Curator Dashboard

To support Drug Development Tools development efforts, FDA established qualification programs for animal models for use under Animal Rule, biomarkers, and clinical outcome assessments. DDTs are methods, materials, or measures that have potential to facilitate drug development. Examples of DDTs may include, but are not limited to biomarker2 used for clinical trial enrichment, clinical outcome assessment used to evaluate clinical benefit, and animal model used for efficacy testing of medical countermeasures under regulations commonly referred to as Animal Rule3.

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• SciCrunch
• 13 years ago - by Anonymous

A collaboration to test an adaptive clinical trial model that would assess the efficacy of a candidate therapeutic earlier than traditional clinical trials, potentially enabling drugs to be developed and approved using fewer patients, less time and fewer resources. This trial focuses on women with newly diagnosed locally advanced breast cancer to test whether adding investigational drugs to standard chemotherapy is better than standard chemotherapy alone. It uses genetic and biological markers from individual patients' tumors to screen several promising new treatments simultaneously and allows doctors to quickly measure the effectiveness of the treatment prior to removing the tumor. The experimental adaptive trial design uses patient outcomes to immediately inform treatment options for subsequent trial participants. The trial has 5 components that differentiate it from conventional clinical trial models. # I-SPY2 uses tissue and imaging biomarkers from individual cancer patients' tumors to determine eligibility, guide/screen promising new treatments and identify which treatments are most effective in specific tumor subtypes. # The trial's adaptive design allows the Team to learn as they go, enabling researchers to use data from patients early in the trial to guide decisions about which treatments might be more useful for patients who enter the trial earlier. I-SPY2 provides a scientific basis for researchers to eliminate ineffective treatments and graduate effective treatments more quickly. # The neoadjuvant treatment approach - in which chemotherapy is given to patients prior to surgery - allow the team to evaluate tumor response with MRI before removal. This approach is safe as treating after surgery, allowing tumors to shrink, and more importantly, it enables critical learning early on about how well treatments work. # The ability for the team to screen multiple drug candidates developed by multiple companies. New agents will be selected and added as those used initially and either graduate to Phase III, or are dropped, based on their efficacy in targeted patients. # The trials informatics system allows data to be collected, verified, and shared in real-time. This allows data to be assessed early and in an integrated fashion - with an aim to enhance and encourage collaboration

• Organization
• Consortia-pedia, a FasterCures Project
• 13 years ago - by Anonymous

Project to develop a drug safety database from the pharmaceutical industry legacy toxicology reports and public toxicology data; innovative in silico strategies and novel software tools to better predict the toxicological profiles of small molecules in early stages of the drug development pipeline. The project is creating this pharmaco-toxicological database with an aim to: * Reduce the number of animal tests * Decrease the attrition rates of new drug candidates * Increase the success rate of new molecular entities becoming drugs * Improve the safety of drugs on the market The project consists of three different systems, * eTOX VITIC Database a unified database containing all confidential and non-confidential data collected in eTOX (historical data from the pharmaceutical industry) * ChOX Database a unified database containing public data (literature and public database) * eTOXsys Query and Prediction System an interface providing a uniform access to the two databases (VITIC and ChOX) and to all developed prediction models and systems

• Organization
• Consortia-pedia, a FasterCures Project
• 13 years ago - by Anonymous

Consortium to identify, fund and support breakthrough technologies that will significantly enhance biopharmaceutical R&D productivity and accelerate the development of new safe and efficacious drugs. CQDM is a neutral ground that brings patient groups, academia, governments, biotech and the pharma industry together to work collaboratively on complex medical challenges. Projects supported by the consortium are highly relevant to the pharmaceutical sector and typically address: * Opportunity for new therapeutic approaches and research * Safe and effective new drug development * Enhancing the efficacy of already existing drugs * Reducing costs, time and risks associated with the discovery and development of new drugs Funded projects typically involve multidisciplinary collaborations between research teams that represent both the academic and the private sector, who are mentored by industry scientists provided by the consortium sponsors.

• Organization
• Consortia-pedia, a FasterCures Project
• 13 years ago - by Anonymous

A non-profit consortium of Boston academic medical centers and universities (and growing) to accelerate the healthcare innovation cycle by fostering interdisciplinary, inter-institutional collaboration among experts in translational research, medicine, science, engineering, healthcare implementation and entrepreneurship in concert with industry, foundations and government to rapidly improve patient care. It concentrates on early stage, high-risk ideas, projects and supports them through to a commercial exit from academia. It provides innovators with resources to explore, develop and implement novel technological solutions for today's most urgent healthcare problems. CIMIT is dedicated to helping develop medical technology that will help both military and civilian patients.

