Coordination Of Clinical Trials Research Articles

Translational Cancer Nursing Research: What Will Your Contribution Be?

Over the past decade, reference to translational research has increasingly dominated our research semantic. There are multiple definitions of translational research, but the most commonly understood is the transfer of biomedical knowledge from bench to clinical trial and from clinical trial to bedside as a component of usual care. As an international community of cancer nurse clinicians, researchers, educators and leaders, it is our collective responsibility to redress this omission. This article depicts ways in which cancer nurses can, and already do contribute to knowledge translation.

Justification for conducting neurological clinical trials as part of patient care within private practice.

The aim of this review was to assess the benefits and drawbacks of conducting neurological clinical trials and research in private practice for the patients, clinician, Practice Manager, sponsors/Clinical Research Organisations (CROs) and Clinical Trial Coordinator (CTC) to determine if this is justified for all involved. A combination of literature reviews, original research articles and books were selected from 2005 to 2015. Provided that the practice has sufficient number of active trials to prevent financial loss, support staff, adequate facilities and equipment and time, the benefits outweigh the drawbacks. Clinical trials provide patients with more thorough monitoring, re-imbursement of trial-related expenses and the opportunity to try an innovative treatment at no charge when other options have failed. For the clinician, clinical trials provide more information to ensure better care for their patients and improved treatment methods, technical experience and global recognition. Trials collect detailed and up-to-date information on the benefits and risks of drugs, improving society's confidence in clinical research and pharmaceuticals, allow trial sponsors to explore new scientific questions and accelerate innovation. For the CTC, industry-sponsored clinical trials allow potential entry for a career in clinical research giving CTCs the opportunity to become Clinical Research Associates (CRAs), Study Start-Up Managers or Drug Safety Associates.

Biosimilar Trials in Developing Countries: Detecting and Eradicating Barriers to Patient Recruitment

Introduction:Biologic drugs are high-cost technologies that represent a challenge to the economic management of healthcare systems. Biosimilar drugs (BSD) are designed to be highly similar, in terms of safety, purity and efficacy to an existing licensed reference biologic drug (RBD). Furthermore, the use of BSD can reduce up to 35% of the cost of treatment compared to RBD, so the approval of BSD worldwide will strongly influence prescriptions, particularly in emerging markets. Previous studies have identified challenges regarding BSD prescription and patient recruitment in developing countries. Our goal was to identify potential barriers to patient accrual during biosimilar clinical trials (CT) in Brazil and propose solutions to enhance the process.Methods: A panel of specialists comprising investigators and site coordinators from 25 research sites in Brazil was invited to discuss recruitment barriers and related challenges in biosimilar trials. Participants were required to debate three open-ended questions. First: considering the biosimilar trial on rituximab, which are the main barriers/challenges to patient recruitment? Second: which aspects were determinant to an unsuccessful recruitment and why. Third: do the previous conclusions express my personal belief regarding the causes of the unsuccessful recruitment? Through a series of dynamic activities, problems were identified and collective solutions were proposed.Results: A group of 16 investigators, 23 clinical trial coordinators and 14 members of the sponsors' staff participated in the meeting. Investigators had a mean experience of 20 years of clinical practice and 15 years on clinical trial conduction. Criteria for unsuccessful recruitment and investigators' beliefs regarding the causes of low recruitment were consistent among the answers. Barriers, perceptions and possible solutions to improve patient recruitment in BSD trials are depicted on Figure 1. The main barriers for recruitment were distributed among different domains, including the biosimilar drug itself, limitations on the public healthcare system (PS) and established perceptions (status quo), among others. According to the panel the main issues are lack of information regarding BSD among patients and physicians and the negative attitude toward CT participation among patients. The lack of physicians' and patients' awareness regarding biosimilar development pathways was emphasized by all the panelists. Also, logistics played and important role in limiting patients' participation.Conclusions: The lack of information among patients and investigators was the main challenge regarding accrual in BSD trials, leading to negative attitudes towards CT in general by both patients and physicians. Providing information on BSD and CT to all players, as well as to society in general in fundamental in enhancing patient accrual and the comprehension on the benefits of participating in clinical studies. [Display omitted] DisclosuresCastilho:Libbs Farmacêutica: Employment. Almeida:Libbs Farmacêutica: Employment. Miyashiro:Libbs Farmacêutica: Employment.

