Lotus Unified Site Methodology Program

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