Participant retention in clinical trials is key to the success of any study. I have mentioned in a few previous blog posts that I am a huge fan of thanking patients. This means acknowledging in some way the site’s and sponsor’s appreciation for their commitment to taking part and maintaining participation until the study ends.
The Importance of Retention in Clinical Trials
To further emphasize the importance of retention, here are a few key statistics. In the UK, a survey was done almost a year ago of a cross-section of 4,000 patients. Only 9% of those patients were invited to participate in or made aware of clinical trials. Of those who were informed about clinical trials that might benefit or interest them, 47% decided to participate. These statistics are specific to the UK but are very much mirrored across the globe.
About one-third of trials recruit participants as planned and only 5% of eligible patients participate in clinical research. Therefore, every recruited patient is vitally important to the success of a study.
Once the first hurdle is cleared and participants are successfully enrolled, the next hurdle is keeping them in the study to completion. The average cost to recruit one patient into a clinical study is $6,533. Unfortunately, approximately 30% of participants drop out of clinical trials.
Patients dropping out of trials has a huge impact:
- If a participant drops out or leaves a trial, the cost to recruit a new replacement patient is over $19,500
- The time needed to start over with new participants can delay a study by months or years
- Data collected isn’t usable after a participant leaves the study
- If the drop out is due to how the participant felt they were treated or listened to during the study, there is a risk they will share this on social media or online advocacy groups, and possibly damage future enrollment
Retention in clinical trials is clearly essential from time, cost, and data perspectives.
The Research Participant’s Perception
I conducted a series of interviews with four research participants. Only one of the participants I spoke to received any sort of thanks or token of appreciation. For that one participant, the personal touch was greatly appreciated:
“During Christmas time, they always send a personal postcard, to your home, from the team of researchers, which is really received well by me personally, because that’s something like emotional support. They think of you. But I think it has nothing to do with the trial itself, it’s more with the attitude of the team.”
Improving clinical trial engagement by extending appreciation for participant involvement is a hugely missed opportunity in our industry. If we thank them for participation, they feel a greater sense of value, worth, and inclusion. Study participants are less likely to drop out of a study, even if it is challenging for them because they understand the value that has been placed on their participation. They are also more likely to tell friends, family, or work colleagues about participating in a study when they receive a token of thanks to share. This culturally promotes a positive attitude about trial involvement.
I am interested in finding out why thanks aren’t given more often in clinical trials when it seems so logical to me, and in all honesty to every person I speak to about it (and I’m afraid I do – passionately!)
The Research Industry Perspective
My colleagues and I attended the DIA Global Annual Meeting in Boston. When we had the chance, we asked anyone in the industry who came to our booth a few questions to delve further into their attitudes about thank-you gestures for trial participants.
The responses were by and large a mix of people being either uncertain if their company sent out or provided any type of thanks or appreciation to participants, or saying in full certainty that thanks were not given.
Most felt that the idea of saying thank you was nice, they wished it was done, and they wanted to discuss options that could be offered by way of thanks. They also thought the idea of thanking patients was a positive way to enhance clinical trial engagement. Some said they loved the idea of providing updates like newsletters but the company they worked for found it too costly or challenging to pursue.
A surprising number said that they weren’t sure it was allowed to thank patients from a regulatory perspective. The regulations attached to trial participation are very clear. You can’t promote or incentivize trial participation, although lower-value items can be used to assist with recruitment and retention initiatives. We do lots of these sorts of items for global studies. Capturing or using patient data like a home address is also very highly regulated. BUT you can provide the sites with thank you cards or other similar appreciation items to share with patients.
The Importance of Expressing Gratitude
According to positive psychologists, studies have shown that expressing gratitude makes the helper (in this case, the participant) feel their participation is truly appreciated, gives a sense of self-worth, and makes it more likely they will help again in the future.
Showing gratitude is especially important in long-term studies. Birthday cards and study anniversary cards work well. After completing lengthy and onerous steps or milestones within a trial, certificates provided to participants are also a great way to show appreciation and encouragement and foster a connection to support continued participation. There are plenty of ways to tell a participant: you are valued and your time has made a difference in this study. A thank you card, greeting card, or certificate are the easiest and most cost-effective options.
Thank You Surveys Coming Soon
I aim to get a wider impression of industrywide appreciation gestures for participants. Who does what, when, and why. What are the motives for providing thanks, or perhaps reasons for not? I will be sending a survey out soon to get industry input, so we can better understand what we are and are not doing across the industry.
Perhaps by working together, we can make saying thank you more commonly done and retention in clinical trials will improve.
When our children are little, we teach them to say “please” and “thank you,” it’s part of their learning how to be a good human. Setting the moral compass, if you like, right from a young age.
When people open doors, or do nice things for us, by and large, we say thank you. We acknowledge what they did, recognizing their contribution.
Yet for participants in clinical trials, who are essentially taking on risk for research, we rarely say thank you. Perhaps the site clinical trial teams sometimes do, but the client – the owner of the drug or treatment rarely thanks those who are quite frankly the most valuable and critical part of the study.
What Does Saying Thank You Mean to You?
Without participants, there are no trials. No data, no results, no outcome. No blockbuster drug that goes on to make drug makers millions of dollars.
We need participants, and the overall cost and effort to thank this key stakeholder and potentially enhance retention in clinical trials is in all honesty, significantly underwhelming in the industry at the moment.
We have a real opportunity here. Review what saying thank you really means to us, and then create a corrective action. Let’s make saying thank you part of our compass again.
I love hearing about great ways to thank patients – so please share what you have done. Shout it from the rooftops!
Contact Imperial if you would like to discuss great ideas for enhancing clinical trial engagement.