Textual inference for eligibility criteria resolution in clinical trials

Clinical trials are essential for determining whether new interventions are effective. In order to determine the eligibility of patients to enroll into these trials, clinical trial coordinators often perform a manual review of clinical notes in the electronic health record of patients. This is a very time-consuming and exhausting task. Efforts in this process can be expedited if these coordinators are directed toward specific parts of the text that are relevant for eligibility determination. In this study, we describe the creation of a dataset that can be used to evaluate automated methods capable of identifying sentences in a note that are relevant for screening a patient’s eligibility in clinical trials. Using this dataset, we also present results for four simple methods in natural language processing that can be used to automate this task. We found that this is a challenging task (maximum F-score=26.25), but it is a promising direction for further research.

The impact of registration of clinical trials units: the UK experience.

Over the last decade, the United Kingdom has invested significant resources in its clinical trial infrastructure. Clinical research networks have been formed, and some general oversight functions for clinical research have been centralised. One of the initiatives is a registration programme for Clinical Trials Units involved in the coordination of clinical trials. An international review panel of experts in clinical trials has been convened for three reviews over time, reviewing applications from Clinical Trials Units in the United Kingdom. The process benefited from earlier work by the National Cancer Research Institute that developed accreditation procedures for trials units involved in cancer trials. This article describes the experience with the three reviews of UK Clinical Trials Units which submitted applications. This article describes the evolution and impact of this registration process from the perspective of the current international review panel members, some of whom have served on all reviews, including two done by the National Cancer Research Institute. Applications for registration were invited from all active, non-commercial Clinical Trials Units in the United Kingdom. The invitations were issued in 2007, 2009 and 2012, and applicants were asked to describe their expertise and staffing levels in specific areas. To ensure that the reviews were as objective as possible, a description of expected core competencies was developed and applicants were asked to document their compliance with meeting these. The review panel assessed each Clinical Trials Unit against the competencies. The Clinical Trials Unit registration process has evolved over time with each successive review benefiting from what was learned in earlier ones. The review panel has seen positive changes over time, including an increase in the number of units applying, a greater awareness on the part of host institutions about the trials activity within their organisations, more widespread development of Standard Operating Procedures in key areas and improvements in information technology systems used to host clinical trials databases. Key funders are awarding funds only to registered units, and host institutions are implementing procedures and structures to ensure improved communication between all parties involved in trials within their organisation. The registration process developed in the United Kingdom has helped to ensure that trials units in the United Kingdom are compliant with regulatory standards and can meet acceptable standards of quality in their conduct of clinical trials. There is an increased awareness among funders, host institutions and Clinical Trials Units themselves of the required competencies, and communication between all those involved in trials has increased. The registration process is an effective and financially viable way of ensuring that objective standards are met at a national level.

Organizational update: American Heart Association Stroke Council.

