Clinical Trial Sponsors Research Articles

Developing a model of a patient-group pathway to accessing cancer clinical trials in Canada.

Colorectal Cancer Canada, in partnership with a Scientific Advisory Committee, is developing a Canadian Patient Group Pathway to Accessing Cancer Clinical Trials ("Pathway"). A central element of the Pathway is presented here-namely, a set of recommendations and tools aimed at each stakeholder group. A summary of the peer-reviewed and grey literature informed discussions at a meeting, held in June 2017, in which a cross-section of stakeholders reached consensus on the potential roles of patient groups in the cancer clinical trials process, barriers to accessing cancer clinical trials, best practice models for patient-group integration, and a process for developing the Pathway. Canadian recommendations and tools were subsequently developed by a small working group and reviewed by the Scientific Advisory Committee. The major output of the consensus conference was agreement that the Clinical Trials Transformation Initiative (ctti) model, successfully applied in the United States, could be adapted to create a Canadian Pathway. Two main differences between the Canadian and American cancer clinical research environments were highlighted: the effects of global decision-making and systems of regulatory and funding approvals. The working group modified the ctti model to incorporate those aspects and to reflect Canadian stakeholder organizations and how they currently interact with patient groups. Developing and implementing a Canadian Pathway that incorporates the concepts of multi-stakeholder collaboration and the inclusion of patient groups as equal partners is expected to generate significant benefits for all stakeholders. The next steps to bring forward a proposed Pathway will involve engaging the broader cancer research community. Clinical trial sponsors will be encouraged to adopt a Charter recognizing the importance of including patient groups, and to support the training of patient groups through an independent body to ensure quality research partners. Integration of patient groups into the process of developing "real world" evidence will be advanced by a further consensus meeting being organized by Colorectal Cancer Canada for 6-7 November 2018.

Computer physician order entry (CPOE) as a strategy to estimate laboratory activity and costs associated with cancer clinical trials.

IntroductionMost of clinical laboratories are not properly reimbursed for their activity related to clinical trials (CTs) conducted in their institutions due to a lack of measurement strategies. We implemented a specific computer physician order entry (CPOE) environment for CTs in order to facilitate ordering to providers and estimate the associated costs to be compared with the standard of care (SOC).Materials and methodsFour specific electronic formularies, restricted to two new virtual CTs clinical services (onco - CT and haemo - CT), were implemented in January 2015. For each clinical trial displayed in the panels there were several box-cells that contained several profiles based on the different phase of the trials. Tests included in the profiles were the tests required by protocol. Laboratory costs (€) per patient were compared between the CTs services and their regular outpatients clinical services (onco - Out and haemo - Out, considered the SOC) for three years.ResultsCosts per patient were higher for CTs services and increased progressively each year (25%, 70% and 70% and 0.6%, 2.7% and 17% in 2015, 2016 and 2017 for Oncology and Haematology, respectively). Taking into account all these differences and the number of patients attending a total difference in expense of + 130,377.7 € for the period 2015-2017 was obtained between CTs and outpatients services.ConclusionsStrategies through CPOE systems based on restricted and specific profiles for CTs ordering are a promising tool that can improve laboratory associated costs estimation and provide robust evidence in reimbursement negotiation processes with CTs sponsors.

PCP32 - INTRODUCTION OF TRIAL-BASED ECONOMIC EVALUATIONS IN UKRAINE: ANALYSIS OF PERSPECTIVES AND BARRIES

In conditions of health system reform in Ukraine, which is aimed at increase of healthcare quality and effectiveness, economic evaluation of drugs becomes of special importance and actuality. Cost-effectiveness analysis alongside randomized clinical trials is acknowledged as an important tool to obtain health-economic data. This is a perspective way of obtaining valuable and sound health economic data minimizing costs of HTA studies. Highly experienced investigators as well as quality clinical trial infrastructure, which are available in Ukraine, provide necessary facilities for valid economic evaluations of investigated drugs. Incorporation of CEA into clinical trials conducted in Ukraine will allow sponsors to show the proved effectiveness and economic advantages of drugs studied in Ukraine. This information could also be used by a sponsor for marketing purposes, for instance, substantiation of pricing policies of a studied drug. Further, evidence-based data showing economic advantages of the studied drug are important for its introduction into governmental registries of medicines procurement. Unfortunately, some issues create a serious barrier for RCT-CEA in Ukraine. Sponsors of multicenter clinical trials are not encouraged to perform economic evaluations in Ukraine due to low motivation by other stakeholders. In addition, current data about the value of medical resources provided at health-care institutions are lacking that significantly impedes trial-based economic evaluations. However, financing mechanisms of Ukrainian health system are now in process of reformation and advancement that will enable clear estimation of medical resource costs in near future. Moreover, the introduction of eHealth system which includes the development of patient registries will provide important facilities for CEA alongside clinical trials. These trends demonstrate high perspectives and importance for RCT-CEA studies in Ukraine. Thus, currently, it is important to promote stakeholder's acknowledgment concerning trial-based economic evaluations and elaborate the sound practical framework enabling its performing in Ukraine.

Collateral benefits: how the practical application of Good Participatory Practice can strengthen HIV research in sub-Saharan Africa.

IntroductionThe Good Participatory Practice (GPP): Guidelines for Biomedical HIV Prevention Trials, second edition (2011) were developed to provide clinical trial sponsors and implementers with a formal stakeholder engagement framework. As one of the largest African research institutes, Wits Reproductive Health and HIV Institute (Wits RHI) became an early adopter of GPP by implementing its principles within large‐scale national and regional clinical trials. This article examines Wits RHI's lessons learned from implementing GPP, its ongoing efforts to institutionalize GPP, and the yet to be realized potential in creating fully sustainable structures for meaningful stakeholder engagement in HIV prevention research, implementation science and beyond.DiscussionFor the past seven years, Wits RHI has undertaken both centralized leadership roles in implementing GPP across multi‐party regional research consortia as well as overseeing GPP for smaller investigator‐driven trials. Through this iterative roll‐out of GPP, key lessons have emerged. Obtaining upfront funding to support GPP activities throughout and between the research life cycle, and a trained multi‐disciplinary team of GPP practitioners have helped facilitate an enabling environment for GPP implementation. We further recommend formally integrating stakeholder engagement into study documents, including monitoring and evaluation plans with indicators and performance metrics, to assist teams to track and refine their GPP strategies. Finally, institutionalizing resources and supporting organization‐wide GPP along with ongoing support can help build efficiencies and maximize economies of scale toward a pragmatic and innovative application of the GPP Guidelines.ConclusionsThanks to a growing global network of GPP practitioners and a burgeoning GPP Community of Practice, there has been substantive progress in making GPP an integral component of clinical HIV prevention research. The Wits RHI experience highlights the possibilities and the challenges to translating the GPP principles into concrete practices within specific clinical trials and across a research institute. Realizing the full potential of GPP, including direct and indirect – ‘collateral benefits’ will require the collective buy‐in and support from sponsors, implementers and community stakeholders across the research field. As the HIV prevention research field expands, however, a more conscious and systematic implementation of GPP is timely.

Data sharing platforms for de-identified data from human clinical trials.

Data sharing of de-identified individual participant data is being adopted by an increasing number of sponsors of human clinical trials. In addition to standardizing data syntax for shared trial data, semantic integration of various data elements is the focus of several initiatives that define research common data elements. This perspective article, in the first part, compares several data sharing platforms for de-identified clinical research data in terms of their size, policies and supported features. In the second part, we use a case study approach to describe in greater detail one data sharing platform (Data Share from National Institute of Drug Abuse). We present data on the past use of the platform, data formats offered, data de-identification approaches and its use of research common data elements. We conclude with a summary of current and expected future trends that facilitate secondary research use of data from completed human clinical trials.

