Freedom of Information for Clinical Trial Participants
Running clinical trials generally requires participants to give their informed consent. But how much information they actually get depends on the trial. So here I will try to convince you, fellow test person, to try to get all the information you can get your grubby fingers on.
Documents out there
Here are two important documents, that you might want but probably don’t have:
The study protocol defines in detail how the trial is conducted. What treatments and tests will take place, who does what, what happens in a case of emergency. Because of that, they can be 100 pages long, or longer. As a participant, you probably also have a document outlining the trial procedure. But is it much shorter? If yes, then it is probably the abridged version.
The Investigator’s Brochure outlines what is known already about an investigational product that is being studied. This includes what is known from earlier human or preclinical trials. They get updated as new information becomes available.
Besides that, there are countless other documents relating to every trial. You might reasonably be interested in the contracts that made your trial happen, for example. Or maybe you want to know how whatever is being tested was discovered or invented.
Why to get them
There are many reasons you might want to get these documents. Maybe curiosity or a healthy sense of “skin in the game”. Having detailed documents might also allow a doctor or researcher you personally know and trust to give you a more substantive second opinion.
The big worry about releasing too many documents is that it threatens trade secrets and might therefore hurt innovation. That is a legitimate worry. But there are also positive externalities to publishing trial information. As people in the open science movement like to point out, researchers often don’t publish their detailed methodology and results even when it would make sense. Even when there are laws requiring some disclosures for human trials, these often just end up being ignored. Trial participants might be in a particularly promising position to promote scientific openness here, since their right to information is so widely acknowledged.
How to get them
First of all, you can of course ask the people conducting the trial, they are after all responsible for ensuring your informed consent. You can also try to search for this information yourself. Earlier research might already be published, and probably your trial has an entry in databases like clinicaltrials.gov or clinicaltrialsregister.eu.
But in case this doesn’t work, I would like to highlight a more thrilling option: Many countries now have some freedom of information laws. The details depend on the jurisdiction, but usually it allows people to request copies of information and documents held by government offices. The details vary, like whether people need a reason for their request, whether requests costs money, or what happens for documents concerning third parties.
Where it gets interesting for trial participants is that often there is relevant information held at government offices that participants are not provided with. Trials need to be approved by national authorities and ethics committees. Often public universities are in involved in the research too.
Here are some successful examples: The Australian Therapeutic Goods Administration has published documents including a redacted version of the Investigator’s Brochure for the Pfizer–BioNTech vaccine and Study Protocols for the Oxford–AstraZeneca vaccine. The British Medicines and Healthcare products Regulatory Agency has released most documents used to approve a trial by Johnson & Johnson. In the US, the FDA has also released different document including Study Protocols and summaries of results.
Personally, I only got the study protocol of the trial I’m currently in after a request to Germany’s Paul Ehrlich Institute and another to the university conducting it. And let’s see about that Investigator’s Brochure.
If you want to add yourself to this list, I would recommend using a specialized website, like this one in the US. They make the process pretty straightforward and allow you to share your request and results with others.