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
- 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