LOS ANGELES WIRE   |

March 28, 2024
Search
Close this search box.

Decentralized Clinical Trials Capabilities and Solutions

Meta: In this article, we explore the benefits of a decentralized clinical trial. It’s fascinating stuff; go check it out.

Decentral is Essential

With the introduction of COVID-19, an industry-wide push has been made to use a different approach to traditional studies due to the necessity to change how clinical trials are conducted. Adopting decentralized clinical trials (DCTs) has become necessary to meet social distancing standards while continuing to conduct critical research. Even though pandemic restrictions are being relaxed and more clinical sites permit participants to return for research, the multiple advantages of a decentralized strategy have made this study paradigm an appealing option for future clinical trials.

DCTs, as opposed to traditional clinical research, take a more patient-centered approach by lowering barriers to participation through the use of various technologies and methodologies to recruit and retain participants. The research design also saves participants time by avoiding travel to the trial site and disturbing their daily routines. In addition, DCTs have benefits that are not confined to study participants. Sponsors gain from decentralized trials with lower costs, less travel time, improved data accuracy, and real-time data monitoring.

It has been difficult for decentralized trials to gain traction – and it’s easy to see why. Healthcare is a highly regulated field, so experts are naturally risk-averse, and change at the highest levels can be incredibly difficult. The old site-centric clinical trial strategy must alter if the pharmaceutical industry is to continue moving forward with medication discovery. Regulators appear to favor decentralization, which is encouraging. Sponsors will understandably seek clear instructions from regulatory agencies before establishing new technology and processes, as they need to be confident in their ability to apply them.

Here now are some of the critical benefits of a decentralized clinical trial.

Patient Disruption

The primary purpose of decentralization is to make clinical trial participation as straightforward as possible, allowing participants to go about their daily lives with minimal disruption. Patients are persons, not simply numbers or data. Many potential study participants will be dealing with health issues while running businesses, working full-time jobs, and raising children. In this instance, compelling patients to attend site visits, which include hours of travel and compounded fees, is not only challenging but also impossible in some cases.

Time & Money

DCTs benefit both patients and sponsors. According to Pharmafile, 85 percent of studies failed to end on time in 2016, costing sponsors up to $8 million a day. Decentralization can help sponsors overcome these obstacles by accelerating recruiting, boosting compliance, and decreasing drop-out rates. Furthermore, gathering high-quality clinical and real-world data using DCTs can help to generate more substantial evidence packages and better reflect the value created for patients. Sponsors can also use digital endpoints to generate differentiated label claims via DCTs.

Patient Participation

Consumer use of digital health technology is increasing year after year. Fitness wearables and online activities, such as Peloton for workouts and Strava for tracking routines like running and bicycling, continue to rise rapidly. The COVID-19 epidemic has also boosted physicians’ comfort in using remote technologies. Clinical trialists believe there will be a threefold rise in remote patient participation following the epidemic.

Patient Reporting

One of the primary advantages of decentralization is the convenience of patient reporting, which improves clinical trial retention. Researchers collect more extensive data sets because patients may record daily updates on their smartphones or home PCs. For example, only one participant withdrew from a recent asthma and allergy trial involving 2,000 people after a year. They had 10% of the patients in the research trial fill out allergy symptoms every day for a year. This was made possible by choosing a decentralized architecture where patients could log information via smartphone rather than phoning a doctor or driving to a clinic.

The clinical-trials business has a once-in-a-lifetime opportunity to shift toward a more patient- and site-centric paradigm, making participation more accessible, comfortable, and sustainable for patients and physicians. Many sponsors are currently investigating ways to integrate a patchwork of quickly deployed treatments, such as consumer-grade videoconferencing and home nursing, into a holistic strategic approach to trial virtualization.

The COVID-19 pandemic has highlighted the significance of decentralization in making clinical trials more patient-centered. Our discussions with sponsors, investigators, and service providers have shown a preference for more decentralized trial designs. The transition will continue to reshape the business and benefit sponsors, physicians, and patients.

Share this article

Ambassador

This article features branded content from a third party. Opinions in this article do not reflect the opinions and beliefs of Los Angeles Wire.