In this article, I’m going to share with you 9 strategies for you to set-up virtual clinical trial operations.
But before we get started, let’s look at the main reasons why adoption of virtual trial operations has been slow for sites, sponsors and CROs.
- High software costs to implement virtual trials
- Resistance to change. Virtual trials requires doing things differently from the way they’ve always been done
- Frustrations with a steep learning curve that comes with new technology
- Privacy, security, and confidentiality concerns with software
- Regulatory authorities acceptance of virtual clinical trial operations
The recent pandemic has challenged sponsors, sites, and CRO stakeholders to re-think their clinical trial processes.
If we want to conduct clinical trials while following CDC guidelines for social distancing, we will need to change how we go about conducting clinical trials.
In many ways the pandemic has and will continue to accelerate the adoption of virtual tools and processes in clinical research.
Enter the world of Virtual Clinical Trial Operations.
Going virtual does not mean you need to purchase expensive software or capital equipment.
In fact, most CROs, sponsors, and site personnel will be able to go virtual with little financial investment, leveraging many of the tools that already exist, and updating processes to operate remotely.
Now let’s get to the 9 strategies that can help you design and conduct a virtual clinical trial operation with little or no money.
1. Collaborate on the development of trial documents using document sharing tools
If you currently conduct clinical trials, chances are that you have a shared document structure such a Google Suite Drive, Microsoft’s OneDrive, Dropbox, or a shared folder that can be accessed via sFTP (secure file transfer protocol).
If not, that’s okay.
Most people are used to saving files on their computer and sharing them via email for feedback or redlines.
Email is possibly the worst platform to share documents.
The main issue with email is that when you’re working with a cross-functional team, you need to wait for the other person to provide their feedback before you can make your edits.
Email leads to a sequential review process versus a parallel review process.
The best way to get around this problem is to implement a document sharing policy, training team members on how to utilize document sharing platforms, and reinforcing the importance of utilizing such a platform.
With the help of internet and document sharing technology, Sponsors, CROs, and sites can easily collaborate and finalize key clinical trial documents such as protocol and informed consent templates.
If you are part of a larger institution that has strict policies around file sharing, you can consider starting a pilot at the department level and then slowly extending out to external stakeholders once the team is more comfortable with using the system and it’s security settings.
Tools Your Need: Document sharing software such Google Suite which includes Google Docs and Google Sheets, Dropbox or FTP enabled shared server
Cost: $6+ per user per month
2. Utilize electronic consenting software (eConsent)
Electronic consenting, also known as eConsent, enables clinical trial sites to consent with patients from their homes.
Although use of eConsent will not automatically make every clinical trial “virtual”, many trials can benefit from eConsent technology.
There are eConsent solutions designed to meet the needs of clinical trials. However, out of the box solutions such as DocuSign may work just fine if you’re trying to find affordable options that are secure and safe.
Clinical researchers can make videos of their treatment protocol, get IRB approval of such patient-facing videos and share them with patients at the time of remote consenting.
A simple workflow could be where the research coordinator emails the patient the consent form for eSignature along with the link to the video explaining the consent and the treatment.
The patient is requested to watch the video, read the consent and then schedule a call with the clinician.
The physician or research coordinator gets on a call to answer any questions the patient may have, go over the risks and benefits of the trial, and then walk the patient through the steps for signing the consent.
Tools Your Need: eSignature solution such as DocuSign or HelloSign, video creation solution such as Telestream or Camtasia and video hosting platforms such as Vimeo.
Cost: $40+ per user per month for eSignature, one time license fee of $129+ for video creation software, $20+ per month for video hosting
3. Perform remote clinical data review
If you are a Sponsor or a CRO, now is a great time to plan and implement your remote clinical data review workflow.
The first step to establish remote clinical data review is for your clinical team to identify critical fields that need to be reviewed. This step usually requires a cross-functional partnership among the study manager, biostatistician, medical director, and data manager.
Once the critical fields are identified, you need to provide your team with access to study database and clinical data reports.
Chances are that you are already utilizing an electronic data capture (EDC) system. Using your EDC systems built-in reporting functionality, you can generate reports that capture the critical fields your data management team can review remotely.
For custom reports, you can hire a programmer to help you write a piece of code that will generate data cleaning reports that meet your needs.
Once your data review reports are built, train your team on how to use the reports and what to look for when performing remote review. Sponsors and CRO staff can then work with site personnel to resolve any data discrepancies.
Pro tip: Batch your requests to sites so they are not inundated with a continuous, never ending, stream of queries.
Tools Your Need: EDC system and clinical data reports
Cost: There is generally no additional cost to perform remote review. In most cases you will save time and money as team members do not need to travel to sites to perform data review.
4. Perform patient visits using video
For clinical trials with follow-up visits, the use of in-person and phone calls has been the norm.
However, the use of video follow-up visits is a relatively new phenomenon. The COVID-19 pandemic has accelerated the adoption of remote video communication technologies.
In fact the department of Health and Human Services (HSS) now lists some vendors that provide HIPAA-compliant video communication products and that they will enter into a HIPAA business associate agreements (BAA).
- Skype for Business / Microsoft Teams
- Updox
- VSee
- Zoom for Healthcare
- Doxy.me
- Google G Suite Hangouts Meet
- Cisco Webex Meetings / Webex Teams
- Amazon Chime
- GoToMeeting
- Spruce Health Care Messenger
In fact, the FDA guidelines in response to COVID-19 pandemic, support the use of video conferencing.
These days most patients have access to a smartphone or a computer with a camera. So consider including video visits in your clinical trial protocol.
Clinical trial investigators can then leverage video technology to follow-up with patients remotely.
