Managing Clinical Trials in the Cloud

By Bruce Maches

August 24, 2010

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.

 

Subscribe to HPCwire's Weekly Update!

Be the most informed person in the room! Stay ahead of the tech trends with industy updates delivered to you every week!

Trinity Supercomputer’s Haswell and KNL Partitions Are Merged

July 19, 2017

Trinity supercomputer’s two partitions – one based on Intel Xeon Haswell processors and the other on Xeon Phi Knights Landing – have been fully integrated are now available for use on classified work in the Nationa Read more…

By HPCwire Staff

Fujitsu Continues HPC, AI Push

July 19, 2017

Summer is well under way, but the so-called summertime slowdown, linked with hot temperatures and longer vacations, does not seem to have impacted Fujitsu's output. The Japanese multinational has made a raft of HPC and A Read more…

By Tiffany Trader

Researchers Use DNA to Store and Retrieve Digital Movie

July 18, 2017

From abacus to pencil and paper to semiconductor chips, the technology of computing has always been an ever-changing target. The human brain is probably the computer we use most (hopefully) and understand least. This mon Read more…

By John Russell

The Exascale FY18 Budget – The Next Step

July 17, 2017

On July 12, 2017, the U.S. federal budget for its Exascale Computing Initiative (ECI) took its next step forward. On that day, the full Appropriations Committee of the House of Representatives voted to accept the recomme Read more…

By Alex R. Larzelere

HPE Extreme Performance Solutions

HPE Servers Deliver High Performance Remote Visualization

Whether generating seismic simulations, locating new productive oil reservoirs, or constructing complex models of the earth’s subsurface, energy, oil, and gas (EO&G) is a highly data-driven industry. Read more…

Summer Reading: IEEE Spectrum’s Chip Hall of Fame

July 17, 2017

Take a trip down memory lane – the Mostek MK4096 4-kilobit DRAM, for instance. Perhaps processors are more to your liking. Remember the Sh-Boom processor (1988), created by Russell Fish and Chuck Moore, and named after Read more…

By John Russell

Women in HPC Luncheon Shines Light on Female-Friendly Hiring Practices

July 13, 2017

The second annual Women in HPC luncheon was held on June 20, 2017, during the International Supercomputing Conference in Frankfurt, Germany. The luncheon provides participants the opportunity to network with industry lea Read more…

By Tiffany Trader

Satellite Advances, NSF Computation Power Rapid Mapping of Earth’s Surface

July 13, 2017

New satellite technologies have completely changed the game in mapping and geographical data gathering, reducing costs and placing a new emphasis on time series and timeliness in general, according to Paul Morin, directo Read more…

By Ken Chiacchia and Tiffany Jolley

Intel Skylake: Xeon Goes from Chip to Platform

July 13, 2017

With yesterday’s New York unveiling of the new “Skylake” Xeon Scalable processors, Intel made multiple runs at multiple competitive threats and strategic markets. Skylake will carry Intel's flag in the fight for le Read more…

By Doug Black

Fujitsu Continues HPC, AI Push

July 19, 2017

Summer is well under way, but the so-called summertime slowdown, linked with hot temperatures and longer vacations, does not seem to have impacted Fujitsu's out Read more…

By Tiffany Trader

Researchers Use DNA to Store and Retrieve Digital Movie

July 18, 2017

From abacus to pencil and paper to semiconductor chips, the technology of computing has always been an ever-changing target. The human brain is probably the com Read more…

By John Russell

The Exascale FY18 Budget – The Next Step

July 17, 2017

On July 12, 2017, the U.S. federal budget for its Exascale Computing Initiative (ECI) took its next step forward. On that day, the full Appropriations Committee Read more…

By Alex R. Larzelere

Women in HPC Luncheon Shines Light on Female-Friendly Hiring Practices

July 13, 2017

The second annual Women in HPC luncheon was held on June 20, 2017, during the International Supercomputing Conference in Frankfurt, Germany. The luncheon provid Read more…

By Tiffany Trader

Satellite Advances, NSF Computation Power Rapid Mapping of Earth’s Surface

July 13, 2017

New satellite technologies have completely changed the game in mapping and geographical data gathering, reducing costs and placing a new emphasis on time series Read more…

By Ken Chiacchia and Tiffany Jolley

Intel Skylake: Xeon Goes from Chip to Platform

July 13, 2017

With yesterday’s New York unveiling of the new “Skylake” Xeon Scalable processors, Intel made multiple runs at multiple competitive threats and strategic Read more…

By Doug Black

Perverse Incentives? How Economics (Mis-)shaped Academic Science

July 12, 2017

The unintended consequences of how we fund academic research—in the U.S. and elsewhere—are strangling innovation, putting universities into debt and creatin Read more…