This report represents the Spring 2014 update of the Stroke Council. Much has happened in the past 6 months, and we want to particularly focus on the new strategic plan for the American Heart Association (AHA)/American Stroke Association (ASA) and new research opportunities within the AHA/ASA. Each Stroke Council Update starts with restating our 2020 Goals: By 2020 to improve the cardiovascular health of all Americans by 20% while reducing deaths from cardiovascular diseases and stroke by 20%. To reach this goal, the AHA/ASA has worked hard, with input from throughout the organization, to craft the next detailed strategic plan for the entire AHA/ASA, including the strategic plan for the ASA that will be distributed throughout the organization in the upcoming months. One issue became apparent while reviewing the strategic plan for AHA/ASA: stroke rehabilitation and recovery are not emphasized currently in the Strategic Plan for the AHA as they deserve. In part, this reflects more limited research data and metrics available for assessing the effect of various approaches to stroke recovery compared with extensive research and public data about cardiac rehabilitation. Our stroke strategic plan must prioritize increasing engagement and advocacy for stroke recovery and rehabilitation. For example, in March, Congress passed another temporary fix to the Medicare therapy caps. They extended the exceptions process for 1 additional year (through March 31, 2015). This process allows stroke survivors on Medicare to get more outpatient therapy than the $1920 caps allow but only if their healthcare provider jumps through additional hoops to get those services covered. Although this short-term fix is good and is a direct result of advocacy from many stroke-related organizations, a long-term fix to Medicare therapy caps is paramount, and advocacy by all of us will be needed to ensure a long-term solution. …

Clinical research potential in Victorian hospitals: the Victorian clinician researcher needs analysis survey

The 2012 McKeon Review highlighted the role of clinician researchers in patient based research and the need to foster this capacity. While anecdotal evidence suggests that clinician researchers are under threat and underfunded, Australian data on barriers and enablers of clinician-led research are scant. To describe (i) characteristics of clinician researchers; (ii) for research-active clinicians: areas of research, barriers/enablers of research and factors associated with funding success; and (iii) for research-inactive clinicians: enablers of future research. An online survey distributed through the Bio21 Cluster to clinicians (doctors, nurses, allied health professionals) in 15 Victorian hospitals between November 2011 and January 2012. Seven hundred and seventy of 1027 (75%) of respondents were research-active and were more likely to be male, medical doctors, aged 45-54 years, to work full-time and have a higher degree (all P < 0.01). Of clinicians with a higher degree, 28% were research-inactive. Clinicians identified protected research time (50%), designated research space (42%), clinical trial coordinators (35%), institutional funding (34%) and mentoring (33%) as critical enablers of research. Research-inactive clinicians identified protected research time as the key enabler of future research. To realise recommendations in the McKeon Review, hospitals and research bodies will need to protect research time and provide space and funding. Engaging research-inactive clinicians will build research capacity.

Assessing the challenges of multi‐scope clinical research sites: an example from NIH HIV/AIDS clinical trials networks

Large-scale, multi-network clinical trials are seen as a means for efficient and effective utilization of resources with greater responsiveness to new discoveries. Formal structures instituted within the National Institutes of Health (NIH) HIV/AIDS Clinical Trials facilitate collaboration and coordination across networks and emphasize an integrated approach to HIV/AIDS vaccine, prevention and therapeutics clinical trials. This study examines the joint usage of clinical research sites as means of gaining efficiency, extending capacity, and adding scientific value to the networks. A semi-structured questionnaire covering eight clinical management domains was administered to 74 (62% of sites) clinical site coordinators at single- and multi-network sites to identify challenges and efficiencies related to clinical trials management activities and coordination with multi-network units. Overall, respondents at multi-network sites did not report more challenges than single-network sites, but did report unique challenges to overcome including in the areas of study prioritization, community engagement, staff education and training, and policies and procedures. The majority of multi-network sites reported that such affiliations do allow for the consolidation and cost-sharing of research functions. Suggestions for increasing the efficiency or performance of multi-network sites included streamlining standards and requirements, consolidating protocol activation methods, using a single cross-network coordinating centre, and creating common budget and payment mechanisms. The results of this assessment provide important information to consider in the design and management of multi-network configurations for the NIH HIV/AIDS Clinical Trials Networks, as well as others contemplating and promoting the concept of multi-network settings.

Recent Med School Grad Envisions Career as Psychiatric 'Cultural Broker'

A graduating medical student planning a career in psychiatry turns a background of relinquishment and rescue, poverty and privilege into the goal of treating underserved Americans.

The results of the International Consortium on Acute Promyelocytic Leukemia: a 'proof of concept' of networking as a strategy to improve the outcome of treatment of hematological malignancies in developing countries.

