As Featured in Clinical Leader, July 13 2017
Clinical research has a reputation for being notoriously slow to adopt new technologies. This should come as no surprise to those in the industry, since we operate in a highly regulated environment.
We’re generally skeptical about technology for three main reasons:
- Potential data security and compliance issues
- Ability to integrate various clinical systems
- Usability for our end users
But our view about technology is changing, and it is changing rapidly.
In this article, I will share insights on how sponsors and CROs can engage clinical sites with the latest technologies evolving clinical research. While I am not endorsing any of the specific technology companies or products mentioned, I would encourage you to use this information to learn more about available options and how the categories of products can help you improve your clinical trials… Read more at Clinical Leader as Authored by Kunal Sampat, Senior Manager, Clinical Research, Abbott Vascular.
Electronic Informed Consent Form (eICF)
The purpose of these forms is to inform patients of the risk and benefits of a particular trial and treatment. The consent also explains the type of patient personal health information that will be collected and how it will be utilized.
Today, the majority of trial patients still sign paper consent forms. eICF allows patients to consent on a tablet computer, thereby taking paper out of the equation. If you have questions about elCF, you can learn more by watching this HealthIT.gov video and reading this FDA Q&A document on e-consent technology.
There are many benefits of eICF to clinical sites. The most obvious benefit is it helps reduce (or even eliminate) the use of paper in the consent process. Potential trial patients are also more likely to have a better understanding of the trial through images, audio voice-overs, and videos. Finally, elCF allows sites to remotely consent patients and can reduce the likelihood of patients signing an incorrect version of the ICF. eICF enables sponsors and CROs to control the version of the ICF that is available for the site’s subjects to review and sign. This, in turn, reduces the human error of accidentally having the patient sign an outdated or incorrect version of the paper ICF.
There are several technology companies offering eICF solutions, including Secure Consent, Mytrus, CRF Health, and Parallel 6. Take the time to schedule demos with these companies to find out how their product can help your organization and research sites. As with any product or service, some companies are more mature than others. As a sponsor or a CRO, you want to pick a solution that will fit well in your trial workflow and budget.
Electronic Data Capture (EDC)
I did an outreach on LinkedIn to find out what new technologies sites were currently using in their trials. To my surprise, responders noted that EDC was one of their favorite tools. Even though EDC has been around for many years, sites continue to use and love this evolving technology.
EDC is an electronic method for sponsors and CROs to collect clinical trial data through electronic case report forms (eCRF). Until the early 2000s, many sites were still filling out paper case report forms (CRFs). This made it incredibly difficult to monitor and clean clinical trial data. As a result, EDC was born.
If you’re not already using EDC, here are a few reasons you want to consider it for your next clinical trial:
- EDC systems can be programmed with checks and balances (e.g., parameters) to ensure sites are entering the correct data. For example, if a site tries to enter “5,000 lbs.” as the patient’s weight, the system will flag the entry and prompt the site to fix it right away.
- EDC allows sponsors and CROs to clean data remotely and issue queries in the system. Sites can answer the queries at a time that’s convenient to them.
- Having an EDC system eliminates the risk of missing CRFs and managing a large volume of paper CRFs.
A search on Capterra reveals that there are at least 88 different EDC solutions on the market. A quick review will reveal many options for different size sponsors and CROs.
Clinical Payment Solutions
Processing patient grant payments, also known as site payments, has been an administrative chore for sponsors and CROs. It’s been equally difficult for sites to keep up with invoice generation and tracking. Many sites also wonder if they’ve been reimbursed correctly every time they receive a payment from the sponsor or CRO. Clinical payment solutions are quickly evolving to solve these issues.
A clinical payment solution automates and streamlines the process of managing site payments for research studies. According to a global survey conducted by Society of Clinical Research Sites, there are many benefits of clinical payments solutions. The primary one is timely electronic payments. With clinical payment solutions, sites can receive payment in as little as 30 days, and the money is sent directly to the site’s bank account via electronic transfer.
Additionally, a payment solution provides increased transparency for all site payments. With every check or wire transfer payment, the site expects backup information. For example, if a sponsor or CRO cuts a check for $10,000, the site needs to know whether this payment represents the 30-day follow-up visit for patient A or the 180-day follow-up visit for patient B. Clinical payment systems provide sites easy access to all payments at the study and patient level.
