The pharmaceutical industry faces several persistent issues that make clinical trials operations overtly costly, time consuming, complex and inefficient. The costs associated with trials are spiralling as pharmaceutical companies invest, on average, more than USD 2.5 billion to develop a new medicine. By developing a range of applications that focus on digital security, QCM-based data analysis, and electronic automated data collection, GENUTEX aims to enhance the speed, safety, and analysis of clinical trials whilst dramatically reducing costs.
To achieve this goal, GENUTEX has designed a QCM-driven clinical trials solution with blockchain-encrypted electronic data collection, management, and analysis combined with product authentication capabilities. The Vaultex™ technology platform offers unique insights into clinical trial data by analysing linear and non-linear relationships within large, often incomplete, biometric data-sets collected during the testing phases of pharmaceutical development. Based on proven, proprietary QCM technology, the solution is also capable of detecting the early onset of some medical conditions and would greatly benefit patients where the administration of prophylactic medication would significantly reduce the severity of a condition or even prevent it from occurring.
Vaultex™ MedTech platform – Key points
- Vaultex™ is a data capture, aggregation and analytics MedTech platform built for the pharmaceutical industry and capable of providing unrivalled pharmacovigilant and drug efficacy insights through QCM-driven multidimensional non-linear data analysis;
- Vaultex™ is to be hosted in the most secure, scalable environment, using cutting-edge hybrid blockchain technology for the collection, analysis and dissemination of sensitive patient data and product authentication to our clients (i.e. clinical research organisations and end-user patients);
- Vaultex™ incorporates our proven, proprietary QCM-based Artificial Intelligence Data Analytics (AIDA) module capable of processing vast quantities of biometric data including clinical trial data retrieved through ‘smart’ wearables and fed directly to our cloud-based Vaultex platform;
Genutex’s highly sophisticated data analytics will allow pharmaceutical companies to interrogate their data more thoroughly than ever before. Vaultex™ aims to be the first clinical trials software solution to leverage the advantages of distributed ledger technology and smart contracts with proven AI-based data analytics to monitor and control clinical trials across all four phases of drug development.
Below, examples of QCM-generated pharma sales maps, show interdependencies between consumption trends and indicate “hubs”.
Clinical trials involve multiple parties and intermediaries such as: patients, pharma companies, Contract Research Organisations (CROs), hospitals, doctors, investigators and regulators. The common “value item” that runs through all aspects of drug development is data. Data is used to determine if a drug is safe and effective, and if a marketing authorisation should be granted and maintained. Finding an efficient and secure way to coordinate and collect, evaluate and disseminate data can save drug developers vast amounts of money and time and potentially save the lives of those who take the drugs if approved in time.
Pharmaceutical companies and CRO’s conduct clinical trials to demonstrate the safety and efficacy of newly developed treatments with the objective of gaining regulatory approval from the Food and Drug Administration (US), the European Medicines Agency (EU) and other relevant regulatory authorities around the world. Recent data suggested that less than 20% percent of drugs are approved so the earlier one can detect a failure through rapid and accurate data analysis, the more money is saved. Conversely, more rapid and accurate data analysis can speed up the approval of a successful drug. The following represents a summary of the regulatory phases of drug approval.
Phase 1 trials assess the safety of a drug in the initial phase of testing, which can take several months to complete, and usually includes a small number of healthy volunteers (20 to 100) who are often paid for participating in a study. Phase I testing aims to determine the effects of the drug or device on humans including how it is absorbed, metabolized, and excreted. This phase also investigates the side effects that occur as dosage levels are increased. About 70% of experimental drugs pass this phase of testing.
Phase II trials test the efficacy of a drug or device and can last from several months to two years and often involve several hundred patients. Most phase II studies are randomized trials where one group of patients receives the experimental drug, while a second “control” group receives a standard treatment or placebo. Often these studies are “blinded” which means that neither the patients nor the researchers know who has received the experimental drug. This allows investigators to provide the pharmaceutical company and the regulator with comparative information about the relative safety and effectiveness of the new drug. About one-third of experimental drugs successfully complete both Phase I and Phase II studies.
Phase III trials involve randomised and blind testing in several hundred to several thousand patients. This largescale and often global testing can last several years and provides the pharmaceutical company and the regulator with a more thorough understanding of the effectiveness of the drug or device, its benefits, and the range of possible adverse reactions. Approximately 70% of drugs that enter Phase III studies successfully complete this phase of testing. Once Phase III is complete, a pharmaceutical company can request regulatory approval for marketing the drug.
Phase IV studies, often called ‘Post Marketing Surveillance Trials’, are conducted after a drug or device has been approved for consumer sale. Pharmaceutical companies have several objectives at this stage:
1. Compare their drug with similar drugs already in the market;
2. Monitor a drug’s long-term effectiveness and impact on a patient’s quality of life; and,
3. Determine the cost-effectiveness of a drug therapy relative to other traditional and new therapies. Phase IV studies can result in a drug or device being taken off the market or restrictions of use being placed on it.