Academic Sponsors Research Articles

Map of biomedical research in Cameroon; a documentary review of approved protocols from 1997 to 2012

BackgroundOver the last decade, there has been a rapid increase in biomedical research in Cameroon. However, the question of whether these research projects target major health priorities, vulnerable populations and geographic locations at risk remains to be answered. The aim of this paper is to describe the state of biomedical research in Cameroon which is a key determinant that would guide future health care policies and promote equitable access to healthcare.MethodsA documentary review of all approved protocols (proposals) of biomedical research projects, from 1997 through 2012, at the Cameroon National Ethics Committee. Protocols were reviewed systematically by independent reviewers and data were extracted on a grid. Data were analyzed by calculating proportions at 95% confidence interval, chi-square test (chi2) and p-values.ResultsTwo thousand one hundred seventy two protocols were reviewed for data extraction. One thousand three hundred ninety-five (64.7%) were student projects, 369 (17.0%) projects had international sponsors, and 1528 (72.4%) were hospital-based studies. The most targeted domain was the fight against diseases 1323 (61.3%); mostly HIV 342 (25.8%) and Malaria 136 (10.3%). Over half of the studies were concentrated in the Centre region 1242 (57.2%), with the least projects conducted in the Northern region 15 (0.7%). There was strong evidence that international and local sponsors would influence the research site (p-value = 0.01) and population targets (p-value = 0.00).ConclusionAlthough biomedical research targets some important diseases that pose a great burden to Cameroonians, the most vulnerable populations are excluded from research. Biomedical research scarcely addresses other components of the health system and emerging diseases of vital public health importance. We recommend that the government should play a central role, between researchers from academic institutions, sponsors, NGOs and research institutions, to ensure that biomedical research addresses the health priorities of Cameroonians. It should include vulnerable populations, and address other components of the health system for a balance. These recommendations are critical to ensuring that future research informed health policies reflect the health needs of the populations and promote equity in healthcare access.

The Measures of French Regulatory Agency for Clinical Trials Conduction After the Rennes Disaster

To show how French system reacted to the so-called “Rennes Disaster”, in which six healthy volunteers, after a fatty acid amide hydrolase inhibitor intake, presented serious brain damage and one died subsequently to these lesions. The aim of this communication was to illustrate the requirements of French Ministry of Health after the “Rennes Disaster”, and how the safety and vigilance units of academic sponsors implemented these new requirements in their routine activity. The key points of changes in French regulatory requirements were summarized. Thereafter, a focus on the actions of the Revise (REflections on VIgilance and SafEty of Clinical trials) Network was presented. The Revise Network was created on 2007, and it now federates around fifty safety units of academic sponsors. From the beginning, the majority of them were supported by a pharmacology department in the context of French regional centres of pharmacovigilance. After the Rennes Disaster, the ministry of health imposed that in all study on drugs performed on healthy subjects, every serious adverse reaction leading to hospitalisation must be considered as an emerging safety issue and reported immediately to the French Drug Safety Agency (Agence Nationale de la securité du Médicament, ANSM). The study must be interrupted immediately and, to restart with the inclusions, the sponsor must bring proof its harmlessness to ANSM. Moreover, all healthy subjects must be informed and give a new consent before any new administration. Later on, the Jardé law considered all serious adverse events observed on healthy volunteers as a safety issue and must be reported immediately to ANSM. In any other clinical trial phases, life-threatening or fatal SUSARs (suspected unexpected adverse drug reaction) must be reported without any delay to ANSM. The extreme short time to assess serious adverse events before the transmission, imposed to reinforce the organisation of vigilance units for their management. The Revise Network proposed 30 guidelines to harmonies the procedures, such as a guideline for a safety management plan tailored to the evaluation of benefit risk assessment based on clinical pharmacology expertise. The French authorities and the vigilance units promptly reacted to the Rennes Disaster. The Revise Network, university hospital directorates and the institutional pharmacology units are working together to help in better preventing and managing the safety of people included in clinical trials.

THE ROLE OF LOCAL CONTRACT RESEARCH ORGANISATIONS IN BUILDING GCP-COMPLIANT CLINICAL RESEARCH IN POVERTY-RELATED DISEASES IN AFRICA: A CASE OF CLINWIN RESEARCH SERVICES

BackgroundAfrica carries the largest burden of the poverty-related diseases in the world. Most of her populations live in resource-limited settings. These act as catalysts for poverty-related diseases in those populations....

