Transparency trends, regulations push sponsor commitment to publish clinical trial results
According to a survey, published by TrialScope, a clinical trial transparency and compliance solutions provider, sponsors plan to provide up to 1,600 additional trial summaries to participants and patients in the coming 12 months.
Of those sponsors, 25% plan to provide up to six new plain language summaries per month, according to the report. Additionally, when asked why they plan to share the results, 75% of respondents said it is an important part of their patient engagement efforts.
“Sponsors of clinical trials are increasingly committed to providing trial results summaries to participants of their trials and the patient community,” TrialScope’s Chief Strategy Officer, Thomas Wicks told Outsourcing-Pharma.com.
According to the survey, there are only about 300 of these results summaries available to date though this is expected to increase by 200-300% in the next 12 months, he said, noting that sponsors are now focused on evolving their processes, capabilities, and systems to meet transparency commitments.
Wicks said that the biggest surprise from the survey was that almost 90% of sponsors plan to provide trial results summaries and that over a third have already updated their policies and processes to support this commitment.
Driving this increase in clinical trial result sharing are pending regulatory requirements in the European Union (EU) and evolving transparency trends, Wicks explained.
“The regulations in the EU are expected to come in to effect later in 2019, but many sponsors are already working on their plans to meet these requirements,” he said.
“The transparency trends are causing sponsors to evaluate how providing trial results summaries may support their patient engagement initiatives and help meet their ethical obligations to trial participants.”
However, there are still questions surrounding the best way to author and distribute the summaries as well as concerns around the risk of having summaries views as promotional, though Wicks said sponsors are “dedicated to sharing the results of clinical trials with participants and the patient communities.”
“Providing results summaries to participants in clinical trials is the right thing to do, recognizing and honoring their participation in the research,” he added.
“As a long-time member of the clinical transparency community and, perhaps more importantly, as a parent of a child who was enrolled in a clinical trial and who never received any follow-up information, I am excited by the prospect that all participants will receive relevant information about their trials in the future.”