Clinical Trial Staff Research Articles

The Good Clinical Practice guideline and its interpretation - perceptions of clinical trial teams in sub-Saharan Africa.

To explore the advantages and challenges of working with the Good Clinical Practice (GCP)-International Conference of Harmonization (ICH) E6 guideline and its interpretation from the perspective of clinical trial teams based in sub-Saharan Africa. We conducted 60 key informant interviews with clinical trial staff at different levels in clinical research centres in Kenya, Ghana, Burkina Faso and Senegal and thematically analysed the responses. Clinical trial teams perceived working with ICH-GCP as highly advantageous and regarded ICH-GCP as applicable to their setting and efficiently applied. Only for informed consent did some clinical trial staff (one-third) perceive the guideline as insufficiently applicable. Specific challenges included meeting the requirements for written and individual consent, conditions for impartial witnesses for illiterates or legally acceptable representatives for children, guaranteeing voluntary participation and ensuring full understanding of the consent given. It was deemed important to have ICH-GCP compliance monitored by relevant ethics committees and regulatory authorities, without having guidelines applied overcautiously. Clinical trial teams in sub-Saharan Africa perceived GCP as a helpful guideline, despite having been developed by northern organisations and despite the high administrative burden of implementing it. To mitigate consent challenges, we suggest adapting GCP and making use of the flexibility it offers.

SU‐F‐P‐13: NRG Oncology Medical Physics Manpower Survey Quantifying Support Demands for Multi Institutional Clinical Trials

Purpose:A survey was taken by NRG Oncology to assess Full Time Equivalent (FTE) contributions to multi institutional clinical trials by medical physicists.No current quantification of physicists’ efforts in FTE units associated with clinical trials is available. The complexity of multi‐institutional trials increases with new technologies and techniques. Proper staffing may directly impact the quality of trial data and outcomes. The demands on physics time supporting clinical trials needs to be assessed.Methods:The NRG Oncology Medical Physicist Subcommittee created a sixteen question survey to obtain this FTE data. IROC Houston distributed the survey to their list of 1802 contact physicists.Results:After three weeks, 363 responded (20.1% response). 187 (51.5%) institutions reporting external beam participation were processed. There was a wide range in number of protocols active and supported at each institution. Of the 187 clinics, 134 (71.7%) participate in 0 to 10 trials, 28 (15%) in 11 to 20 trials, 10 (5.3%) in 21 to 30 trials, 9 (4.8%) had 40 to 75 trials. On average, physicist spent 2.7 hours (SD: 6.0) per week supervising or interacting with clinical trial staff. 1.25 hours (SD: 3.37), 1.83 hours (SD: 4.13), and 0.64 hours(SD: 1.13) per week were spent on patient simulation, reviewing treatment plans, and maintaining a DICOM server, respectively. For all protocol credentialing activities, physicist spent an average of 37.05 hours (SD: 96.94) yearly. To support dosimetrists, clinicians, and therapists, physicist spend on average 2.07 hours (SD: 3.52) per week just reading protocols. Physicist attended clinical trial meetings for on average 1.13 hours (SD: 1.85) per month.Conclusion:Responding physicists spend a nontrivial amount of time: 8.8 hours per week (0.22 FTE) supporting, on average, 9 active multi‐institutional clinical trials.

Obinutuzumab-induced coagulopathy in chronic lymphocytic leukaemia with trisomy 12

We thank the patient and her family for participating in this clinical trial and the GP28331 study site staff on the Hope Unit at the Leicester Royal Infirmary. We also thank Dr Gregory Vosganian and his colleagues at Genentech and Roche for their help and review of the case. Studies were supported by the Leicester Experimental Cancer Medicine Centre (C325/A15575 Cancer Research UK/UK Department of Health).

