Silver Lining: Pandemic Science Drives Approaches to Decentralized Trials for Patients - MedCity News

During the onset of the Covid-19 pandemic, the volume of new clinical trials for cancer therapies has plummeted 60 percent from January to May 2020. This statistic only adds to that 6.3 percent cancer patients in the US before the pandemic were able to enroll in a clinical trial. Conversely, it is estimated that more than 70 percent of Americans would be willing or very willing to participate in clinical trials for cancer treatment if asked to do so.

Our understanding of cancer is constantly evolving, but we know that clinical trials are the most effective means of improving our knowledge and giving patients access to new treatment options. Specifically, two important aspects of clinical trials—diverse patient enrollment and trial site activation efficiency—are key to medical breakthroughs. But in oncology, the mechanics of enrolling and activating clinical trials have historically been complicated—and the process can be painfully slow. A new clinical trial for a cancer treatment often takes upwards of six months from the time a protocol is created to the time the trial is activated and the first patient is finally enrolled. And almost one in five cancer studies fail to enroll enough participants. All of this was before the arrival of Covid-19 and the additional set of obstacles posed by the global pandemic to patients and the healthcare industry.

Because necessity is the mother of invention, increased innovation focuses on leverage digital technologies, especially during the height of Covid-19, has accelerated progress toward more patient-centered clinical trials. Often referred to as “decentralized clinical trials,” these trials reduce the burden on the patient to enroll and participate in a clinical trial in person. This is facilitated by a wide range of tools that enable patients to receive care at home, including telemedicine, mobile phlebotomy, direct-to-patient delivery, electronic informed consent, remote on-site monitoring, integration with primary care and even an additional standardizing clinical trial operations to make it easier to set up local test sites. Digital communication with patients has many improved and in some cases becoming the norm, helping patients feel connected to their care team and expanding opportunities for real-time virtual and localized care. As decentralized approaches continue to gain popularity, more patients, particularly those in underserved and rural communities with traditionally lower participation rates in clinical trials, may have greater access to the treatment they need.

Since the beginning of the pandemic, researchers have been working to adopt these digital and mobile technologies that keep patients safe while ensuring the integrity of clinical trials. Look no further than the success of the highly effective Covid-19 vaccine trials, which happened in record time and showed us all what is possible when efficient trial design and decentralized approacheslike virtual visits, are prioritized.

Now is the time to build on that momentum.

Although decentralized trials have the potential to accelerate research and remove barriers for patients, we still have work to do in the consistent adoption of these technologies. Only then will we be able to open patient access while advancing study enrollment, accelerating therapeutic development timelines, and giving patients access to new treatments. Two low-hanging fruit decentralized clinical trial methodologies include automating data integration for patient trial selection and establishing standardized, electronic templates and procedures for clinical trials.

Take a tumor for example DNA sequencing, a key component in identifying patient eligibility for a clinical trial. DNA sequencing not only reveals molecular insights into a patient’s existing disease and treatment options, but when combined with clinical data, supports more efficient matching with trials. And with appropriate, standardized study operations and procedures—including informed consent forms and other necessary administrative procedures, much of which can be completed remotely with digital tools—we can create decentralized trial sites for an individual patient once they are identified. This process can help trials diversify their patient population, complete patient enrollment much faster, and dramatically minimize the 20+ week industry-wide average for trial activation – reducing activation times and patient consent to days, not weeks or months.

To improve patient care now, we can and must introduce decentralized rapid trial site activation. This is done now in the networks of trials just in time. We can rapidly computationally pre-screen patients for trial eligibility and then immediately initiate a trial at a participating site. This approach removes many of the barriers to access, allowing patients to receive treatment closer to home. It also reduces resource wastage; by leveraging technology and reversing the standard order of recruitment and activation of clinical trials, this approach ensures that trials that will not be able to enroll patients are not activated – a challenge that plagues 20 percent of cancer trials.

Here’s how we can advance decentralized clinical trials in a post-Covid world.

As a medical oncologist focused on rare diseases, patients like mine urgently need better access to clinical trials. An unexpected silver lining from Covid-19 has been the increased focus and adoption of technologies that enable decentralized clinical trials. It really opened the eyes of the medical community and showed us that we can move out of the technological stone age and embrace new digital tools that allow us to better care for our patients by meeting them where they are – literally and virtual.

Now, in a post-pandemic world, we cannot return to the traditional model of clinical research. All of us in the scientific community have an imperative to drive the progress of decentralized clinical trials further and faster to effectively match the right patients to the right trials. We can do this by relying on advanced genetic sequencing techniques to more accurately identify and enroll patients in appropriate trials, ultimately bringing data-driven precision medicine to patients earlier in their cancer journey . We can also continue to push for electronic clinical trial standards and procedures to further streamline the administrative elements that can impede progress. In addition, increased participation of experienced sites in ready-to-activate trial networks can expand opportunities for patients to receive cutting-edge research. Together, all of these factors will improve enrollment times while reducing healthcare costs.

We in the clinical and research community must not lose this momentum. We must continue to adopt and implement new tools that open the door to more decentralized clinical trials to ensure that all cancer patients have access to new, investigational treatments that have the potential to help them live longer and healthier.

Photo: exdez, Getty Images

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