• Organization
• Consortia-pedia, a FasterCures Project
• 13 years ago - by Anonymous

Urinary kidney biomarkers (KIM-1, albumin, total protein, 2-microglobulin, cystatin C, clusterin and trefoil factor-3) that are considered acceptable biomarkers for the detection of acute drug-induced nephrotoxicity in rats and can be included along with traditional clinical chemistry markers and histopathology in toxicology studies. These biomarkers may be used voluntarily as additional evidence of nephrotoxicity in nonclinical safety assessment studies to complement the standard data (BUN and sCr). In ROC analyses, some of these biomarkers showed better sensitivity and specificity than BUN and sCr relative to histopathological alterations considered to be the gold standard when tested with a limited number of nephrotoxicant and control compounds.

• Resource
• SciCrunch
• 13 years ago - by Anonymous

Project designing, prototyping, optimizing, and evaluating a learning health system to improve clinical practice, patient self-management, and disease outcomes of patients with chronic illness. This open, peer production system combines the collective input of patients, clinicians and researchers. It combines large clinical data registries with patient entered data and makes them accessible and interactive. A platform allows researchers to design, test and implement new knowledge and innovations in patient care. To test their platform approach, C3N is working on a model of treating children with Inflammatory Bowel Disease using the ImproveCareNow Network of pediatric clinics. Following this demonstration phase, the goal is to apply the social, scientific and technical platform to transform the care of a variety of chronic illnesses. The C3N effort has the following goals: # Deploy and optimize an integrated set of engagement tools to make it easier for patients and care providers to collect and use the right information during the clinical encounter and in between visits. # Prototype novel interventions to re-design care delivery by promoting the development of tools for real-time and dynamic population management, "just-in time" scheduling of visits, virtual clinic visits, and measuring the impact of these interventions on health, care, and cost. # Pilot and deploy patient-focused technology to improve the flow of data between patients, clinicians and scientists to enable faster learning and improvement.

• Organization
• Consortia-pedia, a FasterCures Project
• 13 years ago - by Anonymous

Data set of standardized terms used to describe human morphology including definitions of terms for the craniofacies in general, the major components of the face, and the hands and feet. This provides a uniform and internationally accepted terms to describe the human phenotype.

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• SciCrunch
• 13 years ago - by Anonymous

A collaborative network among university-led drug discovery centers and programs to allow scientists to exchange technical expertise on drug discovery and development strategies as well as form partnerships with each other, biopharma companies, and drug discovery-focused contract service organizations and consultants. The website will also serve as a repository for drug discovery events, educational material, job postings, and partnership opportunities. Through active member participation this website will become a valuable tool for every scientist working in the drug discovery arena. In addition, involvement of members will enable them to effectively advocate to the NIH and other funding agencies to increase the awareness of the growing number of academic drug discovery scientists and their success as well as their needs.

• Organization
• Consortia-pedia, a FasterCures Project
• 13 years ago - by Anonymous

Project that aims to provide structure and clarity to the research-by-consortium model, presenting both the consortia framework and partnership components in an effort to guide and inform emerging and existing collaborative efforts. Their goal is to ensure that research-by-consortium efforts are at their highest performance and achieving the best possible outcomes. A consortium will thrive if its leadership and governance structure is able to define a mission that's shared by all stakeholders and articulate the desired outcomes of the effort early in the process. For collaborative efforts to move forward, consortia must recognize and leverage the unique strengths and resources that each partner can contribute and bring to fruition. They have found that managing expectations and establishing transparency measures are essential to building trust among all participating stakeholders. Transparency curbs potential conflicts of interest and creates a culture that allows for open sharing of data and a responsible approach to intellectual property negotiations. They found that for collaborations in the medical research and development ecosystem to be effective and sustainable, they must be driven by the ultimate goal of delivering a medical solution that could improve or save lives. Through the project, they are creating several tools for the biomedical research community: * Framework report: This series of reports analyzes a diversity of existing consortia to understand the operational management and framework used to initiate and manage these complex collaborations. * Consortium database * Landscape analysis trends and intended output * Educational webinars and spotlights