TRYMS: the ethical and practical considerations of a double-blind placebo controlled randomised clinical trial

A double blind randomised trial is the gold standard approach to minimise the introduction of bias from trial participants, healthcare professionals and clinical trial staff. Similarly, the use of a placebo is ideal when participant self-reported Quality of Life is one of the primary objectives. However, the combination of these trial design components can present challenging ethical and practical issues for good trial conduct. TRYMS is a randomised, double-blinded, placebo controlled phase IV clinical trial in young male cancer survivors with low testosterone levels. The trial is designed to investigate whether testosterone treatment will result in a reduction of truncal fat mass and an increase in participant self-reported physical functioning scores and recruited 136 participants from 10 centres across the UK. Practical issues relate to the potential for centre and trials unit staff to be unblinded by access to clinical data: for example, retests of testosterone measurements required for dose titration were required in the active arm but were done in the placebo arm to maintain the blind. Other issues relate to managing Investigational Medicinal Product supply requirements: a minimisation programme is used to ensure treatment groups are well-balanced by randomising centre however, a random element and participant replenishment halfway during treatment can result in a temporary skew to a centre’s IMP requirements. The ethical issues relate to non-emergency requests for unblinding due to participant perception of treatment allocation. Our experiences in TRYMS, along with our solutions, will be presented with considerations for the management of similar trials.

Patient Engagement in Neurological Clinical Trials Design: A Conference Summary.

The conference objectives included educating patients and advocates about clinical trials, educating the clinical research community about patient perspectives on participating in clinical trial design, and identifying strategies to increase participation in clinical trial design for neurological disorders. Observations were noted during a 1-day conference attended by patients, patient advocates, clinical trial staff, and investigators. The conference offered didactic sessions, small, and large group discussions. Conference participants were patients, patient advocates, clinical trial staff, students, and investigators interested in engaging patients in clinical trial design for neurological disorders. Conference participants were asked to consider lessons learned that could increase patient engagement in clinical trial design. We found that there is growing interest in including patients in the design of clinical trials for neurological disorders. Several themes emerged on how to move forward: networking; the multifaceted roles of advocates in research; training and education; creating patient-researcher partnerships; and clinical trials regulation issues. The conference provided a forum for dialogue regarding stakeholder engagement in the design of clinical trials for neurological disorders. This experience provides a template for replication and dissemination of this conference and informs next steps to accelerate the pathway from dialogue to action.

PRM154 - The Electronic Age: Integrating Epro/Ecoa To Reduce Patient, Site, And Study Team Burden

While some have fully embraced and incorporated ePROs/eCOAs into protocol designs, many continue to use paper PROs/COAs. This conceptual paper explores reasons for paper PRO/COA continued use, focusing on how PROs can be integrated into the electronic trial solution to reduce the burden to patients/participants, sites, and clinical teams in setting up, maintaining, and closing out a clinical trial. Associated risks and mitigation strategies will be identified in transitioning to ePRO/eCOA collection modes. Strategies recommended for successful transition to integrated electronic PRO/COA solutions will be discussed. Integration of ePRO/eCOA provides several benefits over paper, including improved compliance and higher data quality. Comparing the advantages of electronically captured PRO/COA data vs. paper, the benefits of ePRO/eCOA far outweigh those of paper. Combine this with the support and advocacy of ePRO/eCOA in clinical trials by regulatory authorities and a shift of the general population towards electronic devices; it raises the question why all clinical trials are not using ePRO/eCOA to optimize the integrity of data and trial results. Common obstacles in the selection of a PRO/COA electronic data collection mode include: paper instruments designed for a paper world, inability to determine true risks, unknown total cost of electronic vs. paper administration, instrument author has sometimes costly requirements for migration, unclear translation expectations, and fear of the unknown. An assessment of methods to facilitate the transition to electronic data capture will be performed. Examples include use of items/instruments that are appropriate for electronic platforms and easily migrated and site and patient training plans. In this age of technological advancements, including an integration plan in clinical trials is important to mitigate potential risks and minimize the burden to clinical trial staff and participants. Detailing this up front can help to alleviate many of the obstacles in the transition from paper to electronic PRO/COA.

The acceptability of intermittent screening and treatment versus intermittent preventive treatment during pregnancy: results from a qualitative study in Northern Ghana.