Discontinuation and Nonpublication of Randomized Clinical Trials Conducted in Children.

Trial discontinuation and nonpublication represent potential waste in research resources and lead to compromises in medical evidence. Pediatric trials may be particularly vulnerable to these outcomes given the challenges encountered in conducting trials in children. We aimed to determine the prevalence of discontinuation and nonpublication of randomized clinical trials (RCTs) conducted in pediatric populations. Retrospective, cross-sectional study of pediatric RCTs registered in ClinicalTrials.gov from 2008 to 2010. Data were collected from the registry and associated publications identified (final search on September 1, 2015). Of 559 trials, 104 (19%) were discontinued early, accounting for an estimated 8369 pediatric participants. Difficulty with patient accrual (37%) was the most commonly cited reason for discontinuation. Trials were less likely to be discontinued if they were funded by industry compared with academic institutions (odds ratio [OR] 0.46, 95% confidence interval [CI] 0.27-0.77). Of the 455 completed trials, 136 (30%) were not published, representing 69 165 pediatric participants. Forty-two unpublished trials posted results on ClinicalTrials.gov. Trials funded by industry were more than twice as likely to result in nonpublication at 24 and 36 months (OR 2.21, 95% CI 1.35-3.64; OR 3.12, 95% CI 1.6-6.08, respectively) and had a longer mean time to publication compared with trials sponsored by academia (33 vs 24 months, P < .001). In this sample of pediatric RCTs, discontinuation and nonpublication were common, with thousands of children exposed to interventions that did not lead to informative or published findings. Trial funding source was an important determinant of these outcomes, with both academic and industry sponsors contributing to inefficiencies.

Serious adverse drug events related to non-investigational drugs in academic clinical trials: another source of safety data for risk assessment?

Sponsors of clinical trials have to analyze serious adverse events (SAEs). Both sponsors and investigators determine the relationship between the investigational medicinal product, the investigational device or procedure and SAEs. SAEs related to another cause, such as a non-investigational medicinal product (NIMP), do not have clear pharmacovigilance reporting requirements. The aim of this study was to evaluate the amount and the nature of NIMP-related SAEs recorded by three French academic sponsors and to propose pharmacovigilance requirements for these cases. This was a retrospective descriptive study including all cases of NIMP-related SAEs occurring in clinical trials and reported to three academic sponsors between January 2009 and October 2014. Among 5870 cases of SAEs, 300 (5%) were related to a NIMP in 50 clinical trials. Involved NIMPs were mainly antithrombotics, cytostatics and immunosuppressants. Some of these drugs were currently followed by a risk management plan (e.g. rivoxaban). The most frequent NIMP-related SAEs were neurological, gastrointestinal and infectious disorders. Seven NIMP-related SAEs were known as 'rare' or 'very rare' and two were 'unlabelled'. As far as we know, this is the first study to focus about NIMP-related SAEs occurring in clinical trials. This work highlights the potential high quality source of safety data via NIMP-related SAE collection. Globally, we propose that NIMP-related SAEs occurring in clinical trials should systematically be notified to the pharmacovigilance system of the concerned country. Clearer procedures of interactions between safety units of academic sponsors and pharmacovigilance systems are needed to allow an effective recording of NIMP-related SAEs.

Quality of serious adverse events reporting to academic sponsors of clinical trials: far from optimal.

The purpose of this study is to evaluate the quality of the serious adverse events (SAE) reported to an academic sponsor. Assessing the safety of a clinical trial relies on information gathering the collection of adverse events reported by the investigators to the sponsor. The accuracy of safety evaluation depends in particular on the quality of the reporting. All SAE case report forms, reported in 2012 to the sponsor from all clinical trials, were evaluated for completeness and accuracy with a standardized data quality evaluation form. Several items were assessed: regulatory mandatory information and items concerning the reported events. For statistical comparisons, Chi2/exact Fisher test was performed. Investigators or patients were not identified in <3% of the reports. The investigational product was not identified in 11.2%. In 3.6% of the reports, the seriousness of the event was unknown. The causality assessment was missing in 9.3%. In 15.0%, the verbatim of the event was considered as not consistent with the description of the event. In 32.4%, the sponsor considered there were insufficient data concerning relevant laboratory/additional examinations performed or relevant history required to help in the assessment. The onset date of SAE was not mentioned in 5.7% of the reports and patient outcome in 12.1%. This study highlighted the far from optimal quality of reporting both in terms of completeness and accuracy. The accurate coding of the events using MedDRA and the safety evaluation by the sponsor can be difficult. The training of investigators in SAE reporting must be improved. Copyright © 2016 John Wiley & Sons, Ltd.