By Ken Chiacchia, Senior Science Writer, Pittsburgh Supercomputing Center

Why Tech is Failing at Diversity and How It Can Succeed

July 11, 2017

The sectors that are supposed to be all about innovation and the future continue to fail spectacularly at gender equity and diversity. UK, US and Canada still haven’t managed to break the average 20 percent threshold for gender equity across STEM academic disciplines. Read more…

By Kelly Nolan

HPC Compiler Company PathScale Seeks Life Raft

March 23, 2017

HPCwire has learned that HPC compiler company PathScale has fallen on difficult times and is asking the community for help or actively seeking a buyer for its a Read more…

By Tiffany Trader

Quantum Bits: D-Wave and VW; Google Quantum Lab; IBM Expands Access

March 21, 2017

For a technology that’s usually characterized as far off and in a distant galaxy, quantum computing has been steadily picking up steam. Just how close real-wo Read more…

By John Russell

Google Pulls Back the Covers on Its First Machine Learning Chip

April 6, 2017

This week Google released a report detailing the design and performance characteristics of the Tensor Processing Unit (TPU), its custom ASIC for the inference Read more…

By Tiffany Trader

Nvidia Responds to Google TPU Benchmarking

April 10, 2017

Nvidia highlights strengths of its newest GPU silicon in response to Google's report on the performance and energy advantages of its custom tensor processor. Read more…

By Tiffany Trader

Trump Budget Targets NIH, DOE, and EPA; No Mention of NSF

March 16, 2017

President Trump’s proposed U.S. fiscal 2018 budget issued today sharply cuts science spending while bolstering military spending as he promised during the cam Read more…

By John Russell

CPU-based Visualization Positions for Exascale Supercomputing

March 16, 2017

In this contributed perspective piece, Intel’s Jim Jeffers makes the case that CPU-based visualization is now widely adopted and as such is no longer a contrarian view, but is rather an exascale requirement. Read more…

By Jim Jeffers, Principal Engineer and Engineering Leader, Intel

Nvidia’s Mammoth Volta GPU Aims High for AI, HPC

May 10, 2017

At Nvidia's GPU Technology Conference (GTC17) in San Jose, Calif., this morning, CEO Jensen Huang announced the company's much-anticipated Volta architecture a Read more…

By Tiffany Trader

Facebook Open Sources Caffe2; Nvidia, Intel Rush to Optimize

April 18, 2017

From its F8 developer conference in San Jose, Calif., today, Facebook announced Caffe2, a new open-source, cross-platform framework for deep learning. Caffe2 is the successor to Caffe, the deep learning framework developed by Berkeley AI Research and community contributors. Read more…

By Tiffany Trader

Leading Solution Providers

How ‘Knights Mill’ Gets Its Deep Learning Flops

June 22, 2017

Intel, the subject of much speculation regarding the delayed, rewritten or potentially canceled “Aurora” contract (the Argonne Lab part of the CORAL “ Read more…

By Tiffany Trader

MIT Mathematician Spins Up 220,000-Core Google Compute Cluster

April 21, 2017

On Thursday, Google announced that MIT math professor and computational number theorist Andrew V. Sutherland had set a record for the largest Google Compute Engine (GCE) job. Sutherland ran the massive mathematics workload on 220,000 GCE cores using preemptible virtual machine instances. Read more…

By Tiffany Trader

Reinders: “AVX-512 May Be a Hidden Gem” in Intel Xeon Scalable Processors

June 29, 2017

Imagine if we could use vector processing on something other than just floating point problems.  Today, GPUs and CPUs work tirelessly to accelerate algorithms Read more…

By James Reinders

Google Debuts TPU v2 and will Add to Google Cloud

May 25, 2017

Not long after stirring attention in the deep learning/AI community by revealing the details of its Tensor Processing Unit (TPU), Google last week announced the Read more…

By John Russell

Russian Researchers Claim First Quantum-Safe Blockchain

May 25, 2017

The Russian Quantum Center today announced it has overcome the threat of quantum cryptography by creating the first quantum-safe blockchain, securing cryptocurrencies like Bitcoin, along with classified government communications and other sensitive digital transfers. Read more…

By Doug Black

Groq This: New AI Chips to Give GPUs a Run for Deep Learning Money

April 24, 2017

CPUs and GPUs, move over. Thanks to recent revelations surrounding Google’s new Tensor Processing Unit (TPU), the computing world appears to be on the cusp of Read more…

By Alex Woodie

Top500 Results: Latest List Trends and What’s in Store

June 19, 2017

Greetings from Frankfurt and the 2017 International Supercomputing Conference where the latest Top500 list has just been revealed. Although there were no major Read more…

By Tiffany Trader

Six Exascale PathForward Vendors Selected; DoE Providing $258M

June 15, 2017

The much-anticipated PathForward awards for hardware R&D in support of the Exascale Computing Project were announced today with six vendors selected – AMD Read more…

By John Russell

  • arrow
  • Click Here for More Headlines
  • arrow
Share This