Although clinical trials are promising, they are expensive and time-consuming. Most clinical trials often fail because they do not satisfy one aspect needed for FDA approval.
There Are Several Phases Involved in Clinical Trials; These Are:
- Phase I: Prospective, single-site clinical trial.
- Phase II: Prospective, multi-center clinical trial.
- Phase III: Prospective, multi-center clinical trial.
- Phase IV: Retrospective follow-up after the end of the clinical trial.
- Phase V: Post-marketing surveillance.
Features That Set Aside Decentralized Clinical Trials from the Rest
There is no one “clinical site” in a decentralized clinical trial”; instead, multiple sites exist. A decentralized clinical trial is designed to collect data from each site and combine them into one dataset. This means that patients can travel from one site to another for treatment or follow-up visits. But it does not include the cost of transportation in the dataset. If a patient needs to travel for follow-up visits between different sites, it is counted as an extra visit because both sites will have already collected data from that patient.
According to Medable, “A combination of DCT platform and training programs enable you to plan and execute decentralized clinical trials while upskilling your workforce.”
Merits And Demerits of A Decentralized Clinical Trial:
There are some advantages and disadvantages of using decentralized trials over standard trials with centralized study centers. One advantage is that patients can receive care closer to home, which reduces transportation costs. It also allows more flexibility with treatment schedules. Another advantage is that all data gets recorded simultaneously at multiple sites instead of having only one centralized database. Data collected from one centralized site would not accurately reflect. How everyone in a study responded to treatment at different locations due to different weather conditions or other factors?
However, there are some concerns with the use of decentralized trials. One concern is that patients may not be fully aware of the benefits of participating in a decentralized trial and will, therefore, not report adverse effects or side effects as they would if they were being treated in a standard clinical trial. Another concern is that patients will not be as motivated to participate in a study. If they do not understand the full importance of their participation compared to a standard clinical trial.
Another concern with decentralized trials is that sometimes it can be difficult to control who is receiving treatment and how much treatment they receive. It can be problematic because one patient who has been randomly assigned to treatment may need more or less treatment than another patient who was not randomly assigned. But was treated simultaneously for different reasons.
DCT technologies may get used to providing patients with access to new treatments that are not yet available for clinical use. DCTs could also be used to study the effects of different drugs or treatments on a large number of different people to determine. The most effective treatment for a particular disease or condition.
DCTs for decentralized clinical trials have been gaining popularity in recent years. The nuances of decentralized clinical trials lie in the notion of who is enrolled in the study and what treatment they receive.
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