Faculty Opinions recommendation of Therapeutic improvements expected in the near future for schizophrenia and schizoaffective disorder: an appraisal of phase III clinical trials of schizophrenia-targeted therapies as found in US and EU clinical trial registries.

2017 ◽  
Author(s):  
Filippo Drago ◽  
Filippo Caraci
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Schizoaffective Disorder ◽  
Targeted Therapies ◽  
Phase Iii ◽  
Phase Iii Clinical Trials ◽  
Clinical Trial Registries ◽  
Near Future

scholarly journals The case for introducing pre-registered confirmatory pharmacological pre-clinical studies

2018 ◽  
Vol 38 (5) ◽  
pp. 749-754 ◽  
Author(s):  
Olivia Kiwanuka ◽  
Bo-Michael Bellander ◽  
Anders Hånell
Keyword(s):  
Clinical Trial ◽  
Traumatic Brain Injury ◽  
Clinical Trials ◽  
Brain Injury ◽  
Network Analysis ◽  
Clinical Studies ◽  
Phase Iii ◽  
Phase Iii Clinical Trial ◽  
Phase Iii Clinical Trials ◽  
Experimental Drugs

When evaluating the design of pre-clinical studies in the field of traumatic brain injury, we found substantial differences compared to phase III clinical trials, which in part may explain the difficulties in translating promising experimental drugs into approved treatments. By using network analysis, we also found cases where a large proportion of the studies evaluating a pre-clinical treatment was performed by inter-related researchers, which is potentially problematic. Subjecting all pre-clinical trials to the rigor of a phase III clinical trial is, however, likely not practically achievable. Instead, we repeat the call for a distinction to be made between exploratory and confirmatory pre-clinical studies.

scholarly journals A Review of Phase III Clinical Trials of Prostate Cancer Chemoprevention

2007 ◽  
Vol 89 (3) ◽  
pp. 207-211 ◽  
Author(s):  
JF Thorpe ◽  
S Jain ◽  
TH Marczylo ◽  
AJ Gescher ◽  
WP Steward ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Prevention ◽  
Age Of Onset ◽  
Cancer Chemoprevention ◽  
Phase Iii ◽  
Phase Iii Clinical Trials ◽  
Prostate Cancer Prevention ◽  
Phase Iii Trials

INTRODUCTION Prostate cancer is an excellent target for chemoprevention strategies; given its late age of onset, any delay in carcinogenesis would lead to a reduction in its incidence. This article reviews all the completed and on-going phase III trials in prostate cancer chemoprevention. PATIENTS AND METHODS All phase III trials of prostate cancer chemoprevention were identified within a Medline search using the keywords ‘clinical trial, prostate cancer, chemoprevention’. RESULTS In 2003, the Prostate Cancer Prevention Trial (PCPT) became the first phase III clinical trial of prostate cancer prevention. This landmark study was terminated early due to the 24.8% reduction of prostate cancer prevalence over a 7-year period in those men taking the 5α-reductase inhibitor, finasteride. This article reviews the PCPT and the interpretation of the excess high-grade prostate cancer (HGPC) cases in the finasteride group. The lack of relationship between cumulative dose and the HGPC cases, and the possible sampling error of biopsies due to gland volume reduction in the finasteride group refutes the suggestion that this is a genuine increase in HGPC cases. The other on-going phase III clinical trials of prostate cancer chemoprevention – the REDUCE study using dutasteride, and the SELECT study using vitamin E and selenium – are also reviewed. CONCLUSIONS At present, finasteride remains the only intervention shown in long-term prospective phase III clinical trials to reduce the incidence of prostate cancer. Until we have the results of trials using alternative agents including the on-going REDUCE and SELECT trials, the advice given to men interested in prostate cancer prevention must include discussion of the results of the PCPT. The increased rate of HGPC in the finasteride group continues to generate debate; however, finasteride may still be suitable for prostate cancer prevention, particularly in men with lower urinary tract symptoms.

Paucity of economic analyses of phase III clinical trials conducted by the cooperative oncology groups: A review of the evidence

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 17052-17052
Author(s):  
K. Fitzner ◽  
J. McKoy ◽  
C. L. Bennett
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cost Effectiveness ◽  
Cancer Care ◽  
Phase Iii ◽  
Economic Data ◽  
Direct Medical Costs ◽  
Phase Iii Clinical Trials ◽  
Need To Evaluate ◽  
Economic Analyses

17052 Background: Cancer care is expensive, accounting for $72 billion in direct medical costs. New oncology drugs are frequently costly, and can be > $100,000 per patient. Hence, assessments of the costs and cost-effectiveness of cancer pharmaceuticals alongside phase III clinical trials conducted by the NCI-sponsored cooperative oncology groups represents an important opportunity to generate relevant economic data. Methods: Review of published cost and cost-effectiveness analyses for cancer drugs conducted alongside phase III clinical trials conducted by the NCI-sponsored cooperative clinical trial groups. Results: See Table . Conclusions: Despite increasing concerns over the high costs of cancer pharmaceuticals and the need to evaluate the costs and cost-effectiveness of these agents, NCI sponsored phase III clinical trials rarely include economic assessments. Future phase III clinical trials with expensive new cancer agents conducted by cooperative clinical trials groups should include prospective economic assessments. [Table: see text] No significant financial relationships to disclose.

