A clinical hold is an order issued by a regulatory body to suspend or restrict a clinical study related to a particular drug product. The regulatory body may force a clinical hold due to many reason, such as issues with the study, product, or researcher.
A clinical hold is implemented for an Investigational New Drug - IND. It is a drug stage under clinical trials to investigate its efficacy & safety, and has not been officially allowed to market & used by patients.
In the event of a clinical hold, the party may respond to the clinical hold, which is evaluated by the regulatory body. Depending upon the response, the body may decide to lift the hold or not.
Clinical hold plays a critical role in drug development by allowing the investigator more time to remediate the issues found at that stage. It also helps to reduce the underlying risks by preventing the participants from harmful impacts of investigative drugs until rectified and reduced.
The agency may use the telephone or other rapid mode of communication to convey the order of hold. The order will include studies under hold and the reason for such a decision.
Types of Clinical Hold
There are two types of clinical gold - Complete and Partial.
In complete clinical hold, the agency holds the entire clinical activity, and no part is allowed to be proceed in any of it's stage. It is when an agency finds discrepancies in the whole clinical studies not fit and dangerous for human health.
In partial clinical hold, the agency holds part of the entire clinical study. The other parts of the clinical research are allowed to continue.
Reasons for Clinical Hold
Let's discuss some common reasons behind pharmaceutical clinical hold
Safety risks to human participants
One basic reason for clinical hold is risk to the human participants involved in the clinical studies. If the drug product poses significant dangers to human health or life, a regulatory agency imposes a clinical hold. Because, researchers are ethically bound to protect the health of human participants and is considered a failure of the Institutional Review Board - IRB.
For example, in a certain study, if more than a specific number of participants face fatal bleeding, the agency can clinically hold the research until proper mechanisms and appropriate corrective measures are performed and then approved.
Incompetence of the clinical investigator
The clinical investigator is a person under the guidance of which clinical studies are performed. It is their responsibility to execute the activity according to the agreed specifications.
If there is any deviation in the study at any stage, the clinical investigator is held responsible. Additionally, non - compliance and misconduct by any participant is also considered incompetency of the clinical investigator
If a regulatory agency finds such deviation related to an investigator, it can impose a clinical hold.
In addition to the reasons mentioned above, other are also possible, that can include but limited to the following.
● Failure to report adverse events
● Protocol violations, such as enrolling participants that do not meet the acceptance criteria
● Failure to carry out safety evaluations for the participants
● Failure to obtain adequate informed consent
● Deliberate manipulation or alteration during a research study indicating the safety of the drug under trial
● Failure to obtain IRB approval when a change in protocol is required.
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