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Patient Safety During A Clinical Trial – What You Need To Know

For a clinical research organization (CRO) like Veristat, patient safety is the top priority in a clinical trial. It involves ensuring patients are safe and well-cared for their well-being and the success and ethical conduct of the trial. However, recently, there have been massive adoptions of remote trials. Such trials are highly convenient and cost-effective. However, the trials face unique challenges that can undermine the patient’s safety. This post will look at some factors to consider in guaranteeing patient safety.

Remote monitoring

If you conduct at home clinical trials, you need to be aware of remote monitoring. Remote monitoring involves using specialized tools and technology to collect and record trial data. It is vital to ensure the safety of the patient during the trial. The technologies used include wearable devices such as monitors and sensors. These tools provide continuous, real-time data on the patient’s condition. The devices are then integrated with smartphone apps, allowing patients to record and report adverse events in real time. This information is shareable with other trial investigators; through this, it is easier to make informed and quick decisions. Remote monitoring is an entire concept on its own; it has various tools and options. As such, CROs can find the appropriate technology that meets their trial requirements. Whichever you choose to use, ensure your patients and personnel receive proper training on how to use it.

Informed consent

The second thing you should know is informed consent. Informed consent involves informing patients about the trial’s nature, risks, and benefits. This gives them a chance to decide whether or not they will participate. Informed consent is a crucial ethical concept that safeguards the rights and welfare of participants. The process usually follows several steps, including an explanation of the trial, disclosure of the risks and benefits, disclosure of any alternative treatment, the opportunity for the participants to ask questions, voluntary participation in the trial, and documentation of the consent. This process ensures that patients make the best decision regarding participating or withdrawing. In at-home trials, obtaining informed consent can be challenging. This makes it difficult to ensure patients understand the risks and benefits. To resolve this, CROs should ensure patients can access comprehensive information about the trial. This information should be clear and easy to understand. There should also be a platform for patients to ask questions and seek clarification.

Patient selection

Patient selection is a critical and time-consuming process. However, it is necessary to ensure patient safety and the study’s success. It involves finding and selecting patients who are viable for the trial. If a patient has any underlying medical conditions, has difficulty adhering to study protocols, or requires frequent monitoring, they may not be suitable for the trial. This is because such patients are susceptible to compromise, which can affect the credibility of the trial results. In the case of at-home clinical trials, CROs should evaluate the patient’s medical history, including medications that may compromise their safety. The patients should also be screened for any possible adverse reactions to the study medication. Lastly, CROs should ensure patients comply with study protocols and medication regimens and have access to remote monitoring technology.

Patient safety is vital for the success of any trial, more so for at-home clinical trials. As such, CROs should ensure they implement remote monitoring with the appropriate technology and tools. These will help ensure patients remain safe and healthy during the trial.

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