Patient compliance technologies - a great opportunity for CROs
clinical trials is set to drive the growing interest of drug
developers and in particular contract research organisations (CROs)
for new technologies that improve compliance, despite their current
high price, says new report.
According to new research published by Applied Data, clinical trials continue to represent a major resource factor, consuming significant amounts of time and money, and patient compliance is increasingly being seen as the main culprit.
"What we see is that clinical trials don't fail so much as they don't succeed," George Perros, managing director of Applied Data told OutSourcing-Pharma.com
"And what usually happens is they don't meet an endpoint which can result in regulators asking drug developers to conduct additional studies for example."
Indeed, thanks to significant improvements in clinical trials design in the last few years, drug developers have been able to gain increasing control over safety issues in trials, with the exception of a few rare examples - Pfizer recently had to withdraw its cholesterol drug torcetrapib from late stage clinical trials after results showed increased risk of death in patients - and the main challenges they still have to cope with are related to uncertainties in clinical trials outcomes due to patient compliance.
In a recent US survey, nearly two-thirds (64 per cent) of patients who were prescribed regular medication reported that they did not or forgot to take their medication, with 11 per cent saying that this has happened "often" or "very often".
Non-compliance is said to cost pharmaceutical companies $30bn (€24.9bn) each year in prescriptions and repeat prescriptions that are never filled, as well as imposing additional healthcare costs on government and society.
But monitoring patients' behaviour in clinical trials can be difficult and compliance remains a significant risk area.
"What the drug companies are now trying to do is to make sure they control everything they can so the outcome of the trial is positive," Georges Perros, managing director of Applied Data told OutSourcing-Pharma.com
"And human nature being what it is, patient compliance has been a very difficult area for them to control."
As a result, in the past few years, new technologies in the form of so-called smart packaging, wireless device, radio frequency identification (RFID) and electronic patient logs have gained interest as a means to achieve a higher level of compliance and patient cooperation with trial protocols, said the report.
There are many new devices emerging to try and control the issue of patient compliance, including electronic packaging to monitor when a patient has taken his medication, interactive voice response systems, and electronic blister packs.
"However, these technologies are not terribly widespread and the reason is the cost involved as they are very expensive right now, so they are only used in a small percentage of trials," said Perros.
Therefore, only a handful of big pharma companies can afford to consider investing in these new patient compliance technologies. AstraZeneca is one of them.
The drug giant recently entered a deal with drug delivery device service provider Bang & Olufsen Medicom to develop a new electronic monitor that can tell whether patients are correctly taking their medication or not.
The monitor will initially be used to measure patient compliance with drug delivery devices during clinical trials, with the aim of later expanding its use into products in the market.
Unsurprisingly, further details of the agreement and in particular financial ones are being kept confidential.
"There are a dozen main players at the moment in this sector and Medicom are the Mercedes of the industry but the issue is that their price entry point is very high," said Perros.
"But as with any new technology, as results from those early adopters are published and get to be known within the industry, more trials are going to be employing these technologies and that is going to drive competition and the prices are going to come down."
Perros added that there is handful of packaging companies who provide smart packaging to increase patient compliance and who are trying to put a foothold into the marketplace.
And for contract research organisations (CROs), who play a very large role in the clinical trials market, the opportunity is substantial.
"For CROs the challenge is to gain expertise on these evolving technologies and how to integrate them," he said.
"The CRO who is at the top of the patient compliance technology industry will get more contracts for clinical trials and therefore more business."
The question now for CROs is to assess whether adopting these new technologies is well worth the money and to evaluate their actual benefits on clinical trials outcome.
But according to Perros, it's just a question of time as he predicts that in the future, the use of these new technologies is going to be the standard way of doing things.
