Trends In Clinical Trials Research Articles

Research Trends in Pharmacopuncture Treatment for Lateral Epicondylitis

The aim of this study was to examine pharmacopuncture treatment for lateral epicondylitis, and to contribute to developing a standardized treatment regimen by reviewing trends in clinical trials. Five randomized controlled trials, 1 case-control study, and 8 cohort studies published after 1999, that involved pharmacopuncture for lateral epicondylitis, were selected from Korean and international online databases (<i>n</i> = 8). The type of pharmacopuncture, dose, frequency, efficacy, and adverse events were analyzed. Seven types of pharmacopuncture were used, namely Bee Venom, Illicium henryi Diels, Akebiae Caulis, Angelicae sinensis Diels, Ligusticum chuanxiong Hort, Hominis Placenta, and Salviae Miltiorrhizae Radix. Dose, treatment duration, and treatment frequency varied widely. One study assessed the treatment efficacy according to frequency. Nine studies lacked data on adverse events. The quality of 5 randomized controlled trials was low. Although pharmacopuncture treatment appeared to be effective for lateral epicondylitis, it was difficult to standardize the regimen for lateral epicondylitis.

High expectations: The landscape of clinical trials of medical marijuana in oncology

PurposeGiven the infancy and evolving complexity of medicinal marijuana, an evolving political landscape, and the growing frequency of its use in cancer care, it is important for oncologists to be actively engaged in developing and successfully implementing clinical trials focusing on medical marijuana. The purpose of this study was to analyze and evaluate trends in clinical trials focused on medical marijuana in oncology. Patients and methodsUsing 3 web-based registries, Clinicaltrials.gov, European Union Clinical Trials Register (EU-CTR), and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP), we queried for search terms related to marijuana and oncology. This search identified approximately 48 oncology clinical trials involving medical marijuana. We restricted our selection to clinical trials registered between January 2002 and May 2019. Data were summarized using descriptive statistics, and qualitative data were represented as frequency and percentage. ResultsA total of 474,043 trials were queried in the databases and the search strategy returned 48 trials since 2002 that met criteria for analysis in the current study: 36 from ClinicalTrials.gov, 8 from EU CTR, and 4 from ICTRP. Mean trial enrollment was 370 participants, median 53, with range of 6–10000 participants. In total, 25 % trials were phase I, 12.5 % were phase I/II, 27.1 % were phase II, 4 % were phase II/III, 18.8 % were phase III, and 12.5 % were unknown. The recruitment status were "not yet recruiting", "recruiting", "active, not recruiting", "completed", “terminated/withdrawn”, and "unknown" in 6 (12.5 %), 14 (29.2 %), 0 (0 %), 20 (41.7 %), 5 (10.4 %), and 3 (6.3 %) trials, respectively. The trial start years were “2002-2005″, 2006–2009, 2010–2013, 2014–2017, and 2018-Present in 4 (8.3 %), 5 (10.4 %), 10 (20.8 %), 15 (31.3 %), and 14 (29.2 %) of trials, respectively. Lastly, synthetic or branded compounds were investigated in 26 (54.2 %) of trials since 2002. ConclusionOur results indicate that across oncology, there is growing interest in clinical research in the use of medical marijuana.

A Bibliometric Analysis of Acupuncture Research Trends in Clinical Trials

A Bibliometric Analysis of Acupuncture Research Trends in Clinical Trials

Trends in clinical trials for stroke by cell therapy: data mining ClinicalTrials.gov and the ICTRP portal site

Definitive treatment of stroke constitutes an important thesis of regenerative medicine in the cerebrovascular field. However, to date, no cell therapy products for stroke are yet on the market. In this study, we examined the clinical research trends related to cell therapy products in the stroke field based on data obtained from the ClinicalTrials.gov website and International Clinical Trials Research Platform (ICTRP) portal site. These data do not offer results of clinical trials comprehensively but provide information regarding various attributes of planned clinical trials including work in progress. We selected 78 cell therapy studies related to the field of stroke treatment from ClinicalTrial.gov and ICTRP. These were analyzed according to, e.g., the reporting countries, origin (autologous or allogeneic), of cell used, cell types and source organs, the progress of translational phases, target phase of the disease (acute or chronic stroke), and route of administration. This analysis revealed a trend whereby in the acute phase, mesenchymal stem cells were administered intravenously at a relatively higher dose, whereas in the chronic phase a small number of cells were administered intracranially. Only two randomized controlled Phase III studies with over 100 patients are registered, but none of them has been completed. Thus, cell therapy against stroke appears to constitute a premature area compared with cartilage repair as assessed in our previous report. In addition, tracking by means of the ID number of each trial via PubMed revealed that 44% of clinical studies in this field have corresponding published results, which was also discussed.