BackgroundAffecting mother and child, malaria during pregnancy (MiP) provokes a double morbidity and mortality burden. Within a package of interventions to prevent MiP in endemic areas, the WHO currently recommends intermittent preventive treatment (IPTp). Concerns about anti-malarial resistance have however prompted interest in intermittent screening and treating (IST) as an alternative approach to IPTp. IST involves screening for malaria infection at scheduled antenatal care (ANC) clinic visits and treating malaria cases. In light of the need to comprehensively evaluate new interventions prior to roll out, this article explores the acceptability of IST with artemether-lumefantrine (AL) compared to IPTp with sulphadoxine-pyrimethamine (SP) and in Upper East Region, northern Ghana.MethodsData were collected alongside an open-label, randomized, controlled trial of IST-AL and IPTp-SP in Kassena-Nankana District. Thirty pregnant women enrolled in the clinical trial participated in six focus group discussions. Ten in-depth interviews were carried out with clinical trial staff. Observations were also made at the health facilities where the clinical trial took place.ResultsTrial participants were generally willing to endure the discomfort of the finger prick necessary for a rapid diagnostic test for malaria and this reflected a wider demand for diagnostic techniques. Reports of side effects were however linked to both trial anti-malarials. Direct complaints about SP were particularly severe with regard to women’s experience of vomiting. Although the follow-up treatment doses of AL for IST were not supervised, based on blister inspection and questioning trial, staff were confident about participants’ adherence to the treatment course. One case of partial adherence to the AL treatment course was reported.ConclusionDespite the discomfort of the finger prick required to perform the intermittent malaria screening, trial participants generally expressed more positive sentiments towards IST-AL than IPTp-SP. Nonetheless, questions remain about adherence to a multiple dose anti-malarial regimen during pregnancy, particularly in endemic areas where MiP is often non-symptomatic. Any implementation of IST must be accompanied by appropriate health messages on adherence and the necessary training for health staff regarding case management.

Bridging the US and China together to conquer cancer: report of the 4th Annual Meeting of the US Chinese Anti-Cancer Association (USCACA)

A global collaborative effort is pivotal to conquer cancer. Themed “Emerging role of China in global clinical development of novel anti-cancer drugs”, the US Chinese Anti-Cancer Association (USCACA) held its 4th annual meeting in Chicago on June 2, 2012, in conjunction with the American Society of Clinical Oncology (ASCO) annual meeting to further bridge the US and China together to outsmart cancer. Although a young organization, USCACA has made significant contributions to this goal in the 3 years since its inception through extensive collaboration with academic organizations, the pharmaceutical industry, and governmental agencies. USCACA has engaged various stakeholders in developing translational and personalized medical strategies to facilitate new anti-cancer drug development and clinical trials in China. USCACA has initiated and implemented the USCACA-National Foundation for Cancer Research (NFCR) scholarship to encourage overseas returnees to continue cancer research in China. USCACA announced the Hengrui-USCACA scholarship to fund clinical trial staff from China to conduct the observation of early oncologic clinical trials in the US. During the annual meeting, distinguished panelists and the audience discussed the following critical topics: (1) oncologic translational research and early development capabilities in China; (2) novel chemical entity development and partnership with Chinese companies; and (3) Chinese participation in global anti-cancer drug development. USCACA will continue to promote collaborations among cancer researchers and clinicians in the US and China by engaging in more frequent communications and joint efforts across fields, disciplines, and countries, diligently working together toward curing and eliminating cancers.

Assessment of suicidal ideation and behavior in clinical trials: challenges and controversies

The association between several psychoactive medications and suicidal adverse events, as well as the recent focus on treatment of suicidal behaviors, has resulted in increased attention on the assessment of suicidal ideation and behavior within clinical trials. Measurement of suicidal adverse events is now required in clinical trials of a range of medications. The Columbia Suicide Severity Rating Scale is the leading measure of suicidal adverse events. It is brief, measures both suicidal ideation and behavior, contains definitions of each term and has promising psychometric properties. While such measures may assist clinical trial staff, suicidal events remain a challenge to assess. Clinical trial design features from studies of interventions for suicidal patients may guide the design of trials in which assessment of suicidal adverse events is now required, including patient selection, safety plans for at-risk patients, flexible treatment algorithms and clear assessment protocols and referral pathways.

