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Clinical Trials at NASA: What Makes A Clinical Trial & What Are the Requirements for International Partners?

ClinicalTrials.gov is a public registry designed to fulfill ethical obligations by providing information about clinical research studies to the general public, patients, medical practitioners and the research community. In the United States, recent revisions to human subject’s regulations have prompted new criteria for what constitutes a clinical trial along with requirements not typically requested for other types of human subject’s research. Identification of investigational clinical trials is the shared responsibility of NASA, the IRB, and the scientific investigators designing and conducting the research. This talk aims to educate attendees on the history of the development of Clinicaltrials.gov, discussion of why these requirements are important to both participants and researchers, and information on how to identify clinical trials research. In addition, we will provide information on the different requirements for clinical trials conducted at NASA or aboard the International Space Station.

Clinicaltrials.gov↗

NASA NTRS1995

Reliability Stress-Strength Models for Dependent Observations with Applications in Clinical Trials

We consider the applications of stress-strength models in studies involving clinical trials. When studying the effects and side effects of certain procedures (treatments), it is often the case that observations are correlated due to subject effect, repeated measurements and observing many characteristics simultaneously. We develop maximum likelihood estimator (MLE) and uniform minimum variance unbiased estimator (UMVUE) of the reliability which in clinical trial studies could be considered as the chances of increased side effects due to a particular procedure compared to another. The results developed apply to both univariate and multivariate situations. Also, for the univariate situations we develop simple to use lower confidence bounds for the reliability. Further, we consider the cases when both stress and strength constitute time dependent processes. We define the future reliability and obtain methods of constructing lower confidence bounds for this reliability. Finally, we conduct simulation studies to evaluate all the procedures developed and also to compare the MLE and the UMVUE.

Kushary, Debashis↗

NASA NTRS2017

It's Only a Phase: Applying the 5 Phases of Clinical Trials to the NSCR Model Improvement Process

NASA limits astronaut radiation exposures to a 3% risk of exposure-induced death from cancer (REID) at the upper 95% confidence level. Since astronauts approach this limit, it is important that the estimate of REID be as accurate as possible. The NASA Space Cancer Risk 2012 (NSCR-2012) model has been the standard for NASA's space radiation protection guidelines since its publication in 2013. The model incorporates elements from U.S. baseline statistics, Japanese atomic bomb survivor research, animal models, cellular studies, and radiation transport to calculate astronaut baseline risk of cancer and REID. The NSCR model is under constant revision to ensure emerging research is incorporated into radiation protection standards. It is important to develop guidelines, however, to determine what new research is appropriate for integration. Certain standards of transparency are necessary in order to assess data quality, statistical quality, and analytical quality. To this effect, all original source code and any raw data used to develop the code are required to confirm there are no errors which significantly change reported outcomes. It is possible to apply a clinical trials approach to select and assess the improvement concepts that will be incorporated into future iterations of NSCR. This poster describes the five phases of clinical trials research, pre-clinical research, and clinical research phases I-IV, explaining how each step can be translated into an appropriate NSCR model selection guideline.

Elgart, S. R.↗

NASA NTRS2011

The First Intervention Study in Elder Self-Neglect: A Randomized Clinical Trial to Improve Vitamin D Levels

Despite high mortality rates, elder self-neglect is characterized by refusal of medical and social interventions. To date there have been no tested clinical interventions in elders who self-neglect. Previous research from the TEAM Institute has shown significantly low vitamin D levels in this population. This study aimed to determine the feasibility of a clinical intervention. Replacement of vitamin D was chosen because of its ease of administration and favorable safety profile. Methods: A randomized clinical trial using directly observed therapy of vitamin D was conducted using 50 elders, >65 years of age, with Adult Protective Services (APS) validated self-neglect. A staggered intervention with waiting controls was used to maximize statistical power. One-third (n=17) of the group was administered 50,000 IU vitamin D2 (ergocalciferol) monthly and the remainder (n=33) were administered 400 IU monthly. Serum 25-OH vitamin D was assessed at baseline and 5-months. Results: 69% agreed to participate in the study and of those n=40 (80%) remained at 5-months. At baseline, 12% (n=7) were deficient in vitamin D (<30nmol/L) and approximately 38% (n=22) had inadequate vitamin D levels (<50nmol/L). The baseline 25-OH vitamin D level was 59 nmol/L +25 (mean SD), and increased significantly to 72nmol/L +21 nmol/L at 5-months. Conclusion: These data are the first to provide evidence that clinical interventions are feasible in elders who self-neglect. The increase in vitamin D levels confirmed that the study personnel were able to successfully intervene community-dwelling elders with self-neglect. This study sets the precedent for future intervention and prevention studies

