Hybrid paper and electronic data capture (EDC) in clinical trials
In 1960, the time taken to bring a new drug to market was three years. At the start of the new millennium, the figure had risen to 12 years. Today, it takes between 15-20 years while the cost per new drug produced is estimated to have grown at an annual rate of 13.4% since the 1950’s (Source: University of Birmingham, writing in the BMJ Open Journal, 2013).
Clinical trials are the longest and most expensive component of the drug development process with a three phase trial involving hundreds to thousands of people and costing millions. Some of the cost is linked to data collection in clinical trials and it is widely acknowledged that clinical development remains largely a paper driven process.
With trial managers under pressure to effectively manage costs to ensure their budgets and timelines are controlled, this is one area where efficiencies can be created.
The nature of clinical trials means that we need highly accurate data to be captured from a large user-base in a timely manner. The TeleForm solution, provided by ePC, has allowed SEWTU to expand its productivity with these objectives in mindJohn Evans, Information Manager, South East Wales Trials Unit (SEWTU)
At ePC, we specialise in electronic and paper based solutions for automated capture from paper, fax and electronic trials, patient follow-up, CRF and survey forms.
We enable clinical trials organisations - including a number registered with the UK Clinical Research Collaboration (UKCRC) - to process high volumes of paper and online forms more effectively at a time when the number of participants taking part in clinical research in England is increasing with more than 618,000 people involved in 2014/15 (Source: NIHR Clinical Research Network / Department of Health).
eClinical reads handwritten forms via a scanner and/or fax server to extract data, record marked diagrams, spot mistakes and validates the data before automatically exporting the results into your existing databases.
ePC are making a valuable contribution to our aim of running clinical trials in an efficient and cost effective mannerDr. Ingrid Potyka, Senior Clinical Operations Manager, UCL
- Accelerate all phases of the drug discovery process
- Reduce costs of drug discovery and clinical trials
- Enforce a completely 21 CFR Part 11, Medicines Act (1968), GCP and GMP compliant process
- Reduce CAPA processing time by over 80%
- Minimise staff costs and time spent processing forms
- Eliminate mistakes, improve accuracy and reduce time spent retrieving paper copies
How it works
- Create your clinical trial forms with TeleForm Designer
- Capture clinical trial data capture from paper, fax, PDF or eMail
- Ensure accuracy of clinical trials data and highlight issues for clarification in TeleForm Verifier
- Export clinical trials data and integrate with your preferred database, or in-house application
- Archive and retrieve trials data securely and conveniently for total accountability
Oxford Pain, Activity and Lifestyle (OPAL) study
Surveying 4,000 adults across England, the OPAL study is a 5-year cohort study seeking to determine the causes and consequences of mobility and functional disability in later life, and the role that musculoskeletal problems (particularly low back pain) have in that process.
The University of Oxford is using eClinical to scan, verify and export paper case report forms directly into a database.
Faecal Immunochemical Test (FIT) study
The Faecal Immunochemical Test (FIT) is a study to see whether people with symptoms need to have a bowel test (colonoscopy) to look for signs of bowel cancer. Researchers hope that around 5,500 people from England will take part in the study.
York Teaching Hospital NHS Foundation Trust is using eClinical to collect data using electronic case report forms (eCRF).
BioImpedance To Maintain Renal Output (BISTRO) Trial
The BISTRO trial is a NIHR HTA funded pragmatic, multicentre randomised controlled trial (RCT) designed to test whether taking regular measurements with a bioimpedance device, which gives information about body composition, improves outcomes for people who have newly started haemodialysis treatment for kidney failure.
Keele University is using eClinical to scan, verify and export paper case report forms directly into a database.
MenAfriCar (the African Meningococcal Carriage Consortium) is a global research effort to study meningococcal meningitis carriage in households in Africa and document the impact of a new vaccine (PsA-TT) on reducing transmission of serogroup A meningococcal meningitis. It is believed to be the first multi-centre and multi-country longitudinal meningococcal carriage study.
MenAfriCar is using eClinical to scan, verify and export paper case report forms directly into a database.
Avon Longitudinal Study of Parents and Children (ALSPAC)
The Avon Longitudinal Study of Parents and Children (ALSPAC), also known as Children of the 90s, is a world-leading birth cohort study, charting the health of 14,500 families in the Bristol area.
The University of Bristol is using eClinical to scan, verify and export paper case report forms directly into a database.
An international randomised controlled trial to compare TARGeted Intraoperative radiotherapy (TARGIT) with conventional postoperative radiotherapy after breast-conserving surgery for women with early-stage breast cancer (the TARGIT-A trial).
The Surgical & Interventional Trials Unit (SITU) is using eClinical to manage patient feedback in clinical trials.
The Centre for Trials Research at Cardiff University conduct clinical trials across four main themes of behaviour change, cancer, children and young people, and infections.
The centre is currently using eClinical to scan, verify and export paper case report forms, questionnaires, and patient feedback forms directly into a database across various studies.
SentiMAG multi-centre Trial
The SentiMAG multicentre trial evaluates a new technique for Sentinel Lymph Node Biopsy (SLNB) against the standard technique.
King's College London is using eClinical to scan, verify and export paper case report forms directly into a database.
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