DEI Special Edition Spring / Summer 2024
Bring the trial, as much as possible, into familiar environments of their homes and familiar physician offices.
Utilize DCT utilities as a vector to connect the needs of our patients to the regu- lations of our industry.
Do not force local physicians into becoming the PIs or Sub - Is and consequently discourage them from engaging, alongside the patients who trust them, in clini- cal trials. Instead, treat them solely as the local HCPs who have fostered an in- valuable relationship with our patients.
Ahmed Fall from Raleigh, NC area– Autistic 9 year old
“ The Regulators and Sponsors won ’ t allow this. ” – FALSE! Get ready. The FDA ’ s upcoming DCT guidance is laying the groundwork to allow local HCP offices the ability to “ host ” clinical trial visits. Clinical research is com- ing to local HCP offices. Once published, HCP offices may collaborate with community sites via Task Logs without extensive staff - level training requirements and Sponsors will indirectly give permission to perform “ DCT Compatible Trial Visits ” as they begin to in- clude a DCT component into IRB - approved protocols. We are witnessing in this industry the groundwork to access patient populations throughout healthcare settings. The only reason we do not accommodate our autistic patients in re- search …. will be our own. How may CRAs help to accommodate autistic trial partici- pants? I ’ ve talked to many a CRA about DCT utilities and the DCT guidance. Their knee - jerk reaction is – there ’ s no way this will ever work and this would be a disaster to monitor. I get it! Its new, its unknown, nobody wants to be the failing guinea pig, and it ’ s so new that we do not yet have rulebook or guard rails to follow.
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