Burnett, Jason↗

NASA NTRS1992

Comparison of computer- and human-derived coronary angiographic end-point measures for controlled therapy trials

The Cholesterol Lowering Atherosclerosis Study, a randomized angiographic clinical trial, demonstrated the beneficial effect of niacin/colestipol plus diet therapy on coronary atherosclerosis. Outcome was determined by panel-based estimates (viewed in both still and cine modes) of percent stenosis severity and change in native artery and bypass graft lesions. Computer-based quantitative coronary angiography (QCA) was also used to measure lesion and bypass graft stenosis severity and change in individual frames closely matched in orientation, opacification, and cardiac phase. Both methods jointly evaluated 350 nonoccluded lesions. The correlation between QCA and panel estimates of lesion size was 0.70 (p less than 0.0001) and for change in lesion size was 0.28 (p = 0.002). Agreement between the two methods in classifying lesion changes (i.e., regression, unchanged, or progression) occurred for 60% (210 of 350) of the lesions kappa +/- SEM = 0.20 +/- 0.05, p less than 0.001). The panel identified 442 nonoccluded lesions for which QCA stenosis measurements could not be obtained. Lesions not measurable by QCA included those with stenosis greater than 85% that could not be reliably edge tracked, segments with diffuse or ecstatic disease that had no reliable reference diameter, and segments for which matched frames could not be located. Seventy-nine lesions, the majority between 21% and 40% stenosis, were identified and measured by QCA but were not identified by the panel. This comparison study demonstrates the need to consider available angiographic measurement methods in relation to the goals of their use.

NASA Center JPL↗

NASA NTRS1983

Development and marketing of a prosthetic urinary control valve system

An implantable prosthetic for the control of urinary incontinence was developed and marketed. Three phases are presented: bench development studies, animal trials, and human clinical trials. This work was performed under the direction of a Research Team at Rochester General Hospital (RGH). Bench trials were completed on prototype hardware and provided early verification of the device's ability to withstand repeated cyclic testing. Configurational variants were evaluated and a preferred design concept was established. Silicone rubber (medical grade) was selected as the preferred material for the prosthesis.

Tenney, J. B., Jr.↗

NASA NTRS2011

Pharmacokinetics of Intranasal Scopolamine Gel Formulation During Antiorthostatic Bed Rest, a Microgravity Analog

Statement of Purpose, Innovation or Hypothesis: Space Motion sickness (SMS) is a long-standing problem for astronauts on both short and long duration space flights. Scopolamine (SCOP) is frequently used for the treatment of motion sickness (MS), and is available as transdermal patch and tablet dosage forms. These formulations of SCOP are ineffective for the treatment of SMS. Intranasal dosage forms are noninvasive with rapid absorption and enhanced bioavailability, thus allowing precise and reduced dosing in addition to offering rescue and treatment options. An intranasal gel dosage formulation of scopolamine (INSCOP) was developed and pharmacokinetics (PK) and bioavailability were determined in clinical trials with human subjects under IND guidelines.Description of Methods and Materials: The present clinical trial compares PK and bioavailability of INSCOP in 12 normal, healthy subjects (6 male/ 6 female) during ambulation (AMB) and antiorthostaticbed rest (ABR) used as a ground-based microgravity analog. Subjects received 0.2 mg and 0.4 mg doses of INSCOP during AMB and ABR in a 4-way crossover design.Data and Results: Results indicated no difference between AMB and ABR in PK parameters after 0.2 mg dose, Clearance (Cls) decreased with a concomitant increase in maximum concentration and area under concentration-versus-time curve (AUC) during ABR after the 0.4 mg dose.Interpretation, Conclusion or Significance: The difference in AUC and Cls at the higher (0.4 mg) but not the lower dose (0.2 mg) during ABR suggests that ABR may affect metabolism and/or clearance of INSCOP at higher doses . These results indicate that dosing adjustment may be required for treatment of SMS with INSCOP in space.