Geographic Trends in Clinical Trials in Lymphoma, 1997-2017

BackgroundIn order to fulfil their medical and academic mission, clinical trials have to be available to the very populations they are intended to serve. A broad and homogenous geographic distribution is thus paramount to ensure patient fairness as well as to allow optimal generalizability of trial results to real-world populations. We aimed to investigate trends in the geographic distribution of clinical trials in lymphoma performed over the past 2 decades.MethodsWe systematically searched the Clinicaltrials.gov registry for phase 3 and 4 clinical trials in lymphoma conducted between 01/01/1997 and 12/31/2017. We divided the time period into two intervals and analysed the geographic distribution of trials during these time periods. The Gini coefficient, a statistical measure of inequality ranging from 0 (equal distribution) to 1 (most unequal distribution), was calculated for each period.ResultsWe found 633 clinical trials in lymphoma conducted between 1997 and 2017 globally. 284 and 349 trials were performed in the 1997-2007 and 2008-2017 time periods, respectively. 127 (50%) and 138 (39.5%) of the trials were done in the US. Hodgkin Lymphoma accounted for 55 (19.3%) and 42 (12.0%) studies in the two time periods. CA, TX, IL and NY were consistently in the upper one-fifth of trial-abundant states (each accounting for 3.5-4.5% of all trials). AK, WY, MT and RI were consistently in the lower one-fifth of trial-abundant states (each accounting for 0.13-0.84% of trials). The trial participation of NY and AK mildly increased during the time period while that of TX and RI decreased. In each of the time periods, the 12 most trial-intense states accounted for 41.5% of all investigations. The 12 least trial-intense states were responsible for 8.8% of all the trials. The extent of geographic inequality increased over the years with the Gini coefficient rising from 0.246 to 0.3 between the first and second study period. The geographical pattern of state-specific trial intensity was strongly mitigated after adjusting for each state's population size.ConclusionsThe geographic distribution of clinical trials in lymphoma in the U.S is not uniform. Our data suggests that the trend of geographic mal-distribution is worsening, a phenomenon that may lead to deleterious public health outcomes. As patients' enrolment continues to be linked to geographic factors, patients' ability to enter clinical trials may be limited and the representation of real-world participants may be skewed (towards particular zip codes, socio-economical status and education levels, etc), consequently affecting the yield and generalizability of clinical trials. Innovative solutions must be devised to minimise any barriers to trial participation for suitable patients. DisclosuresNo relevant conflicts of interest to declare.

Trends in clinical trials for articular cartilage repair by cell therapy

Focal and degenerative lesions of articular cartilage greatly reduce the patient’s quality of life. Various therapies including surgical treatment have been developed, but a definitive therapy is not yet known. Several cell therapy products have already been developed and are available in the market. In this study, we examined the clinical research trends related to cell therapy products in the cartilage repair field based on data obtained from the ClinicalTrial.gov website. Although this website does not provide comprehensive results of clinical trials, it offers information on prospective clinical trials, including work in progress, and thus allows for chronological analysis of the data. We selected 203 studies related to the field of cartilage regeneration from ClinicalTrial.gov. The results showed a shift in the clinical translational trend in utilized cells from cartilage- and bone marrow- to adipose tissue-based cells. Whereas the studies that used cartilage as the cell source included many phase III trials, fewer studies using bone marrow and adipose tissue cells progressed to phase III, suggesting that most clinical developments using the latter sources have not been successful so far. One product covered the entire period from the start of phase I to the completion of phase III, with a time to completion of more than 100 months. Translational trends in autologous chondrocyte implantation were also discussed. The use of ClinicalTrials.gov as the sole data source can yield a perspective view of the global clinical translational trends, which has been difficult to observe up to this point.

