5 Tips for Conducting a Clinical Trial

Clinical trials should be planned and performed by qualified personnel at all levels; sponsor, vendors and sites.  Clinical trials must be carefully planned and conducted in accordance with industry, international and local regulations.

From the very early stages, choosing the correct partner/s will allow you to build the trial strategy optimally. The following 5 tips should be taken into consideration when selecting your partner/s: 

• Statistical point of view for trial design:
  • Simulate all options of study design and then choose the optimal sample size
  • Which attributes does your trial focus on? Efficacy, safety, PK and/or something else?
  • What do you wish to show? Superiority, equivalence, non-inferiority, dose response or something  different?
  • What statistical methods are expected by the regulator?

• Regulatory preparation:
  • Good literature review of prior relevant submissions, including the statistics section.
  • Know the relevant regulatory guidances and regulatory pathways
  • Ask yourself:
    • What data would the agency like to review in order to answer the question you have asked?
    • What story do you plan to tell with the study? Are there any issues that need to be addressed
            head-on?
  • Provide clear, concise messages that support your clinical methodology
  • Use of electronic quality management system(eQMS) can be an advantage

• Using advanced tools to streamline your clinical trial:
  • Electronic Data Capture- EDC.
          Use flexible, user-friendly systems which can respond to the need of required additional modules:  eSource, pharmacovigilance, laboratory data processing, medical coding, etc.
  • Risk-based monitoring vs. classic monitoring
  • Logistics and distribution: Inventory status, expiry information, shipment and more

• Conduct the study in the most professional and effective way:
  • Select the right site/s (good feasibility assessment). Remember that the KOL’s site is not necessarily              the best recruiting site.
  • Consider opening more sites to speed up recruitment.
  • EDC system should reflect the study status at every given moment; use it wisely for follow-up and                  shortening study duration.
  • Enhance subject recruitment.

• Choose experienced service provider/s for effective brainstorming and insights:
• Experts that meet your company approach and needs
• Experienced team in all clinical study phases
• Effective and open communication
• Ability of all members to cooperate with different vendors and personnel