{"id":71136,"date":"2024-09-12T14:02:56","date_gmt":"2024-09-12T14:02:56","guid":{"rendered":"https:\/\/www.imperialcrs.com\/blog\/?p=71136"},"modified":"2024-09-12T14:02:56","modified_gmt":"2024-09-12T14:02:56","slug":"long-term-clinical-trial-participation-6-retention-tips","status":"publish","type":"post","link":"https:\/\/www.imperialcrs.com\/blog\/patient-engagement\/long-term-clinical-trial-participation-6-retention-tips\/","title":{"rendered":"Long-Term Clinical Trial Participation: 6 Tips to Retain and Keep Patients Engaged"},"content":{"rendered":"

Retaining participants in studies is an ongoing challenge that the clinical trials industry grapples with daily. One analysis1<\/sup>\u00a0 I came across pegged the participant dropout rate at an average of 25-26 percent per study. Every single loss is costly and, among other problems, can prolong the trial and reduce the significance of study data. What can be done to improve retention rates? While there are no magic bullets to enhance long-term clinical trial participation, the following tips may help.<\/p>\n

Key tools<\/h2>\n

Education and communication are powerful tools. Ensure that your recruitment materials, such as websites, brochures, and posters, provide essential information about the level of commitment required of the participant. This should include study duration and the number of visits. While these two details do not tell the whole story, they convey the basics of committing to the study.<\/p>\n

The Informed Consent Form (ICF)<\/h2>\n

When writing the ICF, keep the patient\u2019s reading level2<\/sup> in mind. When meeting with a potential participant, go over all of the study details and don\u2019t assume they know which questions to ask. If the participant could be placed in a placebo group, make sure they are aware and understand what this means.<\/p>\n

An evaluation3<\/sup> of study participants in Spain revealed that 26 percent signed the ICF without reading it. That should never happen. Make sure a potential participant has plenty of time to review the ICF and ask any questions they may have. Encourage them to share the ICF with their family. Loved ones are often very much a part of the study, and family buy-in is important as they can exert influence as part of the participant\u2019s support system during the study.<\/p>\n

One option worth considering is an item we routinely create for many of our clients: an ICF presentation flipchart. Physicians and study teams use this document to present detailed study information to potential participants pre-consent. The flipchart is double-sided so the physician and patient can review ICF information at the same time. The patient\u2019s view is written in lay terminology, and the physician\u2019s view contains more detail that prompts them to ensure they discuss key critical elements of the study.<\/p>\n

Are decentralized trials the answer to long-term clinical trial participation?<\/h2>\n

\"Decentralized<\/p>\n

The decentralized trial4<\/sup> is a concept that brewed for a long time, progressed slowly, then evolved into more common use during the COVID-19 pandemic. Despite the apparent convenience and appeal of home visits from a study nurse for simple procedures like blood draws and vital signs, plenty of patients aren\u2019t interested in visits taking place in their homes. Therefore, decentralized trials are not a guaranteed solution for retaining participants.<\/p>\n

 <\/p>\n

Once they have committed to your study<\/h2>\n

Ease the burdens of participants<\/h3>\n

I spoke with Imogen Cheese<\/a>, Imperial director of business development. She is very experienced with trials and is a dynamic patient advocate. She reinforced the importance of prioritizing the patient burden when addressing clinical trial patient retention.<\/p>\n

Imogen pointed out that adherence to long-term clinical trial participation can hinge on a single concern, such as getting to and from the trial site. \u201cIf the issue is ongoing travel, then think about transportation assistance, help with parking solutions, or even providing elements of the study at alternate locations closer to the participant,\u201d she said. \u201cThis hybrid solution can reduce the number of interruptions to their and their family\u2019s schedules.\u201d<\/p>\n

Communicate<\/h3>\n

Imogen also highlighted the significance of communication between study visits. \u201cLong-term adherence can always be helped through different means of communication,\u201d she told me. \u201cThink about sending the patients reminders about study visits and the importance of taking their study treatment.\u201d<\/p>\n

Imogen also said sponsors and CROs should remember to tap into the participant\u2019s initial reason for being involved in research. \u201cThe participant was motivated to take part in the study. Help them keep that in mind. An excellent way to facilitate that is through participant newsletters that include information about their indication and also study updates. Unfortunately, that level of communication is costly and time-consuming, and it involves more back-and-forth with IRBs. Many clients and sponsors are reluctant to add those expenses, but it\u2019s worth considering because of the connection it provides.\u201d<\/p>\n

I mentioned to Imogen that when reviewing complex protocols, it is clear that something special exists inside of participants that helps them commit to taking part. Something noble.<\/p>\n

\u201cAltruism does play a part, no question,\u201d she said. \u201cEach study and patient dynamic will be different. In rare disease or oncology studies, the study can literally be lifesaving or life-changing. Those patients may be more willing to sacrifice quality of life for a long-term study. But that doesn\u2019t make their burden any less than others on a simpler style of study. And we need to be mindful that just because they might be more willing to take part with a reduced quality of life, we need to ask ourselves as we design the studies, should they? If the table was turned, would I take part? If the answer is no to either, we should be looking at the trial design again to see how we can make participation more palatable.\u201d<\/p>\n

Appreciate<\/h3>\n

Next, I spoke with Alejandro Serricchio<\/a>, another Imperial director of business development. He agreed with Imogen\u2019s advice. \u201cI would just add that it\u2019s key for long-term studies to make sure the participant constantly feels appreciated.\u201d<\/p>\n

\"Thank \u201cThat means the study doctor or nurse should reach out regularly, even just to say hello. There are many digital tools available, such as messaging systems and auto-alerts. But the personal touch, especially in a participant\u2019s sometimes cold medical journey, goes a long way, he said.\u201d<\/p>\n

I agree that thanking participants and making them feel appreciated throughout the study is essential and can also influence others to consider taking part in a trial. Word-of-mouth marketing5<\/sup> has long been a powerful tool, and in today\u2019s digitally connected world, it\u2019s more far-reaching than ever.<\/p>\n

Summing up<\/h2>\n

Though clinical trial patient retention is an issue that will never be fully alleviated, adopting a patient-centric focus from the beginning, maintaining a consistent commitment to reducing the patient burden, and staying connected with participants throughout the trial will help fight attrition and keep your studies on track.<\/p>\n

The Imperial Advantage<\/h2>\n

Imperial will help you connect with study participants to enhance long-term clinical trial participation. This includes the beneficial tools mentioned above, as well as branded comfort and activity items, tokens of appreciation, milestone and thank you cards, and certificates of completion. Contact us and let\u2019s talk about your studies.<\/p>\n

References:<\/h2>\n

1<\/sup>Challenges in retention<\/a><\/p>\n

2<\/sup>Writing with the audience\u2019s reading level in mind<\/a><\/p>\n

3<\/sup>Participants and ICFs<\/a><\/p>\n

4<\/sup>Decentralized clinical studies<\/a><\/p>\n

5<\/sup>Word of mouth marketing<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Retaining participants in studies is an ongoing challenge that the clinical trials industry grapples with daily. One analysis1\u00a0 I came across pegged the participant dropout rate at an average of 25-26 percent per study. 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