Monthly Archives: April 2013

Q&A with Greg Bailey: IVR vs IWR – Which is Best for YOUR Needs?

Greg Bailey Knows IVR IWR EDC ePRO Patient Diaries

Greg Bailey Knows IVR IWR EDC ePRO Patient Diaries

1.       It’s like alphabet soup – what do all the initials mean?

  • IVRS is Interactive Voice Response System – this is what is usually referred to as voice menus (“Press 1 for this, Press 2 for that”), and we use those functions to allow patients to input detailed answers to trial-related survey questions.
  • IWRS is Interactive Web-based (or Web-board) Reporting System– this is the part of the system that the trial site and the sponsor use to see the results of patient input
  • ePRO – Electronic Patient Reported Outcomes – uses  IVR and IWR to capture and report all this trial data from patients
  • EDC is Electronic Data Capture, or another way to describe the IVR-IWR system as a whole

2.       How do you implement IVR systems for a trial?

  • Criterium hosts our IVR applications in Boca Raton, Florida.  We contract with a toll free forwarding company to take international calls and forward them to the Florida Data Center.  This means we are able to provide a local number anywhere on the Globe that is then transferred to Florida. Once the application is moved into a production environment the focus of technical support is making sure the IVR will pick up when called.
  • The system manager in Florida utilizes automated monitoring software in conjunction with manual testing of the production applications.  Someone on the study team will be trained and involved throughout the development, testing and deployment process so they will have a good understanding of the application as a whole.  That will allow the project member to respond quickly to questions from the client.

3.       Have IVRS systems replaced IWRS systems — or vice versa?

  • No, the IVRS and IWRS systems are built to complement each other.  Both systems access the same database so they are really just two portals into the same information.
  • IVRS is better suited for situations where there is limited internet access or the type of information being collected is minimal and concise, such as patient diaries, patient registration or randomization.
  • IWRS is better suited for reporting and entering textual information, such as comments, and where internet access is stable.
  • The IWRS can do anything the IVRS can do, while the IVRS is limited to what can be entered via telephone keypad entries.

4.       Does Criterium have its own servers?

  • Yes, we have our own servers and all necessary equipment to handle large volumes of phone calls and web applications.  We have a strong investment in the infrastructure.  We have redundant internet and phone circuits as well as servers.  Our server room has backup power supply and is in a very secure location.

5.       Which is most cost effective – IVR or IWR?

  • That depends on the application.  Usually the IWRS is built first to allow administrative functions (site maintenance, login maintenance, reporting, and more) and then the IVR registration / randomization of subjects is added.  Since it is tailored to every specific trial’s requirements, it’s easier to say that it’s a real-time data advantage that you can’t afford NOT to have!

Read more about EDC from Greg Bailey:

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Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com

 

The Advantages of Translational Research Methodology

Applying basic research knowledge to practical applications is a well-known obstacle to progress in science. This issue is seen most often in medical science. There is often a lag between emerging scientific findings and their application as treatments to patients who may benefit from them.Translational research is aimed at taking basic science  research to the next level. It connects new discoveries to application in patients.

Multidisciplinary Collaboration
There are four basic steps to consider in this research tactic.

  • Development of techniques to translate new knowledge generated in a lab environment, or at the bench level, to human testing
  • Refinement of human study results for  clinical use
  • Transference of practices from academic medical centers to use in the care of patients in community practice
  • Continued evaluation of data from the previous steps to provide confirmation of the efficacy and tolerability of new therapies

The goal of translational research is to quicken the transition from the lab to the patients who may benefit from the basic science findings. Thus translational research is a collaborative effort among basic researchers, academic physicians and community health professionals to provide new treatments to appropriate patient populations.

Funding Options
Translational research can potentially expand the funding options for a project.

  • Researchers benefit by working with a center that is able to provide seed funding. They reduce overall project costs by utilizing basic science center personnel for development of new therapies that then can be applied to patients in the community..
  • For universities, setting up a translational research center is a tactical approach to improving funding options. Through the research center, academic organizations develop strategic plans to provide improvements in public health benefitting overall community.
  • Communities benefit by gaining a stake in the study. The community becomes a contributing member of innovative medical research.

Stoking Excitement in a Field of Study
The developing barriers between research and clinical applications tend to dim interest in research projects. Moving towards a translational approach expands these possibilities. The power to take new knowledge from the bench to a clinic setting and then back to the bench for analysis lifts some of the impediments to expanding interest in a project.

Translational Science Research

Physicians in the community are able to see
basic research translated into practical application. A project that was once unapproachable due to time constraints and the complexity of the study boundaries will now draw interest and participation.

