The Pandemic Changed How Sites Conduct Oncology Trials Forever
Many cancer patients rely on clinical studies to receive oncologic care, but the routine conduct of trials has significantly changed because of the pandemic. This has forced Veristat study designers to develop a resilient oncology trial design. The study designers have had to re-imagine the entire trial, from the clinical development processes to bring life-changing therapies to the market.
As a result, they now base their new oncology clinical trial design on Covid-19 protocols while maintaining appropriate oncologic treatments for patients. For instance, in-person patient visits to clinical centers are declining quickly, while virtual care is becoming increasingly popular. That said, here’s a look at how the pandemic has rapidly changed the conventional ways of oncology trials.
Decentralized Clinical Trials (DCTs) are Now Common
Decentralized clinical trials are executed through mobile/local healthcare providers and telemedicine. Instead of patients visiting the trial site, investigators are taking the research to the participants. Such trials have increased in popularity since the pandemic hit the world. Despite the deadly disease, clinical sites around the world are implementing creative and flexible solutions. Their primary concern is maintaining a high level of care and safety for patients without violating their privacy. For instance, there were limited patient visits to the site during the pandemic. Instead of participants visiting the hospital for routine assessments, nurses (equipped with Covid-19 PPE) would go to the patients at their homes collecting blood samples and performing other medical procedures. The idea of nurses bringing the clinical trials to patients is attracting new interest among researchers post the pandemic.
Use of telemedicine in clinical trials
Another post-pandemic paradigm shift in oncology trials is the use of telemedicine. It is an offsite delivery of healthcare using electronic information and technology, like video conferencing, satellites, computers, cameras, the internet, and wireless communication. Some of these temporary changes during the pandemic are becoming permanent. They are positive changes that boost recruitment and patient retention in the trials. Other oncology trial changes that exploded during the pandemic include electronic signatures for patient acceptance forms, remote monitoring of clinical trial results, and shipping oral medications directly to patients. Clinical trial investigators are more likely to incorporate these changes into future studies since they inject efficiency into the trial.
Important Lesson for Clinical Trial Stakeholders From the Pandemic
The biggest lesson from the pandemic sheds light on the need for a solid contingency plan. You should be prepared with pre-existing resources like a set laboratory infrastructure, highly trained personnel, solid data management systems, institutional oversight, and patient safety monitoring. Clinical trial investigators and designers should have a future-proof master protocol that boosts resilience in a research ecosystem. They must picture the worst-case scenario when drafting a master trial protocol. As a result, you’ll not only be ready for any outbreak but also other future diseases that may arise with no existing medication. The pandemic has caused a paradigm shift in oncology clinical trials. This has seen changes in trials during the pandemic quickly replacing the traditional ways of conducting a clinical study.
The innovative methods of maintaining patients’ safety and sticking to Covid-19 regulations during clinical trials are becoming the new normal. As such, most of the changes during the pandemic are more efficient than conventional clinical trial methods.