Challenges and potential solutions to meeting accrual goals in a Phase II chemoprevention trial for prostate cancer

ObjectiveThe goal of this report is to describe the on going strategies, successes, challenges and solutions for recruitment in this multi-center, phase II chemoprevention trial targeting men at high risk for prostate cancer. MethodsWe developed and implemented a multi-center clinical trial in institutions with supportive infrastructure, lead by a recruitment team of experienced and committed physicians and clinical trial staff, implementing multi-media and community outreach strategies to meet recruitment goals. Screening logs were reviewed to identify trends as well as patient, protocol and infrastructure -related barriers impacting accrual and revisions to protocol implemented. ResultsBetween January 2008 and February 2011 a total of 3547 individuals were prescreened with 94% (n=3092) determined to be ineligible based on diagnosis of cancer or benign biopsy results. Of these, 216 were considered eligible for further screening with 52% (n=113) declining to participate due to patient related factors and 14% (n=29) eliminated due to protocol-related criteria for exclusion. Ninety-four (94) subjects consented to participate with 34% of these subjects (n=74) meeting all eligibility criteria to be randomized to receive study agent or placebo. Across all sites, 99% of the recruitment of subjects in this clinical trial is via physician recruitment and referral with less than 1% responding to other recruitment strategies. ConclusionA contemporary approach to subject recruitment and frequent evaluation is needed to assure responsiveness to emerging challenges to accrual and the evolving scientific literature. A focus on investing on improving systems for physician recruitment may be key to meeting recruitment target in chemoprevention trials.

Supporting MCRN research through improving clinical trial delivery by hospital pharmacies

<h3>Objectives</h3> (1) To scope pharmacy clinical trial services in Birmingham and Black Country and the West Midlands. (2) To devise a strategy to deliver services with best use of resources. Topical Research Networks have been set up to increase quality research in NHS. Medicines for Children Research Network is dependent on hospital pharmacies having the capability to run CTIMPs (Clinical Trials of Investigational Medicinal Products). Nationally Pharmacy has been identified as a block, hence the need to scope the underlying local situation and identify what is needed to improve pharmacy clinical trial delivery. <h3>Methods</h3> Review of survey of Chief Pharmacists in the North West1 used as basis for West Midlands Chief Pharmacist Questionnaire in August 2009. 20 semi structured interviews of key stakeholders in Birmingham and Black Country Comprehensive Local Research Network carried out between June and September 2009. <h3>Results</h3> The North West survey identified the issues and proposed a model for central support but there was no mention of outcome targets or evidence based management. 30 trusts surveyed, 66% response rate. With the West Midlands Chief Pharmacist Questionnaire 18 trusts were surveyed, 22% response rate. This indicated that a wider scoping method was needed. The findings from the interviews with Birmingham and Black Country Comprehensive Local Research Network key stakeholders indicated inadequate staffing, recruitment problems with insufficient training and education available. Pharmacy clinical trial staff were not integrated into the research infrastructure. The funding mechanisms were unclear. Insufficient storage facilities and lack of aseptic capacity for clinical trials were identified. Standards for running clinical trials were variable. <h3>Conclusion</h3> The existing system is dysfunctional and a new co-ordinated strategy for delivering clinical trials, expert input and associated funding is needed across the region. Short term strategy: A pharmacy clinical trial network is needed with a lead pharmacist, lead clinical trial centre and management committee. Finance needs to be sufficient and targeted to support staffing. Existing centres need assistance with legislation and guidance, with access to a knowledge base and training. New centres need to be developed. Communication needs improving so that pharmacy liaises with R&amp;D. The profile of clinical trials as a specialty needs raising with Directors of Pharmacy. Medium term strategy: Quality of clinical trial delivery depends on processes with site audits to inform on standards. For capacity planning the development of clinical trial units on each site with the necessary facilities is needed. To provide staffing the hub and spoke mechanism will operate with CLRN funded staff contributing back to the centre. Long term strategy: In order to improve recruitment and retention a career structure for CT staff needs to be set up with input into education both at universities and colleges with designated training and competencies.