Singh, Rajendra P.↗

NASA NTRS1991

Cooperative research and development opportunities with the National Cancer Institute

The Office of Technology Development (OTD) of the National Cancer Institute (NCI) is responsible for negotiating Cooperative Research and Development Agreements (CRADAs), whereby the knowledge resulting from NCI investigators' government-sponsored research is developed in collaboration with universities and/or industry into new products of importance for the diagnosis and treatment of cancer and acquired immunodeficiency syndrome (AIDS). The NCI has recently executed a unique 'clinical trials' CRADA and is developing a model agreement based upon it for the development and commercialization of products for the diagnosis and treatment of cancer and AIDS. NCI drug screening, preclinical testing, clinical trials, and AIDS program capabilities form the basis for this new technology development/technology transfer vehicle. NCI's extensive drug screening program and 'designer foods' program serve as potential sources of investigational new drugs (INDs) and cancer preventatives. Collaborations between NCI and pharmaceutical companies having the facilities, experience, and expertise necessary to develop INDs into approved drugs available to the public are being encouraged where the companies have proprietary rights to INDs, or where NCI has proprietary rights to INDs and invites companies to respond to a collaborator announcement published in the Federal Register. The joint efforts of the NCI and the chosen collaborator are designed to generate the data necessary to obtain pharmaceutic regulatory approval from the Food and Drug Administration (FDA) to market the drugs developed, and thereby make them available to health care providers for the diagnosis and treatment of cancer and AIDS.

Sybert, Kathleen↗

NASA NTRS2014

Pharmacokinetic Modeling of Intranasal Scopolamine in Plasma Saliva and Urine

Wu, L.↗

NASA NTRS2014

Pharmacokinetic Modeling of Intranasal Scopolamine in Plasma Saliva and Urine

An intranasal gel formulation of scopolamine (INSCOP) was developed for the treatment of Space Motion Sickness. The bioavailability and pharmacokinetics (PK) were evaluated under the Food and Drug Administration guidelines for clinical trials for an Investigative New Drug (IND). The aim of this project was to develop a PK model that can predict the relationship between plasma, saliva and urinary scopolamine concentrations using data collected from the IND clinical trial with INSCOP. METHODS: Twelve healthy human subjects were administered three dose levels (0.1, 0.2 and 0.4 mg) of INSCOP. Serial blood, saliva and urine samples were collected between 5 min to 24 h after dosing and scopolamine concentrations measured by using a validated LC-MS-MS assay. Pharmacokinetic Compartmental models, using actual dosing and sampling times, were built using Phoenix (version 1.2). Model discrimination was performed, by minimizing the Akaike Information Criteria (AIC), maximizing the coefficient of determination (r²) and by comparison of the quality of fit plots. RESULTS: The best structural model to describe scopolamine disposition after INSCOP administration (minimal AIC =907.2) consisted of one compartment for plasma, saliva and urine respectively that were inter-connected with different rate constants. The estimated values of PK parameters were compiled in Table 1. The model fitting exercises revealed a nonlinear PK for scopolamine between plasma and saliva compartments for K21, Vmax and Km. CONCLUSION: PK model for INSCOP was developed and for the first time it satisfactorily predicted the PK of scopolamine in plasma, saliva and urine after INSCOP administration. Using non-linear PK yielded the best structural model to describe scopolamine disposition between plasma and saliva compartments, and inclusion of non-linear PK resulted in a significant improved model fitting. The model can be utilized to predict scopolamine plasma concentration using saliva and/or urine data that allows non-invasive assessment of pharmacotherapeutics of scopolamine in space and other remote environments without requiring blood sampling.