The results of the International Consortium on Acute Promyelocytic Leukemia: a 'proof of concept' of networking as a strategy to improve the outcome of treatment of hematological malignancies in developing countries.

M04 European huntington's disease network registry: current status

BackgroundThe European Huntington's disease Network's (EHDN) REGISTRY is an observational, prospective, longitudinal, multi-national, multi-centre cohort study of Huntington's disease (HD). It is the largest study of HD to date, and...

Outsourced Psychiatry: Remote Support

![Figure][1] Looking for help. An overcrowded mental hospital in Banda Aceh, Indonesia. CREDIT: G. MILLER/ SCIENCE In his News Focus story “Who needs psychiatrists?” (16 March, p. [1294][2]), G. Miller highlights the burgeoning psychiatric morbidities in regions left devastated by conflict. Social media can now provide access to an additional conduit of expertise, which can offer remote support and help in constructing virtual healthcare architecture in politically fragile nations. In Somaliland, with a population of 3.5 million people, United Kingdom–based organizations are already using social networking portals to support continuing medical education for interns ([ 1 ][3]) and to provide real-time mentoring for doctors managing challenging psychiatry cases. This support is crucial in a country with no psychiatrists in the public sector and in which chaining affected patients to the floor is common. With an unpredictable political climate limiting interventions by foreign agencies, social networks provide a practical means of offering regular, intercontinental support to doctors who would otherwise be isolated. Such technology could further be deployed to gather electronic healthcare workforce records, augment coordination of clinical trials, and monitor health economies. The disparities in medical capacity between Northern and Southern partners are already narrowing. If security and identity verification are safeguarded, social media could rapidly accelerate progress. 1. [↵][4]1. A. E. Finlayson 2. et al ., J. Telemed. Telecare 16, 181 (2010). [OpenUrl][5][Abstract/FREE Full Text][6] 2. All authors are affiliates of [medicineafrica.com][7], a social enterprise providing a platform for healthcare educational partnerships. [1]: pending:yes [2]: /lookup/doi/10.1126/science.335.6074.1294 [3]: #ref-1 [4]: #xref-ref-1-1 View reference 1 in text [5]: {openurl}?query=rft.jtitle%253DJournal%2Bof%2BTelemedicine%2Band%2BTelecare%26rft.stitle%253DJ%2BTelemed%2BTelecare%26rft.aulast%253DFinlayson%26rft.auinit1%253DA.%2BE.%26rft.volume%253D16%26rft.issue%253D4%26rft.spage%253D181%26rft.epage%253D184%26rft.atitle%253DAn%2Binternational%252C%2Bcase-based%252C%2Bdistance-learning%2Bcollaboration%2Bbetween%2Bthe%2BUK%2Band%2BSomaliland%2Busing%2Ba%2Breal-time%2Bclinical%2Beducation%2Bwebsite%26rft_id%253Dinfo%253Adoi%252F10.1258%252Fjtt.2010.004004%26rft_id%253Dinfo%253Apmid%252F20511568%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx [6]: /lookup/ijlink/YTozOntzOjQ6InBhdGgiO3M6MTQ6Ii9sb29rdXAvaWpsaW5rIjtzOjU6InF1ZXJ5IjthOjQ6e3M6ODoibGlua1R5cGUiO3M6NDoiQUJTVCI7czoxMToiam91cm5hbENvZGUiO3M6NToic3BqdHQiO3M6NToicmVzaWQiO3M6ODoiMTYvNC8xODEiO3M6NDoiYXRvbSI7czoyNDoiL3NjaS8zMzYvNjA3OC8xNTIuMS5hdG9tIjt9czo4OiJmcmFnbWVudCI7czowOiIiO30= [7]: http://medicineafrica.com

States find creative ways to finance cancer programs

States find creative ways to finance cancer programs

CMR endpoints for clinical trials: impact of operator experience on the accuracy of image analysis

