Conduct Study
The processes under the Conduct Study stop ensure the trial is conducted as planned, including patient recruitment, retention, data collection and oversight.
Description
Clinical study conduct is the process of implementing a clinical trial protocol to collect data on the safety and efficacy of a new intervention.
Clinical study conduct is a complex process that involves a number of steps, including:
- Screening and enrollment: Identifying and enrolling eligible participants.
- Randomization: Assigning participants to treatment or control groups.
- Intervention: Administering the intervention to participants.
- Data collection: Collecting data on the safety and efficacy of the intervention.
- Monitoring: Ensuring that the trial is conducted according to the protocol and that participants are safe.
DCT-specific Considerations/Inputs
Some of the specific clinical trial conduct considerations that are unique to DCTs include:
- Data collection: Data collection in DCTs is often conducted remotely, using eSource and direct data capture in a DCT technology platform. electronic data capture (EDC) systems or other technologies may also be used. .
- Patient engagement: Patients in DCTs are often more geographically dispersed than patients in traditional clinical trials. This is a key benefit of DCTs, and different communication tools may be used in the trial and to ensure patients understand what's expected in the trial and complete assessments to comply with study design.
- Monitoring: Monitoring of DCTs may differ from traditional clinical trials because patients may be treated at an alternative clinical research site. If data is collected in an eSource tool, it may be simpler to monitor for data completeness, and accuracy.
- Security: Security of patient data is a critical consideration in all clinical trials, but it is especially important in DCTs where data is collected and managed remotely. Patients and research sites need to understand who has access to which data ensure those compliance to those limitations.
By carefully planning for these specific clinical trial conduct considerations, sponsors and investigators can help to ensure that DCTs are conducted in a safe and ethical manner and that the results of the trials are credible.
Here are some additional considerations for conducting DCTs:
- Technology: DCTs rely on technology to collect and manage data, so it is important to ensure that the technology is reliable and secure.
- Training: All staff involved in the trial, including patients, investigators, and data managers, must be trained on how to use the technology and the trial protocol.
- Communication: It is important to communicate effectively with patients throughout the trial, including providing them with support and resources to help them participate, especially if technology needs or protocol assessments are new to them.
- Monitoring: Like all trials, DCTs must be monitored closely to ensure that the trial is conducted according to the protocol and that patients are safe.