Report study results or face a big stick: the pros of regulatory penalties

| by Tamsyn Frost

Reporting your clinical trial results is both a legal requirement and a moral imperative. Whether your product failed early on, failed in later-stage trials, or was successful, the data from those trials could be transformational.

Until recently, though, companies faced few consequences if they didn’t report their results. In April 2021, the FDA threatened to fine a company for not submitting to ClinicalTrials.gov. This is exactly what needs to happen, and hopefully EMA and other regulators will follow suit; indeed, there are indications they are moving in that direction, with some of the toughest European regulators issuing reminders to companies for missing trial results.

Keep it simple

While there are barriers to reporting study results – cost, time, too many disparate databases to report to – the results are important. And reporting doesn’t have to be onerous – it’s simply about putting results into the database with a letter of explanation, for example, if you are stopping a study early due to side effects. The data is in your pharmacovigilance reports already, so the workload is not huge. Furthermore, the sooner you report, the easier it is to do, because the data is top of mind for the team.

As part of our role as EU legal representative, we send out regular reminders to sponsors about complying with the results reporting requirements and deadlines, and often they will ask us to help them understand the local requirements and handle the submissions for them. While we’re very happy to support however we can, and it is advisable to use a trusted partner experienced with the requirements and various registers and portals to manage the submissions themselves, it seems too common that these considerations are left out of the project plans and end up a being a surprise urgent task, a year after the study has finished, and the team have moved on to their next projects.


Consider your study report early on, include it as part of your CRO contract, make sure it’s on your Gantt charts, in the budget, and is part of your project management process.”

Include your report in your development plan

Ideally, have the study report as part of your development plan, make sure it’s on your Gantt charts or part of your project management strategy, and that budget and resources are allocated. It might even be something to consider as part of a contractual agreement with your CRO, especially if you don’t have your own medical writers. However, it will need to be written in at the start of a contract since once the study ends, usually, so too does the contract with your CRO.

Regulatory transparency

While the objective is to achieve transparency from industry, it could also be said that the regulators themselves need to be more transparent with their processes, including:

  • How is a product reviewed?
  • Who reviewed it and approved it?
  • Who are they connected to?

Just as companies are expected to be transparent about their data, regulators ideally should be talking about how they are looking into products, and who is responsible. The reviewers are highly qualified, highly experienced people, but the public doesn’t know that, so be upfront. Provide disclaimers on the people that did the rolling reviews, such as for Pfizer/BioNTech, and their connections to those companies. Tell the public these are top scientists doing their job.

Transparency at agencies could improve. Certainly, the FDA have fairly transparent processes, such as if a company is sent a warning letter that information goes online. I do think EMA could be more open about its processes. I would also like to see the WHO take a more central role. While they can’t regulate anything since they have no jurisdiction in any country, they can provide guidelines for international authorities to follow, both with regards to ensuring greater transparency and more centralised processes.

It’s unfortunate that the FDA had to start threatening to fine companies, but it is what needs to happen if we are to ensure these vital reports are completed thoroughly and on time.

 

Leave a Reply

Your email address will not be published.