In earlier posts I provided an overview of the various phases of the drug approval process. In a nutshell this consists of drug discovery, development, and testing. Across all of these phases various clinical trails are performed to test the drugs effects on people and how well the effectiveness of the drug.
These clinical trails that are a part of the overall drug development process consist of 3 distinct types:
Phase I Clinical Development (Human Pharmacology) – Thirty days after a biopharmaceutical company has filed its IND, it may begin a small-scale Phase I clinical trial unless the FDA places a hold on the study. Phase I studies are used to evaluate pharmacokinetic parameters and tolerance, generally in healthy volunteers. These studies include initial single-dose studies, dose escalation and short-term repeated-dose studies.
Phase II Clinical Development (Therapeutic Exploratory) – Phase II clinical studies are small-scale trials to evaluate a drug’s preliminary efficacy and side-effect profile in 100 to 250 patients. Additional safety and clinical pharmacology studies are also included in this category.
Phase III Clinical Development (Therapeutic Confirmatory) – Phase III studies are large-scale clinical trials for safety and efficacy in large patient populations. While phase III studies are in progress, preparations are made for submitting the Biologics License Application (BLA) or the New Drug Application (NDA). BLAs are currently reviewed by the FDA’s Center for Biologics Evaluation and Research (CBER). NDAs are reviewed
While the logistics of all types of trials are very similar, Phase III trials represent the most time consuming and expensive one of the three. These types of trials are meant to provide proof to the FDA on the actual effectiveness of the drug and can require thousands of test subjects and take years to complete. Out of the entire drug development process a significant portion of the expense is incurred in completing the Phase III tests.
Here is a brief synopsis of some of the issues and tasks involved in executing long term Phase III clinical trials:
- Protocol design – creating the overall design of the trial as to patient profiles, drug dosage, administration, tracking of patients, data capture, managing adverse events or side effects reporting, trial supply chain management
- Enrolling patients – in many cases thousands of patients are required to be involved in the trial to get the information required to obtain FDA approval
- Complex logistics – scheduling all of the patient visits and getting the test supplies and drug products to the research centers for administration to patients
- Geographically disperse – most trails are held in multiple locales with many companies are now performing clinical trials overseas
- Expensive – as mentioned before it can cost tens to hundreds of millions of dollars to complete a Phase III trial
- Time consuming – trials can run for years especially for drugs to be taken continuously for chronic disease conditions
- Patient data security – ensuring the security and integrity of the patients personal and health information
- Data access – providing appropriate and secure access to the data for the scientists, researchers and primary investigators
- Data management – all trials create large amounts of data including Case Report Forms (CRF’s) where the results of each patient interaction are recorded
- Regulatory compliance – ensuring that the supporting systems and processes meet both 21 CFR Part 11 and HIPAA regulatory compliance guidelines
To support large scale clinical trials, the life science CIO has to deal with the challenges of provisioning and supporting the necessary hardware and software infrastructure. While there are a number of applications on the market for managing clinical trials many life science companies are looking to cloud based offerings to reduce the complexity along with the time and expense for performing these trials.
Several companies are stepping into this space and providing cloud based SaaS applications that can drastically cut the time and costs required to put into place the systems and processes required to support the clinical trial process. Software companies, such as Cmed with their eClinical system, ClinPlus with their CTM application and Clinical Systems with their Clinical Trials Management Software package. To alleviate concerns about putting patient data in the public cloud many vendors are providing their applications via a private cloud where security, validation and data protection can be ensured and to only allow access to properly trained users as part of their Part 11 compliance efforts.
These cloud based clinical trails applications provide a number of advantages:
– No need to provision hardware and provide associated infrastructure
– Data security and disaster recovery are built in
– FDA compliance is a part of the overall environment
– Support and maintenance of the system is provided by the vendor
– Many of these systems are quickly configurable so that new trials and associated protocols can be quickly defined and made ready for use
– Centralized control of the entire environment
– Easier access for the sharing of data and results
By utilizing cloud based applications to facilitate phase 3 clinical trials life science CIO’s can drastically reduce both costs and time required to get new medications to market.