Lotus ensures consistent data across its site network with an intensive, multi-tiered training program, using:
Network-Wide, In-Person Study-Specific Training
- As each Lotus site is brought on to a study, all participating staff undergo a full-day in-person training on study drug, study endpoints, placebo response mitigation as it relates to the investigational drug’s method of administration, and other key topics
- Staff participate in dedicated training centered on which study data relate to the study’s primary endpoint, which clinical assessments support it, and how its value will be calculated
- Staff participate in didactic training, role-playing, hands-on exercises and Q & A
- Staff review written summaries and complete a post-test to ensure comprehension
Network-Wide Webconferences, Video Training and Testing on Key Methodology Topics
- Lotus leadership and staff convene quarterly for a deep dive on a specific methodology topic such as appropriate use of rescue (see topics list below)
- Lotus network staff participate in periodic interactive online sessions featuring didactic video training followed by a comprehension test (see topics list below)
- Instructors train staff using case study scenarios and other tools designed to ethically reduce unnecessary early terminations and other outcomes that can result in missing data.
Biweekly Podcasts/ Conference Calls
- Lotus’ CSO Neil Singla, MD hosts podcasts and group discussions on scientific topics relevant to current Lotus studies
Quality Control of Training Procedures via Site Data Review
- To ensure that Lotus’ methodology training is optimally implemented at all sites, leadership team regularly reviews study data provided by each site
- The team inspects data for consistent/ expected placebo response and other key variables, across sites
- Outlier sites are reviewed/ retrained
Topics covered in our training include:
Mitigating Placebo Response
- Neutral Collection of Study Assessments
- Educating Patients on Clinical Research vs. Standard Clinical Care
- Avoiding Bias During Informed Consent
- Limiting Inter-Patient Interaction
Study-Specific Primary Endpoint Training
- Understanding the Study’s Central Experimental Question
- Prioritizing “Make or Break” Primary Endpoint Data in Data Capture
Optimizing Study-Specific Procedures and Assessments
- Appropriate/ Ethical Use of Rescue Medication while Optimizing Study Outcomes
- Proper Handling of Early Terminations/ Effects of Dropouts on Study Outcomes
- Optimal Dose Timing
- Accurate Recording of Concomitant Medications
- Importance of Accurate Postoperative Baseline Measurement
- Standardizing Anesthetic Techniques and Perioperative Care
- Standardizing Interventional Techniques
- Osteoarthritis-Specific Placebo Response Training for Injections
Emerging Analgesic Trends/ New Methodologies and Techniques
- Periodic team updates on new best practices/ new innovations in clinical trials
