Applied Clinical Trials
Survey reveals mixed adoption of paperless data collection in clinical trials, pointing to the need for greater alignment of new eClinical technologies and study conduct.
In January 2014, the FDA presented a webinar “Promoting eSource Data Capture,” to explain its Final Guidance on Electronic Source Data in Clinical Investigations. In a slide, the FDA said the worst case for source data capture is “transcription of data from paper or electronic sources to the eCRF (electronic case report form).” The reason being that there was no intervening paper step needed, less confusion on what is source and the decreased likelihood of data errors.
In April of this year, we conducted a survey with SCORR Marketing to evaluate the paperless trial. In this survey, of 143 respondents, 25% said 0%-10% of their data collection in clinical trials was paperless. The next highest was 22%, who said that greater than 75% of their trials were paperless. And 15% said between 51% and 75% were paperless. So the majority fall in the middle of paperless processes, leaving room for greater adoption in the coming years.
In fact, the majority of respondents-27%-said that in the next three years, 75% to 99% of the processes for clinical trials would be paperless. With the plethora of new technologies surrounding data aggregation, mining, and analytics in all critical areas of study conduct, we can only see that our respondents are correct in their view.
For more information, download SCORR’s free report here.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
The State of the Opioid Epidemic
March 26th 2024In part 1 of this video interview, Greg Sturmer, co-founder and CEO of Elysium Therapeutics discusses the current state of opioid usage including how pain treatment is often mismanaged and how the industry can adopt greater safety standards in developing pain therapies.