In July 2019, the European Union (EU) Clinical Trial Regulation No. 536/2014 will go into effect, requiring all sponsors, including academia, conducting clinical trials to draft a lay or plain-language summary for phase 2-4 clinical trials. These lay summaries need to be published to the new portal that will be hosted by the European Medicines Agency (EMA) within 12 months from the close of each clinical trial.
“Any sponsor with a clinical study that is set to complete after July 2019 will need to be in compliance,” said Kasim McLain, Manager, Disclosure Services at MMS, and former Manager, Clinical Disclosure Lead at GlaxoSmithKline. “With the ever-changing landscape of clinical trial disclosures, it is not clear if there will be retrospective requirements for studies that have completed before July 2019.”
McLain explains further, “If a clinical study ends in July 2018, it’s not clear at this point if a lay summary will need to be submitted for that study when the regulation goes into effect one year later, in July 2019. Retrospective disclosure has been required as a part of other EU legislation in the past.”
If retrospective disclosure comes into play, sponsors have the potential to be hit with a large backlog of studies when the clinical trial regulation goes into effect.
Developing processes at a sponsor level
“Each sponsor should currently be developing their own internal processes for drafting lay summaries,” said McLain.
Part of this development should include drafting and defining a lay summary template, and gathering input from a variety of parties, including, regulatory teams, legal, the medical monitor, third-party experts, and more. Following the finalization of the template, a process for reviewing each lay summary should be ironed out, according to McLain, prior to submitting the summary to patients and the agency.
“There could be 10 reviewers for a single lay summary,” explains McLain. “Commonly, I have seen a global medical lead, multiple clinicians, multiple statisticians, and the portfolio attorney all review the plain language summary for a clinical trial. Each stakeholder may want the lay summary to focus on something different, and reaching a consensus requires a robust review and approval process not to mention time for all these reviews and edits.”
Additionally, these summaries need to be non-promotional in nature, and each person needs to be comfortable with the data being disclosed. Determining who should be involved in the review process to work through questions regarding promotional language, the intended audience, and the technicality of data is a key step in the process.
As the composition of a clinical team and legal review is different for each sponsor, creating an appropriate workflow for review that is consistent across the organization ahead of time becomes vital. This is where a pilot program helps.
Creating a pilot program
“A pilot program is recommended for all sponsors this year to test out the internal process and gain valuable patient feedback before the legislation goes into effect,” said McLain.
Read more at: http://www.mmsholdings.com/mms-blog/expert-insights-blog-start-plain-language-summaries-early-or-get-left-behind/