Mechanisms of the placebo response and their impact on clinical trials and clinical practice

Pain ◽  
2005 ◽  
Vol 114 (1) ◽  
pp. 3-6 ◽  
Author(s):  
Damien G. Finniss ◽  
Fabrizio Benedetti
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Placebo Response

Controlling Hypertension and Stroke Prevention – From Guideline to Clinical Practice

2011 ◽  
Vol 3 (1) ◽  
pp. 30
Author(s):  
Anding Xu ◽  
Zefeng Tan ◽  
◽  
Keyword(s):  
Risk Factors ◽  
Blood Pressure ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Stroke Prevention ◽  
Modifiable Risk Factors ◽  
Cerebrovascular Events

Hypertension is the most important of the prevalent and modifiable risk factors for stroke. Based on evidence, blood pressure (BP) lowering is recommended in guidelines for the prevention of stroke. However, there are still some uncertainties in the guidelines for controlling BP and preventing stroke in patients with previous cerebrovascular events, such as the goal BP, who to treat and which class of BP-lowering drugs to use. This article discusses these questions by reviewing guidelines and corresponding clinical trials, with the aim of reducing the gap between guidelines and clinical practice.

ANTIBODY-DRUG CONJUGATES FOR TARGETED CANCER THERAPY

2019 ◽  
Vol 65 (6) ◽  
pp. 777-784
Author(s):  
David Korman
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Gemtuzumab Ozogamicin ◽  
Brentuximab Vedotin ◽  
Cytostatic Agent ◽  
Cytostatic Agents ◽  
Drug Conjugates ◽  
Natural Substances ◽  
Intracellular Release ◽  
High Antitumor Activity

Monoclonal antibody (MAB) conjugates with cytostatic agents (ADC) are intended for selective delivery of a cytostatic agent to a tumor cell. Three ADC have been approved for clinical use (gemtuzumab ozogamicin, brentuximab vedotin, trastuzumab-DM1); a few dozens of other ADC are undergoing clinical trials. Several derivatives of natural substances (antibiotics and inhibitors of microtubules) having a high antitumor activity are used as cytostatic agents included in ADC. They are inapplicable in clinical practice as self-sustained drugs due to their considerable toxicity. Of great importance for the implementation of the ADC effect is the character of a linker connecting MAB with a cytostatic agent and ensuring selective intracellular release after ADC internalization. The structure, mechanisms of action, and the results of clinical trials of a number of ADC are considered here as an illustration (by way of example). The development of ADC can help introduce new effective cytostatic agents into clinical practice.

scholarly journals International teleproctoring in neurointerventional surgery and its potential impact on clinical trials in the era of COVID-19: legal and technical considerations

2020 ◽  
pp. neurintsurg-2020-017053
Author(s):  
Emanuele Orru' ◽  
Miklos Marosfoi ◽  
Neil V Patel ◽  
Alexander L Coon ◽  
Christoph Wald ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
High Resolution ◽  
Situational Awareness ◽  
Flow Diverter ◽  
Multiple Sources ◽  
Remote Supervision ◽  
Angiography Suite ◽  
The Us ◽  
Travel Restrictions

BackgroundExisting travel restrictions limit the mobility of proctors, significantly delaying clinical trials and the introduction of new neurointerventional devices. We aim to describe in detail technical and legal considerations regarding international teleproctoring, a tool that could waive the need for in-person supervision during procedures.MethodsInternational teleproctoring was chosen to provide remote supervision during the first three intracranial aneurysm treatments with a new flow diverter (currently subject of a clinical trial) in the US. Real-time, high-resolution transmission software streamed audiovisual data to a proctor located in Canada. The software allowed the transmission of images in a de-identified, HIPAA-compliant manner.ResultsAll three flow diverters were implanted as desired by operator and proctor and without complication. The proctor could swap between images from multiple sources and reported complete spatial and situational awareness, without any significant lag or delay in communication. Procedural times and radiologic dose were similar to those of uncomplicated, routine flow diversion cases at our institution.ConclusionsInternational teleproctoring was successfully implemented in our clinical practice. Its first use provided important insights for establishing this tool in our field. With no clear horizon for lifting the current travel restrictions, teleproctoring has the potential to remove the need for proctor presence in the angiography suite, thereby allowing the field to advance through the continuation of trials and the introduction of new devices in clinical practice. In order for this tool to be used safely and effectively, highly reliable connection and high-resolution equipment is necessary, and multiple legal nuances have to be considered.

