Clinical trials are a critical part of the development of medicine and treatments. In the United States, there are just under 400,000 clinical trials in progress at the time of this writing. However the clinical trial market is becoming increasingly saturated, with a smaller participant pool to recruit from. This causes many to cancel clinical trials before they even start, which can lead to a loss of money and time invested. So, how can you keep your clinical trial on track to ensure efficiency throughout?
In order to develop an efficient clinical trial, or make your current clinical trial more effective, you will need to consider the important steps necessary to execute the trial. We're going to take it back to the basics and cover some basic steps that are important for any clinical trial and discuss the ways in which those steps can be executed with supporting technology.
Once your clinical trial is registered, you will want to begin thinking about recruit your participants. You've likely already determined the criteria set aside for your participants at this point, but how do you find them? Better yet, how do you effectively capture, organize and review applicant data to qualify them for your trial?
We recommend using technology to support your recruitment. In the past, trial coordinators have
Consider these potential avenues for spreading awareness about your clinical trial:
- Primary physicians - Primary care doctors are a trusted source of information for your potential participants. If you're able to communicate the value of your trial effectively with physicians, they in turn would be able to refer patients to your trial. Also, developing relationships with the physicians will make it easier to collect the patients' records later down the line (more on that later in this blog).
Once you have participants, you will need to capture and organize their information and medical history in a database that you will be able to reference later. This entails collecting the basic information from the patient directly and potentially sourcing their medical files from various providers. With anywhere from several hundred to several thousand participants, this task can feel extremely daunting and can be a source of errors in a clinical trial. The ability for participants to self-populate their basic information can help increase efficiency in preliminary qualification, but the process of gathering their past medical information can be more complex.
Depending on the type of trial, participants will likely have a wide range of past medical records from various different doctors. This can range from written reports, DICOM images and scans, to large files such as pathology. If it is necessary to your trial to include all of this information, you will need an efficient way to:
- Contact their past physicians
- Collect signed medical release forms
- Capture medical records without waiting weeks for the physical media to come in the mail
- Organize the information to ensure all of the appropriate files are tagged to the correct participant
If you do not have a solution that can do steps 1 and 2, you may consider requiring participants to collect their own medical records and upload them directly to your technology solution.
Once the records are uploaded and tagged to the appropriate patient case, your team will likely need to access and review these files. Rarely are all of the people who need to access records all in one geographic location. Implementing a technology solution that can make records available wherever and whenever they are needed is a crucial element of an efficient clinical trial.
This can become complex when you need to view large, complex files such as DICOM. If your clinical trial requires the review of these scans and images, it is important to have a web-based viewer such as Purview’s integrated viewer, or an open-source web viewer such as Horos. A web-based solution affords you the flexibility to gain access to these files from anywhere in the world as long as you have internet access.
You will also want to consider how you will anonymize the data to eliminate any bias. You do not want the reviewing physicians to be aware of whose file they are reporting on to avoid any conscious or unconscious bias from leaking into your study.
Another important element of an efficient and accurate clinical trial is the ability to maintain and review audit logs. Not only is it ideal, but it is also required for your clinical trial to be compliant. According to Treximo, “Audit trail review is then one strategy in a clinical research team’s toolkit to identify errors in data collection and reporting and ensure a high level of data integrity, all critical when discussing patient outcomes and healthcare research.”
Having access to audit trails is particularly useful to monitor system access, data changes, data collection, reporting, and device concerns. Ensure that you have a technology with traceability in those areas to remain compliant and reduce any errors in your data.