What does it mean to participate in a clinical trial?

Participating in a clinical trial primarily involves a time commitment for the study participant and their family members.

The time required is due to study visits, which take place in addition to regular treatment appointments. Even when a regular treatment appointment (every three to four months) is combined with a study visit, a longer stay in the outpatient clinic is to be expected.

For separate study visits, in addition to the actual duration of the visit (“net time”), the time required for travel to and from the site (“gross time”) must also be factored into the schedule.

Travel expenses are usually reimbursed by the clinical trial sponsor (for trials conducted by pharmaceutical companies) or from donations (for academic trials).

Apart from the time required, the other burdens (from blood draws, ECGs, weight measurements, and lung function tests) are considered minimal.

The study teams at ALS centers deliberately reach out to ALS patients who are medically eligible based on the study’s inclusion and exclusion criteria and for whom the time and travel requirements are reasonably manageable.

It is important to emphasize that participation in any study is voluntary and that patients (and their families) must be generally open to participating in ALS studies.

It is possible to withdraw from the study even while it is in progress. However, it is in the interest of the ALS Center and ALS research as a whole to keep the number of study withdrawals as low as possible in order to ensure that the study results are scientifically valid and to complete the planned testing of the drug.