Are all phase 1 trials on healthy volunteers?

Short answer is: no. In certain circumstances, Phase 1 clinical trials also involve patients, particularly those with advanced diseases for which existing treatments are ineffective. This approach is often seen in oncology trials, where new cancer treatments are tested on patients who have not responded to standard therapies.

In these cases, the primary aim remains to evaluate the safety and determine the optimal dose of the new treatment, but the context shifts to include the potential for therapeutic benefit, even at this early stage. Including patients in Phase 1 trials allows researchers to gather preliminary data on the drug’s efficacy in a specific patient population while still focusing on safety and dosage parameters.

This method offers hope to patients with few other treatment options and provides valuable insights that can guide the development of the drug for broader use. The involvement of patients in Phase 1 trials underscores the adaptability of clinical research approaches to meet the urgent needs of those with critical health conditions, blending the goals of safety assessment with the potential for immediate therapeutic benefit.