Marylana Saadeh Helou, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Boston office, was quoted in Law360 Healthcare Authority, in “FDA Offers Road Map for Remote Trials, but Questions Linger,” by Dan McKay. (Read the full version – subscription required.)
Following is an excerpt:
New federal guidance may encourage drug and medical device companies to carry out more of their research in decentralized, remote clinical trials, allowing them to enroll a more diverse set of participants but generating new legal questions. …
Marylana Saadeh Helou, a Boston-based healthcare and life sciences attorney at Epstein Becker Green, said it's clear the FDA responded to comments submitted by the industry and tried to streamline the guidance after a draft was issued last year.
"I don't think it added any unnecessary red tape," she said in an interview. "Its impact could very well be to encourage sponsors to conduct more studies with decentralized elements." …
“The guidance, Saadeh Helou said, “helps stakeholders understand, how do I practically implement this aspect of decentralization within my trial?” …
Helpful as the guidance is, experts say, it doesn't address some of the practical and legal challenges researchers will face as they carry out decentralized trials.
For example, the document doesn't explain how a study sponsor can provide digital health technologies to trial participants without violating anti-kickback rules, Saadeh Helou said.
There may also be privacy challenges, she said, especially if information is collected or shared at home, where the participant may live with roommates or family members.
"There were certain questions that were left unanswered," Saadeh Helou said.
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