A comprehensive analysis of clinical trials including both immunotherapy and radiation therapy

Radiation therapy (RT) may work synergistically with cancer immunotherapies but clinical trial data is needed to validate this paradigm. We isolated the portfolio of trials that investigate the primary immunomodulatory properties of RT and examined recent trends in clinical trials that combine immunotherapy and RT (ITRT). We queried clinicaltrials.gov for trials initiated since 2002 using both radiation and immunotherapy as mandated interventions. We designated the trials that examine the specific aspects of RT or its abscopal properties as “Primary RT Immunomodulation” trials. Chi-squared analysis determined differences between primary RT immunomodulation trials and those that incorporate RT as a secondary intervention. Joinpoint regression modeling determined the rate of change of the introduction of new trials over time. One hundred and ninety trials met inclusion criteria. Targeted immunostimulatory agents, including checkpoint inhibitors, were the most common immunotherapy (n = 79 [41.6%]). Sixty-six (34.7%) trials included RT as the primary intervention, with 50 (75.6%) of these utilizing stereotactic body radiation (SBRT). All ITRT trials increased at a rate of 14.8% per year. Primary RT immunomodulation trials increased at a rate of 26.8% per year. Primary RT immunomodulation trials were more likely to utilize targeted immunostimulatory agents (p < 0.01), and SBRT (p < 0.01), and more likely to involve metastatic sites (p < 0.01). The number of ITRT studies increased drastically in the latest two years of the study. The number of new ITRT clinical trials is increasing rapidly. This increase in quantity may improve the clinical application of the immunomodulatory properties of RT.

CURRENT STATUS OF CLINICAL TRIALS IN ETHIOPIA:HOW MUCH IS DONE?

Introduction: Clinical trials are a cornerstone of modern evidence based medicine. They are an important step in discovering new treatments for certain diseases as well as new ways to detect, diagnose, and reduce the risk of disease. They also highly support the clinical practice by generating local evidence. The aim of this study is to evaluate the status and trend of clinical trials in Ethiopia from international trial registries. Material and Methods: We have searched WHO International Clinical Trial Registry Platform (WHO ICTRP) for all trials with at least one recruitment center in Ethiopia. The results were exported in XML format and a rational database was formed. Results: Up to November 15,2016; 145 clinical trials were found to be registered from Ethiopia. Majority of trials were design on infectious disease (n = 87, 60%) and the rest were done on NCD. The five most common infectious disease evaluated were Malaria (n=15; 10%), Tuberculosis (n=13; 9%), trachoma (n=12; 8%), HIV (n=11; 8%) and helminthiasis (n=6; 4%). The most common NCD was malnutrition (n = 19; 13%) and only one trial was on cancer, namely Wilms Tumor (1%). London School of Hygiene and Tropical Medicine was the sponsor with the highest number of registered trials (n=8, 6% of all trials), followed by Columbia, Jimma and Ghent University with 5 (3%) trials each. Conclusions: The clinical trials done in Ethiopia are very much limited in number and variety. To improve the situation the government, industry, academic institutions, patient advocacy groups, professional societies and other organizations should work together.

Trends of clinical trials from 2014 to 2016 in South Korea.

Mandatory registration of clinical trials in public registry can ensure the transparency of clinical trials. Public clinical trial registry of can provide current chronological and geographical distribution of clinical trial throughout the country. We used public clinical trial registry provided by Ministry of Food and Drug Safety to analyze current status of clinical trial from 2014 to 2016 in South Korea. The number of clinical trials in antineoplastic and immunomodulating agents area was the greatest, followed by cardiovascular system and antiinfectives for systemic use as a whole. From 2014 to 2016, overall number of clinical trials decreased while the number of phase I clinical trials increased. Seoul accounted for more than half number of clinical trials in Korea. Supports for clinical trials in non-metropolitan area needs to be considered.

Recent Trends in Clinical Trials Related to Carrier-Based Drugs

Clinical trials related to carrier-based drugs have recently attracted attention because carrier-based drugs hold promise for high efficiency drug delivery and for reducing drug-related side effects. In this commentary, we introduce recent clinical trials involving the use of various carriers, including liposomes, nano and micro particles, micelles, emulsions, and polymeric carriers. Liposomal drug carriers are currently the most intensively tested carriers in clinical trials, but other carriers such as polymeric carriers, albumin-based carriers, and metal nanocarriers have also recently been studied in clinical trials. Each carrier has specific properties, advantages, and disadvantages. The recent clinical trials introduced herein provide information critical to understanding current trends in carrier-based drug research.

Clinical trials in dentistry in India: Analysis from trial registry.

Introduction:Evidence-based practice requires clinical trials to be performed. In India, if any clinical trial has to be performed, it has to be registered with clinical trial registry of India. Studies have shown that the report of clinical trials is poor in dentistry. Hence, the present study has been conducted to assess the type and trends of clinical trials being undertaken in dentistry in India over a span of 6 years.Methodology:All the clinical trials which were registered with the Central Trial Registry of India (CTRI) (www.ctri.nic.in) from January 1, 2007 to March 3, 2014 were evaluated using the keyword “dental.” Following information were collected for each of the clinical trials obtained from the search; number of centres (single center/multicentric), type of the institution undertaking the research (government/private/combined), study (observational/interventional), study design (randomized/single blinded/double-blinded), type of health condition, type of participants (healthy/patients), sponsors (academia/commercial), phase of clinical trial (Phase 1/2/3/4), publication details (published/not published), whether it was a postgraduate thesis or not and prospective or retrospective registration of clinical trials, methodological quality (method of randomization, allocation concealment). Descriptive statistics was used for analysis of various categories. Trend analysis was done to assess the changes over a period of time.Results:The search yielded a total of 84 trials of which majority of them were single centered. Considering the study design more than half of the registered clinical trials were double-blinded (47/84 [56%]). With regard to the place of conducting a trial, most of the trials were planned to be performed in private hospitals (56/84 [66.7%]). Most (79/84, 94.1%) of the clinical trials were interventional while only 5/84 (5.9%) were observational. Majority (65/84, 77.4%) of the registered clinical trials were recruiting patients while the rest were being done in healthy participants. From 2011, some of the postgraduate thesis trials had also been registered (2011-8; 2012-8; 2013-13; 2014-6). Inadequacy in reporting the method of randomization and allocation concealment was observed in 37/67 (55.2%) and 31/67 (46.2%) clinical trials respectively. A considerable number of postgraduate theses was also registered with CTRI in dentistry and majority of the clinical trials despite being completed are not yet published.Conclusion:The number of clinical trials in dentistry are low in India, and more focus should be placed by dental investigators regarding the reporting standards. Furthermore, researchers and trial sponsors should aim at publication of the research findings so that it is made publically available for use. A clear-cut need exists for an increase in both the quantity and quality of clinical trials in dentistry.

A Review of Skull Base Tumor Clinical Trials: Past Trends and Future Opportunities.

Objective Tumors of the anterior and lateral skull base (TALSB) are relatively rare but can be devastating to patients. By examining trials focused on TALSB, we can characterize the studies that predominate and better understand current directions of study. This gives us a better understanding of future studies to pursue. Study Design This is a retrospective analysis. Settings We set skull base tumor clinical trials in the United States which are listed in ClinicalTrials.gov. Subjects and Methods We used the information available on ClinicalTrials.gov to identify trends in clinical trials studying sinonasal/anterior skull base (SNASB) tumors, vestibular schwannoma (VS), and pituitary tumors. The publication rate for these trials was examined using PubMed.gov. Results Of the 71 trials analyzed, 83% investigated treatments for pituitary tumors, 16% for VSs, and 1% for SNASB tumors. Drug studies comprised 90% of all trials, while 9% included radiation therapy in their treatment and 10% included and surgical component. Overall, 64% had their results published in a peer-reviewed journal. Conclusion Among TALSB clinical trials we analyzed, they are weighted heavily toward drug trials. Radiation therapy and surgery, common treatment modalities, are underrepresented in clinical trials. There is a gap between the trials conducted and the rate of reporting, with an emphasis on positive results.

Regulatory Informatics Reveals Minimal Residual Disease Trends in Hematologic Malignancies.

The application of regulatory informatics to identify trends in clinical trials is a new methodology with the potential to shape drug development programs. As an endpoint in hematologic malignancies, minimal residual disease (MRD) measures the depth of response to treatment, and has been given initial attention in draft regulatory guidelines and workshops by health authorities in the EU and US. In this paper, we analyze hematologic malignancy trials by searching for terms in Trialtrove, parsing the data sets with ActivePerl, and determining significance with the statistical package R. We identify trends in the use of MRD compared to other endpoints and in different indications over time from 2005 to 2014. Results show that 2 trends of endpoint and MRD use emerge over time and the use of MRD as a primary endpoint is growing. We also take a case-study approach to investigate the functional context of MRD in chronic lymphocytic leukemia and show that it is predominantly used to determine MRD-negativity and also in correlation with other endpoints. The application of informatics tools to regulatory science can evaluate the role and context of MRD as it evolves in the changing pharmaceutical landscape.

