While the clinical research industry was collectively dipping its toes into the decentralized and hybrid trial waters, the tide came in. As social distancing requirements due to COVID-19 created invisible barriers between patient and researcher and virus transmissibility threatened the health and retention of participants, an en masse move to hybrid and decentralized clinical trials (DCTs) became the only clear path forward.
This hastened adoption of different trial types led to many questions about how to respect the rights and guard the safety of participants from a distance. While there are relatively few concrete answers, there are several best practices you can follow to help ease the process for your clinical trial.
Collaboration Is Key
When it comes to working with your IRB, start the collaboration process early. This is sound advice regardless of the trial type, but it’s particularly true for DCTs and hybrid trials, where a lack of official guidance raises questions that rely on your specific research parameters for answers. When the processes and problems are ironed out on the front end, it inevitably saves time on the back end. While there will often be surprises that pop up during your trial, the earlier you address the issues you can account for, the more you increase participant protection and data integrity and avoid potential trial delays.
This means you must be thorough and organized from the start. Simply coming to your IRB with an initial plan or draft protocol can help accelerate the pace of your research. As you develop your materials, be sure to fully consider how you can ensure the safety of your participants and the reliability of the data. Some starting points include:
- How can you adequately assess a patient virtually?
- Can you detect side effects without visual identification?
- What can you do to help participants remain compliant given the level of self-reporting?
- What precautions are you taking to ensure privacy is maintained during participant communications?
- What specialized education or training is needed and who needs it?
- How are you making sure informed consent documents are securely sent and received?
- Are you providing participants with a contact phone number?
While the list of considerations feels endless, starting in on one line of questioning tends to lead you logically to the next. The process requires fastidiousness, logic, and empathy, but doing this preparation before you start your IRB collaboration ensures you’ve gone beyond the surface and uncovered the deeper questions that would have otherwise come up at a more inopportune time.
An Age of Interpretation
The DCT and hybrid trial landscape at present features a lot of best practice recommendations and not as many targeted requirements, so thinking through your research to responsibly address all of its elements in full is the best way to ensure participant safety and trial integrity. Once you’ve answered the tiered inquiries, make sure to include this information in your protocol.
Even though your IRB can’t predict when regulations and updated guidance will be released, they can ensure that existing regulations and guidance are interpreted correctly for your specific trial. Detail helps your IRB help you, so being as specific about every element of your trial as possible at the start can keep you from running into problems down the road.
Start Planning
Regulations for DCTs and hybrid trials are in the process of catching up, but clinical trials clearly can’t wait. To protect your participants and safeguard your research, you must evaluate every aspect of DCTs carefully. Following the path from question to question and answer to answer can help you build a robust protocol that sets the stage for a fruitful collaboration with your IRB. A strong start accelerates a strong finish.
Attentive, personalized service and a wide array of expertise guide Sterling IRB’s solutions. Contact us to partner on your DCT or hybrid trial.