The survey from the Association of Clinical Research Organizations (ACRO) examined several technologies and methods for conducting clinical investigations and the obstacles faced in implementation.
John Lewis, Senior Vice President, Policy & Public Affairs at ACRO told us that, while not a huge surprise, the high level of enthusiasm for wearables’ potential “really stood out.”
However, the devices still face several issues, including assessing data quality and standards and integration with other clinical trial data sources, in addition to privacy and security problems.
“On the other end of the spectrum,” added Lewis, “[there was] a relatively lower level of expectation for collecting data from EHRs.”
According to Lewis, this caution may stem from the difficulties in integrating EHRs with EDC and other clinical trial technologies, which he described as a major hurdle. To addresses these issues, the FDA recently released a new draft guidance.
The guidance also addresses the incorporation of EHRs into protocol, trial design, and the data management plan but, according to Lewis, does not provide much direction.
“We also think there will need to be further clarification on the informed consent guidance,” he said.
However, the draft guidance does not address the use of EHRs for observational studies or the use of EHRs for patient recruitment.
“ACRO has been advocating for the past several years to have clinicalrials.gov integrated with EHRs to facilitate patient matching and make more people aware of clinical trials,” said Lewis.
“This is not an FDA issue per se but an example of where the agency may be able to use its influence,” he added, commenting that these issues may be addressed in future guidances.
Taking steps towards adoption
Lewis said that it is important that the FDA “very publicly” support and encourage the adoption of new technologies.
“Commissioner Califf is a great messenger for this with his extensive background in clinical research,” he said. “But as importantly, the FDA needs to ensure that it adjusts its audit processes to take into account new technologies, including more automation of the process and advanced training of auditors so they understand and adapt to the new technologies. We need the message to penetrate all the way through the agency.”
According to Lewis, the widespread adoption of new technologies will change many aspects of how clinical trials are conducted – from protocol design to recruitment.
“We cannot simply tack on new technologies to the old processes but must really work to reinvent the process to be more efficient and easier for investigators and patients to participate in the research,” said Lewis.
Ultimately, he said that the greatest impact will be on the patients as these technologies, wearables in particular, will make clinical trial participation more appealing and convenient.
The pharma industry is highly regulated, and thus very cautious, as much is at stake in the development of a new drug.
“At the same time, we have generally lacked regulatory guidance on the uses of these technologies so while there has been a lot of experimentation, especially within the CRO sector, all of the potential is not being realized,” added Lewis.
According to Lewis, one of the other major areas where for potential benefit and a high likelihood of adoption is in the use of social media for patient recruitment.
“Right now, social media is one of several tools our members are using but this is an area where more guidance from the regulators could really make a big impact,” he said.
Lewis explained that he would specifically like to see the FDA convene a meeting of stakeholders, including sponsors, CROs, investigators, patients, IRBs, to examine the issue and ensure that social media is “encouraged as a method of patient recruitment and everyone is comfortable with the rules.”