New Trends in Clinical Trials: A Conversation with Pfizer's Craig Lipset.

Technological advances, such as electronic data capture and the prevalence of Wi-Fi connectivity, are driving changes in how clinical trials are conducted and analyzed. As the power to track and analyze data expands, clinical trials are becoming more efficient and objective, and patient experiences are improved.

Patenting drug delivery technology: tips for formulating practical and effective patent portfolio.

Pharmaceutical Patent AnalystVol. 5, No. 2 CommentaryPatenting drug delivery technology: tips for formulating practical and effective patent portfolioTakeshi S KomataniTakeshi S Komatani*Author for correspondence: E-mail Address: tskomatani@shupat.gr.jp SHUSAKU·YAMAMOTO, Osaka, JapanSearch for more papers by this authorPublished Online:18 Feb 2016https://doi.org/10.4155/ppa.15.42AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInRedditEmail View articleKeywords: active pharmaceutical ingredientdrug delivery systemintellectual propertypatentpatent term extensionportfoliosupplementary protection certificatePapers of special note have been highlighted as: •• of considerable interestReferences1 Coelho JF, Ferreira PC, Alves P et al. Drug delivery systems: advanced technologies potentially applicable in personalized treatments. EPMA J. 1(1), 164–209 (2010).Crossref, Medline, Google Scholar2 Mastrobattista E, Hennink WE, Schiffelers RM. Delivery of nucleic acids. Pharm. Res. 24(8), 1561–1563 (2007).Crossref, Medline, CAS, Google Scholar3 Xu L, Anchordoquy T. Drug delivery trends in clinical trials and translational medicine: challenges and opportunities in the delivery of nucleic acid-based therapeutics. J. Pharm. Sci. 100(1), 38–52 (2011).Crossref, Medline, CAS, Google Scholar4 US Code: Title 35 (35 USC) Sec. 101.Google Scholar5 Japanese Patent Act. Article 29(1), main paragraph.Google Scholar6 European Patent Convention Article 53(c).Google Scholar7 European Paten Office. www.epo.org/law-practice/case-law-appeals/recent/t080234eu1.html.Google Scholar8 The Commissioner of Japan Patent Office v. Takeda Pharmaceutical Inc. The Supreme Court of Japan, Heisei 21 (Gyo-Hi) no.324–326, 28 April 2012 (2012). ••These decisions, directed to the patent term extension based on a drug delivery system patent, set out the Japanese Supreme Court's position on what is necessary for obtaining patent term extensions, based on the premise that the drug delivery system patent is ‘valid’.Google Scholar9 Komatani TS. Patent term extension in Japan: challenges still lay ahead even after the 2011 revision. Pharma. Pat. Anal. 2(1), 63–76 (2012).Link, Google Scholar10 Japan Patent Attorneys Association. www.jpaa.or.jp/english/court_decisions/6-PacifCapsuleCase.pdf.Google Scholar11 Regulation (EC) no. 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products.Google Scholar12 Massachusetts Institute of Technology. Case C-431/04 (2006). http://curia.europa.eu/juris/showPdf.jsf?text=&docid=56613&pageIndex=0&doclang=EN&mode=lst&dir=&occ=first&part=1&cid=642888.Google Scholar13 Neurim Pharmaceuticals Ltd. v. The Comptroller General of Patents. Court of Justice of the European Union, C-130/11; 19 July 2012 (2012).Google Scholar14 D'Oca G, Sklan A, Komatani TS. Cases update. Pharm. Pat. Anal. 1(4), 372–374 (2012).Google Scholar15 MPEP section 2750. www.uspto.gov/web/offices/pac/mpep/s2750.html.Google Scholar16 JRC Science & Policy Report, Farid, Reasonable & Non-Discriminatory (FRAND) Licensing Terms (2015). http://is.jrc.ec.europa.eu/pages/ISG/EURIPIDIS/documents/05.FRANDreport.pdf.Google Scholar17 The White House. www.whitehouse.gov/the-press-office/2015/01/20/remarks-president-barack-obama-prepared-delivery-state-union-address.Google ScholarFiguresReferencesRelatedDetails Vol. 5, No. 2 Follow us on social media for the latest updates Metrics Downloaded 64 times History Published online 18 February 2016 Published in print March 2016 Information© Future Science LtdKeywordsactive pharmaceutical ingredientdrug delivery systemintellectual propertypatentpatent term extensionportfoliosupplementary protection certificateDisclaimerThis commentary describes the opinions and observations of the author as a Japanese patent attorney and does not necessarily represent the viewpoints of the author's employers or author's firm. By its nature, the subject article provides the author's general opinion, and necessarily limited discussion of various topics; it does not purport to give specific legal advice or a substitute for legal counsel. As legal advice must be tailored to the specific circumstances of each case, nothing provided herein should be used as a substitute for advice of competent counsel. The author and the author's firm assume no liability for the use or interpretation of information contained herein. The author and the author's firm expressly disclaim all liability in respect of anything done or omitted to be done wholly or partly in reliance of this material.Financial & competing interests disclosureThe author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.No writing assistance was utilized in the production of this manuscript.PDF download

