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Training for the clinical research workforce does not sufficiently prepare workers for today’s scientific complexity; deficiencies may be ameliorated with training. The Enhancing Clinical Research Professionals’ Training and Qualifications developed competency standards for principal investigators and clinical research coordinators.
Clinical and Translational Science Awards representatives refined competency statements. Working groups developed assessments, identified training, and highlighted gaps.
Forty-eight competency statements in 8 domains were developed.
Training is primarily investigator focused with few programs for clinical research coordinators. Lack of training is felt in new technologies and data management. There are no standardized assessments of competence.
The translation of discoveries to drugs, devices, and behavioral interventions requires well-prepared study teams. Execution of clinical trials remains suboptimal due to varied quality in design, execution, analysis, and reporting. A critical impediment is inconsistent, or even absent, competency-based training for clinical trial personnel.
In 2014, the National Center for Advancing Translational Science (NCATS) funded the project, Enhancing Clinical Research Professionals’ Training and Qualifications (ECRPTQ), aimed at addressing this deficit. The goal was to ensure all personnel are competent to execute clinical trials. A phased structure was utilized.
This paper focuses on training recommendations in Good Clinical Practice (GCP). Leveraging input from all Clinical and Translational Science Award hubs, the following was recommended to NCATS: all investigators and study coordinators executing a clinical trial should understand GCP principles and undergo training every 3 years, with the training method meeting the minimum criteria identified by the International Conference on Harmonisation GCP.
We anticipate that industry sponsors will acknowledge such training, eliminating redundant training requests. We proposed metrics to be tracked that required further study. A separate task force was composed to define recommendations for metrics to be reported to NCATS.
For more than 120 years, the coastal exposures of the Santa Cruz Formation have
been fertile ground for recovery of vertebrates from the late Early Miocene
(~18 to 16 million years ago, Ma). As long ago as the 1840s, Captain
Bartholomew Sulivan collected fossils from this region and sent them to Charles
Darwin, who passed them to Richard Owen. Carlos Ameghino undertook several
explorations of the region starting in the late 1880s. Carlos' specimens were
described by his brother Florentino, who believed that many of the species were
more ancient than now understood and represented the ancestors of many Holarctic
mammalian orders. Ameghino's novel claims prompted William B. Scott to organize
fossil collecting expeditions in the Santa Cruz beds led by John B. Hatcher. The
fossils were described in a series of exhaustive monographs with the conclusion
that the fauna was much younger than Ameghino thought. Several brief expeditions
took place during the twentieth century, led by researchers from different
institutions. Since 2003, we have undertaken the collection of over 1600
specimens, including large series of relatively complete skeletons. In this
edited volume we have gathered together a group of researchers to study the
coastal Santa Cruz Formation and its associated flora and fauna to provide a
paleobiological reconstruction of the Santacrucian vertebrate community and to
place it in its biotic and physical environment.
The paleoenviroment and paleoecology of the Santa Cruz Formation (SCF) is
summarized, combining the data from the chapters of this book and new
examination of the community structure of the vertebrate fauna using modern
analogs. Emphasis is placed on the SCF outcrops along the coastal Atlantic
between about 50.3° and 51.6° S and their faunas (~17.9 to
16.2 Ma; Santacrucian SALMA). New data on the sedimentology, the ichnology, and
the flora and fauna of the SCF is particularly strong for the lower parts of the
SCF south of the Río Coyle (FL 1–7). FL 1–7 (~17.4
to 17.5 Ma) is analogous to a single modern fauna of limited geographic and
temporal scope. As paleolatitude during Santacrucian times was the same as that
of today, FL 1–7 was extratropical and had highly seasonal day lengths.
