Clinical trials often require adjustments to the original protocols at some point during the course of the trial. Whether that need is based on new information learned from patients, A/B testing, or simply the inability to enroll enough patients, it’s almost guaranteed that at least one adjustment will need to be made. Trial modifications add challenges to the process, however.
Consider this example of a clinical trial for a new cold medication:
Initial requirements for participants specify that they need to be seen in-person at a clinical site within 48 hours of the first indication of a mild cold or sore throat. Once seen and included in the study, patients are required to return for additional visits on days 3, 7, and 28. Because the trial is intended to run only through cold and flu season, there is a short window for completion.
One month into the study, it becomes clear that most patients wait a few days after initial symptoms before visiting a clinic, and thereby are not meeting the 48-hour window. Additionally, the requirement for three follow-up visits within a 30-day period is causing many participants to fall out of adherence. Without adjustments to the protocol, the trial will not be completed within the timeframe planned.
Test developers decide to extend the response time for the first in-person visit from 48 hours to 72 hours and to enable two of the four visits to be conducted virtually. These two modifications will significantly increase acquisition and retention rates for the trial.
Making a protocol amendment, however, requires review and approval from the Institutional Review Board (IRB) and signing a new consent form from the patients. Once approved, test sites are sent an amendment and a revised consent form. The sites then need to train on the changes and inform the patients of the changes. The IRB determines which patients need to sign the new informed consent and whether it must be completed in person or if patients can complete it via mail or electronically.
Introducing virtual visits into this scenario simplifies the process in multiple ways
Using a virtual platform, patients have a direct route to connect with their principal investigator (PI) via chat, phone, or video to easily ask questions and share their experiences.
Patients may be able to review and sign the new informed consent during a video chat with their PI who can walk them through the process as they complete the form to reduce errors in signing and avoid delays. Additionally, enabling patients to complete day 3 and day 7 visits virtually, will significantly reduce the number of patients that would have otherwise dropped out of the trial.
Virtual trials are in use today and can make clinical trials more efficient for pharmaceutical companies, clinical staff, and patients alike. VirTrial is an innovative company in this space and represents ‘The Future of Virtual Clinical Trials.’ Contact us online or by phone at 480-462-2222 for a demonstration.