Anti-American Behavior in the Middle East: Evidence from a Field Experiment in Lebanon

Based on public opinion data, anti-Americanism of one form or another is endemic in the Middle East. This paper examines the extent to which hostility generalizes beyond opposition to American foreign policy but is unique to the United States. It conducts a field experiment in Lebanon that manipulates the putative sponsor of a survey and draws on a simple behavioral outcome: do people refuse to be interviewed based on who they think is asking the questions? Results show that academic sponsors do not affect participation rates but that refusals spike under government sponsorship of multiple nationalities—behavioral patterns which replicate in communities that vary widely in their a priori levels of hostility to the United States. Ironically, systematic opt-outs by political opponents make people in the government conditions appear more rather than less supportive of US-favored policies compared to their peers in the other treatment groups.

Osteopathic postdoctoral training institutions' 2014 annual report.

In 2013, the Board of Trustees of the American Osteopathic Association approved the new mission and vision statements of osteopathic postdoctoral training institutions (OPTIs) to ensure that OPTIs were operating effectively as academic sponsors of osteopathic graduate medical education. Since then, OPTIs have made substantial strides in meeting and exceeding the new mandates. The authors discuss the revised OPTI accreditation standards, the OPTI annual report, and recent activities.

Multi-country stem cell trials: The need for an international support structure

Highlights • The paper tackles the organizational challenges of international stem cell trials • It explores the obstacles that result from regulatory variation across countries • The article argues for the formation of an international support structure • Such a structure will be of use to academic and corporate trial sponsors • Five steps through which such a support structure could be realized are introduced

Anti-American Behavior in the Middle East

Based on public opinion data, Anti-Americanism of one form or another is endemic in the Middle East. This paper examines the extent to which hostility generalizes beyond opposition to American foreign policy but is unique to the United States. It fields an experiment in Lebanon that manipulates the putative sponsor of a survey and draws on a simple behavioral outcome: do people refuse to be interviewed based on who they think is asking the questions? Results show that academic sponsors do not affect participation rates, but that refusals spike under government sponsorship of multiple nationalities -- behavioral patterns which replicate in communities that vary widely in their a priori levels of hostility to the United States. Ironically, systematic opt-outs by political opponents make people in the government conditions appear more rather than less supportive of U.S.-favored policies compared to their peers in the other treatment groups.

Accelerating the clinical trial start-up process for early-phase cancer studies: A test of process change to support rapid activation in an academic medical center.

e17507 Background: Clinical trial sponsors have strong scientific, financial, and regulatory interests in rapidly activating studies at participating sites. Academic medical centers have difficulty activating trials within a few weeks of sponsor agreement because, among other inefficiencies, they engage the necessary committee reviews, regulatory approvals, contracting, and budgeting in serial fashion. Incremental revisions in such workflows do not result in strong improvements. Methods: We redesigned our institutional workflow to complete clinical trial activation tasks within six weeks. Historical procedures were replaced rather than scrutinized. A high level leadership committee was required to change and integrate procedures across the medical center, and engage sponsors to improve their turnaround times. A web-based collaborative workflow tracking tool was created to help coordinate the necessary tasks and measure performance. Six clinical trials from the Cancer Center portfolio were used to test and improve the new workflow. Results: Clinical trial activation redesign took one year. For the six studies used as tests of change, the activation times were 49, 54, 78, 58, 62, and 32 days. Times in excess of 6 weeks were largely due to sponsor delays. Conclusions: Considerable effort is required to significantly alter a complex workflow like clinical trial activation. Appropriate priorities, leadership, staffing, and tools are required. Markedly shortened study activation for a small series of cancer trials taught our academic medical center lessons that will be useful for improving the process for all clinical trials, and will make us a better partner for pharmaceutical and academic sponsors as well as for investigator initiated research. [Table: see text]

CPC-110 Pharmacy Involvement in the Management of Academic Clinical Trials

BackgroundThe sponsor is the person or entity that initiates a clinical trial, manages it and provides funding. We define two types of promoters, commercial sponsors and academic sponsors (mainly hospitals)....