The Andes had not risen to a sufficient altitude to block westerly winds and
moisture from reaching the Atlantic coast. New dates for FL 1–7 indicate
that the mid-Miocene global climatic cooling had not yet begun. Several taxa
recovered at FL 1–7 or in nearby penecontemporaneous levels (e.g. palm
trees, the frog Calyptocephalella, the lizard
Tupinambis, the anteater Protamandua, and the primate Homunculus) strongly indicate that the climate of
FL 1–7 was much warmer and wetter than today. The overall mammalian
species richness and niche composition, expressed as percentages of arboreal or
scansorial, frugivorous, and grazing, suggest that overall rainfall was in the
range of 1000 to 1500 mm per annum. Occurrence of trees and forest-dwelling
birds and mammals (porcupines, spiny rats, sloths, scansorial marsupials, and
monkeys) supports this conclusion. The occurrence of calcareous root casts in
paleosols indicates high seasonality in rainfall with cool wet winters and dry
warm summers. Grasses were also present, and a number of vertebrate taxa (giant
terrestrial birds, many notoungulates, glyptodonts, and armadillos) appear to
have been adapted to open environments. Consideration of sedimentologic,
ichnologic, floral, and faunal elements taken together suggests a landscape for
FL 1–7 consisting of a mosaic of open temperate humid and semi-arid
forests, with ponds in some areas and seasonal flooding in others, no doubt
promoting the formation of marshlands with a mixture of grasses and forbes.
Over the past century, the Santa Cruz Formation of coastal Argentina (late Early
Miocene) has yielded a remarkable collection of platyrrhine primates. With few
notable exceptions, most of the specimens have been included in Homunculus patagonicus Ameghino, 1891, a stem
platyrrhine. Homunculus patagonicus was
approximately 1.5 to 2.5 kg in body mass, about the size of a living saki monkey
(Pithecia) or a female Cebus. Molar structure indicates that the diet
consisted of a mixture of fruit and leaves. A deep jaw, large postcanine tooth
roots, large postglenoid processes and moderately large chewing muscle
attachments (i.e. massive zygomatic arches, sculpted temporalis origins) suggest
that physically resistant foods were key components of the diet. Heavy tooth
wear suggests large amounts of ingested silica or exogenous abrasives. Incisor
morphology suggests that exudate harvesting may have been part of the behavioral
repertoire, although not a specialization. The canines were small, providing no
evidence of sclerocarpic foraging. Canines were sexually dimorphic, suggesting
that the taxon experienced some intrasexual competition rather than being
solitary or pair-bonded. Brain size was small and the frontal cortical region
was proportionately small. From the small size and structure of the orbits, the
structure of the organ of hearing, the reduced olfactory fossae and the
relatively large infraorbital foramina, we infer that Homunculus was probably diurnal, with acute vision and hearing,
but with a poor sense of smell and little reliance on tactile vibrissae.
Homunculus was an above-branch arboreal
quadruped with leaping abilities. The semicircular canals show evidence of
considerable agility, reinforcing the inference of leaping behavior. The overall
locomotor repertoire is not unlike that of the forest-dwelling extant saki
monkey Pithecia. Considered together, the
mosaic of dietary and locomotor morphology in Homunculus suggests that Homunculus inhabited an environment – as compared with
earlier Colhuehuapian and Pinturan primate habitats – shifting towards
greater seasonality in patchy forests near river courses.
Coastal exposures of the Santa Cruz Formation in southern Patagonia have been a fertile ground for recovery of Early Miocene vertebrates for more than 100 years. This volume presents a comprehensive compilation of important mammalian groups which continue to thrive today. It includes the most recent fossil finds as well as important new interpretations based on ten years of fieldwork by the authors. A key focus is placed on the paleoclimate and paleoenvironment during the time of deposition in the Middle Miocene Climatic Optimum (MMCO) between twenty and fifteen million years ago. The authors present the first reconstruction of what climatic conditions were like and present important new evidence of the geochronological age, habits and community structures of fossil bird and mammal species. Academic researchers and graduate students in paleontology, paleobiology, paleoecology, stratigraphy, climatology and geochronology will find this a valuable source of information about this fascinating geological formation.