Increasingly clinical trials are coming under the regulatory lense because of lack of necessary accounting of the patient and drug effects information. The following article takes a look at the new trends in electronic data capture that help track the data better.
The adoption of electronic medical records (EMRs) in both hospitals and private practice is on a steady incline. Alongside the growth in EMR, Electronic Data Capture (EDC) systems are today used in an estimated 30-35% of clinical trials, again in both hospitals and private practices. The use of electronic data capture technologies provides the opportunity to significantly enhance clinical trial conduct through improved efficiency and accuracy, as well as the potential for real-time response to possible adverse situations. The data captured in clinical trial systems may be based upon a prior electronic source (eSource), such as EMR.
Unfortunately, many of the EMR systems that manage the electronic source today cannot be used reliably for clinical research purposes because of the variability among these systems and the fact that they are not required to meet regulatory requirements for clinical trials. Therefore the data that are in the EMR system have to be printed or hand-transcribed and re-entered into the EDC system. The duplication of tasks, generation of paper and associated costs and inefficiencies, will only grow with the increasing use of electronic data sources. With the transformation in healthcare data collection migrating from a paper world to an EDC one, the scenario begs the question, “How can EDC integrate with these systems at sites and avoid redundant data collection?”
The eClinical Forum (www.eclinicalforum.com) and PhRMA EDC/eSource taskforce is very active in formulating standards around integrating aspects of clinical trial data with healthcare data. This article has reference to many of the survey work and visionary publications of these groups.
EDC is a technique for collecting clinical trial data in such a way that they are delivered to the sponsor in electronic form instead of paper. This includes the following scenarios:
- Information that is first recorded on paper by the investigator's staff or the patient, is subsequently entered into a computer at the investigator's site, and is delivered electronically to the sponsor or sponsor's representative such as a Clinical Research Organisation (CRO), without a hand-written case report form. The computerised system into which the site enters the clinical trial data is generally provided and maintained by the sponsor or a third-party vendor.
- Clinical laboratory data that are transmitted to the sponsor electronically and batch-loaded into the sponsor's database (includes other electronic data such as device data).
- Patient data that are directly captured by instrumentation.
- Electronic patient reported outcome (ePRO) i.e., information that is entered by the patient directly into an electronic device, such as personal digital assistant (PDA), or directly into a web-based system.
- Information that is entered by the investigator's staff directly into a computer, without first writing the data on paper (i.e., electronic source (eSource) data) and which must then be backfilled to the patient's permanent record (paper or EMR) in order to satisfy regulatory obligations.
The use of electronic data capture (EDC) by the bio-pharmaceutical industry to conduct prospective clinical trials on new drug candidates is growing as bio-pharmaceutical companies face increasing pressure to bring new, innovative products to market faster and in a more cost-conscious manner than ever before. At the same time, increasing concern over product safety has resulted in the need for more and longer trials, causing costs and time-to-market to increase. The use of EDC is seen as a way to improve data quality and drive efficiency in the clinical research process.
The capture of patient data into electronic systems, initially used for patient care purposes, is an emerging concept and has great potential to be a source of data for clinical trials, enabling automated transfer. Today, the terms Electronic Health Record (EHR), Electronic Medical Record (EMR), Electronic Patient Record (EPR), Clinical Patient Record (CPR) and Lifetime Clinical Record (LCR) are all used by various individuals and organisations, at times to mean the same thing and at other times to mean different things.
In the remainder of this article, the term Electronic Health Record (EHR) will mean eSource data captured in a format that enables structured electronic transfer to clinical research systems. Using this definition, other eSource data, such as the electronic patient reported outcomes (ePRO) and central laboratory data are not considered parts of EHR data, as these data are not captured within the EHR initially, although they could be integrated with it subsequently.
The vision: EHR/EDC integrated system
The existing “transitional” or “emerging” environment of EHR and EDC systems both being used in an investigator's office may at times seem like a step backward. For various reasons, the records are entered and maintained in up to three or four different places. Healthcare practices often involve a process in which the provider hand-writes information on a patient chart, which is then later entered into the EHR system. This same information may be printed off the EHR system and transcribed for entry into the EDC system. At the end of the study, regulations require that the data in the EDC system remain with the investigator, necessitating printing or copying it to a CD for inclusion with the patient's medical information.
Collaboration between these two worlds may work as follows:
- Pharmaceutical company designs and deploys study at the site using a clinical data management/electronic data capture solution (possibly provided by the vendor). This solution would have an in-built module that employs standard interface definitions developed by a standards committee within bio-pharmaceutical community and healthcare industries. Using which, the clinical module can be recognised by any certified electronic health record (EHR) system being used by the investigator sites.
- The investigator staff will have access to each patient's entire history, regardless of where the care was given. This would include any third party diagnostic parameters (such as lab tests, x-ray results etc.). The staff will record all information pertinent to the patient visits. Additional information and screens (related to clinical trials) will be displayed to prompt the staff to collect the same and to assist with scheduling and patient visit reminders.
- The clinical trial patient data will physically reside in both the EHR system and the sponsor's analysis database. But only the EHR system's clinical data module will be considered the source, and it must stay in a validated state under the control of the investigator. Security features surround this module so that it is in compliance with all regulations pertaining to clinical data.
- At the end of the study, data from this module will be archived in a standard format (perhaps XML or PDF) such that it can be easily read by the investigator and/or an auditor in the future, using standard tools, if need be.
Why it's necessary to merge these worlds
EDC provides acknowledged benefits over paper Case Report Form (CRF) data capture. Since a significant portion of the clinical data (e.g., medical history, medical procedures, prescribed medications, vital signs) needed for the trial will already be available in an electronic form through the EHR, the introduction of the clinical research processes in EHR systems and processes will extend and accelerate the existing benefits of EDC into an increasing number of clinical trials and an increasing number of hospitals and healthcare clinics.
Clinical trials available to more physicians
Additionally, more physicians could become involved in clinical research barring one major hurdle to participation, which would be eliminated if, clinical data capture were to be straightforward and readily available for those facilities that have adopted EHR systems that include EHR/EDC technology.
Avoid duplicate tasks
Duplicate tasks increase cost of clinical research and thus increase costs for marketed medications. Significant benefits can be accrued through collaboration of both the healthcare and research worlds by effectively and efficiently sharing data. Without such collaboration, and as the use of EHRs grows, both the healthcare sector and bio-pharmaceutical companies will be obliged to spend valuable resources on duplicate tasks, increasing the overall cost of clinical research and its product.
Benefits to patients
All patients whose healthcare provider participates in a nationwide EHR system will reap benefits of that system facilitating clinical research. These benefits are:
- Potential to address underserved populations through clinical trial recruitment and participation.
- Greater possibility of being identified for a clinical trial because their physician will have better ability to search his/her patient population for inclusion criteria.
- New therapies get to market and reach patients faster due to more efficient clinical research process.
- Higher data quality leads to better safety.
Benefits to investigator staff