The global e-Clinical trial technology market is expected to reach $1.37 billion USD by 2018. Currently around 15% of newly initiated trials are using technology. Electronic Data Capture (EDC) is the fastest growing technology being adapted in the clinical trial environment despite concerns over efficiency. ARITHMOS discusses overcoming these concerns and why Sponsors should evaluate EDC options for their next study.
The United States and Western Europe have generally been the largest adopters of EDC technology. The U.S. eClinical trial technology market alone is growing 23% annually. The market is also shifting towards other geographical locations which can provide low cost, efficient solutions.
The main driver for adopting technology is the pressure on pharma, biotech and medical device companies to improve productivity, accelerate the drug development process and, of course, cut costs. There is an increasing number of clinical resources passing from preclinical to clinical trial phases, and study leaders need to be able to validate and analyze data in real-time in order to make crucial decisions.
Despite the numerous benefits – such as increased patient compliance, quicker data cleaning and real-time data – clinical trial leaders are still hesitant to adopt EDC technology. Many fear there is an added workload including double data entry, EDC edit check and technological implications. Clinical trial leaders believe that technical problems, such as complications with the actual system of lack of training and knowledge, can lead to time consuming activity.
The scope of EDC can also include the integration of an ePRO device. Another barrier to EDC/ePRO use has been the intuitiveness of devices used. While most people are comfortable using PCs, fax machines, scanners and email, many incorporating new devices such as smartphones and tablets can be challenging and require training and a different mindset.
Despite concerns, why should Sponsors still evaluate EDC solutions for future studies?
The availability of integrated data can enhance the overall drug development process through greater efficiency and effective decision-making. With adequate training and HelpDesk resources to provide continuous technical support, Sponsors should feel at ease implementing EDC technology. The main benefits include:
1. Immediate Feedback: Sponsors can resolve discrepancies faster and reduce time and costs with immediate feedback from patients. Data can be transferred in real time during the study into the eCRF. Query management is accelerated, and any inconsistencies in CRF or ePRO data can be checked in real time.
2. More Accessible Trial Information: An EDC solution can organize multi-language, global study data into a single database. Biostatisticians can receive up-to-date study metrics and statistical reports can be carried out in the short term with low risk of data blinding errors.
3. Higher Data Quality: Data is stored in an encrypted mode preventing data from being changed, deleted or modified. The data cleaning process is faster with Alert and Query Managers and edit and discrepancy checks are automated.
ARITHMOS also knows that one EDC system does not fit all studies. EDC selection can vary based on study phase, therapeutic area, patient enrollment and budget. Consult Arithmos for your next study to decide which EDC system or EDC/ePRO integration solution is best for your study.