Methods 20 CMR studies of acute coronary syndromes were included in this study. 6 observers with three levels of training conducted the image analysis: Observers 1+4: expert SCMR level 3 operators; Observers 2+5: trainees with SCMR level 2 experience; Observers 3+6: a cardiologist and a clinical trial coordinator with no previous CMR experience. The latter level underwent a 4hr tutorial on how to use the software on 10 practice cases. All 6 observers analysed 20 studies, and re-analysed 10 studies 24 hours after. Volumes and mass were analysed using semi-automated software (Argus, Siemens), infarct size (IS) was manually planimetered using a 2SD threshold.

Extending the clinical research network approach to all of healthcare

The development of Clinical Research Networks (CRN) has been central to the work conducted by Health Departments and research funders to promote and support clinical research within the NHS in the UK. In England, the National Institute for Health Research has supported the delivery of clinical research within the NHS primarily through CRN. CRN provide the essential infrastructure within the NHS for the set up and delivery of clinical research within a high-quality peer-reviewed portfolio of studies. The success of the National Cancer Research Network is summarized in Chapter 5. In this chapter progress in five other topics, and more recently in primary care and comprehensively across the NHS, is summarized. In each of the ‘topic-specific’ networks (Dementias and Neurodegenerative Diseases, Diabetes, Medicines for Children, Mental Health, Stroke) there has been a rapid and substantial increase in portfolios and in the recruitment of patients into studies in these portfolios. The processes and the key success factors are described.The CRN have worked to support research supported by pharmaceutical, biotechnology and medical device companies and there has been substantial progress in improving the speed, cost and delivery of these ‘industry’ studies. In particular, work to support the increased speed of set up and delivery of industry studies, and to embed this firmly in the NHS, was explored in the North West of England in an Exemplar Programme which showed substantial reductions in study set-up times and improved recruitment into studies and showed how healthcare (NHS) organizations can overcome delays in set up times when they actively manage the process. Seven out of 20 international studies reported that the first patient to be entered anywhere in the world was from the UK. In addition, the CRN have supported research management and governance, workforce development and clinical trials unit collaboration and coordination. International peer reviews of all of the CRN have been positive and resulted in the continuation of the system for a further 5 years in all cases.

A Healthy Dose of Heavy Metal: Magnesium and Acute Lung Injury

Acute lung injury (ALI) and its more serious manifestation, acute respiratory distress syndrome (ARDS), are all too common occurrences in intensive care units around the world that create a large debt to society both in the short term [ 1 Rubenfeld G.D. Caldwell E. Peabody E. et al. Incidence and outcomes of acute lung injury. N Engl J Med. 2005; 353: 1685 Crossref PubMed Scopus (2783) Google Scholar ] and the long term [ 2 Herridge M.S. Tansey C.M. Matte A. et al. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011; 364: 1293 Crossref PubMed Scopus (1671) Google Scholar ]. These clinical syndromes claim thousands of lives each year and have been the object of many high profile studies in the past two decades. Unfortunately, despite extensive research efforts, we still have relatively little we can do to treat this condition. First described in 1967 [ 3 Ashbaugh D.G. Bigelow D.B. Petty T.L. et al. Acute respiratory distress in adults. Lancet. 1967; 2: 319 Abstract PubMed Google Scholar ] with acute dyspnea, hypoxia refractory to oxygen therapy, and diffuse lung infiltrates, the ALI/ARDS definition was further refined in 1994 by the American-European Consensus Conference on ARDS, which is still in use today. ALI requires: (1) acute onset, (2) a ratio of arterial oxygen tension to inspired oxygen concentration (PaO2/FiO2) of less than 300 mm Hg, (3) bilateral infiltrates on chest radiograph, and (4) absence of left ventricular dysfunction [ 4 Bernard G.R. Artigas A. Brigham K.L. et al. The American-European Consensus Conference on ARDSDefinitions, mechanisms, relevant outcomes, and clinical trial coordination. Am J Respir Crit Care Med. 1994; 149: 818 Crossref PubMed Scopus (5235) Google Scholar ]. The definition for ARDS is the same except it requires the PaO2/FiO2 to be less than 200 mm Hg. Magnesium Sulfate Mitigates Lung Injury Induced by Bilateral Lower Limb Ischemia-Reperfusion in RatsJournal of Surgical ResearchVol. 171Issue 1PreviewLower limb ischemia-reperfusion (I/R) elicits oxidative stress and causes inflammation in lung tissues that may lead to lung injury. Magnesium sulfate (MgSO4) possesses potent anti-oxidation and anti-inflammation capacity. We sought to elucidate whether MgSO4 could mitigate I/R-induced lung injury. As MgSO4 is an L-type calcium channel inhibitor, the role of the L-type calcium channels was elucidated. Full-Text PDF