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• SciCrunch
• 13 years ago - by Anonymous

Data sets of information regarding the health and well-being of older persons in Taiwan (from 2000 and 2006), in particular the relationship between life challenges and mental and physical health, the impact of social environment on the health and well-being of the elderly, and biological markers of health and stress. The study collected self-reports of physical, psychological, and social well-being, plus extensive clinical data based on medical examinations and laboratory analyses. Examination of health outcomes included chronic illnesses, functional status, psychological well-being, and cognitive function. Questions regarding life challenges focused on perceived stress, economic difficulties, security and safety, and the consequences of a major earthquake. Biological markers were used to identify cardiovascular risk factors, metabolic process measures, immune-system activity, the hypothalamic-pituitary adrenal axis, and sympathetic nervous system activity. The study design consists of face-to-face interviews with participants drawn from a random sub-sample of participants from 27 PSUs from the 1999 Survey of Health and Living Status of the Middle Aged and Elderly in Taiwan. Hospital visits and blood and urine specimens also were collected. A second wave of SEBAS was conducted in 2006 using a similar protocol to SEBAS 2000, but with the addition of performance assessments conducted by the interviewers at the end of the home interview. * Dates of Study: -2000, 2006 * Study Features: Longitudinal, International, Anthropometric Measures * Sample Size: 27 PSUs

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• SciCrunch
• 13 years ago - by Anonymous

Assessment test imposing strict guidelines for administration and scoring to improve the reliability of the Mini-Mental State Examination (MMSE), a screening test for the purpose of evaluating cognitive impairment in older adults.

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• SciCrunch
• 13 years ago - by Anonymous

4-item questionnaire, where the name is an acronym of its four questions, that can indicate potential problems with alcohol abuse and has been extensively validated for use in identifying alcoholism. It has been determined that CAGE test scores >=2 had a specificity of 76% and a sensitivity of 93% for the identification of excessive drinking and a specificity of 77% and a sensitivity of 91% for the identification of alcoholism. The most important question in the questionnaire is the use of a drink as an Eye Opener, so much so that some clinicians use a yes to this question alone as a positive to the questionnaire; this is due to the fact that the use of an alcoholic drink as an Eye Opener denotes abuse since the patient is going through withdrawal in the morning, hence the need for a drink as an Eye Opener.(Adapted from Wikipedia) Scoring: * 2 (or more) yes responses indicates the possibility of alcoholism

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• SciCrunch
• 13 years ago - by Anonymous

A test to measure narcissism as a personality trait in social psychological research. Although there are several versions, a forty-item forced-choice version (Raskin & Terry 1988) is the one most commonly employed in current research. It is based on the DSM-III clinical criteria for narcissistic personality disorder (NPD), although it was designed to measure these features in the general population. Thus, the NPI is often said to measure normal or subclinical (borderline) narcissism (i.e., in people who score very high on the NPI do not necessarily meet criteria for diagnosis with NPD). Raskin and Terry (1988) identified seven factors of the NPI (i.e., Authority, superiority, exhibitionism, entitlement, vanity, exploitativeness and self-sufficiency), mapping roughly onto the DSM criteria for NPD. Since then, several studies have further examined the factor structure of the NPI with varying results. It should take most people five to ten minutes to complete.

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• SciCrunch
• 13 years ago - by Anonymous

An eleven-item, multiple-choice diagnostic questionnaire which psychiatrists use to measure the severity of manic episodes in patients. The scale was originally developed for use in the evaluation of adult patients who were suffering from bipolar disorder, but has since been modified for use in pediatric patients. A similar scale was then developed to allow clinicians to interview parents about their children's symptoms, in order to ascertain a better diagnosis of mania in children. Clinical studies have demonstrated the effectiveness of the parent version of the scale. The scale provided is in a slightly reworded form as a self-assessment. This may not be as accurate when self-administered, as people suffering from mania are often unable to properly assess relevant outward symptoms.