PRM158 Placebo-Controlled Clinical Trials: A Difficult Balance “Justification Versus Feasibility” for Academic Sponsors

PRM158 Placebo-Controlled Clinical Trials: A Difficult Balance “Justification Versus Feasibility” for Academic Sponsors

Impact assessment of the European Clinical Trials Directive: a longitudinal, prospective, observational study analyzing patterns and trends in clinical drug trial applications submitted since 2001 to regulatory agencies in six EU countries.

BackgroundShifts in clinical trial application rates over time indicate if the attractiveness of a country or region for the conduct of clinical trials is growing or decreasing. The purpose of this observational study was to track changes in drug trial application patterns across several EU countries in order to analyze the medium-term impact of the EU Clinical Trials Directive 2001/20/EC on the conduct of drug trials.MethodsRates of Clinical Trial Applications (CTA) for studies with medicinal products in those six countries in the EU, which authorize on average more than 500 trials per year, were analyzed. Publicly available figures on the number of annually submitted CTA, the distribution of trials per phase and the type of sponsorship were tracked; missing data were provided by national drug agencies.ResultsSince 2001, the number of CTA in Italy and Spain increased significantly (5.0 and 2.5% average annual growth). For Italy, the gain was driven by a strong increase of applications from academic trial sponsors; Spain's growth was due to a rise in trials run by commercial sponsors. The Netherlands, Germany, France and the UK saw a decline (1.9, 2.3, 3.0 and 5.3% average annual diminution; significant (P < 0.05) except for Germany) in clinical drug trials. The decrease in the UK was caused by a sharp fall in academic trial activities. Across the six analyzed countries, no EU-wide trial-phase-specific patterns or trends were observed.ConclusionsThe EU Clinical Trials Directive 2001/20/EC did not achieve the harmonization of clinical trial requirements across Europe. Rather, it resulted in the leveling of clinical trial activities caused by a continuing decrease in CTA rates in the Netherlands, Germany, France and the UK. Southern European countries, Italy and Spain, benefited to some extent from policy changes introduced by the Directive. In Italy's case, national funding measures helped to considerably promote the conduct of non-commercial trials. On the other hand, the EU Directive-driven transition from liberal policy environments, based on non-explicit trial approval through notifications, towards red-taped processes of trial authorization, contributed to the decreases in trial numbers in Germany and the UK. In the latter case, national research governance concerns had a share in the country's marked decline. However, different EU member states successfully developed best practices, which a new European legislation should take into consideration to resume Europe's attractiveness and international competitiveness for the conduct of clinical trials.

Involving young people as co-researchers in a photography project

To reflect on involving young people as co-researchers in a photography project in England. The literature includes many different approaches to engaging with young people, seeking their views about health issues and involving them in research projects. Using young people as co-researchers brings with it ethical and methodological challenges. A photography project with the author that elicited the views of young people aged 13 to 17 to explore their health beliefs. A critical reflective account is included to highlight the important issues related to involving young people as co-researchers, especially those associated with data collation and analysis such as the balance of power between adults and young people in decision making, and the importance of training, support, ethical considerations, time and resources. How young people can be involved in the iterative process of data collection and analysis to inform the study with their greater understanding of their peers' perspectives. The young people involved in the study were enthusiastic and readily engaged in the photography workshops and process. If researchers are to help young people to participate in projects as co-researchers, they must give full consideration to their involvement in all stages of research. Time and resources need to be built into the bid process and from the start of planning. There are challenges to involving young people as co-researchers that need to be overcome, such as resistance from academic institutions, health professionals, sponsors and/or other professional researchers.

