Decentralized Clinical Trials Offer New Ways to Broaden Patient Participation

Agnieszka Gackowska, MD, Senior Director, Global Site Solutions, Parexel

“We need to work on giving patients more choice in clinical trials, even at the protocol level,” says Agnieszka Gackowska, MD, senior director for Global Site Solutions with Parexel. She’s a big proponent of leveraging technology and concepts surrounding decentralized clinical trials (DCTs) to increase participation by making it easier for patients to engage and remain involved for the duration of the trial.

Most experts agree the COVID-19 pandemic changed the way clinical trials are conducted, and Gackowska is among that group. Like the majority, she also believes many of those changes will remain long after the pandemic is a memory. “There’s no going back from how we’ve been reimagining clinical trials” to adjust to COVID-imposed limitations, she says.

Gackowska acknowledges that the initial financial considerations associated with DCTs could make trial conduct more costly for the clinical trial industry, but the effort will ultimately more than pay for itself. If leveraged properly, DCTs will result in “faster recruitment and higher retention, so overall costs will drop,” she says.

However, the industry must do a good job when it comes to educating and informing all stakeholders about the logic behind and benefits and costs of the changes involved in embracing technologies for conducting more trial operations away from traditional brick and mortar sites. “These changes must be accepted by all stakeholders, especially patients,” Gackowska says.

Gackowska is excited to share her insights and learn from other participants when she participates in a panel discussion on DCTs for the May round of ACRP 2021 virtual conference topics. “I give my heart to this role,” she says. “I feel our mission passionately.”

Among other topics, the panel will address the pros and cons of DCTs and home visits, Gackowska says. She sees the volume of home visits as part of clinical trials increasing, but notes some patients may prefer to go to a site or participate in a trial in some other way. “We have to make sure all patients are happy” with the conduct of the trial, she advises.

Author: Michael Causey