The Rules of Engagement: CTTI Recommendations for Successful Collaborations Between Sponsors and Patient Groups Around Clinical Trials

ObjectiveTo identify the elements necessary for successful collaboration between patient groups and academic and industry sponsors of clinical trials, in order to develop recommendations for best practices for effective patient group engagement.MethodsIn-depth interviews, informed by a previously reported survey, were conducted to identify the fundamentals of successful patient group engagement. Thirty-two respondents from 3 sectors participated: patient groups, academic researchers, and industry. The findings were presented to a multistakeholder group of experts in January 2015. The expert group came to consensus on a set of actionable recommendations for best practices for patient groups and research sponsors.ResultsInterview respondents acknowledged that not all patient groups are created equal in terms of what they can contribute to a clinical trial. The most important elements for effective patient group engagement include establishing meaningful partnerships, demonstrating mutual benefits, and collaborating as partners from the planning stage forward. Although there is a growing appreciation by sponsors about the benefits of patient group engagement, there remains some resistance and some uncertainty about how best to engage. Barriers include mismatched expectations and a perception that patient groups lack scientific sophistication and that “wishful thinking” may cloud their recommendations.ConclusionsPatient groups are developing diverse skillsets and acquiring assets to leverage in order to become collaborators with industry and academia on clinical trials. Growing numbers of research sponsors across the clinical trials enterprise are recognizing the benefits of continuous and meaningful patient group engagement, but there are still mindsets to change, and stakeholders need further guidance on operationalizing a new model of clinical trial conduct.

Abstract TP307: Industry Sponsored Clinical Trials Have Reshaped Stroke Guidelines & Therapies

Background: Evidence based medicine usually derives from well conducted clinical trials. The findings from these trials often become part of a guideline and subsequently are written into practice protocols. Recent debate has been focusing on the influence of clinical care paradigm by the findings from the industry supported clinical trials. This study examined stroke clinical trials that have been supported by the industry. Method: Large medical database such as Google Scholar, Pubmed, Embase and Medline were searched in order to identify published stroke trials. These trials were categorized into either non-industry supported or industry supported groups by examining the disclosure statements printed in the publication. Trials were further categorized by their indications/agents tested. Descriptive statistics were used for the analysis. Results: Since 1970, 148 stroke related clinical trials were identified. Among them, 42 (28%) had no identifiable information of industrial support and 20 (14%) had no available information. However, 86 (58%) trials had full or partial industrial support. Among them, 23 (16%) were for carotid stenting, 22 (15%) for antiplatelet agents, 11(7%) for thrombolytics and 6 (4%) for anticoagulants. All published intravenous tPA plus intra-arterial thrombectomy trials using new generations of stent assisted clot retrievers were fully or partially sponsored by industry and all 4 new oral anticoagulants trials were fully sponsored by the industry. Conclusion: This was the first study examined the sponsorship of clinical trials to treat stroke. Industry supported trials are important in our search for new and better stroke therapies. The findings from many of these trials have been incorporated into stroke care guidelines. The influence is significant. They are much more productive comparing to NIH sponsored trials. To great extent, the findings from the industry sponsored trials have reshaped the stroke treatment paradigm.

An enhanced mixture method for constructing gatekeeping procedures in clinical trials

ABSTRACTIt is increasingly common to encounter complex multiplicity problems with several multiplicity components in confirmatory Phase III clinical trials. These components are often based on several endpoints (primary and secondary endpoints) and several dose-control comparisons. When constructing a multiplicity adjustment in these settings, it is important to control the Type I error rate over all multiplicity components. An important class of multiple testing procedures, known as gatekeeping procedures, was derived using the mixture method that enables clinical trial sponsors to set up efficient multiplicity adjustments that account for clinically relevant logical relationships among the hypotheses of interest. An enhanced version of this mixture method is introduced in this paper to construct more powerful gatekeeping procedures for a specific type of logical relationships that rely on transitive serial restrictions. Restrictions of this kind are very common in Phase III clinical trials and the proposed method is applicable to a broad class of multiplicity problems. Several examples are provided to illustrate the new method and results of simulation trials are presented to compare the performance of gatekeeping procedures derived using this method and other available methods.

The Evolution of Clinical Trials in Renal Cell Carcinoma: A Status Report for 2013-2016 from the ClinicalTrials.gov Website.

