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2007, Vol. 21, No. 4 (pp. 263-270)
ISSN: 1364-9027
Current Opinion
Electronic Health Records and Patient Recruitment
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Int J Pharm Med 2007; 21 (4): 263-270
1364-9027/07/0004-0263/$44.95/0
CURRENT OPINION
 2007 Adis Data Information BV. All rights reserved.
Meeting the Challenges of Patient Recruitment
A Role for Electronic Health Records
Christian Ohmann and Wolfgang Kuchinke
Coordination Centre for Clinical Trials, Heinrich-Heine-University, Duesseldorf, Germany
Abstract
The recruitment rate of adult patients into clinical trials continues to be low. There are a number of barriers to
recruitment and, for the most part, these can be classified as patient-, physician-, organisation- or protocolrelated. For practical reasons the process of trial recruitment can be divided into three steps: awareness of the
trial, assessment of patient eligibility and the decision to participate. Two key strategies to improve patient
recruitment are related to (i) knowledge, information and data management, and (ii) changing the behaviour of
physicians and patients. Patient recruitment strategies cover individual services (e.g. call centre, web-based
outreach campaigns) or integrated services (e.g. provided by recruitment companies). Unfortunately, there is
only limited and inconclusive evidence from randomised or quasi-randomised trials comparing different
recruitment strategies.
The integration of electronic health records (EHRs) into clinical trials has major potential to increase
recruitment rates, as demonstrated by a small number of recent studies. However, there are prerequisites for the
successful application of EHR systems in clinical trials, including the provision of adequate patient data,
availability of technical solutions from vendors and dual operability between the worlds of medical care and
clinical research; changes in the attitudes of physicians and patients are also required. Nevertheless it should be
borne in mind that patient recruitment is a complex process and successful strategies are likely to require several
complementary approaches in order to achieve the goal of improved enrolment rates.
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1. Current Challenges to Recruiting Patients for
Clinical Trials
Without the cooperation of patients, it is not possible to run
clinical trials. However, problems with patient recruitment impede
the clinical research process from start to finish. Therefore, a good
deal of thought has been invested into how to improve recruitment
strategies. Recently, new comprehensive electronic strategies have
been described that may meet these recruitment challenges.
The current recruitment rate of adult patients into clinical trials
is low. On average, <3–5% of newly diagnosed cancer patients are
enrolled into clinical trials.[1] Improved patient enrolment presents
one of the largest opportunities to eliminate common problems
and delays in clinical trials; however, recruitment for a clinical
trial is a very complex, multilevel process. Many factors, including
psychological, organisational, legal and technical elements, influence the recruitment process.[2] Obviously, there are obstacles
associated with each of these elements of patient recruitment.
Many surveys and prospective studies have investigated the
reasons for non-participation in clinical trials. Recently, a systematic review and meta-analysis was published that summarised the
results of 12 qualitative and 21 quantitative studies on barriers to
participation in clinical trials.[3] Many issues were identified as
influencing recruitment; these factors can be classified as patient-,
physician-, trial- or protocol-related, or belong to a remaining
group of ‘other’ factors.[3-9]
Figure 1 provides a systematic view of the components identified in studies on recruitment to clinical trials, distinguishing
between baseline factors (patient, physician, organisation and
clinical trial characteristics) and their interactions. The figure
illustrates the most important interactions relevant to patient recruitment and shows that there is a strong psychological component involved. Patients and physicians bring their underlying
attitudes, beliefs and expectations to research and treatment. In
addition, the attitude and policies of the organisation (e.g. hospital)
toward clinical research influences the extent of support and
Ohmann & Kuchinke
264
Patient
· individual background
· social, cultural, religious variables
· illness perception
· attitudes towards clinician and
information
· attitude towards research
Patient-physician interaction
· physician as caregiver vs researcher
· decision-making process
Physician
· time and resources for research
· attitude towards research/motivation
· physician preferences for treatment
Physician-organisation interaction
· incentives and support to clinician for
accrual
Patient-physician-organisation-trial
interaction
· Decision-making about trial participation
Organisation
· attitudes towards research and
priorisation
· resources for clinical research
Patient-trial interaction
· expectation towards trial
· knowledge about trial
· patient/family preference
Clinical trial
· trial type and characteristics
· protocol complexity
· no. of visits/investigations
· eligibility criteria
· selection of study sites and investigators
Physician-trial interaction
· awareness of trial
· attitude towards trial (toxicity, adverse
effects)
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Fig. 1. Model of factors related to clinical trial participation.
resources provided for the trial. Furthermore, the trial itself may be
characterised by its complexity, the resources required to conduct
the trial, the risk involved and other specific study characteristics.
Studies have identified the patient-physician interaction as crucial to the recruitment process and this is influenced, in part, by the
physician’s role as a caregiver versus a researcher. The physicianorganisation interaction is characterised by, among other factors,
the extent of incentives and support given to clinicians for accrual.
Knowledge, expectations and the preferences of patients with
respect to clinical trials play a major role in the patient-trial
interaction. The physician-trial interaction is mainly influenced by
awareness and attitude towards the trial by the physician. Ultimately, a combination of all these factors and interactions result in
the patient’s final decision of whether or not to participate in the
trial.
In the past, research on patient recruitment was mainly dedicated to the identification and quantification of individual factors
involved in the patient enrolment process. Recently, the necessity
to develop more systematic approaches and models has been
expressed. Conceptual social psychological models, such as the
Health Belief Model or the theory of reasoned action, have been
applied to find a systematic approach to explain and predict patient
behaviour and, thus, characterise patient-related factors.[10] In an 2007 Adis Data Information BV. All rights reserved.
other study, investigating factors associated with participation in
breast cancer trials, systematic scales (knowledge scale, perception of trial benefit scale, drawback scale) were developed and
evaluated.[11]
The process of trial recruitment can be divided, for the sake of
practicality, into three sequential steps: (i) awareness of the trial,
(ii) assessment of patient eligibility, and (iii) the decision to
participate.[12]
Awareness of the trial is a prerequisite for trial recruitment. The
patient may have knowledge about a trial, for example, through
internet searches or patient support groups. The physician may
know about the trial from meetings, presentations, mailings, opinion leaders, registers or clinical information systems.
In the next step, the evaluation of eligibility is influenced not
only by the specific eligibility criteria of the trial but also by the
perception of the physician. In a systematic review, it has been
demonstrated that the physician’s perceptions about age and the
tolerability of treatment are a major barrier to the recruitment of
older patients into cancer clinical trials.[7] Recent studies have also
been met with the challenge of a decreased patient pool because of
especially stringent eligibility criteria or for trials in rare diseases.
Here the influence of pharmacogenetic limitations may play a role
by decreasing the pool of patients suitable for inclusion in a
Int J Pharm Med 2007; 21 (4)
Electronic Health Records and Patient Recruitment
specific trial. In addition, patients are increasingly recruited internationally, in many cases from Eastern Europe or Asia, with
positive (e.g. faster recruitment in those countries) and negative
(e.g. decrease in knowledge, competencies and resources related to
clinical research in some countries) effects.
Finally, if eligibility has been determined, informed consent is
necessary to include the patient in a clinical trial. This is a major
hurdle to patient enrolment involving a complex decision-making
process where attitudes, beliefs, perceptions, expectations and
preferences play a major role. However, from the viewpoint of the
patient, the benefit of participation is usually the most important
consideration.
2. Possible Solutions
265
(NIH) clinical trials site (http://clinicaltrials.gov/) or Current Controlled Trials (http://controlled-trials.com/), in which clinical trials
have had to be registered since 2005 in order to get published in
many peer reviewed journals. Recently the WHO has taken lead in
this field by initiating its International Clinical Trial Registry
Platform (http://www.who.int/ictrp/en/). In addition, information
on ongoing trials is disseminated by conferences, workshops,
working groups, the media and mailings.
The critical point of this stage of the recruitment process,
however, is to be aware of a suitable clinical trial at the point of
care, when a patient seeks treatment. Not remembering active
protocols, and a lack of time and resources to find the appropriate
trials, may lead to poor physician triage and decreased recruitment.[4,8] One promising approach would be to present information
on open trials of potential relevance for an individual patient at the
point of care. There are already several alerting systems in use.
However, it seems that recruitment during routine patient visits is
often viewed as too time-consuming for the physician.[13]
The next critical step in the recruitment process is to evaluate
patient eligibility. Knowledge of the eligibility criteria and the
availability of patient data are necessary for the physician to make
this assessment and it is evident that this process can be supported
efficiently by information technology (IT). If the available data are
insufficient to make a decision from, this step of the enrolment
process may be time consuming and therefore a barrier to recruitment. Extracting data related to patient eligibility from their chart
is promising, but far from trivial. Furthermore, data may be
missing and, thus, the eligibility criteria status unclear. The optimal system for this stage of the recruitment process requires the
availability of a comprehensive, integrated, computerised patient
record system with access to diverse data sources.[14] Due to the
complexity of inclusion and exclusion criteria in the majority of
clinical trials, computer-based eligibility screening systems with
decision-support facilities may offer substantial help. This has
been partly shown, for example, for breast cancer trials; however,
these systems were not integrated with patient record systems and
they used separate data entry.[15-17]
It is clear that the attitude of the physician and the patient, their
beliefs, perceptions, expectations and preferences are of the utmost importance in making the decision to participant in a clinical
trial. These attitudes have to be taken into consideration if we wish
to encourage patient and/or physician behaviour towards greater
clinical trial recruitment. It is clear from the field of clinical
guidelines that knowledge about a guideline and agreement with
the content does not necessarily mean that the guideline is followed by the clinician. This also happens with clinical trials,
where knowledge of a trial and agreement with the trial’s objective
and design do not necessarily result in changed behaviour.[11] As
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Complex recruitment problems require intelligent solutions
(see table I). In the past, attempts to improve only single aspects of
patient recruitment have failed; therefore, more extensive and
integrative approaches are now necessary. There are two areas in
particular that need to be tackled in order to improve the recruitment of patients into clinical trials: one is related to knowledge,
information and data management, the other to changing the
behaviour of physicians and patients.
Information and data management are central to the improvement of awareness of clinical trials and the evaluation of eligibility. Furthermore, there are different recruitment strategies necessary for different patient populations. Therefore, to increase awareness of trials, different strategies are necessary. Patient support
groups, websites and databases are used to inform patients about
ongoing clinical trials that are recruiting patients. Examples include Orphanet (http://www.orpha.net/), a database of rare diseases and orphan drugs, which includes information on clinical trials
conducted in Europe, and CenterWatch Clinical Trial Listing
Service (http://www.centerwatch.com/) in the US. Physicians
and patients may also get information about ongoing trials from
public databases such as the US National Institutes of Health
Table I. Potential solutions to low rates of patient recruitment
Increase awareness of trials using clinical trial registers, websites, etc.
Influence human behaviour using marketing principles (including social
marketing)
Improve physician and patient attitudes to clinical trials (e.g. by
educational interventions)
Support recruitment with optimised clinical trial infrastructures (e.g.
established clinical trial groups, electronic support tools)
Utilise automatic notification/clinical trial alert systems
Development of integrated/global approaches by recruitment companies,
pharmaceutical firms, etc.
 2007 Adis Data Information BV. All rights reserved.
Int J Pharm Med 2007; 21 (4)
Ohmann & Kuchinke
266
mentioned previously, many physicians consider the process of
recruitment, and in particular the requirements of informed consent, during routine patient visits to be too time-consuming.[13]
Thus, patient recruitment is a complex process requiring
knowledge of human behaviour, marketing, management expertise and scientific expertise,[18] with the marketing of research
becoming more and more an integral part of patient recruitment.[19]
Social marketing, a process for influencing human behaviour
using marketing principles for the purpose of societal rather than
commercial benefit, may be a promising strategy to stimulate trial
participation.[20]
Patient recruitment technologies can be grouped according to
the following categories: repurposed tools (e.g. e-mail, web-based
outreach campaigns), monitoring/support technology (status of
current recruitment efforts) and planning/design tools (queries
against a database, electronic health records [EHRs]).[21] Patient
recruitment companies, pharmaceutical firms, contract research
organisations (CROs) and consulting companies provide individual services (e.g. call centres) or integrated services. Some examples of an integrated approach are a sponsor-integrated solutions
model,[22] an integrated process approach with a physician-centric
Investigator Relationship Management (IRM) model[23] and comprehensive patient access plans.[24]
BBK Worldwide (Newton, MA, USA), a patient recruitment,
planning and implementation company, has developed and institutionalised a code of conduct called ‘Good Recruitment PracticeSM’ (GRP). GRP is a set of principles for improving the
recruitment of both patients as study participants and physicians as
investigators. For this purpose it helps in creating a communication-rich atmosphere. BBK Worldwide promote GRP as combining the best practices of research with the marketing science of
healthcare communications.[25] GRP provides guidance to study
sponsors, investigators, study coordinators and other study site
staff, referring physicians, recruitment service providers and institutional review boards (IRBs) through an organised set of principles.[26] In contrast to good clinical practice (GCP) where rules
determine the conduct of clinical trials, GRP consists only of a set
of practical suggestions for improvement.
Despite the fact that a few controlled studies have been performed to evaluate interventions to improve recruitment, most
reports have been rather anecdotal. Therefore, successful strategies for patient recruitment need to be evaluated in randomised or
quasi-randomised trials before they are adopted. Unfortunately
there is little high level evidence available on interventions
targeted specifically at increasing patient recruitment in clinical
trials.
The effectiveness of strategies aimed at recruiting under-represented populations into cancer clinical trials was investigated in a
systematic review.[27] The authors identified five studies that compared the efficacy or effectiveness of different strategies.[28-32]
These five studies used various strategies but only three reported
that their specific recruitment strategies, such as media campaigns
and church-based project sessions, resulted in an improvement in
accrual to cancer trials. The authors of the review concluded that
there was limited evidence for efficacious or effective strategies to
recruit under-represented populations in cancer-related trials.[27]
In order to improve the accrual of older patients to cancer
treatment trials, a cluster randomised trial was performed to investigate a multifaceted educational intervention that targeted physicians. The accrual of older patients was not increased by this
intervention for various reasons.[33]
In a double-blind, randomised trial, an opt-in approach (asked
to actively signal willingness to participate in research) was compared with an opt-out approach (patients were contacted repeatedly unless they signalled an unwillingness to participate). The optin approach resulted in lower response rates (38% vs 50%) and a
biased sample, favouring the opt-out approach as a recruitment
strategy.[34]
In a before-and-after comparison between a test and control
region in the US, an intervention aimed at improving clinical trial
enrolment by using a rapid-tumour reporting system, a nurse
facilitator, a quarterly newsletter and a health educator was not
found to be effective.[32]
In an historical comparison, the inpatient recruitment rate at a
tertiary care hospital in Germany was improved by 30% by establishing a central coordination office for clinical trials.[35] Similar
improvements have also been achieved in specific research networks and with targeted interventions to support recruitment;
however, the accrual rate remained non-satisfactory in the majority of cases.[5,36]
It should be noted that in specific areas, and with well structured clinical networks and coordinating units, high recruitment
rates can be achieved. Based on an analysis comparing incidence
data from the German Paediatric Oncology Register with trial
recruitment rates, it could be demonstrated that German paediatric
oncology study groups are able to include >80% of patients to
clinical trials compared with 10–20% of adult cancer patients.[37]
Additional approaches to overcome recruitment problems cover specific communication courses for patient recruitment[38] and
the use of recruitment consulting companies.[39] Another approach
is based on personal health records (PHRs) with self-reported data
from patients. One example is BreastCancerTrials.org, a personalised Internet tool that matches breast cancer patients to the eligibility criteria of clinical trials.[40] The available data suggest that
combinations of different types of interventions may be needed to
improve accrual to clinical trials.