Finally, with automatic payments, no manual invoicing is involved. Payments are triggered automatically once the site completes the required fields in the case report form. The site no longer needs to generate manual invoices for most payments.
If you’re interested in a clinical payment solution, consider evaluating solutions offered by Greenphire, DrugDev, and Bioclinica (formerly Clinverse). Demos with these suppliers will give you an idea of whether such an automated payment solution is the right fit for your organization.
Regulatory And Document Management System (eBinder)
When it comes to clinical technologies, eBinder is my personal favorite. An eBinder makes it extremely easy for sites, sponsors, and CROs to share study- and site-level documents. If you’ve used Dropbox, iCloud, or Google Drive to save your personal photos or files, then you already know how an eBinder works.
An eBinder is a CFR Part 11-compliant, cloud-based platform that enables exchange of clinical trial information between sites, sponsors, and CROs. Using an eBinder, sponsors and CROs can share study files such as the protocol, ICF, and patient materials with sites on an ongoing basis.
Sites are also sharing documents such as institutional review board (IRB)/ethics committee (EC)-approved ICFs, and IRB/ EC approval letters, with sponsors and CROs. Rather than having printed binders at the site, eBinders make the entire regulatory document management process electronic.
eBinders provide many benefits to sites. Stephanie Cardenas, a clinical research nurse at South Texas Cardiovascular Consultants, nicely summarizes the benefit of this technology:
We have two cardiology research locations and found it difficult to manage regulatory documentation across each office. We were constantly scanning and emailing files back and forth. Now, we store all our documents and correspondence in one cloud-based location so we can access all docs from any location. And it’s really easy to use. Our monitors like it because they can get what they need and see the narrative of an entire trial from beginning to end without coming onsite.
Sharing documents via email is cumbersome and prone to errors. Additionally if the document size is large or there is an email firewall, attachments won’t go through. Most importantly, an eBinder solution can help streamline the management of regulatory and study-level documents at the site, making the site audit ready at any time.
Florence Healthcare and Complion are great starting points for sponsors and CROs looking for an eBinder solution.
Social Media And Apps
According to the Social Media Examiner 2017 Report, 92 percent of marketers stated social media is important to their business, and 62 percent chose Facebook as their most important social media platform.
Clinical researchers (sites, sponsors, and CROs) are in the business of recruiting patients for clinical trials. Social media allows clinical sites to directly advertise their trials to patients. Since social media campaigns are patient-facing, IRB/EC and sponsor/CRO approval is required prior to going live.
Lauren Gaudet of Coastal Clinical Research, Inc. (CCR) has been using social media since 2015. According to Lauren, CCR has completed 50+ campaigns to date. “We’ve maximized our enrollment with custom campaigns and most sponsors reimburse our site for social media advertising,” she says.
As far as apps are concerned, they can fulfill many functions such as e-consenting, randomization, study contact information, protocol criteria, and more. Sponsors/CROs have the choice of creating their own app or using an off-the-shelf technology from companies such as StudyPal.
Sites can utilize social media and apps to educate and engage potential patients and ultimately increase the number of patients in screening and enrollment.
Doug Surowitz, president & CEO of Health Awareness Inc., shares an example of the importance of social media: “”The use of social media platforms has allowed not only a segue to accessing potential participants, but really promoted greater awareness through the access to the population. We see about 5 to 10 times the number of responders now using these platforms than what we used to see through traditional media for the same cost”.
Apps allow sites to have the most up-to-date clinical trial information such as inclusion/exclusion criteria, study contact information, and patient follow-up visit calculators at their fingertips.
It goes without saying that any and all patient-facing materials require regulatory agency, sponsor/CRO, and IRB/EC approval. If sites don’t have internal resources for social media outreach, there are companies such as StudyKik and ClinEdge that can work with sites directly to develop and launch social media campaigns.
Considerations For Selecting And Implementing A New Technology
In summary, when it comes to technology, there are many options to choose from. Irrespective of which new technology you decide to implement in your next trial, always remember to choose a solution that will keep clinical trial data secure and compliant, integrate with existing systems, and be useful to the sites.
If you’re experimenting with a new technology, I also recommend collaborating with a small number of sites to set up a proof-of-concept. During the proof-of-concept, you’ll learn a lot about the opportunities and challenges that come with each technology.