Due to its large-scale accessibility, mobile health technology could undoubtedly make clinical trial participation easier and more convenient for participants. However, the potential of mobile health reaches beyond the benefit to study participants. Mobile technology can also act as a resource for clinical research professionals to improve operational performance and potentially reduce the risk of clinical trial deficiencies.
While apps such as Slack and Trello help facilitate business communications and project management tasks, there is a need to address the idiosyncrasies of the clinical research environment. Below are two free apps created specifically to help industry professionals improve their clinical research practices.
Purpose: Address the issue of non-compliance at the site-level.
Compliance is always a large concern in the clinical research industry and FDA inspections are a scary proposition for many clinical trial sites. For some, it’s a struggle to prepare for an inspection and ultimately avoid non-compliance. Some of the most common compliance deficiencies in clinical trial practice include participant safety concerns, protocol deviations, informed consent violations and failure to maintain adequate case histories. Sites that consistently struggle with the above deficiencies are often issued FDA 483 documents followed by a requirement to take corrective action.
The app No 483 for Me!, developed by William Tobia, M.S., M.B.A of GlaxoSmithKline Pharmaceuticals, acts as a training and review resource for clinical research site staff to help prevent FDA non-compliance in research practices.
Function: This app functions as an easy-to-use and convenient version of the FDA regulation guidelines.
Rather than struggling to find the correct information on the FDA’s website, clinical research professionals can open the app on an iPhone or iPad, identify the area of concern and click the corresponding icon to view the section of regulation. No 483 for Me! also includes a self-assessment called “Whiz Quiz.” This feature aims to increase retention of FDA regulations for site staff.
Purpose: This app acts as a resource for good clinical practice training and review.
To ensure clinical research professionals are following Good Clinical Practice (GCP) guidelines, organizations such as the Association of Clinical Research Professionals (ACRP) provide their members with training and resources focused on operational best practices. In an effort to increase the efficacy of such training and meet the needs of a modern work environment, ACRP now offers the ACRP GCPartner app.
Function: Similar to No 483 for Me!, the ACRP GCPartner app acts as a pocket reference for GCP guidelines, in an effort to make training and review easier, faster and more effective.
The app allows clinical research professionals to search and save sections of the GCP guidelines for easy accessibility, as well as download helpful GCP resources. ACRP GCPartner app also hosts a library of videos to provide real-world context and increase retention for each section of the GCP guidelines.
As technology continues to evolve and younger generations advance into the workplace, it’s essential that the industry remain fluid to meet the needs of a changing clinical research landscape. Mobile technology could be a valuable asset for clinical research in many areas, such as patient recruitment and retention, staff training and project management. Embracing the advantages of this technology could make the clinical trial process more convenient and efficient for all industry stakeholders.
Learn more about mHealth
In a recent blog series, our authors explored the potential of mobile technology in the clinical research space. Click the button below to read our take on ResearchKit, mobile health for rare disease patients, patient privacy and more: