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!

UCSD, AIST Forge Tighter Alliance with AI-Focused MOU

January 18, 2018

The rich history of collaboration between UC San Diego and AIST in Japan is getting richer. The organizations entered into a five-year memorandum of understanding on January 10. The MOU represents the continuation of a 1 Read more…

By Tiffany Trader

New Blueprint for Converging HPC, Big Data

January 18, 2018

After five annual workshops on Big Data and Extreme-Scale Computing (BDEC), a group of international HPC heavyweights including Jack Dongarra (University of Tennessee), Satoshi Matsuoka (Tokyo Institute of Technology), Read more…

By John Russell

Researchers Measure Impact of ‘Meltdown’ and ‘Spectre’ Patches on HPC Workloads

January 17, 2018

Computer scientists from the Center for Computational Research, State University of New York (SUNY), University at Buffalo have examined the effect of Meltdown and Spectre security updates on the performance of popular H Read more…

By Tiffany Trader

HPE Extreme Performance Solutions

HPE and NREL Take Steps to Create a Sustainable, Energy-Efficient Data Center with an H2 Fuel Cell

As enterprises attempt to manage rising volumes of data, unplanned data center outages are becoming more common and more expensive. As the cost of downtime rises, enterprises lose out on productivity and valuable competitive advantage without access to their critical data. Read more…

Fostering Lustre Advancement Through Development and Contributions

January 17, 2018

Six months after organizational changes at Intel's High Performance Data (HPDD) division, most in the Lustre community have shed any initial apprehension around the potential changes that could affect or disrupt Lustre Read more…

By Carlos Aoki Thomaz

UCSD, AIST Forge Tighter Alliance with AI-Focused MOU

January 18, 2018

The rich history of collaboration between UC San Diego and AIST in Japan is getting richer. The organizations entered into a five-year memorandum of understandi Read more…

By Tiffany Trader

New Blueprint for Converging HPC, Big Data

January 18, 2018

After five annual workshops on Big Data and Extreme-Scale Computing (BDEC), a group of international HPC heavyweights including Jack Dongarra (University of Te Read more…

By John Russell

Researchers Measure Impact of ‘Meltdown’ and ‘Spectre’ Patches on HPC Workloads

January 17, 2018

Computer scientists from the Center for Computational Research, State University of New York (SUNY), University at Buffalo have examined the effect of Meltdown Read more…

By Tiffany Trader

Fostering Lustre Advancement Through Development and Contributions

January 17, 2018

Six months after organizational changes at Intel's High Performance Data (HPDD) division, most in the Lustre community have shed any initial apprehension aroun Read more…

By Carlos Aoki Thomaz

When the Chips Are Down

January 11, 2018

In the last article, "The High Stakes Semiconductor Game that Drives HPC Diversity," I alluded to the challenges facing the semiconductor industry and how that may impact the evolution of HPC systems over the next few years. I thought I’d lift the covers a little and look at some of the commercial challenges that impact the component technology we use in HPC. Read more…

By Dairsie Latimer

How Meltdown and Spectre Patches Will Affect HPC Workloads

January 10, 2018

There have been claims that the fixes for the Meltdown and Spectre security vulnerabilities, named the KPTI (aka KAISER) patches, are going to affect applicatio Read more…

By Rosemary Francis

Momentum Builds for US Exascale

January 9, 2018

2018 looks to be a great year for the U.S. exascale program. The last several months of 2017 revealed a number of important developments that help put the U.S. Read more…

By Alex R. Larzelere

ANL’s Rick Stevens on CANDLE, ARM, Quantum, and More

January 8, 2018

Late last year HPCwire caught up with Rick Stevens, associate laboratory director for computing, environment and life Sciences at Argonne National Laboratory, f Read more…

By John Russell

Inventor Claims to Have Solved Floating Point Error Problem

January 17, 2018

"The decades-old floating point error problem has been solved," proclaims a press release from inventor Alan Jorgensen. The computer scientist has filed for and Read more…