84 LEAN TECHNOLOGY IMPROVES EFFICIENCY IN OUTPATIENT ACADEMIC URO-ONCOLOGY CLINICS

You have accessJournal of UrologyGeneral & Epidemiological Trends & Socioeconomics: Practice Patterns, Cost Effectiveness1 Apr 201184 LEAN TECHNOLOGY IMPROVES EFFICIENCY IN OUTPATIENT ACADEMIC URO-ONCOLOGY CLINICS Sean Skeldon, Andrea Simmons, Bob Broach, Karen Hersey, Michael Jewett, Antonio Finelli, Alexandre Zlotta, and Neil Fleshner Sean SkeldonSean Skeldon Toronto, Canada More articles by this author , Andrea SimmonsAndrea Simmons Toronto, Canada More articles by this author , Bob BroachBob Broach Zionsville, IN More articles by this author , Karen HerseyKaren Hersey Toronto, Canada More articles by this author , Michael JewettMichael Jewett Toronto, Canada More articles by this author , Antonio FinelliAntonio Finelli Toronto, Canada More articles by this author , Alexandre ZlottaAlexandre Zlotta Toronto, Canada More articles by this author , and Neil FleshnerNeil Fleshner Toronto, Canada More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2011.02.148AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Due to high clinic volumes and variability among patient needs, conducting an efficient and streamlined uro-oncology clinic can be challenging. Academic urology clinics pose additional challenges including: teaching (medical students, residents and fellows), clinical trial coordination and formalized biobanking. Lean technology is an industrial engineering tool developed to optimize manufacturing efficiency and has been successfully applied in the health care setting. We set out to determine if Lean methods could improve efficiencies and quality of care among a hospital-based high volume uro-oncology clinic. METHODS Prior to the Lean initiative, baseline data were collected around patient volumes, wait times, cycle times (patient arrival to discharge), nursing assessment time, patient teaching and physician ergonomics (via spaghetti diagram). Value stream analysis (VSA) and a Rapid Improvement Event (RIE) were carried out and significant changes were made to patient check in, work areas and nursing face time. Follow-up data were obtained at 30, 60 and 90 days. Changes from baseline were compared to baseline with probability values less than 0.05 deemed significant. RESULTS Table 1 demonstrates the improvements seen following the VSA and RIE. Figures 1 and 2 show spaghetti diagrams depicting physician and nurse flow prior to and after the RIE. Table 1. Improvement from baseline following Rapid Improvement Event Baseline 30 days 60 days 90 days Average Number of Patients per Clinic 30.4 32.1 32.6 31.2 Median Cycle Time (min) 46 43 31⁎ n/a Wait Time for Initial Assessment (min) 23 5⁎ 10⁎ 5⁎ RN Quick Assessment (min) 0.5 15⁎ 5⁎ 5⁎ RN Teaching (min) 2 n/a 15⁎ 10⁎ Wait Time for Clinical Trial Coordinators (min) 26 18⁎ 6⁎ n/a ⁎ p < 0.05 compared to baseline CONCLUSIONS Using Lean methodology we were able to significantly shorten the patient cycle time and time to initial assessment as well as integrate both an initial RN assessment and RN teaching to each visit. Lean Technology can effectively be applied to improve efficiency and patient care in an academic outpatient uro-oncology clinic setting. © 2011 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 185Issue 4SApril 2011Page: e36-e37 Advertisement Copyright & Permissions© 2011 by American Urological Association Education and Research, Inc.MetricsAuthor Information Sean Skeldon Toronto, Canada More articles by this author Andrea Simmons Toronto, Canada More articles by this author Bob Broach Zionsville, IN More articles by this author Karen Hersey Toronto, Canada More articles by this author Michael Jewett Toronto, Canada More articles by this author Antonio Finelli Toronto, Canada More articles by this author Alexandre Zlotta Toronto, Canada More articles by this author Neil Fleshner Toronto, Canada More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