Su1083 Spectrum of Cancer Phenotypes in Asian Lynch Syndrome Families

Sinha Amitasha ,Anand Rohit,Hasan Sayeedul ,Kumar Alok ,Dutta Sudhir K Background: ClinicalTrials.gov is a unique database started in 2000 by National Institutes of Health to register all federally and industry sponsored clinical trials. While prior studies have reported descriptive study of cardiovascular, mental health and oncologic disorders, however to date there is no study on changing trends in the distribution and characteristics of (GI) disorders. Objective: To assess for changes in trends of clinical trials in diseases, registered in the ClinicalTrials.gov database. Since GI trials overlap with oncology. In the current study we included only non-cancer GI trials. Methods: The ClinicalTrials.gov was queried for all trials on non-cancer disorders using terms gastrointestinal NOT cancer on July 11,2014. The content of the registered trials was assessed for disease, intervention, type of trial, funding source and size. Differences in characteristics of clinical trials over time were also assessed using Cochrane Armitage test for trend. Results: A total of 8038 clinical trials dedicated to GI disorders were examined. 110 trials were excluded as they were not related to GI diseases, leaving a total of 7928 trials with a mean number of 39,690 participants in these trials. The number of ongoing clinical trials significantly increased from 115 in year 2000 to 949 in year 2013 (p<0.001), with 96% of total trials registered 2005 onwards. Clinical trials on liver diseases was consistently the top ranked GI disease over the last 10 years accounting for 40% of total trials to date, of which nearly 2/3rds were clinical trials dedicated to viral hepatitis (B,C). The top 3 areas of clinical investigations in non-hepatic GI disorders were: inflammatory bowel disease, gastro-esophageal disorders and cystic fibrosis. NIH/Federal funding has also significantly decreased over the last decade (p<0.001). The size of the federally funded studies was significantly larger than non-federally funded studies (358,054 vs14,672, p<0.01). While IBS (p=0.05) and infectious enterocolitis (p<0.001) were significantly associated with more federal funding, pancreaticobiliary diseases mainly received non-federal funding. During this period non-industry organizations and universities have provided support for 50% of the total trials, while industry supported 36% of the clinical trials as federal funding has diminished. Therapeutic intervention accounted for 54% of the total number of trials. Conclusion: Ours study suggests major shifts in funding trends for clinical trials in USA in the last 15 years. Major changes include reduction in federal support and significant increase in non-federal and industry support for clinical trials.

Su1082 Changing Trends in the Characteristics of Gastroenterology Clinical Trials: 2000-2014

