Clinical Research and EDC in 2019 – What’s on the Horizon?

What will be this year’s major trends in the field of clinical research? Here’s Viedoc’s opinion of what will happen in the industry in the year to come.

The continued Rise of Patient Centricity and User Friendliness

Patient centricity has been a key factor in clinical trials for several years. A recent report from The Economist Intelligence Unit shows that patient-centric trials spend only of half the time to recruit participants, are able to recruit double the number of patients and the drug is 19 percent more likely to be launched.

“I’m not surprised by the results from The Economist’s report. There’s an old saying that the biggest trial of clinical trials is to recruit and retain patients. That’s still very much a truth and a key reason for why patient centricity will only continue to grow even more important in the coming years” says Henrik Blombergsson, co-founder and COO of Viedoc and continues:

“Patient centricity is not only about making the participation as easy, comfortable and undemanding as possible, but also that the study is designed with the patient in mind, and that it measures outcomes that are of value and use to the patients and society as a whole.”

The intensification of interoperability

Integrating various systems, wearables and other new sources of data is becoming increasingly important. At the start of last year, HL7 announced the release of a new version of the FHIR standard (Fast Healthcare Interoperability Resources), a framework whose purpose is to enable interoperability by simplifying the process of moving, sharing and collecting health data. FHIR is already in use in the US, making it a global standard would revolutionize the entire health care sector.

“A standard such as FHIR enables information transfer between different e-service platforms and business systems, for example between an EDC and an EHR. Ultimately, this allows clinical researchers to collect anonymized, relevant data straight from medical journals without having to transcribe it. This won’t replace the current way of collecting data from study-specific patients, but it’s a complement that will change how data is collected and shared”, says Sverre Bengtsson, co-founder of Viedoc.

Interoperability is also closely connected to patient centricity since one major effect is a transition of the data collection process from the clinic or hospital to the patients’ everyday life, but it’s also a way for researchers to collect relevant data every minute, or even every second.

“When we started working in the field, data collection was performed once every week or month. With the possibility to collect real time data continuously without any increased efforts from the patient, researchers can get a whole new understanding for the patient and for what is being measured”, says Sverre Bengtsson.

Accepting the cloud

2019 will be the year when the usage of cloud solutions is fully accepted by the clinical trial business, according to Jens Pettersson, Technical Fellow at Viedoc. The former scepticism about data information security when using cloud services is rapidly transforming into trusting that cloud vendors have far greater resources and skills in keeping data safe than local on-premise solutions. Compliance with local and regional regulations, like GDPR in the EU, and technical and contract solutions for regional data storage are also paving the way for cloud solutions. And of course the basic foundation of the cloud solution idea that centralized data operations will offer clients a more cost-efficient service with higher availability.

“The biggest challenge now is on the cloud vendors to establish trust and guarantee that foreign authorities and intelligence agencies, with respect to both data locality and data subject origin, cannot silently tap into and monitor data, but that local and regional regulation and legal processes must apply for such inquiries”, says Jens Pettersson.