Abstract A42: Optimizing health care systems recruitment and retention practices for medically underserved populations: Impact of ENACCT cancer clinical trial staff training

Abstract Cancer clinical trials (CCTs) are essential to making progress in cancer care, yet many cancer care sites within health care systems struggle with improving adult trial participation, which nationally is less than 5%, even lower among communities of color. Challenges to improving participation include patient barriers such as fear, lack of awareness and costs as well as institutional barriers (limited staff and resources, study design, provider attitudes and behaviors) that can limit patient access to trials, particularly among minority and medically underserved populations. The Education Network to Advance Cancer Clinical Trials (ENACCT) seeks to improve access to CCTs through education and collaboration with communities, health care providers, and researchers. ENACCT's Pilot Education Program (PEP), was a 3-year community-based intervention designed to enhance access, awareness and accrual to trials. Implemented in three communities nationwide, training was targeted to key stakeholders in trial participation, including CCTs staff. Using an interactive learning format, PEP training for CCT staff focused on the impact of culture and changing demographics within the clinical research setting; the relationship of cultural competency and Culturally and Linguistically Appropriate Services (CLAS) Standards to CCTs participation; and assisted CCT staff to design an action plan to adopt CLAS Standards in the conduct of research at one's own institution. Additionally, local sites addressed policy barriers to enhance access. PEP impact was evaluated using pre and post tests, follow-up assessments, as well as interview and focus group data. PEP trained 61 CCTs staff (70% nurses). Post-training, at first assessment, 94% of CCT staff indicated increased commitment to advocate for adoption of CLAS standards within their institutions and 84% indicated intention to discuss with their peers the importance of cultural competency on patient recruitment and retention. Site initiatives to address access barriers included implementation of consent short forms for limited English proficiency patients, use of Six Sigma quality improvement measures to improve hospital recruitment processes and launching city-wide symposia on CCTs reaching community leaders and health care providers. A total of 3027 website sessions and 88 unique patient profiles were created with a national CCTs matching service associated with PEP. Results from PEP suggest that training CCT staff in strategies to enhance cultural competency in the research setting may positively impact awareness and access to CCTs among medically underserved populations. Citation Information: Cancer Epidemiol Biomarkers Prev 2010;19(10 Suppl):A42.

A qualitative assessment of the experience of participating in a cancer-related clinical trial

This study aims to explore the experiences of patients enrolled in a cancer-related clinical drug treatment trial utilising a qualitative focus-group methodology. Specifically, this study aimed to explore the impact of social and family support, the challenges and advantages of taking part in a clinical trial and the experiences of patients at the conclusion of the trial. A qualitative study was conducted at a public hospital in Melbourne in 2008. A total of 14 participants were recruited. Three focus groups and two interviews were conducted with 13 patients who had completed a cancer-related clinical trial. Comments from a letter written by a trial participant were also analysed. Interviews were audio-recorded, transcribed and coded according to emerging themes. Information obtained was grouped around four main themes; making sense of trial participation, challenges of treatment in the context of clinical trial participation, support during trial participation and coping with trial conclusion. Participants experienced a mixture of hope, uncertainty and apprehension as they considered whether to take part in a clinical trial. At different stages of the trial they made sense of their participation by thinking about the possible benefits of participation. Trial participation was also associated with a number of emotional and practical challenges. Generally, participants were very positive about the support they received from health professionals, family and friends. The end of the trial was associated with a mix of emotions, including relief, disappointment, hope of future help, uncertainty and abandonment. Clinical trial participation is a positive experience for many patients with cancer, although there are a number of associated practical and emotional challenges. Trial participants may benefit from closer follow-up from clinical trial staff, especially the treating doctor, assessment of support needs and help in re-evaluating the meaning of their trial participation if their initial hopes and expectations are not met.

