Clinical trial capacity building to address

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Presentation transcript:

Clinical trial capacity building to address multidrug-resistant tuberculosis: challenges and the way forward

Challenges and efforts in strengthening site pharmacies and pharmacists in the STREAM Trial Jan Komrska and Ishmael Qawiy, Pharmacists, Vital Strategies, USA

Good Clinical Practice Trial drugs can only be provided to eligible patients All subjects are provided information on how to properly use trial drugs

Good Clinical Practice Requirements Facility Processes Staff

Facility Access control to trial drugs Manufacturer recommended storage conditions Sufficient space

Processes Standard Operating Procedures (SOPs) Documentation (packing lists, donation records, destruction records) Dispensing records (stock cards, prescriptions)

Staff Qualification by education, training and experience Pharmacy staff: Pharmacists, Pharmacy technicians, Pharmacy assistants, Field workers On-line GCP course for pharmacy staff Licensing requirements/Continuous education

Challenges Pharmacists are not dispensing medicines directly to the patients Infrastructure requires investment to meet the requirements Installing air-conditioning system does not automatically prevent temperature excursions Inadequate storage conditions for trial drugs outside pharmacies SOPs are not in place or do not reflect actual workflows Management of Pharmacy Site File Documenting GMP status of trial drug manufacturers

Other challenges Language barriers Time zone difference Geographical distance Visa requirements

Thank you!