Summary by EMR Industry:
- Dr Eriksson noted that a recent study by Parexel managed to knock 12 months off the estimated 24 month recruitment time.
- Researchers had the ability to use electronic medical records to accurately isolate a specific cohort of patients with a certain condition.
- Developing these trial protocols from real data is also helpful in gaining market access, explained Dr Eriksson.
- South Korea and Turkey who became the first two countries in the world to have a healthcare system with 100 per cent electronic medical records. The situation is also improving in the US.
ORIGINAL NEWS:
The contract research organisation’s (CRO) VP of clinical services Dr Lollo Eriksson said that use of patient data collected by healthcare systems can identify potential clinical trial participants more quickly and with better precision than traditional procedures.
Dr Eriksson, a former senior director at Merck & Co, noted that a recent study by Parexel managed to knock 12 months off the estimated 24 month recruitment time.
Such efficiency has the potential to cut down research costs tremendously, according to Dr Eriksson, with the price of getting a drug to market now well over the oft-quoted $1bn figure.
The use of electronic medical records – the medical history of a patient kept in a digital format – to support clinical trials has been encouraged by other prominent figures in healthcare, especially in the UK, which, in the NHS, has a healthcare system that covers the entire country.
England’s chief medical officer Dame Sally Davies said last year that NHS data was key to boosting the UK’s ability to attract clinical trials to the county; a view later echoed by Scotland’s chief scientist Dr Andrew Morris at a Diabetes UK conference in March 2013.
Dr Eriksson expanded on just how use of this data can help, saying that researchers had the ability to use electronic medical records to accurately isolate a specific cohort of patients with a certain condition, and then run this cohort against patient profiles – such as demographic, age, gender, etc – to have representativeness in clinical trials.
“We then write a protocol using as much information as we can, that is as close to reality as possible,” he said. “If we get a protocol that has used real data from patients, we will reduce the ‘screen-fail’ ratio.”
This is a crucial development, said Dr Eriksson, considering that between 50 and 65 per cent of potential clinical trial participants fail at the screening stage because they are found not to meet one of the study’s crtieria.
Developing these trial protocols from real data is also helpful in gaining market access, explained Dr Eriksson.
“If you look at what regulators want,” he said “it is protocols that are as close as possible to the population in general, rather than studies of a small pool of patients.”
This protocol can then be used to run a report to find out where relevant patients are being treated and what patients are being treated by physicians registered as investigators, while electronic medical records can then be used to demonstrate suitable patients to investigators.
One of the greatest burdens in using electronic medical records is uptake and compatibility among healthcare systems, which varies between different countries.
This is changing, however, according to Dr Eriksson, who said that countries are now following the route of South Korea and Turkey who became the first two countries in the world to have a healthcare system with 100 per cent electronic medical records that are connected to each other and managed by a central office.
The situation is also improving in the US, where uptake has increased since President Barack Obama introduced an order that all healthcare providers need an electronic medical record system by 2014.
“By 2020, I imagine the whole world will be using electronic medical records,” said Dr Eriksson.
Healthcare systems are also becoming more proactive in developing partnerships in clinical development, according to Dr Eriksson, who heads up a department at Parexel that is focused on building alliances between the CRO, industry and healthcare providers.
“There is a lot of partnership building between CRO and the industry” he said. “But it’s not enough to be in partnership with the industry. We need to have partnership with healthcare and investigator networks.”
