Oversight management is something that keeps reappearing the more I speak with professionals involved in clinical operations and outsourcing. It doesn't take a genius to figure out that when juggling multiple parties in the complex landscape of clinical trials there are numerous challenges to overcome. As regulations have become tighter, trials have become more complex and involved more parties. With that said, it can be easy for sponsor companies to miss adverse events, which could have a detrimental effect on their trial. Therefore, it's important to set up an effective and credible oversight management plan.
As a sponsor, you are ultimately (although there may be other parties involved) responsible for your clinical trial. One key responsibility is selecting qualified investigators, providing them accurate information enabling the investigation to take place in an efficient manner. Sponsors are also responsible for maintaining an effective IND, ensuring the investigation is in accordance with an established protocol. Essentially, as a sponsor you are responsible for making sure the trial adheres to Good Clinical Practice (GCP) throughout the entire process.
Good Clinical Practice provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles from the Declaration of Helsinki. The ICH ECR2 clearly states the guidelines for GCP and should be followed throughout the course of your trial. The purpose of GCP is also to maintain the integrity of your trial.
As illustrated by the table above, the sponsor has numerous responsibilities. Therefore, it is paramount implements an efficient system that manages the quality of the clinical trial, while making sure aspects meet regulatory standards. This can best be achieved by putting together a thorough oversight management strategy prior to the start of your trial.
Taking a risk-based approach is considered key here. It's best to have a team meeting to discuss where the risks may be before putting a mitigation process in place. Furthermore, make sure all the data that's collected is clear and concise, while ensuring the protocol is adhered to.
Monitoring plays an important role in oversight management; with an efficient monitoring plan, deviations from the protocol can be identified and action can be taken straight away to ensure compliance. Significant findings and deficiencies can be reviewed along with any adverse events (AE). It's important that the team are aware of any issues that may arise and that everything is documented just in case.
Ultimately, the key to effective oversight management is tracking - track AE relationship to study drug across sites, track SAEs (serious adverse events), track enrolment study wide, track shipments/dispensation of IP and track clinical protocol compliance. Organise weekly project team meetings (including skype/conference calling where necessary) and make sure you are reading monitoring reports and following up with any suspicious data. Additionally, it's a good idea to do random site visits just to ensure that everything is running as it should be all the time. Most importantly keep training your team and keep everyone involved in the trial informed!