Sinha Amitasha ,Anand Rohit,Hasan Sayeedul ,Kumar Alok ,Dutta Sudhir K Background: ClinicalTrials.gov is a unique database started in 2000 by National Institutes of Health to register all federally and industry sponsored clinical trials. While prior studies have reported descriptive study of cardiovascular, mental health and oncologic disorders, however to date there is no study on changing trends in the distribution and characteristics of (GI) disorders. Objective: To assess for changes in trends of clinical trials in diseases, registered in the ClinicalTrials.gov database. Since GI trials overlap with oncology. In the current study we included only non-cancer GI trials. Methods: The ClinicalTrials.gov was queried for all trials on non-cancer disorders using terms gastrointestinal NOT cancer on July 11,2014. The content of the registered trials was assessed for disease, intervention, type of trial, funding source and size. Differences in characteristics of clinical trials over time were also assessed using Cochrane Armitage test for trend. Results: A total of 8038 clinical trials dedicated to GI disorders were examined. 110 trials were excluded as they were not related to GI diseases, leaving a total of 7928 trials with a mean number of 39,690 participants in these trials. The number of ongoing clinical trials significantly increased from 115 in year 2000 to 949 in year 2013 (p<0.001), with 96% of total trials registered 2005 onwards. Clinical trials on liver diseases was consistently the top ranked GI disease over the last 10 years accounting for 40% of total trials to date, of which nearly 2/3rds were clinical trials dedicated to viral hepatitis (B,C). The top 3 areas of clinical investigations in non-hepatic GI disorders were: inflammatory bowel disease, gastro-esophageal disorders and cystic fibrosis. NIH/Federal funding has also significantly decreased over the last decade (p<0.001). The size of the federally funded studies was significantly larger than non-federally funded studies (358,054 vs14,672, p<0.01). While IBS (p=0.05) and infectious enterocolitis (p<0.001) were significantly associated with more federal funding, pancreaticobiliary diseases mainly received non-federal funding. During this period non-industry organizations and universities have provided support for 50% of the total trials, while industry supported 36% of the clinical trials as federal funding has diminished. Therapeutic intervention accounted for 54% of the total number of trials. Conclusion: Ours study suggests major shifts in funding trends for clinical trials in USA in the last 15 years. Major changes include reduction in federal support and significant increase in non-federal and industry support for clinical trials.

An Analysis of Global Research Trends in Cardiology Over the Last two Decades.

Heart disease today is a major cause of morbidity and mortality plaguing mankind worldwide. The present research was undertaken to ascertain global research trends in clinical trials in Cardiology involving human subjects over the last two decades. Cross-sectional study. A detailed search strategy was employed in December 2013, using the PubMed database. All papers published in 1993-2013 were evaluated. The research trends of various cardiologic subspecialties in the United States and worldwide have been analysed and detailed statistical analysis was done. United States had maximum number of researches. Clinical trials involving infarction were maximum followed by coronary angiography and coronary angioplasty in that order. The year 2013 had the most researches. The United States was the top country and Boston was the top city. Author Christodoulos Stefanadis had the greatest number of researches in this field. American Journal of Cardiology was the most favored journal and Circulation was the journal with the highest impact factor. This effort may help funding agencies, prospective job seekers, fellowship applicants, policymakers and patients Conclusion: The research output in cardiology has increased and improved significantly over past decade. The publication per diplomat is more in transplant cardiology, Also more clinical trials involving coronary restenosis have to be done to know in depth to add to current knowledge and database.

Clinical trials in crisis: Four simple methodologic fixes.

There is growing consensus that the US clinical trials system is broken, with trial costs and complexity increasing exponentially, and many trials failing to accrue. Yet, concerns about the expense and failure rate of randomized trials are only the tip of the iceberg; perhaps what should worry us most is the number of trials that are not even considered because of projected costs and poor accrual. Several initiatives, including the Clinical Trials Transformation Initiative and the "Sensible Guidelines Group" seek to push back against current trends in clinical trials, arguing that all aspects of trials-including design, approval, conduct, monitoring, analysis, and dissemination-should be based on evidence rather than contemporary norms. Proposed here are four methodologic fixes for current clinical trials. The first two aim to simplify trials, reducing costs, and increasing patient acceptability by dramatically reducing eligibility criteria-often to the single criterion that the consenting physician is uncertain which of the two randomized arms is optimal-and by clinical integration, investment in data infrastructure to bring routinely collected data up to research grade to be used as endpoints in trials. The second two methodologic fixes aim to shed barriers to accrual, either by cluster randomization of clinicians (in the case of modifications to existing treatment) or by early consent, where patients are offered the chance of being randomly selected to be offered a novel intervention if disease progresses at a subsequent point. Such solutions may be partial, or result in a new set of problems of their own. Yet, the current crisis in clinical trials mandates innovative approaches: randomized trials have resulted in enormous benefits for patients, and we need to ensure that they continue to do so.

Emerging Trends in Clinical Trial Design

Therefore, randomized trial methodology was initiated only 6 decades ago. As might be expected from such a young field, the pace of advancement remains high. In this editorial, we discuss 3 emerging trends in clinical trial design. The techniques we discuss may be helpful to investigators who are designing randomized trials. They may also be helpful to department leaders who need to allocate resources and guide junior investigators. And finally, an understanding of the methods will also enhance clinicians’ ability to critically read and understand studies on which practice decisions might be based.