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Int J Pharm Med 2007; 21 (4)
Electronic Health Records and Patient Recruitment
Another way to support recruitment is by optimising clinical
trial infrastructures. There are already software solutions on the
market that specifically target the recruitment process. For example, TCN (ClinicalCentralNetSM) from BBK Worldwide supports
the management of enrolment including document dissemination
with a web-based tool[41] that consists of a document management
system for recruitment materials, study enrolment data capture and
data analysis. It creates customised patient recruitment, enrolment
and retention status reports and integrates with other applications
(e.g. electronic data capture systems).
StudyOptimizer from DecisionView Inc. (San Francisco,
CA, USA) allows real-time visualisation of recruitment trends
based on predictive models and differential equations.[42] Its
RecruitmentPlanner module uses standardised best practice for
recruitment planning, facilitates collaboration and manages recruitment plans. The StudyDetail module displays recruitment
data, financial key indicators and performance predictions, allowing dynamic recruitment planning including factors like
seasonality, course correction and alternative recruitment strategies.
Of course, all recruitment support tools can only be effective
when integrated with electronic data capture, clinical trial management systems and other solutions like interactive voice response.
267
operability of systems, standard vocabularies, security and privacy, ownership issues, and organisational and cultural factors. The
major driving forces to overcome these barriers include the provision of national initiatives to (i) aid the implementation of health
information structures; (ii) provide adequate incentives for EHR
adoption; (iii) encourage better data interoperability and comparability by implementing standards (e.g. clinical vocabularies, message standards, ontologies); (iv) put pressure on industry to adopt
open and public standards to enable the integration of systems; and
(v) promote changes in the attitudes of doctors and patients by
demonstrating and communicating the benefits of EHRs in routine
use.
There are also major challenges to the use of EHRs in research,
including issues relating to the reliability and completeness of
databases, variability in medical practice, pervasiveness of unstructured text, lack of specificity of patient data, ability to look
across many records and databases, and privacy and human subject regulations.
Nevertheless, the adoption of EHR is rising steadily in both
hospitals and private practices. Adoption by the regional health
information organisations (RHIOs), umbrella organisations for
networks and gateways in the US, will be a significant step not
only towards a National Health Information Network (NHIN) but
also in providing more effective and efficient identification and
recruitment of clinical trial participants.[45]
A fundamental requirement for the integration of EHR with
clinical data acquisition systems is the development of a common
data standard. Applicable standards for data integration and aggregation have been developed by the Clinical Data Interchange
Standards Consortium (CDISC; an open multidisciplinary, nonprofit organisation that has established worldwide industry standards to support the electronic acquisition, exchange, submission
and archiving of clinical trial data) and Health Level Seven (HL7;
an American National Standards Institute [ANSI] accredited Standards Developing Organization [SDO]) for EHRs.[46] The Biomedical Research Integrated Domain Group (BRIDG) has provided a model to support the development of data interchange
standards and technology solutions that will enable harmonisation
between the biomedical/clinical research and healthcare areas. The
model emerged from a collaborative effort among clinical trial
experts from CDISC, the US NIH/National Cancer Institute (NCI),
the US Food and Drug Administration (FDA), HL7 and other
organisations. Joint modelling efforts are using the HL7 Development Framework (HDF). The NCI has launched the cancer Biomedical Informatics Grid (caBIG) initiative to speed research discoveries and improve patient outcomes by linking researchers, physicians and patients throughout the cancer
community. caBIG is a voluntary network of infrastructure,
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3. Identifying Potential Recruits from Electronic
Health Records
Recently, the use of EHRs has been proposed as an answer to
the challenges of patient recruitment. The EHR is a longitudinal
electronic record of patient health information generated by one or
more encounters in any care delivery setting.[43] Included in this
information are patient demographics, past medical history, vital
signs, medications, laboratory data and reports from surgery,
radiology or pathology. On the other hand, data in clinical trials
must be documented in specifically designed case report forms
and stored with the help of clinical trial management systems.
