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US: Industry calls for More Guidance From FDA on New Clinical Trials Technology


In October 2015, FDA put out a request for more information on the types of technologies and innovations companies are employing to conduct clinical research.

The use of smartphones and tablet devices to collect trial participant data is of particular interest to FDA as its requesting more information on the challenges associated with collecting data on trial participants own devices, which FDA says may be used to access and respond to study-related questionnaires.

Industry Comments

Industry groups, such as the Advanced Medical Technology Association (AdvaMed) and the Association of Clinical Research Organizations (ACRO), and major pharmaceutical companies like Pfizer and GlaxoSmithKline were among the nearly 40 commenters on the FDA’s request for input.

AdvaMed recommends that FDA monitor these new technologies and innovative methods and allow the situation “to develop on a case-by-case basis to promote the use of these technologies rather than prematurely imposing limits. This will encourage early adopters to assess these technologies and develop solutions to key issues. However, guidance will eventually be needed for all clinical trial stakeholders – sponsors, investigators and institutional review boards (IRBs) – with respect to utilization of these new electronic tools and ensuring patient privacy and cybersecurity.”

The group also made clear that a lack of clear guidance will potentially impact primary datasets for submissions and the need for sponsors to understand how FDA will conduct audits on this type of data.

“Establishing unique validation requirements for FDA-regulated trials could slow and complicate implementation, especially when secure data collection and transfer has previously been developed and could facilitate and expedite adoption of these new approaches,” AdvaMed said.

Similarly, ACRO said FDA needs to provide clear guidance in terms of security and monitoring requirements, saying the agency “needs to be willing to share the progress being made in the industry, and provide feedback on the use of new technologies and inspection results.”

ACRO also cited the example of in-silico clinical studies, which are increasingly being accepted as supporting evidence for approvals, which is decreasing the need for costly in-vivo studies.

“However, the predictive value of the models underpinning in-silico clinical studies is directly related to the quality and consistency of data used to generate and test these models. While Electronic Health Record (EHR) data is predominantly used today, usage of standardized clinical trial data, comparable across studies, would support building an increasing number of high quality predictive models; some of these models could be made publically available after testing and validation across the industry and would allow companies to avoid collecting new data that have been collected already in previous trials by other companies,” ACRO said.

Meanwhile, Medidata, a provider of clinical research software, called on FDA to address industry apprehension over whether regulatory agencies will consider data gathered via non-traditional tools or if “existing regulations will categorically prohibit or discourage using mHealth [mobile health] tools. Some sponsors are waiting for others to proceed, while others want to pursue mHealth but are concerned because they feel they do not have enough information to give to FDA in order to have an informed discussion. FDA should evaluate how to open up communications with sponsors to seek formal feedback before conducting a mHealth-enabled clinical trial.”

The company also called on FDA to embrace “digital biomarkers” as potential study endpoints.

“For example, the agency may identify standard measurements, such as a six-minute walk test, that mHealth technology may be able to replace by offering sufficiently objective, sensitive and continuous measurements. Having a target to go after could help generate interest in mHealth investment and lead to new endpoints from the resulting research,” Medidata said.

The Association of Clinical Research Professionals also pointed to the concept of web-based eligibility screening for trials as a “low-hanging fruit” as it presents “the lowest level of risk to potential subjects and to sponsors of research since it would enable potential subjects to consider participation and limit unnecessary study interventions/visits if it appears they are not eligible.”

On the pharmaceutical front, GSK called for more guidance in such areas as Mobile Medical Applications and e‐Source Data, including a discussion on the regulatory requirements for investigational use of consumer health devices (e.g. Fitbit, Apple Watch) and mobile medical apps currently under FDA enforcement discretion during earlier stage exploratory pharmaceutical clinical trials.

In addition, Pfizer noted that although pathways exist for the validation of surrogate and novel endpoints, “Sponsors are unsure about the willingness of the agency to apply these or similar pathways to novel digital/mobile development tools or whether these pathways are applicable to these tools.”

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