Background:We previously published an analysis of clinical trials in renal cell carcinoma (RCC) using the publicly available ClinicalTrials.gov registry. Here we present a 3-year update to understand clinical research current trends in RCC compared to 2013.Methods:The Website’s advanced search function was used to search for RCC trials. The characteristics of the trial were extracted, summarized and compared to 2013 data using Fisher’s exact tests.Results:We locked our search on May 26, 2016 with 165 trials eligible, compared with 169 trials on Sep 25, 2013. There were more phase I and I/II trials in 2016 compared to 2013 (40.8% vs 24.9%, p = 0.05). More clinical trials in 2016 compared to 2013 used immunotherapy (IT) alone or in combination with other drugs (24.2% vs 10.7%, p = 0.001), and the use of targeted therapy alone (TT) declined (32.9% vs 47.9%, p = 0.005). TT+IT combination trials more than doubled (6.7% vs 2.3%, p = 0.07). The number of trials with treatment in (neo)adjuvant settings in 2016 and 2013 were similar (9.7% vs 10.6%, p = 0.77), respectively. Compared to 2013, the number of trials with non-clear cell histology remained low (n = 10). Many more trials were sponsored by the pharmaceutical industry in 2016 vs 2013 (41.5% vs 16.0%, p = <0.001).Conclusion:IT-based and industry sponsored clinical trials significantly increased from 2013 to 2016 with a concomitant drop in TT only trials. The increase in industry-sponsored studies may reflect the rapid uptake of expensive IT drugs. There continues to be a paucity of (neo)adjuvant studies and for non-clear cell histologies.

Improving the accrual of racial and ethnic minority patients in clinical trials: Time to raise the stakes.

Despite decades of attention and study, racial and ethnic minority accrual to clinical trials remains poor. Serious efforts are needed to incentivize providers to enroll patients and clinical trial sponsors to target enrollment for underrepresented groups.

Virotherapy Research in Germany: From Engineering to Translation.

Virotherapy is a unique modality for the treatment of cancer with oncolytic viruses (OVs) that selectively infect and lyse tumor cells, spread within tumors, and activate anti-tumor immunity. Various viruses are being developed as OVs preclinically and clinically, several of them engineered to encode therapeutic proteins for tumor-targeted gene therapy. Scientists and clinicians in German academia have made significant contributions to OV research and development, which are highlighted in this review paper. Innovative strategies for "shielding," entry or postentry targeting, and "arming" of OVs have been established, focusing on adenovirus, measles virus, parvovirus, and vaccinia virus platforms. Thereby, new-generation virotherapeutics have been derived. Moreover, immunotherapeutic properties of OVs and combination therapies with pharmacotherapy, radiotherapy, and especially immunotherapy have been investigated and optimized. German investigators are increasingly assessing their OV innovations in investigator-initiated and sponsored clinical trials. As a prototype, parvovirus has been tested as an OV from preclinical proof-of-concept up to first-in-human clinical studies. The approval of the first OV in the Western world, T-VEC (Imlygic), has further spurred the involvement of investigators in Germany in international multicenter studies. With the encouraging developments in funding, commercialization, and regulatory procedures, more German engineering will be translated into OV clinical trials in the near future.

Analyses of drug combinations using missing data shortens trial periods in phase I/II oncology trials.

In previous phase I/II oncology trials for drug combinations, a number of methods have been studied to determine the dose combination for the next cohort. However, there is a risk that trial durations will be unfeasibly long if methods for evaluating safety and efficacy are based on the best overall response and toxicity during trial design. In this study, we propose an approach to shorten the duration of drug trials in oncology. In this method, the dose combination to be allocated to the next cohort is decided before all data for patients in the current cohort is known and best overall response is determined. The efficacy of drug combinations in patients for whom the best overall response has not been determined is treated as missing data. The missing data mechanism is modeled by nonparametric prior processes. The probabilities of efficacy and toxicity are estimated after applying data augmentation to missing data, and the dose combination to be allocated to the next cohort is decided using these probabilities. Simulation studies from the present study show that this proposed approach would shorten trial durations without the low-performing of the trial design in comparison to existing approaches. Shortening trial durations would enable patients with the targeted disease to receive effective therapy at an earlier stage. This also enables clinical trial sponsors to use fewer patients in drug trials, which would lead to a reduction in the costs associated with clinical development.

