A new survey report from Tufts Centre for the Study of Drug Development has highlighted that life sciences companies plan to use a greater range of patient data in clinical trials for more accurate decision-making.
Survey
The second report from the 2017 eClinical Landscape Study, revealed that 97% of companies (that participated in the survey) will increase the use of at least one clinical data source to make faster, more accurate decisions during trials. However, the results of the survey also demonstrated that 98% currently experience challenges with their clinical data management systems.
“Clinical trial complexity is challenging scientific, operating and technology solution domains,” explained Ken Getz, research associate professor and director at the Tufts Center for the Study of Drug Development. “At the same time that clinical teams are managing traditional data from case report forms and local and central labs, they are being forced to step out of their comfort zone to manage, integrate and analyse data from more diverse and less compatible sources, including smart phone and wearable devices, real-world evidence, and social media.”
Currently, life sciences companies use an average of four data sources in clinical trials. According to the survey, this number is set to rise to six over the next three years, with 70% of companies planning to use a new data source they do not currently leverage.
Additionally, the range of clinical information companies use is set to expand. Almost all of the respondents (93%) expect to use einformed consent data with most also planning to use mHealth, smartphone data and eSource data.
Company size and type also made significant differences to the results of the survey with CROs reporting that they plan to use more data sources than sponsors. In a similar way, companies that currently have higher trial volumes stated they will use more sources of clinical data over the next three years compared with those with lower trial volumes.
According to the survey, 93% of respondents aim to use electronic patient reported outcomes (ePRO) and electronic clinical outcomes assessment (eCOA) as sources in three years. Additionally, 76% stated that they plan to use mHealth as a source.
The majority of data in EDC (78%) is eCRF, however, which only provides one dimension of data into a patient’s overall health. Moving forward, to collect and analyse a higher volume and variety of electronic data beyond just eCRF, there will be a greater need for EDC applications to better access and centralise clinical information.
“Clinical trials are more sophisticated and include a growing amount of patient data from many diverse sources. So, trials are increasingly complex endeavours,” said Scott Fisher, PhD, executive director of emerging therapies at Intrexon Corporation. “The overall volume of data we collect is rising dramatically as we take advantage of mHealth to accumulate billions of data points per patient. Having a modern EDC system to bring this data together will be key to making accurate, real-time decisions and accelerating our clinical trials.”
In response to the question about the biggest challenge with clinical data management systems at the moment, most respondents specified cycle time — including from protocol completion to first patient, first visit (FPFV) and time from last patient, last visit (LPLV) to database lock. Currently, the time from LPLV to database lock is about 36 days, which is longer than 15 years ago.
Cost was the second biggest challenge, followed by the number of clinical systems. The companies that cited ‘number of systems’ as the most prevalent challenge was found to increase as the trial volume increased. So, as companies have more trials to manage, the ability to unify applications and processes becomes more important to improve trial efficiency.
“Life sciences companies want to collect more data from more sources, but are experiencing challenges managing the data they have now,” summarised Richard Young, vice president of Veeva Vault EDC. “There is a significant opportunity for organisations to create a complete picture of their trials as new data points are generated or recorded so they can drive better decisions.”
This survey was sponsored by Veeva Systems and included more than 250 companies, including sponsors and CROs.