Guidelines for emergency treatment of clinical research
The process of ensuring the safety of the subject first, then controlling the research risk, and then supplementing the compliance. The disposal rules of all subdivided scenarios revolve around this core, and no process priority can be higher than the life safety of the subject.
I have been in the clinical research operation post for 8 years, spent time in 12 experimental centers in different treatment fields, and handled 17 emergency incidents with different grades. The most common misunderstanding is that newcomers cling to the process of the plan and put "compliance" before "saving people". I have encountered this kind of thing in a tumor phase III experimental site before: the subject experienced anaphylactic shock 20 minutes after administration, and the first reaction of the newly hired CRA was to take out his mobile phone to take pictures of symptoms and leave evidence, which was directly pulled aside by PI: "Push adrenaline first, and wait until the other person is saved."
When it comes to the emergency scene, no one is waiting for you to turn over the process of the plan. My own habit is to always keep three 24-hour calls in my pocket: the green channel docking person of the central emergency department, the emergency contact person of the ethics Committee, and the medical specialist of the bidding party. It is much more useful to call these three numbers in advance than to open them in the office for half an hour.
The following is a list of emergency graded responses commonly used in the industry, which is also the version that our center has been trying to make in five or six years, taking into account the disposal viewpoints of different schools:
| Emergency classification | Typical scene | First response action | Existing disputes in the industry | Follow-up action |
|---|---|---|---|---|
| mild | The subjects suffered from needle fainting during the visit, mild nausea after oral administration, no other complications, temporary loss of source files and a small amount of test materials. | First, arrange the subjects to lie down and rest/replenish warm water, giving priority to calming their emotions. | Should minor adverse events be recorded in the original medical record? Conservatives believe that there is no need to increase the burden of reporting, as long as there is no abnormality in the follow-up; The strict school requires that all anomalies that deviate from the baseline should be marked to avoid subsequent traceability. | During the 30-minute observation period, it is confirmed that there is no abnormality in the subject, and then the follow-up process is promoted. The lost documents/materials will be traced back within 24 hours, and the whole process record will be reissued. |
| moderate | The subjects developed a grade 3 rash after taking the drug, had a non-research-related car accident during the visit and needed to take insurance, and the test drug had a four-hour temperature drift, and more than three cases were found to have violated the protocol by monitoring. | First, the subjects should be given corresponding symptomatic treatment, and the drugs/documents involved should be sealed as soon as possible. It is strictly forbidden to modify or adjust them without permission. | Do you want to recall the issued batches of test drugs that exceed the storage temperature threshold? Conservatives believe that as long as the temperature drift does not exceed twice the threshold and the duration does not exceed 6 hours, there is no need to recall it to avoid causing panic among the subjects; Radicals believe that as long as there is a temperature drift, it will be recalled in full, and even if millions of experimental drugs are lost, there will be no safety hazards. | Report to the agency office and the applicant within 24 hours, and issue a risk assessment report within 72 hours to determine whether to adjust the test process. |
| serious | The subject has anaphylactic shock/organ damage after taking the drug, the subject committed suicide after taking the test drug, the test drug was taken by an unrelated person by mistake, and the center encountered a temporary flight inspection by the fire department/drug administration and found a core violation. | Immediately start the green channel of the central emergency department, and contact PI to take command at the scene as soon as possible. | Do you want to take blood samples/urine samples simultaneously to test the drug concentration during the rescue? The "rescue priority school" believes that all manpower should be put into rescue, and it is not possible to interfere with the treatment because of leaving samples; The "data school" believes that it is impossible to determine the causal relationship between adverse events and experimental drugs after leaving samples, which may affect the marketing process of the whole trial. At present, the consensus in the industry is: as long as it does not interfere with the rescue, arrange a special person to keep the sample synchronously, but if there is any interference, save people first. | Report to the emergency channel of the Ethics Committee within 2 hours, submit a complete SAE/SUSAR report within 7 days, and simultaneously communicate with the subjects' families to appease them. There must be no public opinion. |
Of course, there are also wonderful situations that are not in the grading. Last year, our center did a phase II trial of diabetes, and one of the subjects took golden hair and bit the experimental medicine in his bag and ate half a box. Finally, we sent the dog to the pet hospital for gastric lavage and confirmed that it was ok before leaving. There was no standard answer to this special situation, so we should handle it flexibly, and the core is not to raise safety issues.
What many people tend to overlook is the finishing work after the emergency, not just saving people and reporting them. For example, after the occurrence of serious adverse events, should other participants be informed? After three or four years of arguing in this industry, there is no unified conclusion: some institutions require that all subjects be informed to protect their right to know, even if it will cause panic; Some institutions think that it is only necessary to update the informed consent form, and the subjects who have been enrolled in the group will inform them. It is not necessary to specifically say that it is necessary to prevent people from taking the initiative to stop taking drugs and affecting the test data. What our center is doing now is to make a risk assessment. If the adverse events are clearly related to drugs, we will call them one by one. If only the subjects are allergic, we will only update the informed consent form, which is a compromise between both sides.
To put it bluntly, I have seen too many sponsors and CRO attach more importance to the test data and listing progress than the subjects. When something really goes wrong, the first reaction is to hide it, but in the end, it is out of control. In fact, the background color of all emergency rules is "people first". As long as you think about "will this do harm to the subjects" before making a decision, the rest of the procedures, compliance and data can be supplemented on this basis, and the order is reversed, and even the perfect emergency plan is useless.
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