Categories: FDA

About a month ago, I had the opportunity to participate at the Inaugural Advances in Clinical Technology conference in London.  The conference covered a broad array of topics relating to how technology can and is changing how clinical trials are conducted.  Here are the top three things that I took away from the conference.

1. The upsides of the e-patient far outweigh the downsides 

Earlier this year, the Wall Street Journal published an article highlighting one of the biggest downsides of the e-patient, their use of electronic communication tools to learn more about their condition, such as social media, could result in study blinding being compromised.  However, the fact that e-patients are actively seeking information about their or their family member's conditions, means that manufacturers can use these tools to recruit patients.  Also, the fact that these patients are engaged in their care may mean they are more likely to be adherent.

2. Regulatory hurdles inhibit broader adoption of some of these advanced technologies

One of the topics discussed was the use of telemedicine to conduct tele-visits which have the potential to not only expand the recruitment area of each study site, but may enhance recruitment/retention by reducing the number of times a subject needs to travel to a study site.  However, companies interested in using tele-visits should take care to ensure the activities they would like to be performed at these tele-visits are permitted under the various state laws.

Others discussed how promising to provide patients with their clinical study data at the end of the trial has increased subject recruitment and retention.  Although the Department of Health and Human Services issued a final rule earlier this year to make it easier for patients to have direct access to their lab results, the rule does not pre-empt all state laws that may require a patient to receive their lab results directly from their health care provider.  Therefore, manufacturers seeking to provide subjects with their clinical data will need to evaluate whether providing such information is permissible under state law.

3. Implementing technology solutions require broad stakeholder input

Three Takeaways from the Advances in Clinical Technology ConferenceA review of the titles of conference speakers provides a lot of insight into how many stakeholders can play a role in the implementation of technology solutions.  Technology solutions are often the result of collaboration between clinical and IT personnel.  However, it is important for companies to involve regulatory personnel to ensure the technology is compliant with current regulatory requirements.  For example, if you wish to collect and use data collected via remote patient monitors, regulatory personnel will need to provide input to ensure the monitors are appropriately validated.  Additionally, as indicated above, laws and regulations tend to lag behind technological developments, therefore, it is important to involve legal personnel to help navigate any potential legal hurdles to implementing technology.  For example, in addition to the two state law issues identified above, other legal issues likely to arise involve personal data privacy issues such as HIPAA compliance and compliance with the EU Data Privacy Directive.

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