Eligibility Criteria

Carefully consider and assess your trials eligibility criteria.

• Examine how each criterion may impact patient participation.
  For example, consider removing strict organ function requirements or unnecessary eligibility tests.
• For exclusion criteria: avoid nonspecific, potentially biased terms (“unacceptable”, “uncontrolled”) and provide specific definitions.
• Government agencies like the FDA, NIH, Health Canada, Medicines and Healthcare products Regulatory Agency (MHRA), and European Medicines Agency (EMA)

Use of Statistics

Solicit the guidance of a statistician to help with the selection of an appropriate sample size and heterogeneous population.

De-centralize Study Activities

Consider opportunities for de-centralizing of clinical trial with study activities closer to home (e.g., mobile nursing or phlebotomy for safety monitoring).

Consult LEEs

Consult with LEEs to understand how much effort may be required for the enrollment objectives.

Leverage Expertise

Leverage the expertise of LEEs, patient advocacy groups, and/or community advisory boards (CABs) to:

• Create a plain language version of the protocol for patients. This version should describe the purpose of the study, key inclusion and exclusion criteria, major efficacy outcomes, potential adverse events, and why the study will benefit the patient population. This document should be translated into different languages as appropriate.
• Develop culturally and linguistically appropriate educational resources for HCPs and patients to build their understanding around why a trial is designed the way it is, e.g., a 1-page information guide on describing the trial that can complement a more in-depth informed consent form (ICF).
• Review your protocol to provide patient-centric feedback.

Incorporate Strategies

Incorporate strategies to effectively engage HCPs or community physicians who will likely be offering your trial to their patients. Your strategies should consider the following:

• Return of the patientto the HCP after the trial is complete.
• Communication of trial resultswith the HCP during and at the end of the trial.
• Acknowledgement of the HCPs participationin the study.

Articulate Recruitment Roles

Clearly articulate recruitment goals to the trial site(s). Note: These recruitment goals should bebased on the demographics of the population impacted by the disease.

Design Consent Forms

Design consent forms that are easy to read and translated into different languages especially for trial sites with significant proportions of patients for whom English is not their primary language.

Audit Study Visits

Avoid the inclusion of unnecessary study visits in the trial design (e.g., excessive PK/PD visits).

Communicate Study Rules

Ensure that patients understand that they can stop participating at any time without risk or repercussions.