SPECIAL EDITION: OUTSOURCING
Clinical trial success: Patient compliance
Speaking with NutraIngredients, Dr Jay Udani, CEO of Medicus Research, a California-based clinical research organisation (CRO) with expertise in natural products, explained that when it comes to compliance, the first and most important thing is having a good relationship with the patient.
“There are so many different methods and technologies for compliance assessment, and re-enforcement, but primarily it has to start with making sure that patients are interested in the study, and really want to be compliant,” said Udani.
He added that making sure patients understands why compliance is important, and what benefits they will achieve from being compliant is “the best thing anyone can do.”
“In the clinic, the doctors, and clinical researchers need to have a good relationship to explain things, and make the patient want to come back. If you’re an unfriendly person, then why should they come back? After all, it’s a voluntary study, they don’t have to,” said Udani.
Compliance phone calls between visits can help too, explained Udani.
“If a person feels uncomfortable calling up to ask a question, we can call them, and ask ‘is everything going o.k’, ‘are you having any problems or concerns’? … That interaction with another friendly person on the phone is something that is greatly appreciated, and helps to keep compliance up pretty well,” he explained.
According to Udani, another major influence on compliance is the perceived efficacy of the product.
“If somebody perceives they are getting benefit then they are much more likely to be compliant,” he said.
Udani explained that many patients have very high expectations for the expected outcomes of a trial– especially in areas such as weight loss or joint pain.
“If patients don’t see a change quickly then they can become discouraged – whether they are on the control or active treatment … So we have to spend a lot of time setting lower expectations up front,” he said.
“For example we might have to explain that with a weight loss trial, body fat percentage may begin to come down, but it could be some time before you actually see a reduction in scale weight.”
He said that, even for dietary supplements, consumer expectations have been set so high by the market place, that if you don’t loose ten pounds in a weekend, then some people begin to believe that something is wrong.
But by setting the right expectations you can make things easier for the patient to be compliant, he said.
Udani said that in addition to the importance of a good relationship, and setting achievable targets, there are several technology platforms that can assess patient compliance on a daily basis.
“The idea is that you want to catch non-compliance, sooner rather than later,” said Udani. “Somebody might go 30 days with a problem, and it isn’t addressed until their monthly check up, all of that data then becomes useless. On the other hand, if the coordinator gets an email saying somebody didn’t take their treatment properly, then you can get on the phone straight away and try to remedy that situation.”
One example of such a technology is a medicine bottle which has a cap that logs a time and date stamp every time it is opened. Other technologies include daily pill boxes which unlock and open at a set time each day, and interactive techniques that require patients to take a time stamped picture and upload it to the trial database using an internet enabled device.
Other technologies include mobile health (mHealth) technologies, such as electronic data trackers that records activity and sleep levels over a 24 hour cycle.
“These can be worn for weeks at a time, so for example we can control for individual energy expenditure very accurately at the end of the study,” said Udani
“We recently did a juice smoothie study, in which patients had to take snapshots of them preparing the smoothie with their cell phone camera every day because that sort of study is a little bit harder than just taking a pill – you actually had to mix the smoothie yourself. So we needed to know time, date, and compliance,” said Udani.
He explained that the pictures were emailed directly to the researchers, where they were tracked to check for compliance.
“What was most fascinating though was how the compliance behavior developed,” he said.
“Initially the pictures were a very simple, ‘here’s my drink’. But as time moved on and it became routine people began to get more creative. We began to get pictures saying ‘here’s my drink at class’, ‘here’s my drink at work’, or ‘here’s my drink relaxing on the beach’ …The patients started to enjoy the compliance reporting itself, they found it fun, got and benefit from it.”