TrialDox Blog – Accelerating clinical trials…

TrialDox supports teams who bring product and services innovations in the clinical trials industry.  The Trial by Fire Solutions team based in Oakland, CA, is one such team bringing an innovative product to the CTMS space: SimpleCTMS.  We recently interviewed Jon and Nancy at Trial by Fire Solutions about the trends in the CTMS market and where they see opportunities for improvements.  Please feel free to reach out to them – they’re an insightful and energetic team doing great work!

What is a CTMS?
A Clinical Trial Management System (CTMS), simply put, is a software application designed to help the study team and key stakeholders efficiently manage the planning, execution and tracking of clinical trials.  When designed well and used appropriately, the CTMS is a flexible and intuitive resource which complements and assists study management workflow, processes and tasks.  The CTMS also provides a collaborative workspace, where geographically dispersed teams have a common view into real-time, up-to-date information, and team members can edit data in a standardized format. CTMS functionality typically includes management of: dates/milestones, sites, subjects/enrollment, teams, monitoring and reporting.  Some systems might also include safety, supplies tracking, regulatory, payments, data management and performance analysis functionality.  CTMS is available in both Software as a Service and Enterprise models.  There are general-use CTMS products on the market, as well as in-house, proprietary systems.

What do you see as drivers of the challenges in the CTMS market?
The CTMS market has evolved over the past 10 years.  Clinical trials have become more complex, with the need to reach farther across the globe for eligible subjects.  Global preferred provider relationships are being replaced by niche vendors who specialize in the local landscape. Tracking tools are plentiful but are neither standardized, flexible, or designed to be integrated. R&D spending is heavily scrutinized and study delays result in products being shelved. Companies are realizing that EDC and CTMS solutions are not one-size-fits-all and often come with extensive resource commitments. Frequently, the pace is accelerating so quickly that project teams have not effectively outlined expectations for status reports and management updates. Having a cost-effective CTMS product readily available and quickly deployable to internal and external global teams can make all the difference in study success.

What benefits would a project team expect to enjoy with a well designed CTMS?
Well designed CTMS products put key information for your role at your fingertips. Expect the CTMS to be comprehensive, user friendly, easy to navigate, and customizable for each individual. When user groups are flexible for common team member roles, study processes become more efficient and team members become empowered. With a well designed CTMS, information is organized and displayed logically and team members are able to quickly identify trends and priorities without excessive data entry demands. By integrating critical information related to sites, subjects, teams and documents, team members can eliminate manual tracking tools that often become inconsistent or outdated. All projects teams can benefit from a CTMS that is uncomplicated in design, accessible by internal and external team members, and provides simple yet powerful outputs.

Implementing a CTMS can be expensive and complicated, do clinical research teams really need it?
With the financial challenges that most organizations face, we understand how much harder it is to complete projects on time and within budget using fewer resources. What could be more complicated than a merger, acquisition, or partnership and not knowing which trial management solution(s) will be deployed across the newly formed organization? Recognizing the indirect expenses related to resource turnovers when information flows only downward and not in a collaborative environment is a challenge. Despite the challenges of fewer resources, less funding and resource shifts, your primary goal of being first to market has not changed. With all this in mind, the current conditions are perfect to adopt a flexible and cost-effective CTMS product to keep your teams organized, informed and on track.  Utilizing a web-based CTMS such as SimpleCTMS, the implementation is quick and uncomplicated. Extensive IT resource commitments and process overhauls are not necessary. Although the benefits of a CTMS may not be obvious, you may find that your teams are able to better focus their time and efforts on the study details and thereby increase efficiency and teamwork while mitigating costly project overruns.

Doesn’t it take a lot of time to adopt a CTMS?
Adopting a CTMS product should not take a lot of time and resources or the utility of a CTMS quickly becomes lost. It is important to recognize that team members are hired based on their strengths and study needs, not to (re)design and implement tracking tools. With the SimpleCTMS SaaS model, adoption occurs in a straightforward and easy 3-step process.  In Step 1, the high-level requirements are quickly determined. With the involvement of the SimpleCTMS founders, this step ensures that the product meets your needs in a logical, timely and ensures an effective product is provided. Step 2 is to train a small group of users on the launched product. Step 3 is to train the extended team on the study-specific product. You are off and running!

Wouldn’t a CTMS just add more duplicate data entry?
Life sciences companies, CROs, and vendors may have their own standard CTMS products, metrics and training tools. Some of these products are linked with performance management and study tracking tools to facilitate ongoing upper management and resource reviews. A flexible, streamlined system such as SimpleCTMS does not result in excessive duplication. We collect basic information related to sites, teams, subjects and documents. If this information is already captured in your system, upload it into ours! If your preference is to first enter information into SimpleCTMS and export to your system, this can be done. The content of SimpleCTMS was designed to provide quick, integrated, high-level detail that study managers and team members require. If needed, you will find that SimpleCTMS also has the ability to capture the necessary detail. For example, individual regulatory documents can be tracked OR the status of the regulatory document package can be tracked for a higher level status view. With SimpleCTMS, our goal is to complement, not duplicate, the daily study management tasks to make the start-to-finish process more efficient and fiscally responsible for all.  It provides time management tools optimized specifically for CROs and study project managers.

Don’t teams need to integrate the CTMS with other eClinical systems to make it useful?
There are many CTMS and EDC choices available on the open market today. While choice is good, it can often lead to confusion when making a selection to fit your needs. Recognize integration can be expensive and timely; this is a common hidden cost associated with enterprise CTMS systems. For your circumstance, maybe the timing is not right, the resources are not possible, or the finances are tight.  As we’ve heard from many of you in the industry, extensive integration often results in delays, frustrations and significant expense. You need a simple solution for your challenges. Consider our integrated SimpleCTMS solution that provides relevant high level items that impact the whole study team. Initiate a simple solution now and integrate areas that make sense for you when you need them without the upfront expense. For example, why spend the time and expense to integrate lab databases; instead provide a mechanism for the team to see when lab transfer and related milestones are planned so they can support the activities effectively. Provide a mechanism to securely produce and post data listings and subject profiles for team member review in lieu of hours and days of printing, collating, distribution, and tracking.

If a research team is already enrolling for a study,  isn’t it too late for a CTMS?
Many of you think that you’re too far down the road with the current trackers and team structure to make a change. Consider that you could be trending issues at sites based on CRA feedback in real time to evaluate whether co-monitoring or additional training should be scheduled or internal audit teams deployed.  It’s never too late to better manage your resources.  Even rescue studies would find immediate benefits in using SimpleCTMS. For example, upload your investigator contact list, team list, and subject enrollment and work with SimpleCTMS team to create a few rules that work for you. For example, override historical target dates and set new, more relevant dates for the current project challenges. Track distribution of protocol amendments as they progress through agency and IRB/IEC review timelines. Identify sites that are not yet activated and set logical document requirement limits for site activation based on historical knowledge. Effectively manage CRA site visits, reports and data crunches to see which CRAs are overworked. Track SUSARs reports by the date of release and eliminate the need to manually manage email distribution lists based on current team members on your study. Ensure team members are trained accordingly and relevant training documentation is in place before data queries and team turn over occur. Track CRF collection efforts to complement the data entry timelines.  SimpleCTMS can do this for you. As we have seen from experience, it is never too late to be efficient and fully knowledgeable of all aspects of study management. Better managed studies result in faster time to regulatory submission and commercialization.

SimpleCTMS was home-grown by experienced Clinical Trial Managers to serve the evolving needs of global project teams, critical relationships with vendors, and collaborative cross-departmental efforts. Our product easy to set up, simple to maintain, and has a modern look and feel. We are here to encourage collaboration and efficiency.

Stop by SimpleCTMS for a quick demo! http://www.SimpleCTMS.com

About Trial By Fire Solutions

Trial By Fire Solutions is a bio-pharma focused, clinical software company featuring SimpleCTMS, a flexible, intuitive and powerful clinical trial management system (CTMS). With many years of experience on the front lines of clinical trial management, we have a passion for innovating eClinical technology to improve planning, execution and tracking of clinical trials.

AT Kearney has evaluated a basket of global markets for clinical trials according to the following criteria:

• Patient pool
• Cost efficacy
• Regulatory conditions
• Relevant expertise
• Infrastructure and environment

The result of their evaluation is an interesting chart, showing that China, India and Russia ranking highest on the list.  More interesting is that China is not ranked drastically lower than the United States (6.88 vs. 6.10).

For the full article, click here.

Interesting chart from PhRMA data:

CROs serve a critical function in design and execution of clinical trials.  Some recent CRO market statistics and trends:

Market Statistics

• 1,100 CROs
• Market size: $10 – $25 billion (Centerwatch article)
• Growth rate: 10 – 15%

Recent Trends

• Small to medium size CROs are forming partnerships to overcome limitations in geographic reach and therapeutic area scope
• Appearance of networking platforms to connect CROs with partners
• Undercurrent of private equity interest in CROs (Clinpage article)

Can personal health records (PHRs) revolutionize the clinical trial industry?  In our opinion: Yes.  We’re interested in what you think, as well.

To foster a discussion to solicit your opinion, find below a primer on PHR and what the public and private sector are doing to promote PHRs.

What are PHRs?

PHR is a patient-controlled document of his or her health information in a format of his or her choice.  (A medical health record, by contrast, is patient health information controlled by a physician, healthcare institution or health insurance company.)  Information documented in a PHR can be as limited as emergency health information to facilitate emergent care or as broad as all provider visits, diagnostic records, prescriptions, and health insurance information.  Storage formats can range from a local computer hard drive, portable hard drive, or internet-based subscription service.

Public sector PHR activity

Medicare (Centers for Medicare & Medicaid Services), since 2006, has undertaken several pilot programs to encourage the use of PHRs.  For more about Medicare pilots, click here.  A number of policy recommendations have been made by the National Coordinator of Health Information Technology.

Certification Commission for Health Information Technology (CCHIT) has assembled a special PHR Advisory Task Force and created an associated workgroup in order to draft a set of certification criteria for PHRs. The certification criteria, which are scheduled for release by 2010, will place an emphasis on industry privacy safeguards while also addressing security and interoperability issues. For more information, click here.

A number of states have introduced legislation to govern the usage of PHRs.  For a survey of state-level legislation, see the National Conference of State Legislatures tracking by clicking here.

Private sector PHR activity

A list of players in the PHRs:

• CapMed.com
• Microsoft HealthVault
• Caregiver Alliance Web Services
• MiVia
• CEND-PHR
• MyGroupHealth (Group Health Cooperative)
• Collaborative Family Health Record
• MyHealtheVet (U.S. Department of Veterans Affairs)
• Dossia
• MyHIN
• FollowMe
• MyMedicalRecords.com
• Google Health
• Myphr.com
• HealthAtoZ
• Patient Gateway (Partners HealthCare)
• iHealthRecord.com
• PatientSite (Beth Israel Deaconess Medical Center)
• LifeOnKey
• RecordsForLiving.com
• Med Alert
• e-Healthkey
• Revolution Health Group
• MedCommons
• VitalChart

While not meant to be exhaustive, the list above suggests that policy announcements have encouraged a proliferation of private sector offerings in the PHR space.  For a more exhaustive list, visit myPHR.  In addition, several non-profit organizations have initiated studies to evaluate standards to optimize interoperability, security and data modification (see Robert Wood Johnson Foundation, PDF).

Opportunity for clinical trials

The “low-handing fruit” for science and clinical research, in our opinion, lies in the intersection of PHRs and these core areas:

• Analysis of diagnostic data for patient identification for clinical trial recruitment
• Self-identification for clinical trial recruitment
• Analysis of historical records for hypothesis creation

Interested in your opinions…

In August 2009, Private Access announced a partnership with large pharma to test a new approach to expedite clinical trials.   Founded upon winning a patent for data privacy technology, the company believes that the solution to clinical trial recruitment lies in unlocking patient health information using their proprietary information privacy technology.

Private Access’s theory is that going directly to patients who are seeking treatment and requesting their permission to share their health information with researchers will decrease the time required to recruit for trials. Seems that Private Access’s strategy is viable if these assumptions are correct:

• Enlisting patients in the Private Access system can be done cost-effectively
• Concerns for privacy of their health data is the major barrier for patients who are seeking experimental treatment to share information with researchers over the internet
• Patients will share information independently without a physician’s guidance
• Patients in the Private Access system can be matched with physicians prepared to conduct a clinical trial

If these assumptions can be or have been validated, as they very well may have been, Private Access will be in a strong position to assist many researchers interested in expediting clinical trials.

Private Access is an innovator in clinical trials. Welcome your perspectives on the Private Access model.

For pharma, this is the curve that needs to be re-shaped:

Source: Morgan Stanley

Most clinical research is happening in oncology, CNS, and cardiovascular:

Source: Company research via Barclays Capital

Pre-phase II R&D accounts for about 35% of total R&D spending:

Source: PhRMA, 2009