Concordance between abstracts, virtual meeting (VM) presentations, and final publication of phase III clinical trials presented at the Annual Meeting of the American Society of Clinical Oncology.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 6622-6622 ◽  
Author(s):  
Suneil Kumar Khanna ◽  
Matthew John Boyko ◽  
Daniel Yick Chin Heng ◽  
Michael M. Vickers ◽  
Vincent Channing Tam
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Annual Meeting ◽  
Primary Endpoint ◽  
Statistical Significance ◽  
Phase Iii ◽  
Key Comparisons ◽  
Inclusion Criteria ◽  
Phase Iii Clinical Trials ◽  
Clinical Trial Results

6622 Background: Phase III clinical trial results described in abstracts in the ASCO Annual Meeting Proceedings often differ from final results seen in publication. We hypothesize that the abstracts may act only as place holders, while the results presented at the ASCO Annual Meeting are more highly concordant with the final publication. Methods: A retrospective review of all abstracts submitted to the ASCO Annual Meeting in 2005 to 2007 was conducted. Inclusion Criteria: randomized, prospective phase III clinical trials of greater than 200 patients with at least one quantitative primary endpoint such as OS or PFS. For each abstract, we viewed the VM presentation and searched Pubmed and Medline for the corresponding publications. Data regarding the clinical trials was extracted from all three sources and statistical comparisons were made. Results: A total of 7,900 abstracts were screened from the ASCO 2005 and 2007 Annual Meetings, of which 124 met the inclusion criteria. An additional 43 studies were excluded due to absence of either a VM presentation or publication. The majority (96%) of these trials were presented as either an oral presentation or poster discussion. Key comparisons of the concordance between the abstract or VM presentation and the final publication are shown in the Table below. Conclusions: While the statistical significance of the primary endpoint and conclusions from all three sources are very similar, the results reported in VM presentations at ASCO Annual Meetings are a better representation of the final publication compared to the abstract. When relying on clinical trial results from these meetings to change clinical practice, physicians should refer to the VM presentation rather than the abstract. [Table: see text]

scholarly journals Effect of applying inclusion and exclusion criteria of phase III clinical trials to multiple sclerosis patients in routine clinical care

2021 ◽  
pp. 135245852098511
Author(s):  
Kris Oliver Jalusic ◽  
David Ellenberger ◽  
Paulus Rommer ◽  
Alexander Stahmann ◽  
Uwe Zettl ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Care ◽  
Routine Care ◽  
Phase Iii ◽  
Exclusion Criteria ◽  
Phase Iii Clinical Trial ◽  
Phase Iii Clinical Trials ◽  
Multiple Sclerosis Patients

Background: Newly approved, drug-modifying therapies are associated with still unknown adverse events, although clinical trials leading to approval have strict inclusion and exclusion criteria and analyse safety and efficacy. Objectives: The aim of this study was to analyse the eligibility of multiple sclerosis (MS) patients treated in routine care into the phase III clinical trial of the respective drug. Methods: In total, 3577 MS patients with 4312 therapies were analysed. Patients with primary-progressive MS were excluded. Inclusion and exclusion criteria of phase III clinical trials in relapsing–remitting MS were adopted and subsequently applied. A comparison in clinical and sociodemographic characteristics was made between patient who met the criteria and those who did not. Results: 83% of registered patients would not have been eligible to the respective phase III clinical trial. Relapse was the single most frequent criterion not fulfilled (74.7%), followed by medication history (21.2%). Conclusion: The majority of MS patients treated in routine care would not have met clinical trials criteria. Thus, the efficacy and safety of therapies in clinical trials can differ from those in the real world. Broader phase III inclusion criteria would increase their eligibility and contribute to a better generalizability of the results in clinical trials.

