Clinical Research Informatics: Challenges, Opportunities and Definition for an Emerging Domain

Improved research planning tools

Advanced clinical research design

Tools cumbersome/poorly integrated

Need for advanced analysis tools/methods

“… the issue is that the tools are cumbersome and poorly integrated with the workflow of patient care, and so you can' t recruit either the investigators or the patients.”

“(Investigators) over-promise because the work is too hard to accomplish with the tools they are given”

“Our computing power is great, yet we are basically using the calculating capability that was available to Fisher and his contemporary 80 yrs ago, without real appeal to the “knowledge level.””

Poor data access

Lack of data integration

Secondary use of data issues

Incorporate research into clinical systems

Need improved analysis across sites

“I think one of the largest challenges institutionally is data access and integration, and that' s the barrier for the investigator.”

“… the interface between the electronic medical record and the clinical research is critical.”

“In the era of integration between clinical systems and clinical trials systems, there remain some interesting unsolved problems.”

Educate students, investigators, clinicians about CRI

Educate those working in CRI

Educate informaticians about CRI

Need for cross-discipline education

Educate senior leadership about CRI

“… it might be worth considering what is the training required, because it is a tremendous leap for a DBA to understand the regulations for running a clinical trial. It is a tremendous leap for an electronic health records guy. CIOs and academic centers do not get it. No offense. This is a big leap here.”

“… (We should) educate some of our informatics colleagues … about the obstacles and roles and needs that we have in this research environment.”

Research billing challenges

Costs of research software

Improved business processes needed

Lack of incentives for adopting research tools/need to demonstrate ROI for CRI solutions

“We are struggling with the appropriateness of tracking research costs and research charges and making sure that we are compliant with that and what is research and what is not. So, there is a whole other set of business processes on the investigator' s side that need to be somehow linked and coordinated with processes on the study side”

“So one of the big things driving this is the complete lack of money or incentive to move beyond paper.”

International CRI activities

Regulatory frameworks

Political obstacles

Regulation mis/over-interpretation as impediments to progress

Security and privacy issues

“A broad issue is the international nature of clinical research, especially clinical trials; for example, clinical trials in developing countries where the informatics infrastructure and the regulatory and ethical oversight are sometimes not as well developed—trials having to respond to a patchwork of national, regional, and international regulations and responsible agencies”

“… overly conservative or incorrect interpretations of a regulation can become an inadvertent impediment to clinical research”

Need for coordinated CRI agenda

Need for setting practical goals

Need for coordination between initiatives/among stakeholders

Desire for leadership/guidance from professional organization

Need for coordination between regulators and CRI community

Need to have CRI professionals represented in institutional leadership

No clear channel for CRI decision making within academic institutions

“… (the part) AMIA can play a role in is keeping up with all of this … so creating this portal that allows people from this group to be able to contribute and to go and understand what is going on in this space.”

“(We need to encourage) open comment from all the different perspectives so we are hearing from the investigator, the vendor, the institution, the NCI and other NIH institutes; it would be fabulous to get that input (about CRI initiatives).”

“… absent leadership from CRI sitting at the table in the Regent' s meeting and at the Hospital board meeting and in the corridors of the Capitol, there is little hope of the software developer curing the problem.”

“… no group across academic medical institutions fully ‘own’ the problem of solving clinical research informatics.”

Ineffective subject recruitment

Current tools make recruitment difficult

Lost opportunities to recruit

Investigator recruitment challenges

Not maximizing existing clinical information systems for recruitment

“Recruitment is the single biggest challenge. The investigators always over-promise. They do feasibility assessment. They try to target as best they can but there is under-performance that causes them to have to do rescues mid-way through. They have to close down sites, start up new sites. They cannot get a good handle on how to predict or estimate, or enhance and augment recruitment.”

“So the issue again rests on what can we do to make it easier so that clinicians are interested in becoming investigators.”

Recognize CRI is about more than informatics for clinical trials

Include support for nursing research

Include research partners in agenda (e.g., pharma, government)

“(We should) expand our vision from clinical trials to encompass all of clinical research, because I think this is going to be critical as we move forward. It is not just the trials. It is the outcomes, the biomarkers. It is the epidemiology studies.”

“Nurses use a wide range of research techniques, and I think we need to be investigating those as well.”

Research/clinical missions not integrated/coordinated

Inadequate/inappropriate resource allocation, use, adoption

Poor stakeholder collaboration

Inappropriate expectations of informatics versus IT groups

Need for CRI data standards, models

Apply clinical standards to research

Need ways to span biological to clinical ontologies

Need to standardize nontechnical institutional and sponsor requirements

“… properly representing medical concepts and the right terminology in order to access anything down stream which includes real world data from insurance and electronic medical records, databases, as well as other knowledge bases.”

“… sponsors/pharma don' t have standards and make each center create things according to each sponsor separately, like invoices, budgets, data entry, SAE reporting, and subject tracking”

Integrate tools into workflow

Inefficiency of research processes, need for effective models

IRB (Institutional Review Board)/regulatory challenges

Need to consider users needs

“… we all complain about the time it takes for IRB review.”

“(Current systems suffer from) a complete lack of integration between patient care processes and clinical research.”

“While a lot of talk has been made about standards, (so) we can move data back and forth, what is actually happening is there' s no work processes that make that happen.”

Research in CRI is critical to advancing field

Research in CRI often secondary to fulfilling current/practical needs

CRI needs to focus on transformative advances rather than just supporting current practice

Academic promotion process does not reward CRI practice

“The paucity of such thinking and research (about transformational approaches and theory) in CRI means that information and technology management advances have been subservient to the current process. There has been little of the disruption and leapfrogging that would change the environment.”

“the leadership in CRI gets bogged down in “pet projects” because that is the nature of their funding, and disruptive theory and models (that help advance CRI), instead of being the raison d' être for their departments, actually is rather scary for them.”

“Academic promotion committees do not require or reward data sharing or data standardization efforts”

Concern about repeating clinical informatics mistakes

Need for best practices

Under-use of current tools/best practices