Translational research is a bench-to-bedside approach to medical developments. With this two-fold methodology, basic science presents tools to clinicians that have the potential to improve patient care. Clinicians are able to make observations and provide valuable feedback about the progression of disease that will lead to more discoveries. A translational model benefits the community by speeding the application of new research findings to patients and thus drives the clinical research progress at a quicker pace.

The Oncology Consortia of Criterium believes this methodology is the best way to speed results of research to benefit the public – it’s why we say we are “Changing the Way Cancer is Managed”.  Read more about our approach at the Academic GI Cancer Consortium or at the Academic Myeloma Consortia web pages.

Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com

Claire WyntersThu, 11 Apr 2013 15:07:00 GMT

Quick Takes: the Pharma C-Suite with Mary Stefanzick, Data & Operations Director


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 The Evolution of the CDL – The Clinical Data Liaison

The CDL is a role that will become a standard in the industry for companies that want to make more efficient use of limited resources: time and money. Criterium has been utilizing the efficiencies of the CDL position since 2001. It is a successful tool we use to streamline our clinical trials.

The CDL position combines the clinical research training skills of the clinical monitor with the data expertise and discipline of a clinical data manager.  The best of both worlds. 

Within any CRO, a CDL is the link to a successful clinical trial.  This individual has the ability to influence the three Cs of site management: connect, communicate, and control. This position is key in that he or she conducts real-time data review and facilitates centralized control of data management. 

To really improve the workflow process, the CDL is a clinical and data expert who connects team members – sites, CRAs, and data managers – through the use of data collection technologies that are used in a workflow that emphasizes real-time receipt and review. The ultimate benefit of the workflow that is managed through the CDL is to reduce the barriers between monitoring and data management.

Three of the most important reasons to utilize CDL’s in your study: 

REDUCES MONITORING COSTS
The CDL position combines the clinical research training skills of the clinical monitor with the data expertise and discipline of a clinical data manager. As such, CDL’s are the first to review CRF’s to make sure that the protocol is being followed. 

STREAMLINES DATA PROCESSING
They are responsible for timely review of data safety values, such as SAE’s, AE’s, lab values, and ECG’s that are critical to the safety of the patients; they do this in the context of the overall database. This is especially important, as the field monitor’s perspective is based on the review of individual site visits.


cdl chart for blog

COST SAVINGS
Because CDL’s monitor site data daily, they are able to identify potential problems before they arise thereby reducing the cost of field monitoring per patient by as much as half when compared with traditional monitoring.

Find out more about this efficient and cost-effective method of trial management:

what_cdl

 

 

Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com

Claire WyntersThu, 28 Mar 2013 20:33:00 GMT

Clinical Trials Monthly Case Study Analysis

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Each month, we take a look at a different Clinical Trial Case Study – this month it’s a look inside an ALLERGY trial that focused on EXCEPTIONAL RESULTS:

The Scenario: Criterium provided an IVR patient diary solution to collect the pivotal efficacy data for an international clinical trial.

We asked ourselves:  What if an after-the-fact paper patient diary could have been disastrous and could have necessitated the client repeating the study?

•             Because the estimated patient compliance rate was critical for the statistical analysis, Criterium daily monitored the patient diaries.

•             Through StudyControl™, Criterium designed reports to evaluate the compliance of each patient during the study. When patient compliance was less than predicted, Criterium informed the client immediately. This critical intervention enabled the sponsor to enroll additional patients into the study.

Additionally, daily management of the site by Criterium’s knowledgeable staff members helped ensure that patient compliance among the additional study participants was at the highest level, thereby meeting the study’s control requirements.

Our Result: The statistical analysis exceeded the client’s expectations.

Creative thinking in designing clinical trials upfront is always the ideal, but it’s important to remember that there are factors and variables that can’t be accounted for during planning.  When we look at trials, we look at all the factors that surround the potential issues facing a trial – technology can be a great tool to keep trials running smooth, but it’s the human factor that allows the technology to be a reliable component of the work.

Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com

Claire WyntersThu, 14 Mar 2013 16:21:00 GMT

Best Practices Series: Communicating with Sites – Know What We Know

We asked two of our top CRA’s, Ed J. and Jaime H. to weigh in on the subject of “Best Practices for Communicating with Sites”Here’s what they had to say in a nutshell: 

Ed:  First of all, sites are our most important asset.  Sites are valued customers for any CRO.  Maintaining good relations with sites helps achieve a win-win situation, ensuring timely patient recruitment and reliable quality data. 

Jaime:  To me, having a positive relationship with the sites is priceless.  Both sides will benefit greatly.  The sites need the CROs to help them manage the data.  It’s crucial to maintain open lines of communications so that you get all the data that you request.

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Ed:  We rely on our sites to take an active interest in each study protocol to be involved in and be knowledgeable of all the procedures and requirements.  This is extremely time consuming, even the smallest mistake can have a huge consequence.  We place enormous pressure on our sites to recruit and perform and without our support, without good relations, we run the risk of creating negativity.  A strong association ensures a good communication and responsiveness.  It’s a two-way street.  It should be just as good from the site’s point of view as it is from ours. 

Maintaining pleasant but professional relationships with sites is one of the first important steps of being a CRA.  Without a good pleasant relationship, you lose the personal connection with your site.  CRAs have to straddle the line between serving the sponsor and still understanding the site’s interests.  CRAs can sometimes be perceived as individuals coming from big pharma companies with an attitude that says we’re in charge.  This can set a negative tone which makes working with sites much more difficult.  It’s important for everyone to recognize their respective expertise Sites are experts in their field and CRAs are experts in theirs.  Together they make a strong study team. 

Jaime_thJaime:  I agree with that.  The respect has to be mutual.  If the CRA treats the site in a friendly, relaxed and professional manner, you’ll likely get the same attitude back from the site.  The study coordinators are the main focus as they do pretty much the bulk of the work.  It’s crucial to treat them with the same respect that you’re entitled to, to ensure they’ll be happy to assist you when you need something.

Want to hear more from Jaime and Ed?  Send us your CRA and Clinical Trial questions and we’ll post the answers here!

Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com

Claire WyntersMon, 25 Feb 2013 19:25:00 GMT

Why run global clinical trials?

Clinical trials are a vital aspect of the pharmaceutical industry – both as a source of validation for previously untested methods, as well as a way to publicly demonstrate the effectiveness of a developing product. As humans across the planet collaborate and network, global clinical trials are a necessity for maintaining accurate data across numerous demographics. Furthermore, conducting trials abroad positively influences the economies and well-being of developing nations.

Globe made of Flags_200All around the world, various ailments and negative conditions affect local populations in differing ways. To best treat the plethora of issues present in these wide-ranging communities, global clinical trials are needed to address the growing variable factors involved. It is a recognized fact that minority groups and third-world citizens are vastly underrepresented in the modern medicine developed primarily by Westerners. This is changing rapidly, as more and more clinical trials are funded and performed globally.

An important aspect of conducting global clinical trials is being aware of the differing regulations that exist in developed countries vs. under-developed countries. Every trial has its own unique ethics and complexities that are carefully monitored and assessed by licensed physicians, and not shoe-horned into a universal set of regulations that may be inappropriate for any specific trial. By hosting testing locations in many under-developed parts of the globe, a more local flexibility can be used in research efforts for effective medicines in indigenous populations.

Additionally, conducting global clinical trials allows for researchers in smaller countries to work at the forefront of their field. While experts often travel to oversee the process, global trial activity means more employment and experience for the local doctors, investigators and clinical personnel. This provides ample opportunity for externally sponsored clinics to receive additional funding and investment which, in turn, can lead to a healthier and happier population overall.

Working in developing nations offers an opportunity to expand the scope of any trial – both seasonally and with groups of people Caduceus_311who have not been exposed to new medicines in a variety of therapeutic areas. Because of these naïve patient populations, more extensive clinical trials can be executed and analyzed. Pharmaceutical corporations concerned about their bottom line have to carefully consider the best allocation of their funds — and it’s important to understand that running trials in developing nations does not always provide a cost savings. Money must still be spent on securing locations, basic products, and housing and care of employees, and budgeting must suit the needs of the specific trial in that specific global location.

Medicine is a particularly important and valuable branch of practical science.  Seeking new, reliable and innovative information can be a timely, costly, and difficult process — and global clinical trials are much needed to improve the health problems of the world at large. Global trials provide more in-depth data across a wider demographic possibility, better freedom to experiment and explore, and more importantly, vital support of local native economies.

Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com

Claire WyntersWed, 30 Jan 2013 14:45:00 GMT

Quick Takes: the Pharma C-Suite with John Hudak, President Hudak-President

john hudak quote_325We have successfully conducted trials for over 20 years – since 1991.
Criterium’s mission to provide our clients, staff, consultants and sites an extraordinary experience, with integrity.

Our focus, for every client, is simple, and we mean it:  Provide Quality Solutions.  Reduce Costs.  Accelerate Timelines.  It’s the root of our business philosophy.  We respond very quickly to clients from their first contact with us for a bid proposal to every aspect of the projects we win.  Every single person on our staff is aware of these company directives and works towards them.  This is a very real, daily, activity for us, not just words.  When I look ahead at the next twenty years, I am enthusiastic about what lies ahead in this field and committed to establishing better and more efficient ways to support drug development, to cut costs and to improve technology resources directly related to these initiatives.

We offer the broadest range of services in our market niche, because we CAN.  We have staff from all aspects of clinical research experience – that allows us to do that.  It’s a unique mix of incredibly bright and dedicated people – I am very fortunate to have them.  As a medium-sized CRO we can be more agile, and have the advantages of moving more quickly than the larger, leviathan CRO’s, starting and completing trials more efficiently, and giving clients a much more personalized, one-on-one experience. Our unique technology-based paradigm allows us to respond to sponsor needs in specific detail and to deploy trials rapidly throughout the world for fast, successful trials.

Our clients are among the top 10 pharma companies to small venture capitalized biotechnology and new formulation companies. They are USA domestic and they are also based in Europe, Israel and Asia. We have worked with generic companies when they need to have bioequivalence studies with clinical endpoints done.  We have a satisfied client list as varied as the therapeutic areas in which we have experience.  Our personalized service experience and “Get to Know Us!” philosophy has proven to serve our clients well. 

Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com

John HudakThu, 17 Jan 2013 22:45:00 GMT

Best Practices Series: Know What WE Know About ICH GCP

The ICH (international Conference of Harmonization) plays a major role in providing pharmaceutical standards, accepted by regulatory authorities across the globe, and GCP (Good Clinical Practice) is no different.  The ICH GCP guideline was developed with an aim to protect the rights and safety of human subjects while assuring credible and internationally acceptable clinical trial data.  Along with WHO (World Health Organization) recommendations, the international ethical and scientific standards for clinical trials involving human test subjects (GCP) from the regions of Europe (EU), United States of America, Japan, Australia, Canada, and Nordic countries were all taken into consideration.

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Importance of GCP
It is safe to say that GCP in clinical trials requires a lot of time and resources. While following best practices protocols when conducting a research does yield more reliable data and strict ethical protocols protect the subject rights and safety, the GCP for any study was in the clinician’s domain until relatively recently. However, loose GCP protocols were not acceptable by regulatory authorities and The Declaration of Helsinki in 1964 provided a foundation for internal GCP guidelines for many organizations.

Under ICH GCP, all crucial aspects of best practices were unified under one guideline. For the independent researchers or noncommercial trials, this guideline can feel to restrictive and demanding, bringing extra paperwork and increased cost. However, the document represents the way of thinking that should be always present, when conducting trials on humans; the same rigorous quality, ethical, and safety protocols should be followed, regardless of the trial type or origin.

ICH GCP and Its Principals
Frequent poor data monitoring, flawed statistical design and analysis, and questionable ethical methods used in clinical trials in the past have all contributed to a growing public and professional concern about research misconduct, and have lead to misleading, and sometimes even hazardous trial results. ICH GCP plays a vital role in assuring sound clinical trials and reliable trial results while protecting the patients rights and safety.

Ethical Aspects 
Clinical trials should be conducted in accordance with the ethical principals of the Declaration of Helsinki, and a study should be conducted only if the potential benefit for the society outweighs the possible risks for the subject.

Clinical Protocol
The trials should have scientifically sound and clear objectives, supported by prior clinical and nonclinical information, and should be conducted in compliance with a detailed protocol, approved by IRB (institutional review board) or IEC (independent ethic committee). Freely given informed consents should be obtained from every subject in the study.

Record Keeping
Every individual involved in conducting a study should be properly educated and trained, all clinical trial data should be properly recorded, handled, and stored, and the subject’s confidential data should be protected.

Study Report
The study report needs to be prepared at the end of the study, regardless of the study phase or the number of participants that were included in the trial. Following ICH GCP principles is crucial to providing significantly increased quality of treatment.

While some of the procedures in the ICH GCP can seem tedious, past experiences shows all of them make sense. Not only do they provide a safe environment for the participants, and improved treatments for society, they ensure that negative trial results are well documented and can prove as useful as positive results in future clinical trials. Along with the obvious benefits of complying with the best practices, apparent hindrances, such as increased bureaucracy and cost, can be greatly reduced with proper study design and utilization of approved clinical trial system and experts. 

Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com

Claire WyntersThu, 03 Jan 2013 20:57:00 GMT

The Expanding Global Reach of Pharmaceutical Clinical Research

The global pharmaceutical industry has continued to evolve over the last few years into different permutations aimed at maximizing research and development (RD) capabilities while minimizing the overall costs associated with the discovery, development, and launching of new drugs.

Mumbai at night_215The environment that has grown from this process has lead to the emergence of an innovative new approach to sustaining product development by integrating a global clinical research framework into the traditional RD landscape with the aim of keeping the industry’s momentum toward continued important pharmaceutical developments.

During this period, the pharmaceutical industry in India has devoted a great deal of focused attention on bringing the subcontinent’s RD infrastructure up to the standards expected by the world’s major enterprises. These efforts have led to over 70 FDA approved US pharmaceutical firms establishing facilities in India, where they now conduct ongoing RD toward finding unique investigational new drugs (IND).

The Evolution of Pharmaceuticals in India
While thepharmaceutical industry in Indiahas advanced in response to this new focus to become the world’s third largest, the fact remains that there are actually a fairly low number of Indian-owned pharmaceutical companies. The lion’s share of these enterprises in India areoperated and controlled as subsidiaries for a wide sampling of the world’s leading foreign companies.

India has developed astrategy to further develop a home grown industry that rests largely on its efforts to build state-of-the-art facilities and infrastructure, while simultaneously working with global bio-tech educators to revised the university curriculum in order to raise the professional level of pharmaceutical researchers in India.

Added to this is the adoption of attractive direct foreign investment regulations in India, which make it both easy — and potentially lucrative — for companies interested in global clinical research options to seriously include India in their calculations.

lab-test-tubes_227The Professional Level
The overwhelming majority of employees involved in the global clinical research aspects of these companies are Indians, freeing foreign enterprises from having to relocate staff to these facilities. The level of committed professionalism instilled by parent enterprises is consistently maintained. As early as 2005, the FDA was already receiving 20% of all submitted ANDAs from Indian based RD.

Foreign firms are able to take advantage of innovative local sourcing ideas derived from knowledge of traditional medicinal systems, as well as associations with local universities, bio-tech institutes, with a wide array of pharmaceutical expertise.

Integrating India as a global clinical research component into your pharmaceutical company’s strategic growth plan offers the opportunity to provide a quality solution that can meet any expectation of a clinical research process — from initial planning all the way through to clinical RD. And each element of this process can be achieved at considerably reduced costs. Our experiences on the ground in India can provide you with valuable guidance.

The bottom line is that incorporating a presence in India into a systematic expansion of global clinical research presents a forward thinking pharmaceutical enterprise with a real opportunity to reap a considerablereturn on their investment.

Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com

Claire WyntersThu, 15 Nov 2012 15:46:00 GMT

Translational Science for Cancer Research – The Consortia Model

Cancer Exploration for the New Millennium

What advantage does a clinical consortia group have over regular trial groups when it comes to innovative cancer treatments?  In some important ways, through Translational Science methodologies. The most important conceptual difference between the classical clinical trial and the Consortia approach is that the Consortia model, with its highly experienced clinical scientists, is involved on an intellectual advisory level with every step of clinical investigation in a cancer study.  Classical clinical trials groups most often have patient accrual as their most substantive role.
 
cancer-attackA Consortia can readily interface translational science with clinical outcomes and can show the value of translational science to a positive outcome of regulatory approval process and is critical to the Consortia’s contribution to research projects.  Consortia institutions have the capability to collect tissue and have access to labs to analyze and interpret data. Consortia sites have been selected for their access to patients with specific diseases and for their ability to enroll such patients on clinical trials.

 
Here’s why: The discipline of clinical and translational science encompasses a broad spectrum of research, extending from basic discoveries with implications for human health to community-based epidemiologic and health services studies. The unifying theme is a commitment to apply scientific methodologies to address a health need. SCTS (The Society for Clinical and Translational Science) defines it as:  “…a multi-dimensional, cross-cutting discipline that encompasses multidisciplinary investigative teams from many different subspecialty areas. Moreover, success in clinical and translational science commonly requires constructive partnerships with industry, granting agencies, public health agencies, and regulatory agencies.”

Criterium’s Core Science Solutions’ Academic Consortia’s for both GI and Myeloma use the translational science model and can streamline cancer treatment research. Take a look at: http://www.criteriuminc.com/css.php or visit www.agicc.org and www.ammyc.org 

Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com

Claire WyntersFri, 19 Oct 2012 14:29:00 GMT