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Regulatory Focus™ > News Articles > 2020 > 6 > BIO: What it takes to make the leap to decentralized trials

BIO: What it takes to make the leap to decentralized trials

Posted 16 June 2020 | By Kari Oakes 

BIO: What it takes to make the leap to decentralized trials

Though there’s excitement and much promise in leveraging technology to meet participants on home turf, “We’re all still taking baby steps in bringing the clinical trial to the patient,” said Rasika Kalamegham, speaking of making the move to decentralized clinical trials. Moderating a decentralized trial-focused session at BIO Digital, she and other session participants discussed how to tease out where promise lies and what hurdles stand in the way of sponsors, regulators, and patient groups.
 
Wade Ackerman, partner at the law firm Covington & Burling, offered his perspective on where the agency, patient communities, and sponsors are in their thinking regarding novel and decentralized trial design. “It’s important to keep in mind with all the work that’s going on at FDA… there’s a lot of authority they already have, and flexibility they already have,” he said. Ackerman pointed out that both FDA and industry have some inertia regarding change: “There’s a tried and true pathway for clinical trials. Does any one sponsor want to take certain risks that FDA may not think the data is reliable, or that there may be gaps?”
 
“In our defense I would say the challenge is not having the comfort of a guidance,” said Kalamegham, group director of US regulatory policy at Genentech. “As an industry I know we should be bolder, and we should be riskier, but I think that we would like to take a smart approach. To that end, having some indication or some information from the agency -- in the form of a draft guidance, even -- would really go a long way toward helping us feel emboldened to take these kinds of trial designs into consideration.”
 
“At the end of the day, the biggest advantage of decentralized clinical trials really is adding convenience to the patients and being less disruptive in comparison with a clinical trial,” noted FDA’s Isaac Rodriguez-Chavez. Trial participants often have considerable travel time, and a decentralized trial can eliminate that major hurdle. Also, multiple conditions, including many rare diseases, cancer, and conditions affecting mobility can limit options for patient to participate in clinical trials, noted Rodriguez-Chavez, of the office of Regulatory Compliance and Policy Development at the agency’s Center for Drug Evaluation and Research. He added, “Convenience to participants is a very important element, and that is enabled because of the use of technologies.”
 
Telehealth “is up and coming in clinical research,” he added, noting that the COVID-19 pandemic has expedited the expansion of telehealth.  The Code of Federal Regulations governs the conduct of medical research, so he cautioned that those seeking to use telehealth in clinical research should ensure they meet local, state and federal regulations governing telehealth and telemedicine.
 
In addition to the communications ease of telehealth options, technology such as wearables can facilitate decentralized clinical trials. However, each piece of technology needs to be evaluated “within the specific objectives and needs of your clinical trials, so you can reliably measure the endpoints that will be connected to the specific objectives of the trial,” said Rodriguez-Chavez. He added, “You have to think about what kind of verification studies and validation studies may have to be customized in addition to the verification and validation studies that are done by the manufacturer; they may have to be customized by the investigator, so at the end of the day you are measuring what you intended to measure.”
 
As with all clinical trials, the pivotal points from the regulator’s perspective remain participant safety and quality and the integrity of the clinical trial, he said.
 
Valerie Paradiz, vice president of services and supports for Autism Speaks, made the point that participants in clinical trials each come from their own perspectives, with their own challenges, and meeting patients along their own path will be a key to success. “This is from my perspective, and the field I work in – but if you were to take a wearable, whether it’s one that you just wear and you don’t do anything, or if you have to do something on a daily basis or a regular basis…from the perspective of the participant in the study, I think getting input on the design from the actual people you aim to serve is important. Also, input from industrial engineers or cognitive engineers can ensure patient participation is maximized.”
 
She added that participants need education regarding the purpose and use of a wearable; for some populations, a period of desensitization should be factored in.  Thinking of herself and others with autism, she said those planning trials need to be “ensuring that you’re communicating that information in the way that an autistic person would need to process it – whether it’s with visual supports or other types of instruction…I think all of that is really critical in terms of all the additional question in terms of data accuracy – but also of retention of participants,” she said.
 
For trials where participants will need to engage with technology to input data, as with answering a tablet-based questionnaire, “Much of that depends on who the population is that’s involved in the trial,” she noted. Again, she advocated for appropriate design and participant education. To this point, Rodriguez-Chavez said that “In decentralized clinical trials, it’s vital that the inclusion criteria include proficiency in the use of the technology, so that there can be full participation in the clinical trial.”
 
Ackerman agreed with Paradiz’ assessment that technology stands to bring new and better data sources to the approval process. However, he cautioned that FDA will still have safety, data monitoring, and enforcement issues to consider, regardless of the means of data acquisition.
 
Kalamegham, in her remarks, concurred with the speakers: “I want to bring it back to the patient. At the end of the day, the reason we’re talking about this is to make it easier for the patient.”
 

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