Wu, L.↗

NASA NTRS2014

A Population Pharmacokinetic Model for Disposition in Plasma, Saliva and Urine of Scopolamine after Intranasal Administration to Healthy Human Subjects

An intranasal gel formulation of scopolamine (INSCOP) was developed for the treatment of Space Motion Sickness. The bioavailability and pharmacokinetics (PK) were evaluated under the Food and Drug Administration guidelines for clinical trials with an Investigative New Drug (IND) protocol. The aim of this project was to develop a PK model that can predict the relationship between plasma, saliva and urinary scopolamine concentrations using data collected from the IND clinical trials with INSCOP. Methods: Twelve healthy human subjects were administered three dose levels (0.1, 0.2 and 0.4 mg) of INSCOP. Serial blood, saliva and urine samples were collected between 5 min and 24 h after dosing and scopolamine concentrations were measured by using a validated LC‐MS‐MS assay. Pharmacokinetic Compartmental models, using actual dosing and sampling times, were built using Phoenix (version 1.2). Model selection was based on the likelihood ratio test on the difference of criteria (‐2LL) and comparison of the quality of fit plots. Results: The best structural model for INSCOP (minimal ‐2LL= 502.8) was established. It consisted of one compartment each for plasma, saliva and urine, respectively, which were connected with linear transport processes except the nonlinear PK process from plasma to saliva compartment. The best‐fit estimates of PK parameters from individual PK compartmental analysis and Population PK model analysis were shown in Tables 1 and 2, respectively. Conclusion: A population PK model that could predict population and individual PK of scopolamine in plasma, saliva and urine after dosing was developed and validated. Incorporating a non‐linear transfer from plasma to saliva compartments resulted in a significantly improved model fitting. The model could be used to predict scopolamine plasma concentrations from salivary and urinary drug levels, allowing non‐invasive therapeutic monitoring of scopolamine in space and other remote environments.

Wu, L.↗

NASA NTRS2000

Outcome analysis of individualized vestibular rehabilitation protocols

OBJECTIVE: To determine the outcome of vestibular rehabilitation protocols in subjects with peripheral vestibular disorders compared with normal and abnormal control subjects. STUDY DESIGN: Prospective study using repeated measure, matched control design. Subjects were solicited consecutively according to these criteria: vestibular disorder subjects who had abnormal results of computerized dynamic posturography (CDP) sensory organization tests (SOTs) 5 and 6 and underwent rehabilitation; vestibular disorder subjects who had abnormal results of SOTs 5 and 6 and did not undergo rehabilitation; and normal subjects (normal SOTs). SETTING: Tertiary neurotology clinic. SUBJECTS: Men and women over age 18 with chronic vestibular disorders and chief complaints of unsteadiness, imbalance, and/or motion intolerance, and normal subjects. INTERVENTIONS: Pre- and post-rehabilitation assessment included CDP, vestibular disability, and activities of daily living questionnaires. Individualized rehabilitation plans were designed and implemented to address the subject's specific complaints and functional deficits. Supervised sessions were held at weekly intervals, and self-administered programs were devised for daily home use. MAIN OUTCOME MEASURES: CDP composite and SOT scores, number of falls on CDP, and self-assessment questionnaire results. RESULTS: Subjects who underwent rehabilitation (Group A) showed statistically significant improvements in SOTs, overall composite score, and reduction in falls compared with abnormal (Group B) control groups. Group A's performances after rehabilitation were not significantly different from those of normal subjects (Group C) in SOTs 3 through 6, and close to normal on SOTs 1 and 2. Subjects in Group A also reported statistically significant symptomatic improvement. CONCLUSIONS: Outcome measures of vestibular protocol physical therapy confirmed objective and subjective improvement in subjects with chronic peripheral vestibular disorders. These findings support results reported by other investigators.

NASA Discipline Neuroscience↗

NASA NTRS1998

Clinical and electrophysiologic attributes as predictors of results of autonomic function tests

Autonomic dysfunction is a feature of some neuropathies and not others. It has been suggested that some clinical and electrophysiologic attributes are predictable of autonomic impairment detected using laboratory testing; however, dear guidelines are unavailable. We evaluated 138 relatively unselected patients with peripheral neuropathy who underwent neurologic evaluation, electromyography (EMG), nerve conduction studies, and autonomic function tests to determine which variables were predictive of laboratory findings of autonomic failure. The variables evaluated were 1) clinical somatic neuropathic findings, 2) clinical autonomic symptoms, and 3) electrophysiologic findings. Autonomic symptoms were strongly predictive (Rs = 0.40, p < 0.001) of autonomic failure. Among the non-autonomic indices, absent ankle reflexes were mildly predictive (Rs = 0.19, p = 0.022) of autonomic impairment, but all others were not (duration, clinical pattern, severity, weakness, sensory loss). Electrophysiologic changes of an axonal neuropathy predicted autonomic impairment while demyelinating neuropathy did not. We conclude that autonomic studies will most likely be abnormal in patients who have symptoms of autonomic involvement and those who have an axonal neuropathy.