Tools Your Need: Video conferencing software (options listed above)
Cost: $200+ per site per month
5. Perform risk-based monitoring
The FDA Guidance document Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring is an excellent resource to help guide you to develop a risk based monitoring approach for your clinical trial.
Even if you’re a huge proponent of on-site monitoring, complementing your on-site efforts to centralized, risk-based monitoring can lead to better data quality and ultimately better outcomes for clinical trials.
Centralized monitoring is also a key feature of virtual clinical trials, where monitors have the ability to review clinical data remotely and statisticians can look at data trends at an aggregated site and study level.
If there is missing data, protocol deviations, or any other data quality issues, sites can be re-trained using remote communication tools such as webinars, email newsletters or on-demand video training.
If you’re wondering if you need any risk based monitoring software to execute on this strategy, the answer is “no”, at least initially.
During the early stages of risk based monitoring, you’ll need to focus your efforts on determining which critical fields you can and need to monitor remotely and your process for reviewing this data on a periodic basis. Once you’ve established your processes, you can explore opportunities to fine tune your risk based monitoring efforts.
In my experience, the biggest challenge companies face when trying to implement risk based monitoring is trying to get internal buy-in on the critical fields and processes for the risk-based monitoring approach.
Tools Your Need: Microsoft Excel or equivalent tool, Electronic Data Capture is preferred
Cost: $0 in additional costs
6. Provide patients with at-home tests and wearable devices
Letting patients follow the protocol required steps at home is no doubt challenging and makes us doubt compliance.
For example, in a wearable device study patients were given a 510(k) cleared watch that they were supposed to continuously wear for a period of six months.
You can probably guess what happened next.
Some patients forgot to charge their devices.
Some patients removed the watch when they were sleeping.
While others simply stopped wearing them after a few weeks into the study.
Although these problems largely remain, there are ways to mitigate such risks with careful planning and ongoing communication with patients.
With increased awareness and use of wearable devices among consumers, patients are more willing and likely to comply with study protocol.
In addition to wearable technology, there are at home test kits that can help with blood analysis. For example, WellnessFX and Directlabs provide customized kits for metabolic, cardiovascular, kidney, blood health and more, which can be incorporated in a clinical trial setting.
Sponsors can take advantage of such at-home tests and wearable devices for routine follow-up visits to reduce the burden of having the patient come into the doctor’s office.
Tools Your Need: Wearable device and/or at home tests
Cost: Depends on your protocol design
7. Create on-demand video training material
Although the written word is not going out of fashion any time soon, video can complement written policies, procedures and training manuals.
Sites, CROs, and Sponsors can use video for study specific training as well as employee training.
To get started with creating a training video, it would be helpful to have a Standard Operating Procedure (SOP) or at least your process mapped out in a document or slide.
Next, using screen recording tools such as ScreenFlow or Loom, you can record your screen and explain the process along the way. With ScreenFlow, you’ll need a video hosting provider such as Vimeo. Loom on the other hand is completely cloud based and you don’t need any video hosting provider.
If you’re looking for an all-in-one video training solution, I recommend you check out Trianual, a software product that helps you create and manage SOP training for your company.
Tools Your Need: Video recording software, video hosting provider
Cost: $4+ per month per user
8. Implement electronic Investigator Site File (eISF)
When it comes to clinical trials and research, most people are extremely conservative when it comes to documentation and rightfully so.
FDA and other regulatory agencies have a slew of documentation requirements for clinical trial sites, sponsors and CRO.
eISF makes it easy and efficient for clinical trial stakeholders to share and collaborate study documents.
If you are a clinical trial site and feel like you have too much paperwork to manage, you may want to consider an electronic workflow to manage your studies.
If you’re curious about eISF, I found this great video from Florence Healthcare that explains how the technology works. You can also check-out my interview with the CEO of Florence Healthcare, Ryan Jones to learn more.
Another company that makes eISF technology solutions is Trial Interactive.
Tools Your Need: electronic regulatory technology software
Cost: Depends on the technology provider (and your negotiation skills)
9. Implement electronic source (eSource)
According to the FDA, electronic source data are data initially recorded in electronic format.
In a typical study, source data captured on paper.
Then the research coordinator manually transcribes the data from paper into an electronic case report form (eCRF) system.
As you can see, this manual transcription step leads to duplicate and unnecessary work.
The concept behind eSource is direct data entry into the eCRF or automatic transmission of data from devices or electronic medical records (EMR) into the eCRF.
If research coordinators are working from a remote location, eSource can be an extremely useful tool for the site. The added benefit of automatic transcription is that it is free of manual data entry errors.
From a Sponsor and CRO perspective, eSource makes it really easy to perform source data verification. In other words, the monitor does not need to travel to the site or spend less time at the site knowing that the data in the eCRF is the original source.
If you are planning to start a new study, I highly recommend considering eSource to bring down monitoring costs and truly going one step further with your virtual clinical trial strategy.
Tools Your Need: electronic source software
Cost: Depends on the technology provider (and your negotiation skills)
Conclusion:
Virtual clinical trials when compared to conventional clinical trials have many benefits from Sponsor, CRO, site and patient perspective.
Leveraging technology to accelerate research forward is not only the right thing to do, it is also a smart thing to do.
In summary, below are the 9 strategies to making your clinical trial operations virtual.
- Collaborate on the development of trial documents using document sharing tools
- Utilize electronic consenting software (eConsent)
- Perform remote clinical data review
- Perform patient visits using video
- Perform risk-based monitoring
- Provide patients with at-home tests and wearable devices
- Create on-demand video training material
- Implement electronic Investigator Site File (eISF)
- Implement electronic source (eSource)
What is your virtual clinical operations strategy?
Let me know in the comments section below.
