Without naming any names, has anyone ever experienced an AE during a clinical trial, either as an investigator or patient?
I have never had one happen during an experiment, but I have had several patients report AEs that occurred during their normal lives, i.e. falling down stairs at home or unexpected seizures, while enrolled. These must also be reported as soon as learning about it, but it is a challenge to get accurate details from a patient reporting an event that happened a month ago. This is especially true for a patient who suffered a traumatic brain injury and now has poor memory. It is helpful in this case to have relatives with the patient or receive medical records from their primary care physician or hospital to back up details.
While I have never participated in a clinical trial as an investigator or patient, one idea for being able to track AEs is by having the patient have a wearable device such as an Apple Watch to help monitor patients when they are outside of a clinical setting. Apple watches are able to provide information on fall detection and ECGs without any discomfort to the patient. This is one option for a patient with poor memory who may live on their own.
This is a good idea to consider for future studies, especially ones that incorporates physical activity. With the growing smart wearable market upon us this is becoming increasingly affordable over time. For a project that includes an ECG in their study protocol, a smart wearable gives us the ability to monitor the subject's heart rate at any time. However, for a study protocol where a smart wearable would be considered more of a luxury and not required as part of the protocol, the investigators should justify their reasoning for having their subjects consent to constant monitoring of private health information.
Although I have never experienced Adverse effect during clinical trials, I agree to the possibility of incorporating wearable technologies into the protocol for effective physiological monitoring. AE's are unanticipated and the wearable sensors provide supporting documentation which can be used during narrative summary of the adverse events. In addition to that underlying medical conditions, Family history and any other recent events that may be a contributing factor for an adverse event must be considered.
Yes, someone very close to me suffers adverse events (effects) as a result of medication that they take for TBI. Traumatic Brain Injury (TBI) alters the brains ability to effectively communicate at all times. There are a few treatments available but in my personal experience with someone close to me the most effective for them is medication alteration. With their particular TBI, they get "stuck" for a lack of a better term. They will start statements and just drift off or start a conversation and it turns into a frustration rant (rightly so sometimes). Their is a medication treatment that helps control their disconnecting for present society- concerta. However, the adverse events for them is on days that they do not take it they literally sleep all day unable to wake. It has been brought to the attention of the psychologist and they frequently change the medications dosage to try to find a happy medium. So a personal account for adverse events for me with be sleepiness as a result of not ingesting concerta.
While I think that wearable device tracking may capture some adverse events that would have otherwise gone unnoticed, I think the issue of patient privacy would be a barrier to the implementation of such a monitoring tool. An advantage that a clinical trial has, as opposed to a normal patient in hospital or medical practice setting, is that the researcher is in close contact with the participant and has scheduled checkpoints to determine the progress of effect of the treatment, drug, implant, etc. Participants are asked to be wary of adverse events, and understanding that they are in a clinical trial, are more likely to actually report if something is wrong or if some other unexpected medical problem occurred. An issue I see with this is that there may be some unconscious bias introduced as the researcher gives examples of AE to help participants understand what to report, leading to an inclination to report certain events and not others. Do you believe this could be an issue? How can it be combatted?