Controlled Clinical Trial↗

NASA NTRS1996

Isokinetic and isometric strength-endurance after 6 hours of immersion and 6 degrees head-down tilt in men

PURPOSE: To determine weight (water) loss levels for onset of muscular strength and endurance changes during deconditioning. METHODS: Seven men (27-40 yr) performed maximal shoulder-, knee-, and ankle-joint isometric (0 degree.s(-1) load) and isokinetic (60 degrees, 120 degrees, 180 degrees.s(-1) velocity) exercise tests during ambulatory control (AC), after 6 h of 6 degrees head-down tilt (HDT; dry-bulb temp. = 23.2 +/- SD 0.6 degrees C, relative humidity = 31.1+/- 11.1%) and after 6 h of 80 degrees foot-down head-out water immersion (WI; water temp. = 35.0 +/- SD 0.1 degree C) treatments. RESULTS: Weight (water) loss after HDT (1.10 +/- SE 0.14 kg, 1.4 +/- 0.2% body wt) and WI (1.54+/- 0.19 kg, 2.0 +/- 0.2% body wt) were not different, but urinary excretion with WI (1,354 +/- 142 ml.6 h(-1)) was 28% greater (p < 0.05) than that of 975 +/- 139 ml.6 h(-1) with HDT. Muscular endurance (total work; maximal flexion-extension of the non-dominant knee at 180 degrees.s(-1) for 30 s) was not different between AC and the WI or HDT treatments. Shoulder-, knee-, and ankle-joint strength was unchanged except for three knee-joint peak torques: AC torque (120 degrees.s(-1), 285 +/- 20 Nm) decreased to 268 +/- 21 Nm (delta = -6%, p < 0.05) with WI; and AC torques (180 degrees.s(-1), 260 +/- 19 Nm) decreased to 236 +/- 15 Nm (delta = -9%, p < 0.01) with HDT, and to 235 +/- 19 Nm (delta = -10%, p < 0.01) with WI. CONCLUSION: Thus, the total body hypohydration threshold level for shoulder- and ankle-joint strength and endurance decrements is more than 2% body weight (water) loss, while significant reduction in knee-joint muscular strength-endurance occurred only at moderate (120 degrees.s(-1) and lighter (180 degrees.s(-1)) loads with body weight loss of 1.4-2.0% following WI or HDT, respectively. These weight (water) losses and knee-joint strength decrements are somewhat less than the mean weight loss of 2.6% and knee-joint strength decrements of 6-20% of American astronauts after Skylab flights to 84 d.

NASA Center ARC↗

NASA NTRS1996

The role of retinal versus perceived size in the effects of pitched displays on visually perceived eye level

Visually perceived eye level (VPEL) was measured while subjects viewed two vertical lines which were either upright or pitched about the horizontal axis. In separate conditions, the display consisted of a relatively large pair of lines viewed at a distance of 1 m, or a display scaled to one third the dimensions and viewed at a distance of either 1 m or 33.3 cm. The small display viewed at 33.3 cm produced a retinal image the same size as that of the large display at 1 m. Pitch of all three displays top-toward and top-away from the observer caused upward and downward VPEL shifts, respectively. These effects were highly similar for the large display and the small display viewed at 33.3 cm (ie equal retinal size), but were significantly smaller for the small display viewed at 1 m. In a second experiment, perceived size of the three displays was measured and found to be highly accurate. The results of the two experiments indicate that the effect of optical pitch on VPEL depends on the retinal image size of stimuli rather than on perceived size.