Integrating EHRs and clinical trial data would provide a significant step towards increasing the efficiency and effectiveness of
clinical trials; therefore, this area is a major focus of research and
experimental activities. However, differences in terminology,
classifications, standards, roles of clinicians, data quality management and software technology between the worlds of medical care
and medical research need to be addressed.
One of the greatest obstacles to the use of clinical data in
research is the low level of adoption of EHRs to date; it is
estimated that overall only 13% of hospitals in the US have an
EHR system in place.[44] Barriers to adoption of EHRs include
costs, infrastructure requirements, acceptance by doctors, inter 2007 Adis Data Information BV. All rights reserved.
Int J Pharm Med 2007; 21 (4)
Ohmann & Kuchinke
268
tools and ideas that enables the collection, analysis, and sharing of
data and knowledge along the entire research pathway from laboratory bench to the patient bedside. In an ambitious project,
CDISC and HL7 have provided a proof-of-concept named ‘single
source’ demonstrating synergistic use of HL7 clinical document
architecture (CDA) and CDISC standards to capture data once for
use with EHRs and clinical trial databases.
Looking forward, one should expect that the incorporation of
standards into tools, data structures and workflow will be crucial
to enabling dramatic improvements in the ability to recruit patients.[21] A joint technology initiative, the Innovative Medicines
Initiative (IMI), has been proposed in the EU.[47] IMI is intended to
become a unique pan-European public and private sector collaboration between large and small pharmaceutical and healthcare
companies, regulators, academia and patients. The IMI strategic
research agenda puts significant value on the availability of quality
EHRs across the EU for the purpose of improved pharmacovigilance and clinical trial design. The Knowledge Management Platform of IMI addresses the need for data integration and aggregation across many data compendia, covering the whole spectrum of
biopharma and pharmacomedical data. These and other initiatives
are likely to have a major impact in the future.
ed health information is prohibited with the exception of a limited
number of uses; these exceptions include using the data to obtain
patients’ authorisation for trial recruitment, use of protected health
information without authorisation provided permission is granted
by an IRB or use of de-identified data.[53] The regulations are
designed to prevent the use of patients protected health information for activities unrelated to clinical care without the patient’s
expressed interest and consent. In order to support trial recruitment
by clinical data from EHRs, compliance with HIPAA and the
corresponding international or national regulations has to be taken
into consideration. Regulatory requirements for clinical trials on
medicinal products and devices, such as international standards
(e.g. GCP) or country specific drug laws, have to be maintained if
data management is expanded to include data from EHRs. The
various technical aspects are dealt with by researchers, patient
portals or EHR vendors, providing prototype solutions for integration.
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At present, EHRs appear to mainly be used on pragmatic and
practical issues and pilot or prototype applications. In a survey of
US academic health centres, the overall implementation of IT to
support clinical research was insufficient and uneven.[48] Only 8%
of respondents reported integration of clinical research data with
patient clinical data from hospital information systems.
