Selecting the right rare disease CRO is something that all companies battle with when they outsource their clinical trials. It becomes even harder when the trial involves participants spread across the globe who have a rare disease. Why? In this post, we will look at why it can be a trying experience.
Lack of Experience
A rare disease is, by its nature uncommon. Which means that there probably hasn’t been a lot of research conducted into it. Normally when choosing a CRO, expertise is one of the things that both partners bring to the relationship.
Rare diseases, on the other hand, require very specialized knowledge. Which means that your chosen CRO might not have the requisite experience. Getting around this can be tough but is a lot easier if your chosen partner has a wide network of experts upon whose experience they can draw.
Additional experience in terms of dealing with participants in different countries may also be required.
More Resources Might Be Required
For a more common disease, like Diabetes, you can find potential test subjects in pretty much every town or country. With rare diseases, you might well find yourself having to travel far and wide to get enough participants for a meaningful study.
That means coordinating with medical personnel in the home countries of the participants. This could be a tough ask for a very small company. That’s why you need to look for a partner with the resources to be able to complete the trial with peak efficiency.
Experience With Drug Approval Can Be Harder To Find
Getting the FDA to approve a new drug is a long and arduous process. It can, and often does, seem like an uphill battle. You need a partner that can help you navigate the pitfalls and help you get the drug approved.
This kind of experience is not something that all CROs do have, so it’s worth checking this before you make your final selection.
Rare Diseases Often Mean Smaller Studies
The problem with smaller studies is that there are a lot of firms who focus on the larger ones. They might feel that a study of forty people is too small for them to bother with. In this respect, it might pay to go with a smaller firm if they have the correct resources.
Why You Need To Make The Right Choice The First Time Round
The medical research industry can be a high pressured one. It is not uncommon for a study to start under the control of one team leader, only for that person to be swapped out at a later stage. It happens quite often, but it’s not ideal when it comes to dealing with sponsors, stakeholders, etc.
Choosing the right team in the first place can help to reduce the likelihood of this happening. This, in turn, allows you to keep all the stakeholders happier.
Finding a CRO to handle your rare disease study can be tougher than for your standard trials. By focusing on companies that have the experience, the correct resources and a network that can be called upon as necessary, you improve your chances of partnering with the right people.