Global drug development in cancer: A cross-sectional study of clinical trial registries

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 2520-2520
Author(s):  
P. Hertz ◽  
B. Seruga ◽  
L. W. Le ◽  
I. F. Tannock
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Drug Development ◽  
Phase Ii ◽  
New Drugs ◽  
Phase Iii ◽  
Cancer Site ◽  
Cancer Type ◽  
Clinical Trial Registries ◽  
Global Drug Development

2520 Background: Clinical trials are increasingly funded by industry. High costs of drug development may lead to attempts to develop new drugs in more ‘profitable’ (i.e., more prevalent) as compared to ‘less profitable’ (i.e., more deadly) cancers. Here we determine the focus of current global drug development. Methods: We determined characteristics of phase II and III clinical trials evaluating new drugs in oncology, which were registered with WHO International Clinical Trial Registries between 01/2008 and 06/2008. Estimates of incidence, mortality, and prevalence in the more- and less-developed world (MDW, LDW) were obtained from GLOBOCAN 2002. Simple correlation analysis was performed between the number of clinical trials and incidence, mortality and prevalence per cancer site after log transformation of variables. Results: We identified 399 newly registered trials. Of 374 trials with information about recruitment, 322 (86.1%) and 39 (10.4%) recruited patients only from the MDW and LDW, respectively, while 13 (3.5%) had worldwide recruitment. 229 (58%) of trials were sponsored by industry and 324 trials were phase II (81%). Most trials (and most phase III trials) evaluated treatments for globally prevalent cancers: breast, lung, prostate, and colorectal cancer (Table). Prevalence of a particular cancer type in both the MDW and LDW correlated significantly with the number of clinical trials (Pearson r = 0.63 and 0.55; p = 0.01 and 0.03, respectively). In contrast, mortality in the MDW (Pearson r = 0.73; p= 0.002), but not in the LDW (Pearson r = 0.38; p= 0.17), correlated significantly with the number of clinical trials. Conclusions: Global drug development in cancer predominates in globally prevalent cancers, which are a more important cause of mortality in the MDW than in the LDW. Cancer sites that are major killers globally, and especially in the LDW (e.g., stomach, liver, and esophageal cancer) should receive priority for clinical research. [Table: see text] No significant financial relationships to disclose.

Molecularly Targeted Therapies for Breast Cancer

2005 ◽  
Vol 12 (2) ◽  
pp. 73-81 ◽  
Author(s):  
Timothy J. Hobday ◽  
Edith A. Perez
Keyword(s):  
Breast Cancer ◽  
Cancer Cells ◽  
Targeted Therapies ◽  
Phase Iii ◽  
New Agents ◽  
Phase Iii Clinical Trials ◽  
Manual Search ◽  
Cellular Pathways ◽  
Near Future ◽  
Phase I And Ii

Background: The management of patients with localized and advanced breast cancer continues to evolve. Chemotherapy, endocrine therapy, and trastuzumab are effective therapies but leave considerable room for improvement. As the cellular aberrations inherent to cancer cells in general and breast cancer cells specifically are better understood, therapies to target specific cellular pathways continue to be developed with the goal of expanding available effective therapy through better patient selection. Methods: We conducted a computerized search of the medical literature as well as a manual search of selected meeting abstracts. Results: Several targeted therapies are in phase III clinical trials testing their promise in the treatment of breast cancer. Many other agents are completing phase I and II testing. An overview of the most promising agents in clinical development is discussed herein. Conclusions: Targeted therapy for breast cancer is a reality at this time, and several new agents hold promise for expanding and refining the pool of patients likely to further benefit from this approach in the near future.

Clinical trial risk reduction in non-small cell lung cancer though the use of biomarkers and receptor-targeted therapies.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 8040-8040
Author(s):  
Adam Falconi ◽  
Gilberto Lopes ◽  
Jayson L. Parker
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Drug Development ◽  
Phase I ◽  
Success Rate ◽  
Targeted Therapies ◽  
Phase Iii ◽  
Clinical Testing ◽  
Phase Ii Trials ◽  
Phase Iii Trials

8040 Background: We analyzed the risk of clinical trial failure duringnon-small cell lung cancer (NSCLC) drug development between 1998 and 2012. Methods: NSCLC drug development was investigated using trial disclosures from publically available resources. Compounds were excluded from the analysis if they began phase I clinical testing before 1998 and if they did not use treatment relevant endpoints. Analysis was conducted in regards to treatment indication, compound classification and mechanism of action. Costs of clinical drug development for advanced NSCLC were calculated using industry data and assumptions, a 9% yearly discount rate and assuming a clinical trial length of 2.5 years for phase I trials, 4 years for phase II trials, 5 years for phase III trials and an average of 5 phase I trials, 7 phase II trials, and 4 phase III trials per approved drug. All funding costs are in US dollars (USD). Results: 2,407 clinical trials met search criteria. 676 trials and 199 unique compounds met our inclusion criteria. The likelihood, or cumulative clinical trial success rate, that a new drug would pass all phases of clinical testing and be approved was found to be 11%, which is less than the expected industry aggregate rates (16.5%). The success of phase III trials was found to be the biggest obstacle for drug approval with a success rate of only 28%. Biomarker-guided targeted therapies (with a success rate of 62%) and receptor targeted therapies (with a success rate of 31%) were found to have the highest likelihood of success in clinical trials. The risk-adjusted cost for NSCLC clinical drug development was calculated to be 1.89 billion US dollars. Use of biomarkers decreased drug development cost by 26% to 1.4 billion US dollars. Potential savings may be even higher if fewer clinical trials are required for successful development. Conclusions: Physicians that enroll patients in NSCLC trials should prioritize their participation in clinical trial programs that involve either a biomarker or receptor targeted therapy, which appear to carry the best chances for a successful treatment response. Given the high adjusted cost of clinical testing alone in NSCLC, efforts to mitigate the risk of trial failure need to explore these factors more fully.

