As the world adapts to an increasingly decentralized clinical research landscape, is your organization prepared for the new normal of clinical trials? This blog will outline the tools your organization needs in order to successfully bring your trial directly to the patient, wherever they may be.
eConsent
eConsent, otherwise known as electronic informed consent, is the most important piece of the clinical trial process as it empowers patients to make informed decisions through the use of interactive, multimedia components. eConsent platforms also enable improved quality and efficiency of clinical studies through insight to the participant experience, improved data quality, and a fully electronic system.
Oversight
Clinical trial oversight is critical as it ensures the protection of patients and the integrity of the collected data. With safety being a huge factor, it is extremely important to have a trained physician or Principal Investigator(PI) overseeing the procedures at the patients home. It is not possible to have oversight without unified data, sponsors will need to invest in tools that provide real time access to clinical and operational context.
Technology
Decentralized trials are leveraging technology such as virtual communication platforms (telemedicine), eCOA (electronic clinical outcome assessment), remote monitoring and electronic data capture (eSource).
Telemedicine allows in-home patients and clinicians to connect with one another using electronic communication tools such as smartphones, tablets, and computers. Telemedicine can be used to help with patient care, advice, reminders, education, intervention, monitoring, and remote admissions.
eCOA consists of applications and devices that are capable of capturing, tracking, analyzing, visualizing, and reporting multiple types of trial information and patient data remotely. eCOA is considered the most effective way to capture high-quality, reliable data than traditional, paper-based methods. Other benefits of eCOA are that it increases patient protocol compliance, prevents inconsistent or conflicting data, eliminates transcription errors, and meets global regulatory standards.
eSource (or electronic source data) is up and coming in the healthcare and clinical trial industry. It is a form of data collection, in which data is entered directly into the electronic record. This technology allows Home Care Providers to collect and enter data electronically, however if the visits are being done virtually, then the PI can enter the data into the EDC directly.
Home Care Providers & Visit Supply
It’s pretty obvious that home care providers will be needed when it comes to in-home trials, but what may not be as obvious is the home care visit supply that is needed for the providers. Home car visit supply can include things like nursing kits, mobile centrifuge, blood pressure monitor, PPE, lab kit needs, and more. You will need to decide what supplies will be needed in order to run a successful, safe, and compliant clinical trial.
DTP/DFP Shipping & Logistics
With new challenges comes new solutions, and (you guessed it!) new acronyms. DTP/DFP refers to Direct-to-Patient/Direct-from-Patient, which in the Decentralized Trial world refers to clinical supply chain logistics specific to the patient’s home. For safety and efficacy trials, transport of IMP direct-to-patient must be adopted for a decentralized trial to be successful, as will be transport of biological samples to labs. A specialty medical courier that is in good standing with regulatory standards will need to be utilized to make our trials truly decentralized.
This blog is meant to help your organization get started with decentralized trials. For more information about how Elligo can help you bring your trial directly to the patient while improving recruitment, compliance, and retention contact us today.