IND-ENABLINg
VIRTUAL Clinical Trials
IND-enabling virtual patient clinical trials use publicly verified clinical-scale human disease models to evaluate the clinical efficacy of investigational new drugs at pre-IND stage as effectively as human clinical trials.
How to reliably know the clinical efficacy of investigational new drugs at the pre-IND stage?
With publicly verified clinical-scale human disease models, virtual clinical trials can be conducted at pre-IND stage that are as effective as human clinical trials when it comes to statistically determine the clinical efficacy of investigational new drugs.
G O L D
STANDARD
Prospective public prediction of ongoing phase 2 and phase 3 clinical trial outcomes is the accepted gold standard for validating disease models as a substitution for human patients in clinical trials.
118 public prospective predictions of clinical trial outcomes is the minimum sample size to determine the accuracy of disease models with 99% Confidence Interval (CI).
Pre-IND pivotal clinical trials with Virtual Patients validated as effective as human patients
Having achieved 84.4% accuracy with 99% CI, DemiurgeTech's virtual patients are statistically as effective as human patients when it comes to determining the clinical efficacy of investigational new drugs at pre-IND stage.
CEOs/CFOs of biopharma companies and GPs of healthcare funds can make go/no-go decision-making based on preclinical assets' clinical efficacy determined by virtual patient clinical trials statistically as effective as human clinical trials.
DemiurgeTech is the first and only company worldwide that has surpassed the 99% CI sample size with a 280+ public prospective predictions published since February 2020.
The runner-up company worldwide has published only 6 public prospective predictions published since 2020.
DemiurgeTech is the first and only company worldwide that have demonstrated 84.4% prediction accuracy (130/154) with an 22-month-long publicly verificable track record.
The runner-up company worldwide has demonstrated 50% prediction accuracy (2/4) without statistical power.
85.1% is the theoretical maximal prediction accuracy of drug clinical efficacy by human clinical trials (Burt et al. 2017 Clinical and Translational Science).
Having achieved 84.4% accuracy with 99% CI, DemiurgeTech's disease models are statistically as effective as human patients when it comes to determining the clinical efficacy of investigational new drugs at pre-IND stage.
What are the inputs and outputs of IND-enabling virtual patient clinical trials?
Non-confidential drug mechanism of action data are the only type of user input necessary for running IND-enabling virtual clinical trials.
Neither proprietary drug data nor proprietary clinical data are needed for running IND-enabling virtual clinical trials (see our COVID-19 IND-enabling virtual clinical trials).
Users can further specify indications, phases and other parameters of IND-enabling virtual clinical trials.
Binary success/failure outcomes are the only type of outputs from IND-enabling virtual clinical trials, which are the most friendly and actionable results for leaders to make go/no-go decisions.
What are the therapeutic areas for IND-enabling virtual patient clinical trials?
90% indications from all major therapeutic areas, including cancer, CNS, diabetes, dermatology, cardiovascular diseases, infectious diseases, gastrointestinal diseases, metabolic diseases, respiratory diseases, muscular disorders, pain, urologic diseases, ophthalmic disorders, otic disorders, transplantation, etc., but excluding genetic diseases and haematological diseases.