NCCN Clinical Practice Guidelines in Oncology: myelodysplastic syndromes.

These suggested practice guidelines are based on extensive evaluation of the reviewed risk-based data and indicate useful current approaches for managing patients with MDS. Four drugs have recently been approved by the FDA for treating specific subtypes of MDS: lenalidomide for MDS patients with del(5q) cytogenetic abnormalities; azacytidine and decitabine for treating patients with higher-risk or nonresponsive MDS; and deferasirox for iron chelation of iron overloaded patients with MDS. However, because a substantial proportion of patient subsets with MDS lack effective treatment for their cytopenias or for altering disease natural history, clinical trials with these and other novel therapeutic agents along with supportive care remain the hallmark of management for this disease. The role of thrombopoietic cytokines for management of thrombocytopenia in MDS needs further evaluation. In addition, further determination of the effects of these therapeutic interventions on the patient's quality of life is important.(116,119,120,128,129) Progress toward improving management of MDS has occurred over the past few years, and more advances are anticipated using these guidelines as a framework for coordination of comparative clinical trials.

F01 The European HD Network REGISTRY: Current status and future directions

BackgroundThe European Huntington's Disease Network's (EHDN) REGISTRY is an observational, prospective, longitudinal, multi-national, multi-centre cohort study of Huntington's disease (HD). It is the largest study of HD to date, and...

A Collaborative Alzheimer Disease Research Exchange

Although barriers to research participation present challenges for researchers trying to recruit participants, community-based organizations typically have a relationship with and access to potential participants, but often lack information about local studies recruiting participants and/or specifics about studies, how to describe them and how to refer their clients to a study. Therefore, a Community-Based Participatory Research (CBPR)model of collaboration may be a mutually advantageous option for recruiting participants to Alzheimer disease research. The broad goal of this study was to assess whether this void could be bridged and relationships developed between the Alzheimer's Association of Greater Indiana and researchers at the Indiana Alzheimer Disease Center, and improve flow of information to increase research participation to any or all of 4 projects recruiting research participants at the time. Of the 257 Helpline callers who received information about the 4 local studies recruiting participants, 4 family caregivers called the research coordinators and 2 participants were enrolled into 2 separate studies. One person was interested and had completed and returned initial paperwork but had not yet scheduled a screening visit. The National Cell Repository for Alzheimer Disease received 0 calls (participation in National Cell Repository for Alzheimer Disease was 1 of the 4 projects offered to potential participants). Active CBPR is a good goal to strive toward. Community partners are critical to gain access to potential participants for our research. Despite the low number of recruits to Indiana Alzheimer Disease Center studies, this CBPR project was considered a success. Distributing information about local studies to family members and persons with dementia using the Alzheimer's Association of Greater Indiana Helpline was seen as important by the family members in this study. The Helpline may prove to be an excellent mechanism to do this once revisions are made to improve the efficiency of the methodology and address several limitations of this study. In particular, the Institutional Review Board had approved only the patient/family caregiver call the clinical trial coordinators. We believe if the clinical trial coordinator could call the caregivers with information about studies and projects, recruitment, and retention through the Helpline would be more successful.