It's often observesd that "there is no 'I' in team." Well, there is an "I" in clinical, but don't let it fool you. Clinical trials require teamwork.
In clinical trials, there are two teams. The Sponsor's Clinical Trial Team and the Site and Investigators Team. Today, let's focus on the synergy of the Sponsor's clinical trial team.
The key players on the Sponsor's Clinical Trial Team are Research & Development Scientists, Quality Control and Assurance, Regulatory Affairs, Data Management, Manufacturing, Technical Support, Biostatistics, and Clinical Affairs.
Everyone's responsibilities are critical though the Clinical Affairs representative takes the lead from the beginning to the end of the clinical study. This process begins with the Protocol and ends with a Final Study report that will hopefully lead to a submission or bragging rights in a publication.
The snapshot below provides an overview of the process and the team members that are integral to the process.
|Study Synopsis||»||R & D, Clinical Affairs, Regulatory Affairs, Biostatistics|
|Site Selection||»||Clinical Affairs and Technical Services|
|IRB Submissions/ Approval||»||Clinical Affairs and Regulatory Affairs|
|Monitoring Plan||»||Clinical Affairs|
|Data Management Plan||»||Data Management, QA, Biostatistics, Clinical Affairs|
|Statistical Analysis Plan||»||Biostatistics, QA, Regulatory Affairs, Clinical Affairs|
|Training Plan||»||Technical Services, QA, Clinical Affairs|
|Study Material Procurement||»||R & D, Clinical Affairs|
|SIV, Monitoring Visits, Close Out Visits||»
|Query Resolution||»||Data Management, Technical Services, Clinical Affairs|
|Data Analysis||»||Data Management, Biostatistics|
|Final Study Report||»||EVERYONE|
And this is my Top 5 list demonstrating the importance of the team approach:
- Clinical Utility
Be sure regulatory is included during the development of the protocol. The regulatory representative will need to explain to the FDA how this trial meets the intended use of the product.
- It Takes A Village
Clinical protocols include patient screening, data requirements and statistical analysis. It is highly unlikely one person can do all this. The team approach will ensure that all aspects of your trial have been met.
- Qualifications of Participants
Some sites still use white out. Enough said.
- Electronic Systems
In the information age, electronic systems speed up data analysis and decision making. However, we are talking about confidential patient information not to mention data quality issues. Therefore, make sure the team works together on ensuring the electronic systems are 21 CFR Part 11 compliance.
- Those Sales Folks
Don’t let the sales/ marketing force take sole responsibility in choosing the sites. It is so easy to blur the line between clinical trial participant and potential customer. Make sure the team understands this distinction because if there is any hint of marketing an investigational medical product, expected a phone call from the FDA.
The #1 Objective must be the success of the project not the success of the individual. By keeping this in mind, clinical trials can be a positive experience for manufacturers and getting them one step closer to marketing their in vitro diagnostic device.
Tags: Best Practices