"You can save time if…"-A qualitative study on internal factors slowing down clinical trials in Sub-Saharan Africa.

BackgroundThe costs, complexity, legal requirements and number of amendments associated with clinical trials are rising constantly, which negatively affects the efficient conduct of trials. In Sub-Saharan Africa, this situation is exacerbated by capacity and funding limitations, which further increase the workload of clinical trialists. At the same time, trials are critically important for improving public health in these settings. The aim of this study was to identify the internal factors that slow down clinical trials in Sub-Saharan Africa. Here, factors are limited to those that exclusively relate to clinical trial teams and sponsors. These factors may be influenced independently of external conditions and may significantly increase trial efficiency if addressed by the respective teams.MethodsWe conducted sixty key informant interviews with clinical trial staff working in different positions in two clinical research centres in Kenya, Ghana, Burkina Faso and Senegal. The study covered English- and French-speaking, and Eastern and Western parts of Sub-Saharan Africa. We performed thematic analysis of the interview transcripts.ResultsWe found various internal factors associated with slowing down clinical trials; these were summarised into two broad themes, “planning” and “site organisation”. These themes were consistently mentioned across positions and countries. “Planning” factors related to budget feasibility, clear project ideas, realistic deadlines, understanding of trial processes, adaptation to the local context and involvement of site staff in planning. “Site organisation” factors covered staff turnover, employment conditions, career paths, workload, delegation and management.ConclusionsWe found that internal factors slowing down clinical trials are of high importance to trial staff. Our data suggest that adequate and coherent planning, careful assessment of the setting, clear task allocation and management capacity strengthening may help to overcome the identified internal factors and allow clinical trials to proceed more efficiently.

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.

Statistical guidance for responsible data sharing: an overview.

Since at least 2004 there has been a focus on data sharing and clinical trial disclosure with the requirements for protocols to be registered in clinicaltrials.gov and for subsequent manuscripts of the study results to be accepted for publication by major journals [1]. However, sponsors of clinical trials have for many years been widely criticised for not adhering to these requirements and failing to disclose clinical trials in a timely fashion (e.g., www.alltrials.net].

The role of corruption and unethical behaviour in precluding the placement of industry sponsored clinical trials in sub-Saharan Africa: Stakeholder views.

Clinical trials still represent the gold standard in testing the safety and efficacy of new and existing treatments. However, developing regions including sub-Saharan Africa remain underrepresented in pharmaceutical industry sponsored trials for a number of reasons including fear of corruption and unethical behaviour. This fear exists both on the part of pharmaceutical companies, and investigators carrying out research in the region. The objective of this research was to understand the ethical considerations associated with the conduct of pharmaceutical industry sponsored clinical trials in sub-Saharan Africa.Corruption was identified as a significant issue by a number of stakeholders who participated in semi-structured interviews and completed questionnaires. Additionally, fear of being perceived as corrupt or unethical even when conducting ethically sound research was raised as a concern. Thus corruption, whether actual or perceived, is one of a number of issues which have precluded the placement of a greater number of pharmaceutical sponsored clinical trials in this region.More discussion around corruption with all relevant stakeholders is required in order for progress to be made and to enable greater involvement of sub-Saharan African countries in the conduct of industry sponsored clinical trials.

Publication trends of clinical trials performed in South Africa.

