Participate in a trial

People who want to participate in trials are invaluable. However, it can be a dilemma for them, whether to enroll in a trial or not. Patients living with ALS usually have little time left and some don’t want to spend extra time in the hospital. For others it might feel as if they are part of the solution, they can add value to something and might benefit from the experimental treatment. Deciding on entering into a trial or not is very personal and something you shouldn’t take lightly. We motivate you to always discuss trial participation with your treating physician and loved ones.  

What to expect? 

Let’s start by saying that every trial can be different. There are, however, some general aspects which are always the same. If you have questions about a specific trial, please contact your nearest participating TRICALS centre. You can find a list of these on each individual trial page. 

The purpose of inclusion criteria

In order to enter into a trial, you have to match the inclusion criteria. For example, these criteria can be your lung capacity or a specific gene mutation. They can be different for every trial. If you do not meet the inclusion criteria, it is very likely you will not be able to enter the trial. This might feel unfair, but these criteria have a purpose. 

Of course there are always small differences between people. But if groups are large enough and divided randomly, these differences can be disregarded. Inclusion criteria are there to ensure that there are no larger differences. For example, if someone has a very slow progressing type of ALS, they will probably react very differently to the experimental medicine than the average ALS patient. Therefore, for research it is necessary to have people in the group who fit the average description of an ALS patient. That is the only way of knowing if the experimental medicine is effective or not. 

Active compound vs placebo

In a trial we want to measure what happens if we make one alteration to a controlled existing situation. In this case, it is giving people an experimental medicine and seeing what happens. We need to be sure that the results we end up with are only due to that one alteration. Therefore, we create two groups: a placebo-group and a treatment-group. The only difference between these groups is the treatment they receive.  

 

I want to participate in a trial, what do I do?

1. Make yourself known

If you are interested in participating in a trial, you can contact your nearest active TRICALS centre. Each trial page on our website lists all the centres which are active in that specific trial. Whether it is possible to participate in a trial taking place in another country depends on the trial, we call this cross-country referral. Whether there is cross-country referral or not, is decided by the sponsoring company.  

We strongly encourage to directly contact the ‘participating TRICALS centre’. Each TRICALS detail page includes the contact information and a contact form that is directly send to the centre. If you experience difficulty contacting the centre, you can consult TRICALS themself for assistance. After you have contacted your nearest TRICALS centre, they will check if you meet the inclusion criteria of that trial

You can also sign-up to the TRICALS registry. This is our own very large database of people living with ALS who want to participate in a trial. Every time we have new participation options, we notify our database.  

2. Randomization

If you have matched all the inclusion criteria, you will be randomly assigned to one of the different groups in the trial. Each trial has a minimum of two groups: a placebo-group and a treatment-group. Almost every trial is randomly, double-blind placebo controlled. That means that neither the doctor nor the patient knows for which group the participant has been selected. A computer randomly assigns people to one of the groups. Only after completing the trial participation the doctor and participant will know the group the participant was selected for. 

3. Participation in the trial

Depending on the design of the trial you will either take the drug at home or you will have to visit the hospital (TRICALS centre). How the drug should be administered depends on the design of the trial as well.   

The design of the trial is always discussed with the participant before entering the trial. This means you can always make an informed decision.  

During the trial, participants are closely monitored by the trial team. Side-effects or other unforeseen events are always reported to the pharmaceutical company. They will discuss them with a team of experts to see if it is safe to continue with the trial. If for some reason the trial has to be terminated early, you will always be notified personally by the trial team. 

4. Completion of the trial

As TRICALS we always strive for an ‘open-label period’, also known as OLE (open-label extension). This means that every participant will receive the experimental medicine once they have completed their trial participation. Whether there is an open-label period or not depends on the pharmaceutical company.  

 

Frequently Asked Questions (FAQ)

Below you can find our frequently asked questions. If something is unclear, you can check if the answer is in our FAQ. If not, you can always contact us via, info@trials.org and we will help you from there.