Industry looks to expand clinical trial design input, while navigating GDPR

By Melissa Fassbender contact

- Last updated on GMT

(Image: Getty/marchmeena29)
(Image: Getty/marchmeena29)

Related tags: GDPR, Clinical trial design, Data collection

Throughout 2018 the industry worked to listen more closely to the voice of the patient, though to secure this data, it must navigate currently misunderstood GDPR requirements in the new year.

The EU’s General Data Protection Regulation (GDPR​) this year emerged as a new obstacle​ and one that is still quite misunderstood.

“There is a variable degree to which the clinical trial community understands the law, creating confusion and misunderstanding resulting in prolonged processes,”​ BBK’s Founding Principal, Bonnie A. Brescia, told us.

GDPR not only applies to EU organizations but also those located outside of the EU if they offer goods or services to EU citizens. The regulation came into full effect on May 25, 2018. If found not in compliance with the new regulation, organizations can be fined up to 4% of annual global turnover.

Brescia said the company has already started to see how the regulation is affecting the length of time for Ethics Committee reviews and approvals, and it will continue to pose challenges to the industry.

“Inherently, the idea of protecting people’s data is very important, but the trend for next year will be the continued misunderstanding of the law and ensuing inefficiencies,”​ Brescia added. “We expect this to be worked through by the end of 2019, but in the process, there will be frustrations and delays.”

Including the site and community voice

In addition to the patient voice, the industry is expected to broaden its focus in the new year to include the site and community voice in the clinical trial design process.

“While there has been a tremendous amount of focus on incorporating the patient voice into the clinical trial experience this past year, we expect the focus to expand to include the site voice and community voice,”​ said Aaron Fleishman, director, market development, BBK Worldwide.

“Understanding the site voice – and the concerns and priorities that impact site staff – will help foster the development of site-centric solutions that free up staff to spend more time on patient care,”​ he added.

Collating even more perspectives from other members of the community, such as caregivers, will serve to further enhance the clinical trial experience, according to BBK. The challenge, however, will be combining the patient’s voice with the site and community voice in a way that produces the greatest impact, said Fleishman.

However, this does not go without saying that the industry will continue its patient-centric initiatives, part of which involves better supporting travel to and from trial sites.

“In 2019, we expect patient travel to broaden and bridge existing gaps in the health care system,”​ said Joan Bachenheimer, founding principal and CEO, BBK Worldwide. “Take for example the fact that when patients are most sick, they prefer to be at home – but the reality is the best place for them to be is in the hospital.”

Bachenheimer posed the example of the family doctor from the 1940s and 50s that would routinely conduct house calls. Today, this service is nearly obsolete – and the promise of telemedicine is still seemly far off, at least for now.

However, Bachenheimer said the upcoming year will see travel services bridge the gap between the patient’s desire to be able to stay in their home for non-emergency treatment and the need to be in a critical care setting. “To do so, the industry will be looking to medical transport companies to create new travel services,”​ she said.

Related topics: Markets & Regulations

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