NASA Center ARC↗

NASA NTRS1996

Exercise thermoregulation after 6 h of chair rest, 6 degrees head-down bed-rest, and water immersion deconditioning in men

The purpose was to investigate the mechanism for the excessive exercise hyperthermia following deconditioning (reduction of physical fitness). Rectal (Tre) and mean skin (Tsk) temperatures and thermoregulatory responses were measured in six men [mean (SD) age, 32 (6) years; mass, 78.26 (5.80) kg; surface area, 1.95 (0.11) m2; maximum oxygen uptake (VO2max), 48 (6) ml.min-1.kg-1; whilst supine in air at dry bulb temperature 23.2 (0.6) degree C, relative humidity 31.1 (11.1)% and air speed 5.6 (0.1) m.min-1] during 70 min of leg cycle exercise [51 (4)% VO2max] in ambulatory control (AC), or following 6 h of chair rest (CR), 6 degree head-down bed rest (BR), and 20 degree (WI20) and 80 degree (WI80) foot-down water immersion [water temperature, 35.0 (0.1) degree C]. Compared with the AC exercise delta Tre [mean (SD) 0.77 (0.13) degree C (*P < 0.05), after WI80 0.96 (0.13) degree C*, and after WI20 1.03 (0.09) degree C*. All Tsk responded similarly to exercise: they decreased (NS) by 0.5-0.7 degree C in minutes 4-8 and equilibrated at +0.1 to +0.5 degree C at 60-70. Skin heat conductance was not different among the five conditions (range = 147-159 kJ.m-2.h-1.degree C-1). Results from an intercorrelation matrix suggested that total body sweat rate was more closely related to Tre at 70 min (Tre70) than limb sweat rate or blood flow. Only 36% of the variability in Tre70 could be accounted for by total sweating, and less than 10% from total body dehydration. It would appear that multiple factors are involved which may include change in sensitivity of thermo- and osmoreceptors.

NASA Discipline Regulatory Physiology↗

NASA NTRS1993

The effect of boron supplementation on lean body mass, plasma testosterone levels, and strength in male bodybuilders

The effect of boron supplementation was investigated in 19 male bodybuilders ages 20-27 years. Ten were given a 2.5-mg boron supplement while 9 were given a placebo every day for 7 weeks. Plasma total and free testosterone, plasma boron, lean body mass, and strength measurements were determined on Days 1 and 49 of the study. Plasma boron values were significantly (p < 0.05) different as the experimental group increased from (+/- SD) 20.1 +/- 7.7 ppb pretest to 32.6 +/- 27.6 ppb posttest, while the control group mean decreased from 15.1 +/- 14.4 ppb pretest to 6.3 +/- 5.5 ppb posttest. Analysis of variance indicated no significant effect of boron supplementation on any of the dependent variables. Both groups demonstrated significant increases in total testosterone, lean body mass, 1-RM squat, and 1-RM bench press. The findings suggest that 7 weeks of bodybuilding can increase total testosterone, lean body mass, and strength in lesser trained bodybuilders, and that boron supplementation had no effect on these measures.

Controlled Clinical Trial↗

NASA NTRS1994

Knee-joint proprioception during 30-day 6 degrees head-down bed rest with isotonic and isokinetic exercise training

To determine if daily isotonic exercise or isokinetic exercise training coupled with daily leg proprioceptive training, would influence leg proprioceptive tracking responses during bed rest (BR), 19 men (36 +/- SD 4 years, 178 +/- 7 cm, 76.8 +/- 7.8 kg) were allocated into a no-exercise (NOE) training control group (n = 5), and isotonic exercise (ITE, n = 7) and isokinetic exercise (IKE, n = 7) training groups. Exercise training was conducted during BR for two 30-min periods.d-1, 5 d.week-1. Only the IKE group performed proprioceptive training using a new isokinetic procedure with each lower extremity for 2.5 min before and after the daily exercise training sessions; proprioceptive testing occurred weekly for all groups. There were no significant differences in proprioceptive tracking scores, expressed as a percentage of the perfect score of 100, in the pre-BR ambulatory control period between the three groups. Knee extension and flexion tracking responses were unchanged with NOE during BR, but were significantly greater (*p < 0.05) at the end of BR in both exercise groups when compared with NOE responses (extension: NOE 80.7 +/- 0.7%, ITE 82.9* +/- 0.6%, IKE 86.5* +/- 0.7%; flexion: NOE 77.6 +/- 1.5%, ITE 80.0 +/- 0.8% (NS), IKE 83.6* +/- 0.8%). Although proprioceptive tracking was unchanged during BR with NOE, both isotonic exercise training (without additional proprioceptive training) and especially isokinetic exercise training when combined with daily proprioceptive training, significantly improved knee proprioceptive tracking responses after 30 d of BR.

Controlled Clinical Trial↗