When a project reaches clinical trials, I can imagine the morale of the project team being very high as they have created a working device that was proven to work and sent off for "testing". Sometimes, as Dr. Simon mentioned, even when a device is in clinical trials, change requests must be issued.
How would the project team approach a DCR during the clinical trial as opposed to during the design process? What sort of changes can you expect and have any of you ever dealt such changes? Finally, how would a project team cope with changes that are implemented well in the product's development?
Any Change or modification to the clinical protocol may be reported in a 5-day notice and they can be implemented if they do not affect:
a)validity of data or information resulting from the protocol
b)scientific soundness of the investigation plan
c)The rights,safety or welfare of the human subjects
And the changes that do not require any FDA approval are:
a)Change in study control
b)Change in method of estimation
c)Early termination of study
d)Reduction in sample size
e)Increasing the frequency at which data or information is gathered (subject follow up period)
f)Modifying the protocol to include additional patient observations and measurements
g)Modifying the inclusion/exclusion criteria to define target population
I would like add to above post. The sponsor is responsible for initially determining if the change meets the statutory criteria. This determination should be made by the person in the company responsible for such decisions, and should be based on the agency’s definition of credible information.
A change to the protocol to increase the sample size or expand the number of investigational sites continues to require submission and approval of an IDE supplement. FDA believes that expanding the study to increase either the number of subjects exposed to an investigational device or to increase the number of institutional sites participating in the trial affects the rights, safety, or welfare of the subjects and thus may not be implemented under the 5-day notice provision.
Other changes that don’t required FDA approval are following:
•Change in primary endpoint variable
•Change in indication
As previously mentioned, it is more difficult to implement a design change during clinical trials than compared to during the design process. When entering a clinical trial, it is important to note that the FDA outlines specific aspects of the design and its goal is to evaluate the most current design. By adding design changes, it would mean that there should be a new clinical trial depending on the weight of design change. A design change could imply that there would be a change in the protocol of the testing, the subjects to whom the tests will be performed, etc. Either way, if it is necessary, the change has to be made and the team and the project must adapt to the new situation. It is integral to have an adaptable team to do so. In my opinion, if the change is necessary for the project to make it a perfect then the team should be willing to accept these changes.
Hello,
As mentioned before, when a project reaches the clinical trial stage, any changes requested through a DCR (Document Change Request) process are typically subject to much more stringent scrutiny than during the design process. This is because any changes made during clinical trials have the potential to impact patient safety, the validity of the study data, and the ability to meet regulatory requirements. The project team would need to approach a DCR during the clinical trial with caution, carefully evaluating the potential impact of any changes on the safety and efficacy of the device, as well as the study timeline and data integrity. They would need to work closely with the regulatory authorities and ethics committees overseeing the study to ensure that any changes made are acceptable. The types of changes that could be requested during a clinical trial can vary depending on the nature of the device and the stage of the trial. For example, a change might be requested to improve the safety or efficacy of the device, to address unexpected issues that arise during the trial, or to address feedback from the trial investigators or participants. Dealing with changes during a clinical trial can be challenging, but it is essential to ensure that the device is safe, effective, and meets regulatory requirements.
As @sah67 mentioned the DCR (Document Change Request) process occurring during the clinical trials stage can have many negative effects on the outcome of the study or even affect the patients partaking in the study. Furthermore, this may cause issues with informed consent since the patients that have agreed to take part in the initial informed consent with the first treatment/procedure and have not agreed to the changes and the implications that they might bring. Due to these complications the changes requested have higher guidelines that the team must follow in order to gain approval. To ensure that these changes are implemented smoothly without any complications it is crucial for the team to maintain effective communication with all parties involved (stakeholders, clients, patients, doctors, CROs). Any document changes made need to be documented, reviewed, approved, and communicated to all relevant parties in an appropriate time manner. As long as all the groups engaged in this project are on the same page and all consequences have been thought out with a risk management plan it is possible to successfully implement a DCR protocol during the clinical trials.