ENACCT's pilot education program (PEP): A model to enhance understanding of cancer clinical trials for community providers and community leaders

e17514 Background: While nearly 20% of adult cancer patients are eligible for cancer clinical trials, less than 3% of cancer patients participate. Rates of participation are lower among communities of color and the medically underserved. Enhanced community engagement and provider training about cancer clinical trials can potentially result in greater awareness, access, and ultimately, patient accrual. Methods: A three-year Pilot Education Program was developed to explore the impact and feasibility of a community-driven outreach and education intervention focusing on community members, community health care providers, and cancer researchers in three medically underserved communities. Using a train-the-trainer model, PEP sought to raise clinical trial awareness among peers and encourage public inquiries about clinical trials. Workshops for clinical trials staff addressed recruitment and retention practices. Additionally, community sites worked to reduce local policy barriers to clinical trials participation.PEP used web-based surveys, interviews, focus groups and field observation to evaluate impact. Results: Seventy-five trainers were recruited. PEP reached 882 community members (63% minority), 374 health care providers (16% minority) and 61 cancer clinical trial staff. Approximately 5,800 individuals were exposed to educational activities through extended community outreach activities and dissemination of educational materials. Among those completing evaluation surveys, 66% of community leader trainees said they spoke to others about cancer clinical trials. Seventy-two percent of health care providers agreed their role is to inform patients about the possibility of receiving treatment through a clinical trial. Among cancer clinical trial staff, 80% indicated intention to work with community groups on cancer clinical trials education. Seventy-seven unique patient profiles were created with a national cancer clinical trials matching service also associated with PEP. Conclusions: Results from ENACCT's Pilot Education Program suggest promise in improving knowledge among community leaders and health care providers, and fostering greater peer-to-peer education about cancer clinical trials. [Table: see text]

Dynamic long distance management of patient variables: Application in ameliorating chemotherapy-associated side effects

Dynamic long distance management of patient variables: Application in ameliorating chemotherapy-associated side effects

Guide for clinical trial staff – implementing good clinical practice

The ICH Guideline for Good Clinical Practice (GCP) defines the standards to which investigators and their staff must adhere to when conducting clinical trials. This standard ensures adequate protection of subjects participating in clinical trials; furthermore, it ensures that all trial activities and data are meticulously documented and reported. However, the interpretation and practical application of ICH GCP guidelines can be very daunting for inexperienced trial staff. This book was written with the primary aim of providing investigators and their staff with a summary of the information they require in order to facilitate the conduct of clinical trials in accordance with ICH GCP. The presentation of the book is a series of chapters covering all key elements of GCP in clinical trials, from the organization and planning, regulatory and ethical approvals, subject recruitment, right through to close out and archiving. Each chapter has an introduction summarizing the element of GCP to be covered. This is followed by a summary of responsibilities of the clinical site staff, cross-referring to the relevant section of the ICH GCP guideline. Thereafter follows a list of detailed actions subdivided into activities to be performed before the start of the study, during the study and after completion or termination of the study. There are check boxes alongside this section with other useful information; for example, what to do/who to consult in case of difficulties, examples of best practice, consequences of not following the requirement. Finally, there are some hints and tips for implementation at the site level, a cross reference to other relevant chapters and an action item list for personal use. Each chapter is presented in a clear, concise format which is highly readable and can be quickly assimilated. The chapters follow a logical order of the activities to be undertaken at the study site level. References to investigator and sponsor responsibilities are included throughout, also guidance on when to consult the study monitor. The book achieves its primary aim of providing clinical trial staff with a reference source for conducting trials in accordance with ICH GCP. It may be recommended to all staff involved in the management of clinical trials as an easy-to-use, quick check summary of the activities required throughout the clinical trial process.

Research misconduct among clinical trial staff

Between 1993 and 2002, 39 clinical trial staff were investigated for scientific misconduct by the Office of Research Integrity (ORI). Analysis of ORI case records reveals practices regarding workload, training and supervision that enable misconduct. Considering the potential effects on human subjects protection, quality and reliability of data, and the trustworthiness of the clinical research enterprise, regulations or guidance on use of clinical trial staff ought to be available. Current ORI regulations do not hold investigators or institutions responsible for supervision and training of clinical trial staff. Given the important issues at stake, the definition of research misconduct should encompass the intentional or negligent mismanagement of scientific projects. Individual institutions and professional associations not only can but should adopt stricter standards of conduct than those reflected in federal regulations.

