Lack of diversity within the clinical trial industry poses a grave problem. We cannot assume medicines work similarly across ethnicities.
While attracting and retaining minority groups to participate in clinical trials has become a primary focus in the industry, many obstacles exist.
There may be help where you’re not looking – the smart phone, which exists in the pockets of almost every human on the planet. The CDC reported that more U.S. households have mobile phones but no landline than vice versa. Almost all minority groups have the same rate of ownership.
So why not go mobile with clinical trials in an effort to reach more minorities? The Clinical Trials Transformation Initiative (CTTI) seeks to increase the use of mobile technology to conduct clinical trials and grow diversity. We couldn’t agree more.
Here’s how a mobile technology can help attract and retain minorities and women as trial subjects.
Mobile Clinical Trials (MCT) Overcomes the Barrier of Location
Three different research studies cited by the FDA in its Review of the Literature: Primary Barriers and Facilitators to Participation in Clinical Research showed both better recruitment and retention of minority and female trial participants when making research visits easier to attend. Socioeconomic factors often make travel more challenging for many potential minority participants. For many women, family responsibilities make participation difficult to consider. To overcome these obstacles, one study included 15-minute phone interviews in lieu of physical site visits. There’s a reason everyone carries a mobile phone. They’re convenient.
MCT Helps Reduce Attrition of Minority and Female Participants
Research reveals participants prefer more communication, compared to less. Communication keeps participants engaged, and the more engaged they are, the more likely they are to remain in the study.
Integrating mobile technology into study design, takes communication from static start-and-stop moments at site visits, to real-time engagement between participants and researchers. In a mobile trial we can use text messages to remind participants of upcoming events. If a participant misses a visit, we can connect with the participant immediately rather than hours or days later. In one example, participants were sent birthday cards. In others, a basic phone call to participants on a regular basis helped forge relationships. With the modern cell phone, voice calls can be video calls, helping to make relationships with participants more personal.
MCT Lets Researchers Do More With Less
MCT allows us to centralize communication. What if your study has participants who speak Spanish or Chinese? In a traditional clinical trial model, we would need multiple translators at multiple sites, a difficult logistical setup which hinders diversity.
Mobile technology removes this barrier, allowing a Spanish speaker to converse via phone, text or email directly with translators. That beats trying to find a translator for every data collection center.
Moreover, clinical trial applications can be built in native languages, allowing study sponsors to recruit global pools.
How to Move Forward With MCT
Implementing mobile phone technology can be done in small incremental ways – a minimal impact to the study design with a positive impact on the study’s results. For example, replacing on-site interviews with phone calls requires little adjustment, but goes a long way in retaining your subjects.
However, if you’re seeking a greater change, consider mobile phone apps designed specifically for clinical trial execution. Mobile apps can ease the barrier of inconvenient travel, increase engagement and recruit globally with ease – all of which help diversify the subject pool.
Like any new technology, limitations exist. Current insurance parity laws that vary from state to state can impinge on the extent to which MCT can be utilized remotely. Yet, many of those restrictions can be accommodated through your study protocol.