The Clinical Trial Process Continues Amid COVID-19
It’s no secret that the top health concern on most Americans’ minds today is COVID-19 – a unprecedented disrupter like we’ve never seen before. However, as the pandemic rages on, many are trying to move forward and keep things in motion and retaining as much sense of normalcy as possible during these challenging times.
There are plenty of essential businesses remaining operational in the face of the pandemic and many processes that simply can’t be halted – clinical trials being one of them. For many of the patients involved in cancer clinical trials, it is absolutely critical that the trial continue while avoiding disruptions that could delay the process, and CROs like TD2 are taking steps to ensure that happens.
With such a rapidly evolving situation, protocols are being updated across the country on varying levels depending on the site size and location of the trial. TD2 keeps the patient’s safety top of mind by enacting modifications that wouldn’t typically be made mid-stream during an oncology clinical trial. Since cancer patients are at higher risk for COVID-19 complications, these modifications are designed to help the patient avoid unnecessary exposure to the virus from visiting the clinic and allows them to stay home in a safer environment. The first step is the change in schedules. Some events, while important, aren’t critical for a successful trial, and it’s important to avoid any events that don’t have a direct impact on the study outcome in the current environment. These changes will inevitably result in protocol deviations, but the FDA has issued a guidance to assist with managing that process and guides a team to help navigate the regulatory environment. The desired result is reducing delays in clinical trial conduct. Sponsors should proactively review their protocol and issue administrative letters to sites indicating events that can be missed in the interest of patient safety.
Another way CROs have found success keeping clinical trials moving and patients indoors is by sending infusion nurses to the patients’ homes. This way, the IV treatment can still be administered and monitored by a licensed professional, while the patient remains in the comfort of their own home. For oral treatments, the patients can be administered a greater amount of medication, such as 30 days worth of dosing opposed to seven days, eliminating the need to go into the clinic for a resupply. Across many studies, plans are being made for telemedicine visits to assess Adverse Events (AEs), local bloodwork draws, patient reporting of symptoms as well as medication review by a study trained sub-investigator.
Remote Trial Monitoring
Per regulatory guidelines, continuous monitoring of the research trial is necessary to ensure patient safety and accuracy of results. Since many research sites have understandably closed their doors to clinical and medical monitors during this time of crisis, the staff at TD2 have implemented new and effective ways to continue monitoring patients’ safety. This includes scheduled weekly calls between the monitors, sponsors and site investigators, remote data monitoring through electronic access to a site’s Electronic Medical Records systems, documented weekly phone calls between the TD2 Clinical Research Associate and site staff and continuous data management. These steps are ensuring that the research protocol is being followed and patient data is readily available for review by medical and clinical staff to further ensure the highest level of patient safety.
Although TD2 is committed to keep study timelines on task and initiate new trials, the start-up of new trials can be a case-by-case and sometimes complicated process these days. Certain sites affiliated with larger health systems may become overwhelmed with patients who have contracted the virus, making it difficult to begin new studies not related to COVID-19 therapies. These sites may not have the ability to add potential complications on their already stretched healthcare system. On the flip side, many community-based sites still have the capacity and desire to start new studies, especially oncology studies since these patients suffer from life threatening diseases that often overshadow the risks presented by the pandemic. Bottom line – although it definitely is more challenging compared to typical circumstances, the possibility to begin new trials in particular disease areas, like oncology, is still a reality.
TD2 takes the responsibility of trial patients’ safety seriously and clinical success remains our goal. Daily operations and constant communication are a key factor in this becoming a reality. Adaptive and flexible in nature, we are positioned to respond to data and information rapidly. Being focused specifically in early clinical oncology trials requires adaptive infrastructure to be successful. This puts the TD2 organization in a unique situation in the clinical trial space where our team is equipped to react, execute and continue trials instead of pausing them. To learn more about clinical trial disruptions and how biotechs are managing them, read the full Biocentury report here.
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About Translational Drug Development (TD2)
TD2 is an oncology development organization that provides innovative services for oncology-focused companies. Using a dedicated team of professionals with broad experience and understanding in drug development, TD2 is uniquely positioned to support improved and accelerated development of medicines for life-threatening oncology diseases. TD2 applies rigorous and high-throughput translational preclinical development, combined with regulatory affairs expertise, to customize clinical trial design and execution. TD2’s suite of capabilities encourages the timely selection of patient populations who are most likely to benefit from a new agent, and the rapid identification of clinically significant endpoints. TD2 is committed to reducing the risks and uncertainty inherent in the drug development process and to the acceleration of patient access to promising treatments. For more information, visit TD2inc.com.