People enrolling in studies must request that their data be made available to ALD researchers in an anonymized way. The informed consent should not be signed without that commitment from the sponsor of the study. Sponsor must commit to more than that the data “may be shared”. It should say “it will be shared with any ALD researcher in an anonymized way”. By default, a clinical trial sponsor will keep your data private unless you take this simple yet powerful step to ensure that your anonymized data are made available to other researchers to help all ALD and AMN patients.
Now that a few companies are talking about initiating ALD/AMN clinical trials, it is important that the ALD community leverage all the data that will be collected to further improve treatments of the disease.
When people with ALD enroll in a clinical trial to determine whether an experimental treatment is of value to them, considerable data is collected that would be extremely useful to any other team interested in developing a treatment. For example, if a person with AMN enrolls in a trial then most likely he/she will have thorough imaging performed at various points during the study. While some of the data collected are proprietary to the sponsor of the trial, much of the data are the person’s data that should be made available to others working on the disease. As an example, the collected data may help find relevant measures to study treatment effect.