The Site Experience: Using Technology to Advance Clinical Research
Dr Vivienne van de Walle offers 9 steps pharma companies can take to improve clinical trials based on her own insights and conversations with other investigators, who agree that using eClinical technologies to collect patient data can improve compliance and data quality, and reduce monitoring time.
Clinical research is undergoing a big transformation as technology evolves. There is so much equipment and systems investigator sites have to use within clinical trials: eDiaries, iPads, large and small screen laptops, trial tablets and of course, most of us have our own office computer. Sometimes I tell my assistants it's never an issue of using the device, but of using the right device, because we have multiple eDiaries for multiple ongoing trials. It can get very complex.
For this article, I contacted several sites to ask about their experiences using technology for clinical research. I was quite surprised they were so eager to share their information and even more surprised but happy to see everybody had the same experiences.
Sites like eClinical technologies for collecting patient data because they improve compliance and hence data quality, and reduce monitoring time. Giving patients eDiaries can have a profound increase on privacy, ease of collection, while diminishing cheating and prevention of dropouts. Everybody knows patients write unclear, inaccurate data or even make data up and there is always the risk of losing paper diaries. There are less inaccuracies, no data transfer mistakes or lost data with eDiaries. The data are in the diary and are transferred directly to the EDC so we get real-time data uploaded every night. Patients are over 80% compliant with eDiaries no matter where the trial takes place or what age group is participating. Patients become adept at using the eDiary; it becomes part of their daily life.
The industry likes to think there is an integration of all the different tools and devices. Sponsors think they know best which technologies to use and when. Sites have had some different experiences. We offer sponsors the following suggestions:
1) Paper or eCOA? – The majority of trials can have electronic tools, but there are still some trials that are not suitable. Ask sites for their input on this question during the feasibility process.
2) Give Sites Flexibility – Bring clinicians into the conversation about how patient data are collected. In one trial, we worked with a tablet. Patients had to answer questions on the tablet and there was a physician interview. I could have two patients come in at the same time – one doing the trial questionnaire while I interviewed the other. But the sponsor would not allow us to do so because the date had to be entered real time. If we perform the interview within the time limits but entered it as soon as the tablet was available, we were generating many queries because the date and time in the trial slate were outside the permitted window. We had to choose, and we limited the number of patients eventually.
3) Use Modern Technology – Patients and sites have modern mobile phones, and it would be great to have the option to use them in research. Patients are familiar and comfortable with their own technology. And if they take a trip they don't have to take multiple cords or chargers. Some people will enjoy doing this and some will not, but sponsors and providers should provide the options for sites and patients to use their own provisioned, current, user-friendly technology.
4) Involve Sites in Technology Development – Today’s generation of investigators grew up with technology. Doctors as a group were among the biggest buyers of the iPad when it was introduced. We’d never be without our smartphone or tablets. Give us tools that work on our devices so we can make patients’ and our own lives easier. For example, I would like to have an app so I can easily check patients entries and compliance where ever I am.
5) Make it Easy – When I go to Apple’s website to buy a product they are so user-friendly, I don’t need training. Sponsors and vendors need to make using clinical trial technology that easy. Patients and sites alike enjoy using technology but it should be current. This is research. It should be an opportunity to use cutting edge technology people enjoy. We need modern, user-friendly devices. Technology should support the conduct of the clinical trial and not be a research project itself.
6) Improve Instruction – When we require instructions, make it more clear and intuitive. Make an instructional video we can post to our website so patients can go back and review. We’ve done this with the informed consent procedure: the whole trial is in a five minute video, and patients love it. They can always go back and see their next visit and what they need to do to prepare.
7) Increased Standardization with Integration – Ask us what tools do we have, and help us integrate them instead of constantly reinventing the wheel. With all these technologies and no standardization, sponsors and sites are losing a lot of time. A lack of generic technology limits the speed of technology development.
8) Certify Sites on eTools – Certification should be available for patient eTools, since the systems do not change much. Sites already can earn certification for using EDC and IVR systems. Certification for patient eTools will ensure investigators understand eTool applications, best practices, issues and regulatory considerations for conducting clinical trials in an electronic environment.
9) Evaluate and Adapt – After you've done a clinical trial, evaluate and blueprint it. Eliminate what hasn’t worked and keep what did. Consider making sites part of the technology selection process in a trial. Sites are beginning to make their own eIC videos (informed consent movies). They are using technology to educate, train and prepare patients for participation in trials. Hence, they can help choose patient technologies.
The main feedback from the sites I interviewed and from our own experiences: we want to work with eClinical technologies and apps. They provide direct access, real-time data collection and quality data, contribution to the safety for patients. This definitely is the way forward.
About the Author
Dr. Vivienne van de Walle is an expert at integrating patient care and clinical research. She studied medicine at the University of Maastricht and the University of Oxford, and received an additional medical science degree for her research in OB-GYN, pediatrics and genetics. Dr. van de Walle is a member of the BROK/GCP exam commission, ACRON, ACRP, SCRS and NVFG.