Letters to the Editor
Readers respond to articles and columnists.
eClinical Wish List
The June 2004 article "Meeting the Challenges of Internet-based Clinical Trials" describes the current state of the art of Internet-based clinical trials. Just to ensure that the technologies do not rest on their laurels, the next generation of technology-e-source documents-will truly revolutionize clinical research.
E-source documents will eliminate batch processing of data and almost all manual transcription, the presence of which guarantees an inefficient and error-prone data capture and reporting process.
Here is my wish list for e-source document technology:
- Wireless tablet computer
- Standard eCRF functionality
- Handwriting and voice capture for progress notes
- Real-time optical character, voice recognition, and progress note transcription (in a low-wage country)
- Real-time access to the informed consent form, protocol, investigator's brochure, etc.
- Real-time chat with a medical monitor
- Automatic time reporting (how long do study activities really take?)
- Real-time integration with sponsor's database for sophisticated data validation and queries
While we're at it, it's time to rethink the source document. Using current source documents is like singing a song with the words on one page (the source document) and the notes on another (the protocol). With a combined "scripted source document," we can eliminate a lot of wasted time and errors by integrating step-by-step protocol instructions with data capture fields.
All the technology to implement scripted e-source documents exists today. What are we waiting for?
Norman GoldfarbPresident & CEO
First Clinical Research
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.