Investigators and sponsors of clinical trials have an ethical obligation to disseminate clinical trial results, whether positive or negative, in a timely manner. To determine the publication rate and average time to reporting for clinical trials carried out in South Africa (SA) and to explore factors indicating whether a study is published or not. A registry-based quantitative retrospective analysis of 79 SA clinical trials for new medicines registered between January 2008 and December 2010 was performed. The relevant trial identification number in the register was used to track all peer-reviewed publications subsequent to registration. Tracking of clinical trials was done through a systematic literature search of the electronic journal databases of the South African Medical Journal (SAMJ), the Cochrane Library, Public Library of Science Medical Journal (PLoS Medicine) and BioMed Central, all of which are indexed on MEDLINE via PubMed. In addition, a manual search of the Open Access Journal of Clinical Trials databases and reference lists on articles related to the trial medicine was performed. Of the 79 clinical trials surveyed, 72 were concluded by December 2014. Only 35 (48.6%) of them had the results published in a peer-reviewed journal, the current benchmark for dissemination of trial results. The majority (82.9%) of those published had a positive outcome. Of the 35 trials that were published, 77.1% were published within 2 years. The average time from completion to initial reporting was 22 months. Fewer than half (40.5%) of the clinical trials surveyed were placebo controlled. The absence of complete outcomes data from SA clinical trials warrants utmost attention. The study puts forward a case to the regulatory body and research ethics committees to compel all data from clinical trials to be made accessible to clinicians and the public in general by being published in an easily accessible form and in a timely manner.

Foetal Injury in Clinical Trials and Accountability to the Child Once Born.

Sponsors of clinical trials have excluded pregnant women from trial participation mainly because of the fear of legal liability for foetal injury. Yet, to prevent untested treatments exposing foetuses generally to unwarranted risks, it is necessary that pregnant women are included in clinical trials. Despite sponsors' fears there are, however, major stumbling blocks for the child once born claiming compensation under English law. Neither the new EU Regulation 536/2014 on clinical trials nor tort law or statutory regulations have achieved a clear and fair avenue for the compensation of children injured in utero. There are also inadequacies with the voluntary pharmaceutical industry guidelines regarding such compensation. Greater clarity and fairness regarding tort and civil liability might encourage sponsors to conduct more trials in pregnant women and more pregnant women to volunteer taking part in research in the knowledge that their children will be compensated if they sustain injuries in utero.

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.

Shackling Innovation the Regulation of Industry Supported Clinical Trials

Over the past three decades, collaborative arrangements between academic biomedical researchers and private industry have grown dramatically, resulting in medical innovations that have benefi ted society greatly. However, a growing chorus of criticism directed at private companies that sponsor and conduct biomedical research casts doubt on the very ethos of science. Academics and anti-business activists have waged a campaign against industry-sponsored clinical trials that denies the fundamentally commercial nature of such research and hinders medical progress. These critics point to a small number of unfortunate and tragic cases in which fi nancial confl icts of interest may have played a role in research-related injuries and deaths in order to unjustifi ably condemn the profi t motive in biomedical research as a whole.The debate over confl icts of interest, once confi ned to the pages of medical journals, has jumped aboard a runaway train. In response to public outcry, the Obama administration and the 111th Congress have promised stronger federal regulation and a far more aggressive role for federal and state governments in the nation’s biomedical economy. Industry critics, however, are pushing for even stricter regulations, including the abolishment of industry-sponsored clinical trials all together. Prohibition or even greater regulation of industry sponsorship makes no sense. Given the paucity of evidence linking fi nancial confl icts of interest to research-related mishaps, these new regulations elevate isolated incidents to the norm, and confuse correlation with causation. The way to prevent dangerous or ineffective drugs from reaching the market is not to eliminate fi nancial incentives, but quite the opposite—to make well-conducted successful research so rewarding, both fi nancially and otherwise, and errors in research so costly, that the only logical choice for researchers is to do their absolute best to produce accurate results. If the profi t motive is removed, so is the most immediate benefi t of doing good work and the long-term cost of doing poor work. The net result of policies that restrict industry sponsored clinical trials will be a slowing of medical advances and a delay in the development and marketing of new medical technologies that have the potential to save thousands of lives. Suggestions for restricting fi nancial incentives are being made without any clear evidence, let alone proof, that doing so will prevent the tragic incidents that fuel today’s movement to restrict industry-sponsored clinical trials. After a careful analysis of both the facts and the arguments for and against restricting industry-sponsored clinical, we suggest that regulators should be moving in a totally different direction. Educating people about drug development, clinical trials, risks and benefi ts, and fi guring out ways to increase compliance with medical instructions is likely to go much further toward reducing adverse reactions to medications than trying to eliminate confl icts of interest.