Shorten the Clinical Trial Process with Mobile-Based Decentralized Trials
By Nick Sargsyan, Clinical Trials Specialist, Net Health
When it comes to the competitive pharmaceutical products and devices marketplace for wound care, speed is everything. The quicker a new product gets to market, the quicker manufacturers can gain market share and brand loyalty, and the faster patients benefit from promising new products.
There’s a critical first step, however, in the clinical trial phases to prove the safety, efficacy, and viability of a product. Unfortunately, these trials may take months, or even years, to complete. Often they start, only to sputter and fizzle due to either poor or unreliable data when patients opt out of the trial. When this happens, valuable time – and research dollars – are lost.
Why Decentralized Trials Provide Faster Results
Today, growing decentralized trials are proving to be the solution to speed the results needed for wound care clinical trials. It’s easy to see why. Some of the benefits of decentralized trials include:
- Ensure faster recruitment of patients by making participation more accessible and less time-consuming (visits and check-ins can be done electronically, via a mobile device like a smartphone or tablet).
- Enable eligible participants to participate from virtually any location by removing geographic limitations.
- Provide faster access to data. Because recruitment is faster, and patients send images and reports electronically, data comes in more rapidly than traditional trials.
Achieving such benefits does require an experienced technology partner and one with the right tools and resources. For example, other organizations with similar services and tools require the use of special equipment such as complex cameras or specialty hardware for data acquisition. Look for partners that enable participants to use devices they already have and know how to use (e.g., an iOS or Android smartphone).
Importance of Mobile Capabilities
These devices should be enabled for every facet of the trial, including recruitment. The traditional recruitment process requires patients to read brochures and materials and fill out lots of forms. Digital trial platforms make the recruitment process simple for participant candidates.
They also streamline the reporting process once the trial starts. Mobile-based clinical trial platforms, especially those that capture 2D and 3D images of wounds, simplify the reporting process while ensuring only registered participants submit data.
Additionally, clinical trial platforms with mobile capabilities enable more communication and encourage engagement. If a participant has a question about a potential adverse reaction or some aspect of the reporting process, they can immediately reach the study team and get answers. Likewise, the study team can easily communicate with patients via in-application messaging.
Today’s highly secure mobile phones facilitate data security, especially those incorporating fingerprint or facial recognition.
How Decentralized Trials Work
While each trial is unique, exploring how a hypothetical Healthy Volunteer – or Safety Trial – for a wound care ointment provides a good overview.
- Software engineers use trial sponsor criteria, the protocol, and/or source document templates to create the trial environment within the mobile app
- Patient recruitment efforts are successful in 2 to 3 weeks and electronic consents are obtained
- Eligible participants receive the investigational product, instructions, and commence participation in the trial
- Participants submit images and report outcomes weekly as outlined by the protocol
- Prompts are sent to patients if their submissions are not received
- Clinicians answer questions or provide guidance if needed
- Data quality is monitored
- Trial is completed after 4 to 6 weeks (or depending on the protocol-specified duration)
- Experienced wound care clinicians assess, review, and provide a comprehensive report with the data to the client to submit to FDA
Working for Wide Range of Wound Care Trials
Think that’s it when it comes to exploring how decentralized trials can bring products to market faster? We’ve got a lot more insights on this topic. Visit our website or call us today for a free analysis.