Patient compliance and retention are critical to the success of your clinical trial. Anyone who has helped recover a noncompliant study or reduce the volume of early patient withdrawal knows the recovery process is stressful and costly for sponsors and investigative sites. Senior management at some of the most innovative drug development companies understand patient retention is top priority, and they recognize that the cost and resource wastage associated with patients lost to follow up is no longer acceptable.
Incorporating patient reminders into your clinical protocol ahead of First Patient In (FPI) can make a significant impact on your trial’s bottom line. Patient Reminders are automated, personalized SMS text messages, emails, calendar alerts, and voice messages that are sent to the patient or caregiver prior to their clinic visit. These reminders and alerts are a win-win for both the patient and the investigative site: the patient is prepared for their visit and feels valued, and the site doesn’t have to worry about placing reminder calls to patients or dealing with no-shows and dropouts.
1) Take a Proactive Approach to Noncompliance
Clinical trial study teams often dedicate most of their energy to getting studies up and running, while they assume sites will take responsibility for patient motivation, protocol compliance, and patient retention. A compliance and retention program is usually an afterthought that is addressed only if a problem arises. This reactive approach is not only extremely inefficient but also it can be detrimental to the success of the clinical trial.
There is also increasing pressure from the US Food and Drug Administration (FDA) on sites to take a more proactive approach to noncompliance. If the clinical study team focuses on engaging and motivating patients at the start of the trial, this will prevent study delays, decrease the burden on investigative sites, and ultimately increase the reliability of study endpoint data.
2) Patients are People: Engage and Motivate Them
In a recent blog, the patient recruitment expert Rebar Interactive notes, “how patients are made to feel will dramatically impact their willingness to consider, initiate, and continue clinical trial participation.” Patients are people and live busy lives. Noncompliance is often non-intentional; patients forget, they have lifestyle changes, or they simply fall victim to everyday distractions. Successful clinical sites can address this by proactively enhancing the patient experience. This may involve implementing a new, patient-friendly technology, sending personalized reminders, or taking extra time to listen to their needs during their visit to the clinic.
Patients also appreciate thoughtful, personalized communication from the clinical site staff. Patients who feel empowered, valued, and engaged are more likely to come to their appointments and stick with long-term clinical trials.
3) Calculate the Cost of Noncompliance and Early Withdrawal
Our own research shows the average cost of a patient lost to follow-up is $5,000, while the value of each episode of noncompliance is $450. Is it worth it? Patient recruitment is the #1 driver of clinical trial costs, consuming on average 32% of the trial budget. A solid patient engagement and retention plan that incorporates tactics like patient reminders will impact the trial’s bottom line by ultimately reducing the costs associated with re-recruiting patients into the trial.
Something as simple as a SMS text message reminder sent to the patient prior to their clinical visit can lead to 40% improvement in clinical trial patient retention rates. These personalized reminders, sent on behalf of the clinical site or physician, make the patient feel valued and engage in the trial. The patient is also less prone to forget their appointment or their dose requirements.
4) Create Happier, More Productive Investigative Sites
Last but not least, a proactive patient retention and compliance plan will increase site productivity and decrease site workload, as site staff will no longer need to worry about making reminder phone calls or patient no-shows. Patients will arrive at the clinic on time and properly prepared for their appointment. When both sites and patients are engaged in the clinical trial and protocol compliant, this will increase the trial’s chances of success through higher quality study endpoint data.
For more information on Patient Reminders and how it works, download our free white paper Science of Patient Reminders. You may also visit our booth at the Clinical Patient Engagement Summit later this month.
Mark brings over twelve years of pharmaceutical industry experience to Cenduit with specialized knowledge in eclinical technologies used to conduct clinical trials. His expertise includes EDC (Electronic Data Capture), IVR/IWR (Interactive Voice and Web Response Technology), ePRO (Patient Reported Outcomes), Web PRO, and Mobile PRO. Mark served as CEO and founder of Patient Reminders Ltd. from 2011 until 2013 when his company was acquired by Cenduit. As the company’s founder, Mark built a highly innovative cloud-based patient messaging and alert hub designed to improve patient retention, adherence and compliance. Prior to his work at Patient Reminders Ltd, he was Business Development Director at CRF Health and Exco Intouch where he was responsible for generating sales for mobile patient reported outcomes and SMS patient retention and compliance solutions. He also held sales director roles at Proven Energy Ltd and Ozone Limited and headed up the European sales and marketing team at etrials Worldwide Inc. Mark holds a degree from South Downs College in Hampshire, United Kingdom.
(Image courtesy of t1ffan1e via Flickr.com)