Over the last decade, mobile solutions have become an integral part of the clinical research process. In fact, tablets and smartphones are already the predominant tools used by patients for data entry, surpassing traditional written surveys and telephone data collection.
Yet despite the fact that mobile solutions are so widely accepted and such an important part of electronic clinical outcome assessments (eCOA), there is still some hesitation among patients to accept the devices, and some questions about how to maintain the integrity of a study when mobile devices, especially patient-owned devices, are used for data collection. In order to ensure that clinical research is conducted appropriately and the results are valid, it’s important that study participants are properly introduced to the mobile data collection protocols. Not only does a thorough orientation ensure that participants are comfortable with the devices and how to use them, but proper training also limits the likelihood of errors, data gaps, and other issues that could skew study results.
Because of the importance of maintaining research integrity, it’s important to follow these best practices for introducing patients to your mobile data collection protocols to ensure both patient engagement and accuracy in data collection.
Training and Education
Perhaps the most important aspect of introducing patients to electronic patient reported data solutions (ePRO) is to provide adequate education and training. In addition to explaining the many benefits of electronic data collection and how it will benefit the patients, this introduction should also include, at minimum:
- Instructions on how to access the data collection portal.
- Instructions on entering data.
- Instructions on correcting data that is entered accidentally or incorrectly.
- Instructions on submitting data.
- Explanations of values; for example, if a drop-down menu asks patients to rate a measurement on a scale of 1 to 5, provide descriptions of each level to improve the consistency of responses.
Ideally, your ePRO solution will be patient-friendly, and include features that ensure the best possible patient experience. Drop-down menus, highlighted fields, grayed-out fields, and other clues can help make it simple for patients to provide information, reducing the stress and hassle of recording information. Again, though, these features must be thoroughly explained to the patients, and resources to answer questions should be made available. This could include a manual, a website with tutorials or FAQs, or in-app features that allow patients to contact study staff for clarification and help.
Because security and privacy are such important issues when it comes to electronic data collection and storage, it’s important that you discuss them with study participants to avoid security issues. Not only do you need to explain to the trial participants how you will be using and protecting the data they submit, but it’s incumbent upon you to provide training in how they can protect the information they submit. This might include:
- Reviewing the requirements for security, including PINs, passwords, and other important tools.
- Educating participants on security risks, and how to identify potential problems.
- What to do if they suspect that their device has been compromised.
Security is especially important when the study is BYOD, and participants use their own personal devices to submit data. Be sure to explain your security protocols and requirements; for example, it may be necessary for participants to update apps or operating systems or add security protection to their devices.
Getting Off on the Right Foot
One of the best ways to ensure the success of your mobile clinical trial is to learn from other studies. In addition to the data you collect for the trial, look at the data from previous mobile research to identify those areas where there are bottlenecks, or that participants are unhappy with, and use that information to guide your study design and procedures.
Mobile data collection can make a significant difference in the success of a clinical trial; in one notable instance, mobile data collection actually led to a 66 percent increase in efficiency over a traditional trial. However, a key part of the success of this method is properly introducing patients to the study protocols and the use of the mobile tools. When you offer training, support, and clear instructions, the experience will be better for the participants and the outcomes will be better for you.