English to Russian Medical Medical: Pharmaceuticals

The inclusion of treatment-naïve pulmonary arterial hypertension (PAH) patients in long-term randomized,
placebo-controlled clinical trials may raise questions with regards to ethics since one-third
of patients who were randomized to placebo did not receive any active PAH treatment. Whether to include
background therapy as a mandatory inclusion criterion was a key discussion point for the Steering Committee
during the design of the trial. However, access to PAH-specific therapy and patient management are not
consistent across all countries (e.g. in Western countries, WHO functional class [FC] II patients may not have been
***eligible for reimbursement of PAH treatment***, in non-Western countries, oral/inhaled/parenteral therapies may not
be routinely available). Making background PAH therapy mandatory would have excluded countries,
sites, and patients with limited access to modern therapies, from the potential benefit of entering into the trial. This
exclusion or discrimination, in itself, would have raised ethical concerns. Therefore, it was considered acceptable
and appropriate to allow treatment-naïve PAH patients to be included.