By Tiffany Trader

US Coalesces Plans for First Exascale Supercomputer: Aurora in 2021

September 27, 2017

At the Advanced Scientific Computing Advisory Committee (ASCAC) meeting, in Arlington, Va., yesterday (Sept. 26), it was revealed that the "Aurora" supercompute Read more…

By Tiffany Trader

Japan Unveils Quantum Neural Network

November 22, 2017

The U.S. and China are leading the race toward productive quantum computing, but it's early enough that ultimate leadership is still something of an open questi Read more…

By Tiffany Trader

AMD Showcases Growing Portfolio of EPYC and Radeon-based Systems at SC17

November 13, 2017

AMD’s charge back into HPC and the datacenter is on full display at SC17. Having launched the EPYC processor line in June along with its MI25 GPU the focus he Read more…

By John Russell

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

IBM Begins Power9 Rollout with Backing from DOE, Google

December 6, 2017

After over a year of buildup, IBM is unveiling its first Power9 system based on the same architecture as the Department of Energy CORAL supercomputers, Summit a Read more…

By Tiffany Trader

Fast Forward: Five HPC Predictions for 2018

December 21, 2017

What’s on your list of high (and low) lights for 2017? Volta 100’s arrival on the heels of the P100? Appearance, albeit late in the year, of IBM’s Power9? Read more…

By John Russell

GlobalFoundries Puts Wind in AMD’s Sails with 12nm FinFET

September 24, 2017

From its annual tech conference last week (Sept. 20), where GlobalFoundries welcomed more than 600 semiconductor professionals (reaching the Santa Clara venue Read more…

By Tiffany Trader

Leading Solution Providers

Chip Flaws ‘Meltdown’ and ‘Spectre’ Loom Large

January 4, 2018

The HPC and wider tech community have been abuzz this week over the discovery of critical design flaws that impact virtually all contemporary microprocessors. T Read more…

By Tiffany Trader

Perspective: What Really Happened at SC17?

November 22, 2017

SC is over. Now comes the myriad of follow-ups. Inboxes are filled with templated emails from vendors and other exhibitors hoping to win a place in the post-SC thinking of booth visitors. Attendees of tutorials, workshops and other technical sessions will be inundated with requests for feedback. Read more…

By Andrew Jones

Tensors Come of Age: Why the AI Revolution Will Help HPC

November 13, 2017

Thirty years ago, parallel computing was coming of age. A bitter battle began between stalwart vector computing supporters and advocates of various approaches to parallel computing. IBM skeptic Alan Karp, reacting to announcements of nCUBE’s 1024-microprocessor system and Thinking Machines’ 65,536-element array, made a public $100 wager that no one could get a parallel speedup of over 200 on real HPC workloads. Read more…

By John Gustafson & Lenore Mullin

Delays, Smoke, Records & Markets – A Candid Conversation with Cray CEO Peter Ungaro

October 5, 2017

Earlier this month, Tom Tabor, publisher of HPCwire and I had a very personal conversation with Cray CEO Peter Ungaro. Cray has been on something of a Cinderell Read more…

By Tiffany Trader & Tom Tabor

Flipping the Flops and Reading the Top500 Tea Leaves

November 13, 2017

The 50th edition of the Top500 list, the biannual publication of the world’s fastest supercomputers based on public Linpack benchmarking results, was released Read more…

By Tiffany Trader

GlobalFoundries, Ayar Labs Team Up to Commercialize Optical I/O

December 4, 2017

GlobalFoundries (GF) and Ayar Labs, a startup focused on using light, instead of electricity, to transfer data between chips, today announced they've entered in Read more…

By Tiffany Trader

How Meltdown and Spectre Patches Will Affect HPC Workloads

January 10, 2018

There have been claims that the fixes for the Meltdown and Spectre security vulnerabilities, named the KPTI (aka KAISER) patches, are going to affect applicatio Read more…

By Rosemary Francis

HPC Chips – A Veritable Smorgasbord?

October 10, 2017

For the first time since AMD's ill-fated launch of Bulldozer the answer to the question, 'Which CPU will be in my next HPC system?' doesn't have to be 'Whichever variety of Intel Xeon E5 they are selling when we procure'. Read more…

By Dairsie Latimer

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