The pandemic has led to the acceptance of hybrid clinical trials. Veristat combines online and offline experiences for patients to improve patient retention through a clinical trial. They provide site-based trial protocols, digital biomarkers, real-world evidence, and access to a broader patient population. Hybrid trials require intricate trial planning to ensure all the components of the trials work seamlessly. That’s why it’s important to know how to plan upfront and still balance the different technologies and options to help you meet your expenses while ensuring your clinical trial success.
Here are some factors you must consider when planning a hybrid clinical trial.
The cost of the trial
The cost is probably the most critical part of clinical trial planning. Hybrid trials require an additional cost due to the small set-up and the traditional site support. Remember that anything new and not adopted at scale is always expensive initially. As time goes by, we are confident that the tech used in the remote setup will be more mainstream, making it more affordable. However, the most important thing for a trial is its success. Retaining patients is better than having a low-cost trial that makes it hard to retain and recruit patients. Hybrid trials involve having both remote and traditional set-up. Planning such a clinical trial will require you to consider the cost, the experience of the CROs, and the patient’s standard of care.
Most regulatory bodies, including FDA and EMA, have never been against virtual trials; they are all for quality data and the safety of the patients. Therefore, it is essential to ensure that you follow all the general requirements. A valid clinical trial requires a specific patient population living in a specific set-up. This means you might have to take your virtual trial to another country. Some countries’ ethics committees and regulatory bodies might approve your hybrid trial, while others might not. You will therefore need to do extensive research to know if a country is likely to approve your trial.
Patient’s pathway and standard care
It is essential to distinguish between what science and regulations approve and what your patients want and need. While planning a clinical trial, listen to the needs of your patients and apply feedback when planning the patient’s pathway. Remember, if your patients are not satisfied with the standard of care, they might withdraw from the trial, leading to trial failure. Your goal is to have high patient retention to improve the trial’s success. Satisfied patients will increase the chances of success of your trial.
Speaking to an investigator who has previously been in a similar trial is crucial. They will help you save money and time since they have an overview of the data collection and the trial’s endpoints. Experienced investigators also know what to expect with the patient experience in a hybrid trial. You will also be able to avoid any friction in your start-up at the beginning of the trial. An experienced investigator is also familiar with the technology, so you will not need to waste time learning new technology before starting the trial.
Knowing how to plan and still maintain a balance between the different options and technologies is the secret to ensuring your trial succeeds while still meeting your expenses.