What does decentralized clinical trials mean?
We define a decentralized clinical trial as a trial centered around patient needs that improves the patient experience. It involves bringing an increasing proportion of a trial’s activities to the patients rather than using the traditional paradigm of bringing patients to a trial site.
What is NIH clinical trial?
NIH clinical trial definition: “A research study in which one or more human subjects are prospectively assigned to one or more interventions4 (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” ( October 23, 2014)
How do decentralized clinical trials work?
Decentralized clinical trials (DCTs) offer a more patient-centric approach, reflecting a transformational philosophy for the conduct of clinical trials in which fewer clinic visits are required and patient and caregiver burden is reduced.
What are the key elements of decentralized trials?
Four activities are essential to implementing DCTs effectively: incorporating the voice of the patient, integrating technologies, selecting an optimal delivery strategy and using the right data.
What are the 3 phases of clinical trials?
There are 3 main phases of clinical trials – phases 1 to 3. Phase 1 trials are the earliest phase trials and phase 3 are later phase trials. Some trials have an earlier stage called phase 0, and there are some phase 4 trials done after a drug has been licensed. Some trials are randomised.
What does the NIH do?
NIH is the steward of medical and behavioral research for the Nation. Its mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.
Why decentralized clinical trials are the way of the future?
Decentralized trials offer a patient-centric approach, addressing various patient needs that often go unmet in traditional designs. DCTs benefit sponsors by accelerating clinical development, enabling more representative patient access and developing a stronger evidence package than traditional trials.
When did decentralized clinical trials start?
On December 10, 2020, the Decentralized Trials and Research Alliance (DTRA) was launched, bringing together more than 50 international organizations, including the FDA and patient advocacy groups, to promote DCT methods.