? If there are other locations with equivalent demographics then you have more areas to choose from.

   2. Is it to get value-based data for a specific healthcare system? If so this is more limiting. If you conduct the study in a different healthcare system there may be differences that make any cost-effectiveness data null and void when you apply the process to the other system. Therefore if this is your purpose you may want to think twice about doing the trial elsewhere.

   3. Is it to break into a new market? If your product is a new prospect in an established space, conducting your study in the target market makes sense as the data will resonate with your potential customers and you have the potential to develop advocates for the product within your study team. On the other hand if this is a product to be introduced across multiple markets more operational factors will drive the decision.

2. Key Opinion Leaders - for some markets the leading voices in a country may be the leading voices globally. For others, perhaps in fast-moving therapeutic areas, the groundbreaking individuals from other markets are the ones that have the most influence. Ideally you would want them involved in your study so that they can speak about your study results and be an advocate for your product.

Having considered these two strategic factors, what about the operational elements of study execution?

1. Patient accessibility – you may know that your target population is present in a market, but can you access them? Are they served by the clinicians that you want involved in your study? Perhaps you can access them directly if you are able to conduct a decentralized trial.

2. Timelines – the regulatory and ethical processes for trial governance can vary widely so investigating these in the context of your particular study and stage of product development is essential.

3. Research infrastructure – understanding how many sites are available in that market and how many qualified clinical research professionals there are will give a strong indication of whether this is a market that can execute your trial to a high standard. Understanding how many competing clinical trials there are is also important as it could impact on how quickly you can get sites on board, and this also relates to patient accessibility. If many patients have already been in a trial the number of patients suitable for inclusion will be reduced. www.clinicaltrials.gov is a good starting point to look into this.

4. Language – If you are reliant on a licensed, validated Patient Reported Outcome tool as one of your primary or secondary objectives, check what validated translations there are. If it doesn’t cover the majority language in the geography you are considering, think about the impact it would have if that outcome measure was not available for a proportion, or worst case 100%, of your study population. Weigh up the pros and cons – does the value of that objective outweigh the benefit of going to a particular market? It may be that the objectives can be altered slightly so that language is not a barrier.

5. Logistics – can you get your product to the study sites in an efficient, cost-effective manner? This requires investigation into the import licences and customs procedures for your product which are likely to vary depending on the regulatory status of your product. Understanding the requirements and ensuring you have everything in place can save a lot of frustration for you and your investigators if your product were to get stuck in customs.

   
   

Many CROs offer country feasibility assessments as a service, helping you to figure out what’s best operationally. However, doing your own diligence on the above factors can result in a clear decision as to which markets to include in the study, or can at least help keep CRO costs down by asking them for feasibility assessments of a very small number of priority markets. Regardless of how you reach your answer, the key thing is to make sure you are considering the question in the first place.