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BACKGROUND: Survey data has suggested a gap between individuals willing to participate in a clinical trial and those who enroll. Clearer research must be done to better understand this discrepancy and the accessibility of patient-desired information, such that steps can be identified to assist sponsors in empowering patients to drive their own clinical trial search journey. METHODS: Patients, sponsors, and health care professionals were engaged through surveys and advisory boards to determine the ideal information for sponsors to provide during a clinical trial search. Public registries were analyzed to assess availability of basic investigator and site contact location information. RESULTS: Data reiterated the need for patients to have easy and unambiguous methods of connecting with the clinical trial site. Analysis of data on registries prove that sponsors have the opportunity to better utilize contact information on databases to enable a patient's clinical trial search journey. CONCLUSIONS: More robust disclosure of site location and contact details on public registries could lay the foundation for a more user-friendly clinical trial search. Allowing sites autonomy in site contact methods while promoting accessibility will facilitate the connection of interested patients with appropriate trial opportunities.
RESUMO
INTRODUCTION: PET imaging of amyloid-ß (Aß) in vivo holds promise for aiding in earlier diagnosis and intervention in Alzheimer's disease (AD) and mild cognitive impairment. AD-like Aß pathology is a common comorbidity in patients with idiopathic normal pressure hydrocephalus (iNPH). Fifty patients with iNPH needing ventriculo-peritoneal shunting or intracranial pressure monitoring underwent [18F]flutemetamol PET before (N = 28) or after (N = 22) surgery. Cortical uptake of [18F]flutemetamol was assessed visually by blinded reviewers, and also quantitatively via standard uptake value ratio (SUVR) in specific neocortical regions in relation to either cerebellum or pons reference region: the cerebral cortex of (prospective studies) or surrounding (retrospective studies) the biopsy site, the contralateral homolog, and a calculated composite brain measure. Aß pathology in the biopsy specimen (standard of truth [SoT]) was measured using Bielschowsky silver and thioflavin S plaque scores, percentage area of grey matter positive for monoclonal antibody to Aß (4G8), and overall pathology impression. We set out to find (1) which pair(s) of PET SUVR and pathology SoT endpoints matched best, (2) whether quantitative measures of [18F]flutemetamol PET were better for predicting the pathology outcome than blinded image examination (BIE), and (3) whether there was a better match between PET image findings in retrospective vs. prospective studies. RESULTS: Of the 24 possible endpoint/SoT combinations, the one with composite-cerebellum SUVR and SoT based on overall pathology had the highest Youden index (1.000), receiver operating characteristic area under the curve (1.000), sensitivity (1.000), specificity (1.000), and sum of sensitivity and specificity for the pooled data as well as for the retrospective and prospective studies separately (2.00, for all 3). The BIE sum of sensitivity and specificity, comparable to that for quantitation, was highest using Bielschowsky silver as SoT for all SUVRs (ipsilateral, contralateral, and composite, for both reference regions). The composite SUVR had a 100% positive predictive value (both reference regions) for the overall pathology diagnosis. All SUVRs had a 100% negative predictive value for the Bielschowsky silver result. CONCLUSION: Bielschowsky silver stain and overall pathology judgment showed the strongest associations with imaging results.