The advanced therapy classification procedure

The classification procedure, introduced by the European Regulation on advanced therapy medicinal products (ATMPs), has received a tremendous interest from companies, academic and public sponsors developing ATMPs. This procedure gives companies the opportunity to verify whether or not the product they are developing can be considered an ATMP and can therefore benefit from the new regulatory pathway introduced in the European Union for these types of medicinal products. This procedure is optional, free of charge and may take place at any stage of the development of an ATMP in advance of applying for a marketing authorisation. In case of doubt, briefing meetings organised by the European Medicines Agency Innovation Task Force may help preparing for an ATMP classification and are a starting point for the interactions between the Agency and the developers of ATMPs. This article reviews the advantages of the classification procedure for both the developers of ATMPs and the European regulatory network. Since the introduction of this procedure and up to 10 November 2010, the Committee for Advanced Therapies (CAT) has finalised 38applications for classification.

Toward a European harmonisation of the requirements for the first clinical use of Advanced Therapy Medicinal Products (ATMPs): Preclinical requirements for cell based medicinal products

The necessity of a consistent approach and a regulatory “memory” was addressed by the EU with the promulgation of the Regulation 1394/2007/EC and the creation of a new committee for the evaluation of the Marketing Authorisation Application (MAA) of ATMPs, the Committee for Advanced Therapies (CAT). However, the scientific background of the ATMPs is rapidly changing due to a high rate of innovation. In fact, often the time frame required to perform the clinical development, usually of at least 5 years, is such that the product or some of its assumption might be obsolete at the moment of the Marketing Application. To favour the Small and Medium Enterprises (SMEs) and academic sponsors, the Regulation contains provisions which are intended to help this transition and to smooth the regulatory hurdles.

How to improve patients and investigators' information on clinical trials: the example of French registry for clinical trials in oncology

Cancer patients' willingness to be informed about clinical trials (CT) is rapidly increasing. Health professionals are also interested on being informed on CT in order to provide their patients the best access to innovative treatments. The French cancer plan (2003-2007) launched the creation of a national registry for clinical trials in oncology. The primary objective was to guarantee patients and investigators comprehensive, high quality and updated information about ongoing CT in France, accessed at www.e-cancer.fr. A second objective was to establish a single channel for registration of French CT in conformity with the requirements of the International Committee of Medical Journal Editors. A unique Web access for patients and investigators was created. Information important for patients is presented in the first pages. Scientific information is accessible under further clicks. An information page about clinical research, intended for patients and their relatives, was also prepared in collaboration with patients' advocacy and healthcare professionals. Achieving comprehensiveness is one of the founding principles of the RECF. Over 600 CT were registered as of end of July 2008. All French academic sponsors have registered their CT; the publication of the industrial trials has begun in early 2008.

How to improve patients and investigators’ information on clinical trials: The example of French registry for clinical trials in oncology

17555 Background: Cancer patients’ willingness to be informed about clinical trials (CT) and their investigation sites is rapidly increasing. In parallel, health professionals are interested on being informed on clinical research in order to provide their patients the best access to innovative treatments. The French cancer plan (2003–2007) launched the creation of a national registry for clinical trials in oncology (RECF). The primary objective was to guarantee patients and investigators comprehensive, high quality and updated information about ongoing CT in France, accessed at INCa's web site (www.e-cancer.fr). A second objective was to establish a single channel for registration of French CT in conformity with the requirements of the International Committee of Medical Journal Editors (ICMJE). Methods: A standard form was sent to all French sponsors in November 2005 asking for data on cancer CT opened for recruitment. From October 2005 to May 2007 the database and web interface were established. A unique web access for patients and investigators was created. Information important for patients, pathology and investigation sites, are presented in the first pages; scientific information, according to the requirements of ICMJE, being accessible under further clicks. A web information page about clinical research, intended for patients and their relatives, was also prepared in collaboration with patients’ advocacy and healthcare professionals. Results: Thanks to the active collaboration of the academic sponsors, about hundred CT were registered as of end of July 2006, date when the RECF was opened to professionals for testing. Since 16 April 2007, the RECF has been available online and continues to be updated; over 300 CT were registered as of end of December 2007 and will be 500 by the end of June 2008. All French academic sponsors have registered their CT. Conclusions: Achieving comprehensiveness is one of the founding principles of the RECF; the publication of the industrial trials will begin in 2008. The basis of a single channel for international registration is established through a close collaboration with the NCI-USA, PDQ and needs to be developed. Specific analysis on patients’ frequentation rate will also be investigated. No significant financial relationships to disclose.

Protocol Writing: Requirements for Academic Sponsors in Terms of Safety

Protocol Writing: Requirements for Academic Sponsors in Terms of Safety