At Miller Tanner, we help pharma, biotech, medical device, and contract research organizations (CROs) orchestrate creative training solutions for investigative sites participating in clinical trials.
Through our work—which includes planning hundreds of investigator meetings —we’ve observed some of the key factors that contribute to successful training programs.
Training Is Critical to a Successful Clinical Research Study
Timely and effective investigational plan training for CROs and site staff is essential to conducting a successful clinical research study.
The integrity of clinical research data and even the study itself can be jeopardized by:
- Lack of/or minimal training;
- Variability in the trainers; and
- Ineffective training methods.
Even simple misunderstandings of the protocol can lead to major issues with subject safety and the overall reportable data.
So how can you avoid these hurdles and ensure you provide the best training to give your clinical trial the greatest chance of success? We’ve got a couple of ideas that can help.
How to Conduct Effective Investigator Meetings
Build strong relationships with your investigative sites and CRO partners by assuring that those who conduct and monitor your investigational plan/protocol have received essential materials and as much training as possible to successfully care for subject safety while producing clean and accurate data.
1. Have Subject Matter Experts (SMEs) Present at Face-to-Face Meetings
There are many different training methods companies use—including providing both written and auditory materials prepared by Subject Matter Experts (SME). These can include protocol or IB materials, step-by-step videos, or “how to” documents.
But, the single best way to convey your enthusiastic message and in-depth knowledge of the product and the protocol is by having your SMEs present at face-to-face investigator meetings.
Your SMEs can present critical points on the disease state, protocol content, and drug/product training; and provide diligence for understanding patient safety and compliance to the investigational plan.
The pharma industry, CROs, and sites continue to report through our surveys that face-to-face training remains one of the best ways to understand the complexities of the investigation plan and/or product, and to collaborate with the sponsor, CRO, and other sites.
2. Use On-Demand Training to Offset Attendance and Attrition Challenges
Attendance by key site staff at face-to-face investigator meetings can vary depending on the timing of the event, country holidays, clinic and hospital schedules, and advance notice of the event to sites for scheduling.
Even with the best planning, an average of 20-25% of the sites are not able to attend the training at all or can only send one study team member to return and convey all the training to their other teammates.
Attrition is another challenge. Turnover at the sites, CRO, and even sponsor companies over the course of the investigational study is inevitable. Ensuring new key team members receive proper training usually involves sending CRAs to the site(s).
A smart approach to managing both attendance and attrition challenges is providing Web-enabled, on-demand training with audio or video capture of your subject matter experts.
This enables team members to view and hear your critical content and materials before they begin to involvement with study and/or subjects. It also allows new staff to train before the CRA is able to schedule an on-site visit.
This training can minimize potential deviations as well as reduce the time on site for the CRA and site staff when a monitoring visit is to be scheduled.
Invest in Training to Position Your Clinical Trial for Success
Pharmaceutical and biotechnology companies continue to invest in training opportunities for CROs and site staff participating in clinical research studies. Make sure you are getting the most for your investment.
Having your subject matter experts present at face-to-face investigator meetings will promote understanding of the product and protocol and encourage collaboration.
Providing on-demand training will help you manage attendance and attrition issues, and ensure more staff members receive training information in a timely and effective manner.
Investigator training is critical to a successful clinical trial. Take the steps necessary to give your study the greatest chance of success!
Frequently Asked Questions
In effort to help readers to summarize the information found within this post, we’ve recapitulated the article in question and answer form.
How is Training Critical to Successful Clinical Research Studies?
A successful clinical research project requires timely and effective investigative plan training for CROs and site personnel. Lack of/or insufficient training, trainer unpredictability, and ineffective training techniques may compromise the integrity of clinical research data and possibly the study itself. Even minor misconceptions of the procedure may result in serious problems with subject safety and the total data that can be reported.
How Can My Company Conduct Effective Investigator Meetings?
Assure that individuals who perform and oversee your experimental plan/protocol have received the necessary materials and as much training as feasible to effectively care for subject safety while generating clean and accurate data.
How Important is Having Subject-Matter Experts (SMEs) Present at Face-to-Face Meetings?
Having your SMEs present in a face-to-face investigator meeting is the single greatest method to communicate your messaging and in-depth expertise of the product and/or procedure. Your subject-matter experts should provide key points about protocol content and training, as well as ensure participant safety and compliance with the investigational plan.
How Important is Having On-Demand Training to Offset Attendance & Attrition?
Attendance in face-to-face investigator meetings by key site personnel may vary based on the event’s time, national holidays, clinic and hospital schedules, and prior notification to sites for scheduling. Even with the greatest preparation, 20-25% of the sites are unable to attend the training or can only send one research team member back to relay the training to their other colleagues.
Should I Invest in Training to Better Position for Clinical Trial Success?
Pharmaceutical and biotechnology firms continue to invest in training opportunities for contract research organizations (CROs) and study site personnel. Make sure you’re getting the most bang for your buck. Face-to-face investigator interactions with your subject-matter specialists will improve knowledge of the product and procedure as well as cooperation.