Some progress in the area of centralised clinical research data
warehouse development has been made, including data mining
tools and cohort identification capabilities. Successful examples
include Partners HealthCare, the Life Sciences System at the
Mayo Clinic developed in collaboration with IBM, the University
of Pittsburgh’s Medical Archival System,[48] the Information
Warehouse at Ohio State University Medical Center[49] and Mount
Sinai’s General Medicine Outpatient Database.[50] EHR systems
used to identify potential participants for clinical trials are, among
others, the Mayo Clinic system and Kaiser Permanente’s EHR
system KP HealthConnect.[44]
Most promising is the marriage of EHR tools already used by
physicians at the point of care with trial recruitment tools.[51] There
are a number of considerations in setting up a trial with eHealth
record recruitment, including patient privacy, data integration,
regulatory and technical aspects.[52] Different user roles and permissions for clinical versus research roles have to be maintained.
However, due to the Health Insurance Portability and Accountability Act (HIPAA) in the US, all unauthorised disclosure of protect 2007 Adis Data Information BV. All rights reserved.
So far, only a few studies have systematically investigated the
effect of EHR-supported clinical trial recruitment. A significant
benefit to clinical trial recruitment rates was reported in a study,
comparing traditional recruitment with an EHR-based clinical trial
alert system in a before-after study in selected outpatient clinics of
a large US academic healthcare system.[54,55] When a patient’s
electronic health data met selected clinical trial criteria, the clinical
trial system prompted physician consideration of the patient’s
eligibility and facilitated secure messaging to the trial’s coordinator. With the trial alert system, a 10-fold increase in the physicians’ referral rate to the trial coordinator and a doubling of the
enrolment rate was achieved.[55]
In another study, a clinical data repository of the electronic
medical record system was used to support recruitment in a
rheumatology trial.[56] Ten months’ experience with the prototype
are reported. While the system helped identify many potential
candidates, the impact on accrual was disappointing. The use of a
real-time automated notification system to identify potential patients for a clinical trial on the basis of information routinely
entered into the hospital’s computerised registration system was
investigated in a before-after study.[57] The automatic notification
system improved study investigator notification.
Recently, 9 years’ experience with an EHR solution to clinical
trial recruitment were reported by a medical group in US, indicating that the involvement of an EHR can streamline patient recruitment by improving the speed of identification of patients, the
accuracy of assessing eligibility and interpretability by alerting to
patients’ involvement in clinical trials.[58] The group emphasises
that the entire cost of EHR implementation and operation is paid
for by its clinical trials programme.
Int J Pharm Med 2007; 21 (4)
Electronic Health Records and Patient Recruitment
4. Conclusions
Integrating EHRs into clinical trials has major potential to
increase recruitment rates. However, the prerequisite for this is the
widespread adoption of EHRs. Major driving forces to overcome
existing barriers include nationwide initiatives for implementation
of health information structures, strict adherence to standards for
data interoperability, software solutions based on open and public
standards not on proprietary technology, and changes in the attitudes of doctors and patients. EHRs should include fresh, rich,
relevant and consistent data and should support interoperability
between the worlds of medical care and clinical research. Physicians should adopt this support to increase referrals to clinical
trials.
However, an integrated EHR or alerting system alone seems
insufficient to improve recruitment as a whole when viewed from
the recruitment lifecycle position. In order to be successful, a
better cooperation between patient, physician, investigator and
other trial participants is strongly needed. Patient recruitment is a
communication intensive process involving many human ‘soft’
factors. Here the influence of human behaviour using marketing
principles can come into play, but additional software tools that
support crucial patient-physician interaction may also be useful to
complement EHR.
269
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Acknowledgements
No sources of funding were used to assist in the preparation of this
manuscript. There are no conflicts of interest for the authors. Dr Q. Yang,
Heinrich-Heine-University, Duesseldorf, Germany, provided writing assistance for this manuscript.
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Correspondence: Dr Christian Ohmann, Coordination Centre for Clinical
Trials, Medical Faculty, Heinrich-Heine-University, Moorenstrasse 5, 40225
Duesseldorf, Germany.
E-mail: [email protected]
Int J Pharm Med 2007; 21 (4)