Rauha Tulkki-Wilke, CRF Health

CWWeekly presents this feature as a spotlight on issues faced by executives in clinical research. This week, Rauha Tulkki-Wilke was interviewed. Tulkki-Wilke leads the development of new eCOA solutions at CRF Health and has been with the company since it was founded. She has more than 13 years of experience with eCOA.

Question: How can the Internet of Everything (IoE) benefit global clinical trials?

Answer: Clinical research is at an exciting threshold, rapidly adopting new interactive and IoE technologies to collect electronic source data that directly reflects patient activities and outcomes. Providing this real-world data through IoE, beyond the traditional clinical setting, is important to the major drug developers as they justify therapeutic costs with high quality, outcome data.

New sensor and measurement technologies, combined with IoE, enable new and novel clinical outcome measures for continuous assessment of clinical interventions. This contributes to higher quality data capture and a more complete understanding of treatment efficacy. Real-time access to data delivers efficiencies, and ease-of-use helps increase patient and site compliance.

Overall, electronic source data enables transmission of data into the upstream database immediately and efficiently. Patients will gain better visibility to their data and to the overall trial process, thereby fostering retention and, ultimately, the completion of the study. IoE can also lower the burden on both the patient and the site by removing the need for site visits and additional manual procedures at home and the study site.

Question: What considerations are needed for choosing the right IoE devices for a study?

Answer: Deciding on the best technologies and IoE approach in a trial, to measure and deliver quality data, takes careful consideration. Beyond the idea to measure something objectively with a measurement device and establishing the data needed, the requirements for accuracy and reliability of the device must be ensured. This consideration needs to go beyond medical device regulations and certifications. Systems used in clinical trials are subject to clinical trial regulations. FDA and local regulator certification of the device, for use globally in the countries participating in clinical trials, will be required. This may cover whether the proposed device, and its local variants, have certifications for use in each country in the study; or whether import and export regulations have been considered and planned for, including the supply of accessories that may have expiration dates and need to be re-supplied mid-study.

Technical considerations concern how the device fits into the clinical trial workflow. Getting data out of the device easily in a remote setting also needs to be established in this evaluation stage to enable data to be transferred at the study site via Bluetooth, USB cable or submitted to the cloud.

Usability is another important factor, most importantly, if a patient is not familiar with a given device. Varying levels of training and support may be needed, as well as practical considerations regarding use beyond site control. Having an experienced partner to take sponsors and sites through this learning curve can be a time and cost-effective element of pre-implementation of IoE in clinical trials.

Good Clinical Practice (GCP) as well as security and privacy regulations such as HIPAA and, most recently, the GDPR can affect device selection. Connected devices with their own apps that enable data capture from sensors may contravene these regulations, e.g. security and privacy rules from the GDPR perspective, especially if patients request to review or remove their data.It is crucial to ensure that any connected device is validated for clinical trial use, as many such devices are manufactured by healthcare companies who operate under different regulations. Whenever a sponsor is considering the use of measurements with these systems, they need to ensure that the whole system is compliant with clinical-trial related regulations.

Many clinical trials benefit from making measurements available in an electronic patient diary. It needs to be considered that if the diary application is used as an accessory to a regulated medical device, transforming it into a regulated medical device would require an FDA review for applications that pose a greater risk to patients. If data is accessible to patients, a detailed understanding of a drug can unblind a study or cause them to change their behavior, thereby causing bias.

Question: Is IoE more applicable in specific therapy areas than others?

Answer: New measurement technologies and IoE can benefit most therapy areas. There are certain indications where we see a lot of interest in the devices because of the end points and nature of assessments. For example, COPD has been one of the first indications where data captured with activity monitors has gained acceptance, and this has led to use in many other therapy areas. Daily functioning measured in real time and across differing periods and activity levels is delivering much better data and measurements of outcomes. Additionally, vital signs measurements taken at home can encourage better remote participation and these developments can impact trials positively across all therapy areas.