scholarly journals EVALUASI KHASIAT DAN KEAMANAN OBAT (UJI KLINIK)

2015 ◽  
Vol 34 (1) ◽  
pp. 31
Author(s):  
Rahmatini Rahmatini
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Phase I ◽  
Phase Ii ◽  
Phase Ii Clinical Trial ◽  
Phase I Clinical Trial ◽  
Phase Iii ◽  
Phase Iii Clinical Trials ◽  
Trial Phase

AbstrakUji klinik adalah suatu pengujian khasiat obat baru pada manusia, dimana sebelumnya diawali oleh pengujian pada binatang atau uji pra klinik. Pada dasarnya uji klinik memastikan efektivitas, keamanan dan gambaran efek samping yang sering timbul pada manusia akibat pemberian suatu obat. Bila uji klinik tidak dilakukan maka dapat terjadi malapetaka pada banyak orang bila langsung dipakai secara umum seperti pernah terjadi dengan talidomid (1959-1962) dan obat kontrasepsi pria (gosipol) di Cina. Setiap obat yang ditemukan melalui eksperimen in vitro atau hewan coba tidak terjamin bahwa khasiatnya benar-benar akan terlihat pada penderita. Pengujian pada manusia sendirilah yang dapat “menjamin” apakah hasil in vitro atau hewan sama dengan manusia.Uji klinik terdiri dari 4 fase, yaitu uji klinik fase I.Uji klinik fase II, uji klinik fase III dan uji klinik fase IV. Uji klinik fase I dilakukan pada manusia sehat, bertujuan untuk menentukan dosis tunggal yang dapat diterima, Uji klinik fase II, dilakukan pada 100-200 orang penderita untuk melihat apakah efek farmakologik yang tampak pada fase I berguna atau tidak untuk pengobatan. Uji klinik fase III dilakukan pada sekitar 500 penderita yang bertujuan untuk memastikan bahwa suatu obat baru benar-benar berkhasiat. Uji klinik fase IV merupakan pengamatan terhadap obat yang telah dipasarkan. Fase ini bertujuan menentukan pola penggunaan obat di masyarakat serta pola efektifitas dan keamanannya pada penggunaan yang sebenarnya.Uji klinik yang baik dilakukan dengan prosedur yang sudah digariskan dan komponen- komponennya disiapkan dengan matang sehingga hasilnya betul- betul dapat dimanfaatkan sebagai acuan pengobatan.Kata kunci : Khasiat- keamanan- uji klinikAbstractClinical trials is a new drug efficacy testing in humans, which previously preceded by testing on animals or pre-clinical testing. Basically, clinical trials confirm description of effectiveness, safety and side effects that often arise in humans because given of a drug. If clinical trials are not done then it can be evil in many people when directly used in general as once happened with thalidomide (1959-1962) and male contraceptive drugs (gossypol) in China. Any drug that is found through experiments in vitro or animal is not guaranteed that the propertiesTINJAUAN PUSTAKA32will actually be seen in patients. Tests on humans themselves who can "guarantee" if the results of in vitro or animal similar to humans.Clinical trial consisted of 4 phases, namely phase I clinical trial, phase II clinical trial, phase III clinical trials, and phase IV clinical trial. Phase I clinical trial, performed on healthy humans, aims to determine an acceptable single-dose, phase II clinical trial, performed on 100-200 patiens to see whether the pharmacologic effects seen in Phase I is useful or not for treatment. Phase III clinical trials conducted on about 500 patients which aims to ensure that a new drug is really efficacy. Phase IV clinical trial is an observation of the drug has been marketed. This phase aims to determine patterns of drug use in society and patterns of effectiveness and safety in actual use.Good clinical trials conducted with procedures that have been outlined and its components prepared and thus the results can actually be used as a reference treatment. Key words : Efficacy – Safety - Clinical trial

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