With COVID-19 impacting the conduct of clinical trials, a lot of discussion has been around what changes have allowed trials to continue recruitment.
Each clinical trial is different and many oncology trials deal with specific patient populations—and these patients have few options outside of participating in a trial as they are dealing with a critical, life-threatening disease. The fear of contracting COVID-19 is a real concern but so is fighting a deadly cancer with no options and no time to waste. Contract research organizations (CROs) that work in oncology are certainly uncovering solutions to continue to make these important trials available to patients.
Protocol Amendments and Schedule Changes
Organizations across the globe have used the current situation to inspire a more innovative approach to how they do things, and CROs are no different when it comes to how clinical trials are operationalized. This crisis has no question exposed processes and policies that needed review. Many of the new clinical trial procedures that were implemented were to increase the safety for patients, such as limiting less essential in-person visits, and these have proven effective and may very well remain an option for future studies. Reevaluating the schedule of events in protocols is a prime example of focusing on what is most critical for study conduct and quality and what is less critical to a trial. Allowing local clinical laboratory sample draws and at-home dosing facilitated by new telehealth related technologies will also continue to be incorporated into clinical trials long after the threat of COVID-19 has passed.
Some restrictions on clinical trial processes will likely loosen before COVID-19 is behind us, but throughout the last few weeks and months, many CROs have carefully evaluated what is necessary to obtain study data from a trial, while protecting patient safety. These changes have compelled sponsors and CROs to more critically assess the types of data collected as well as what is crucial and what is not to successfully complete a trial. This ensures that clinical trials conducted in this new environment won’t compromise the integrity of the trial or the evaluation of the effectiveness of new treatments.
Technology and its Role in Trials Now and in the Future
The pandemic has accelerated the evaluation of emerging technologies and telehealth solutions to enhance the patient experience on clinical trials while ensuring the integrity of the data being collected. These new hybrid trials that incorporate new study practices with the pre-pandemic study procedures are likely to become the norm. Telemedicine has emerged as a means to connect with patients; however, it remains lacking for many oncologists when trying to assess the overall health of their patient, or when a physical exam is really required to make definitive diagnoses. While more convenient for patients, especially those who are required to travel greater distances to undergo treatment, many oncologists are concerned that their ability to effectively manage their patients and identify subtle clues may be lost in the remote setting.
Remote monitoring is another activity which has become a necessity. While this is not a new practice in clinical trial conduct, it was less widely used in earlier phase trials that require a higher percentage of source data verification. Early phase trials will still require on-site review of data but newer technologies being adopted at the site level will make a combination of on-site and remote monitoring a core component of future trials.
In addition to this, technology and compliance have gone hand in hand since the pandemic began, showing increased accuracy in some scenarios. The use of wearables versus a standard visit to evaluate vitals has proven to be extremely helpful in tracking how a patient is doing. These are allowing healthcare providers to remotely and accurately capture data that they otherwise would have had to sit with a patient to collect. For example, if a patient shows a decreased number of daily steps or change in heart rate, the doctor has the data needed to more routinely assess the status of the patient.
Automatic and interactive medication dispensing devices for oral medications have been shown to significantly increase oral compliance, and some of the more sophisticated technologies can also push information from the patient to the medical team to solicit valuable information from the patient in real time. With technology integration this data can now be used by the sponsor to make more well-informed decisions about the development path for their drug. This kind of technology has been adopted at an accelerated rate due to the current situation and is expected to continue into the foreseeable future.
Predicted Timing of Changes
The COVID-19 pandemic has accelerated technology innovation and implementation to improve the quality and integrity of clinical trial data and enhanced patient safety and compliance to study parameters. The pandemic could also lead to lasting changes in how drug developers gather evidence to support regulatory submissions to the FDA. Important changes to how regulatory authorities evaluate patient-reported data as well as aggregated real-world data could accelerate timelines for the approval of promising medicines.
In the near term, it is likely hybrid trials that leverage emerging technologies combined with existing trial standards will be adopted with a focus on following regulatory authority leadership on accelerated mechanisms to define patient benefit from new oncology medicines. We will undoubtedly see technology solutions emerge that are not evident to the industry today and will see the reliance on these emerging technologies continue to rise.
It’s imperative that any CRO focuses on patient safety while leveraging the best available technology and science to accelerate the clinical benefit for patients participating in clinical trials.