Clinical trial enrollers vs. nonenrollers: The Cardiac Arrhythmia Suppression Trial (CAST) Recruitment and Enrollment Assessment in Clinical Trials (REACT) project

The Recruitment and Enrollment Assessment in Clinical Trials (REACT) was a National Heart, Lung, and Blood Institute (NHLBI)-sponsored substudy to the Cardiac Arrhythmia Suppression Trial (CAST). Two-hundred-sixty (260) patients who enrolled in CAST and 140 partially or fully eligible patients who did not enroll were compared across several parameters, including demographic variables, disease severity, psychosocial functioning, health beliefs, recruitment experience, and understanding of informed consent procedures used in CAST. Significant predictors of enrollment included several demographic variables (e.g., being male, not having medical insurance), episodes of ventricular tachycardia, and health beliefs (e.g., extra beats are harmful, a higher degree of general health concern). Enrollment was higher for those who read and understood the informed consent and those who were initially recruited after hospital discharge, particularly nondepressed patients. In the multivariate model, the key variables that emerged were the patient's reading of the informed consent form and the patient's lack of medical insurance. These results suggest that (1) the clinical trial staff's interaction with the patient and the time when recruitment is initiated contribute significantly to the decision to enroll; and (2) it may be a greater challenge to motivate patients to enroll in future clinical trials if health care reform improves access to medical insurance coverage. Some of the significant variables are modifiable, suggesting interventions that may increase enrollment rates in future trials.

Development of standardized simulated patients for quality control of the clinical interview

The evaluation and training of clinical trial staff who counsel patients in lifestyle changes for disease prevention is aided by a review of videorecorded interviews conducted with a simulated patient. This report describes the Inventory of Simulated Patient Characteristics, a listing of 34 generic parameters for developing a simulated patient for use in staff training and evaluation in counseling. The Inventory creates a complete person in all critical aspects of counseling for lifestyle change (e.g., daily routines, family, job). The Inventory was used in the Lipid Research Clinics' Coronary Primary Prevention Trial (CPPT) to examine the trial staff's skills in counseling for regimen adherence. In 1979 and 1980, 85 and 52 clinic staff, respectively, conducted a total of 548 interviews with four different simulated patients developed using the Inventory, and rated the portrayals as highly realistic. The Inventory also was used to verify that the simulated patient portrayals were greater than 90% faithful to their characterizations. While simulated patients limited to specific clinical syndromes have been used widely in medical education, no guidelines exist for their use in training trial staff in regimen counseling. The Inventory provides a simple template for creating simulated patients with broad characterizations that closely mimic actual trial participants.

Development of standardized simulated patients for quality control of the clinical interview

The evaluation and training of clinical trial staff who counsel patients in lifestyle changes for disease prevention is aided by a review of videorecorded interviews conducted with a simulated patient. This report describes the Inventory of Simulated Patient Characteristics, a listing of 34 generic parameters for developing a simulated patient for use in staff training and evaluation in counseling. The Inventory creates a complete person in all critical aspects of counseling for lifestyle change (e.g., daily routines, family, job). The Inventory was used in the Lipid Research Clinics' Coronary Primary Prevention Trial (CPPT) to examine the trial staff's skills in counseling for regimen adherence. In 1979 and 1980, 85 and 52 clinic staff, respectively, conducted a total of 548 interviews with four different simulated patients developed using the Inventory, and rated the portrayals as highly realistic. The Inventory also was used to verify that the simulated patient portrayals were greater than 90% faithful to their characterizations. While simulated patients limited to specific clinical syndromes have been used widely in medical education, no guidelines exist for their use in training trial staff in regimen counseling. The Inventory provides a simple template for creating simulated patients with broad characterizations that closely mimic actual trial participants.