When Clinical Trial Professionals Participate in a Study

At this DIA 2023 session, “The Other Side of the Table: Drug Development Professionals Share Their Experiences Participating as Patients in Trials” the following participants from the industry spoke about their own journey in clinical trials: Peter DiBiaso, Senior Vice President, Clinical Solutions and Strategic Partnerships, WCG Clinical;Maria Florez, Research Consultant, Tufts Center for the Study of Drug Development; Sheila Mahoney Jewels, Drug Development Multi-Functionalist, LifeScieHub and Amber Whaley, Lead Regulatory Chair, WCG

The biggest issue that came the fore during the panel discussion was problems with informed consent.

Whaley explained that when she received the informed consent, she felt that people could be vulnerable to therapeutic misconceptions. Therapeutic misconceptions are inappropriate assumptions by research participants that decisions about their care are being made solely with their benefit in mind.

Also, Whaley said that trials should be as accessible as possible and should include the availability of alternative forms of consent. And, of the three consent forms she needed to sign for the COVID-19 trial she was participating in, only one was provided in advance. “There needs to be improvement there,” she said.

Florez, who was in a hybrid trial, with more decentralization than not for a one-year study, noted the eConsent was used remotely, but the jargon and overly long form and the language used should be something that that should be changed.

Jewels believes that part of the informed consent struggle is related to the fact that material gets “thrown” over to legal departments. She said, “If all legal departments were required to be in a clinical trial, we would not have the informed consent forms we have.”

Technology

As mentioned, Florez was in a primarily remote trial, and the interaction with the study staff was remote, as was the data entered regarding monitoring her own physical state was remotely into a system. As noted, she entered data remotely into the system, however, she found the interface or design was not easy or required too many log-ins.

From her vantage point at Tufts, she said it is found in their research that the site burden when dealing with patient calls regarding technology issue is difficult. “Some sites are having to create new positions to tech-support these patients,” she said.

Whaley needed to supply health questionnaires once a week, remotely. She had minimal technology issues as they loaded her personal iPhone to manage the data. But she wondered, “They didn’t provide phones, so could those participants without a phone participate?”

Data transparency

DiBiaso noted that follow up was poor and he never saw an outcome on the study he was in. He said, “There should be a level of transparency with the data.”

Florez agreed that it important for patient to have access to their data, however, she also thought it would be important ask the physicians if they want the patient to receive the data.

Whaley said that her being in a COVID trial was a unique case and with the large amounts of data that openly shared and covered in the media. While Whaley did not receive results and wasn’t sure if she received the therapy or placebo, participants were allowed to be unblinded if they wanted to get the vaccine to discover if they were able to get it or were already treated.

Final thoughts from the DiBiasio on thinking of participants means advanced moves such as challenging teams on exclusion/inclusion criteria and work toward less endpoints in the protocols. And then some simple acknowledgments, such as giving them thank you cards, or making sure they had ample parking.

As a close, an audience member suggested using the Gratitude Toolkit available from TransCelerate as a great resource to help provide that patient acknowledgment. https://www.transceleratebiopharmainc.com/assets/patientexperience/gratitude-toolkit/

REFERENCE: “The Other Side of the Table: Drug Development Professionals Share Their Experiences Participating as Patients in Trials”, DIA 2023, Boston. June 29, 2023.

Lisa Henderson is Editorial Director of Applied Clinical Trials.