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• SciCrunch
• 13 years ago - by Anonymous

A 5-item self-reported diagnostic scale used to assess the presence and severity manic and hypomanic symptoms, most commonly in patients diagnosed with bipolar disorder. It assesses differences in normal or baseline levels in five subjective and behavioral areas: positive mood, self-confidence, sleep patterns, speech patterns / amount of sleep, and motor activity. Scores above a 5 are indicative of mania, or hypomania, with the severity of symptoms increasing with higher scores. Examining score changes over time is also used to determine the efficacy of a particular treatment in a clinical setting and to qualify whether the severity a manic episode is increasing or decreasing. (Adapted from Wikipedia) Scoring: * 0-5 Normal * 6-25 Probable Manic or Hypomanic Condition, Further Testing Recommended

• Resource
• SciCrunch
• 13 years ago - by Anonymous

A collaboration of international pharmaceutical companies, public health experts, civil society organizations, and U.S., European, and other regulatory authorities to speed the development of new and improved drug regimens for tuberculosis (TB). Its goals include creating innovative tools, including TB data standards and databases. The Initiative is built around four operating arms: Regulatory Science Consortium, Drug Development Coalition, Research Resources Group, and Drug Susceptibility Testing Group. The focus of the consortium is to: * Develop and integrate data standards * Qualify biomarkers through the Food and Drug Administration (FDA) / European Medicines Authority (EMA) * Develop quantitative disease progression (natural history) models * Create disease response metrics, develop target product profiles and supporting assays, and * Develop new pharmacokinetic/dynamic measures of drug interactions Accomplishments include: * Engaged the FDA, which has released updated regulatory guide-lines for developing new TB drug regimens with efforts to create a more favorable environment for combination regimen development * TB Alliance launched the first-ever clinical trial of a novel combination drug regimen for TB, validating the approach to regimen development set forth by CPTR, and is moving to a phase III clinical trial named STAND. * Developed and published TB data standards in collaboration with the Clinical Data Interchange Standards Consortium (CDISC). * Expanded scope to include the CPTR Rapid Drug Susceptibility Testing (RDST) Consortium and an expanded Modeling and Simulation development program. * Pursued several regulatory pathways with the FDA for the Hollow Fiber System Model for TB (HFS-TB). * Submitted a dossier to the EMA on the HFS-TB for qualification opinion consideration. * Submitted a "briefing book" to the FDA via the pre-IND process to review CPTR's data analysis plan and data inventory for liquid culture, with emphasis on time-to-positivity, as a quantitative measure of long-term outcome. * Initiated planning to develop a database supporting the RDST Consortium's goal to develop a rapid TB drug susceptibility test.

• Organization
• Consortia-pedia, a FasterCures Project
• 13 years ago - by Anonymous

An Antibody supplier

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• SciCrunch
• 14 years ago - by Anonymous

A self-report questionnaire used to assess the presence of eating disorders, anorexia nervosa, bulimia nervosa, and eating disorder not otherwise specified including Binge Eating Disorder (BED). The original questionnaire consisted of 64 questions, divided into eight subscales. There have been two subsequent revisions by Garner; Eating disorder inventory-two (EDI-2) and Eating disorder inventory-three (EDI-3). (Adapted from Wikipedia) The EDI-3 consists of 91 items organized into 12 primary scales: Drive for Thinness, Bulimia, Body Dissatisfaction, Low Self-Esteem, Personal Alienation, Interpersonal Insecurity, Interpersonal Alienation, Interoceptive Deficits, Emotional Dysregulation, Perfectionism, Asceticism, and Maturity Fears.

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• SciCrunch
• 13 years ago - by Anonymous

A widely used standardized self-report measure of symptoms and concerns characteristic of eating disorders. The original 40-item version was developed for a study to examine socio-cultural factors in the development and maintenance of eating disorders. A 26-item refinement of the original test has been made and it has been translated into many different languages and used in hundreds of studies. The EAT-26 has been useful as a screening tool to assess eating disorder risk in high school, college and other special risk samples such as athletes. It can be used in a non-clinical as well as a clinical setting not specifically focused on eating disorders. It can be administered in group or individual settings and is designed to be administered by mental health professionals, school counselors, coaches, camp counselors, and others with interest in gathering information to determine if an individual should be referred to a specialist for evaluation for an eating disorder. It is intended primarily for adolescents and adults. The EAT-26 should be used as the first step in a two-stage screening process. According to this methodology, individuals who score 20 or more on the test should be interviewed by a qualified professional to determine if they meet the diagnostic criteria for an eating disorder. The tests are rated on a six-point scale in response to how often the individual engages in specific behaviors. (adapted from Wikipedia)

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• SciCrunch
• 13 years ago - by Anonymous