All of us working in clinical trials set up are acutely aware of the phrase ‘… so you can just do the submission and we will handle the rest’. Many big and small companies fall into one of the biggest pitfalls – the belief that study set up is very simple and everyone can do it. But let’s talk about reality and some of the expressions study start up specialists often hear.
1. ‘We have set up the study in the USA and now we are expanding it in the Europe and Asia. We have set up experience already.’
The reality: You need to understand the healthcare systems of the selected countries to be able to assess if they can recruit participants for your study. While many healthcare systems look similar to outsiders, they have their specific country requirements. You need a local expert to help you navigate the setup of the country.
2. ‘We have set up a study in your country 5 years ago, so we are familiar with the requirements.’
The reality: That’s great! In this case you know the requirements … that were applicable 5 years ago. Although it may not be obvious clinical research changes very rapidly. This means that you need local expert who is up to date with the current requirements to help you. Don’t be surprised when you learn that there are many changes.
3. ‘We have sent our sales team to select the sites for the clinical trial.’
The reality: Your sales team has no experience in setting up clinical trials and selecting the right sites for the study. That is because it is not their job to know that. You can google the specialists in the disease area but that does not mean that they are the right investigators for your study. Some my not be interested in research by commercial companies; others may have many studies and not have capacity to take on the work; some hospitals are very slow to set up and if you have short recruitment period may not even be worth trying; the sites may not have that patient population, etc. There are many factors that influence the site selection.
4. ‘Setting up clinical trial in your country is very quick. We have read the timelines on the regulatory agency website.’
The reality: Many regulatory agencies around the world are not able to stick to their timelines and there are delays. There are many reasons for that but one of the main ones are staff shortages. You need to check with a local expert who can give you realistic timelines for study set up.
5. ‘Our budget is 1,500 Euro per patient fee. That should be sufficient.’
The reality: No, it is not. With the increased cost of living the prices are going up. You need to consider the standard of living of the country where you are setting up the study. The best person to ask for adequate budget is the study start up specialist who can give you an estimate. Asking the physicians is not a good idea since they are not involved in clinical trials budget forecast. However, they can provide you critical information on the standard of care in the country which has to be take into consideration in the budget forecast.
Setting up clinical trials in not easy and not everyone can do it. You really need to find the specialist who has the knowledge to set up your study for success.
Author: Olga Peycheva
Olga is a clinical research professional who has been working in clinical research since 2005. She has extensive experience in clinical research in Eastern and Western Europe.
Published on 2 Aug 2023