scholarly journals Impact on actual clinical practice of the latest evidence for percutaneous closure of patent foramen ovale associated with stroke. A single center experience

2021 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
L Carnero Montoro ◽  
M Ruiz Ortiz ◽  
N Paredes Hurtado ◽  
M Delgado Ortega ◽  
A Rodriguez Almodovar ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Patent Foramen Ovale ◽  
Cryptogenic Stroke ◽  
Percutaneous Closure ◽  
Publication Date ◽  
Foramen Ovale ◽  
Complex Anatomy ◽  
The Mean ◽  
The Impact

Abstract Funding Acknowledgements Type of funding sources: None. Background and aims Since september 14th, 2017. Three large clinical trials demonstrated that, in selected patients, percutaneous closure of patent foramen ovale (PFO) was associated with lower recurrence in patients with cryptogenic stroke (CS). Our aim was to determine the impact of these findings on routine  clinical practice in a tertiary hospital. Methods Patients with percutaneous closure of PFO due to CS (January 2001-January 2020) were included. The clinical characteristics were analyzed individually and grouped in the RoPE score, before and after the publication date. Complex anatomy (CA) defined as interatrial septum aneurysm or basal wide bubble passage was evaluated in both periods. Results 293 patients were included. The mean age was 49 ± 11 years, 15% were older than 60 years, 60% men, 26% hypertensive, 28% smokers and 7%diabetics. The median RoPEscore was 6 [p25-75, 5-7] and 75% met CA criteria. Since september 14th, 2017, the frequency of CA and the mean age of the patients were significantly higher (89% vs. 69% p <0.0005 and 51 ± 11 vs. 48 ± 11 years, p = 0.02, respectively), and RoPEscore, significantly lower (5 [5-7] vs. 6 [5-7], p = 0.02). Conclusion The publication of clinical trials wich demonstrated the benefit of percutaneous closure of PFO in CS had a significant impact on the daily clinical practice of our institution, with an increase in indications for CA, despite a clinical profile suggestive of lower causal probability of PFO.

Sofosbuvir-based regimens in clinical practice achieve SVR rates closer to clinical trials: results from ERCHIVES

2015 ◽  
Vol 36 (5) ◽  
pp. 651-658 ◽  
Author(s):  
Adeel A. Butt ◽  
Peng Yan ◽  
Obaid S. Shaikh ◽  
Raymond T. Chung ◽  
Kenneth E. Sherman ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice

scholarly journals NAB-paclitaxel and gemcitabine in metastatic pancreatic ductal adenocarcinoma (PDAC): from clinical trials to clinical practice

BMC Cancer ◽  
2016 ◽  
Vol 16 (1) ◽  
Author(s):  
Ferdinando De Vita ◽  
Jole Ventriglia ◽  
Antonio Febbraro ◽  
Maria Maddalena Laterza ◽  
Alessio Fabozzi ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Pancreatic Ductal Adenocarcinoma ◽  
Ductal Adenocarcinoma

scholarly journals Oc021—Clinical Trials Registry And Good Clinical Practice: In Indian Scenario

2013 ◽  
Vol 35 (8) ◽  
pp. e9
Author(s):  
A. Prakash ◽  
B. Medhi ◽  
S. Kaur ◽  
S. Kumari ◽  
P. Sarotra
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Good Clinical Practice ◽  
Clinical Trials Registry ◽  
Indian Scenario

Use of a placebo in clinical trials

1998 ◽  
Vol 13 (5) ◽  
pp. 254-263 ◽  
Author(s):  
G Emilien ◽  
JM Maloteaux ◽  
A Seghers ◽  
G Charles
Keyword(s):  
Clinical Trials ◽  
Placebo Response ◽  
Drug Efficacy ◽  
Placebo Treatment ◽  
High Response Rate ◽  
Experimental Methodology ◽  
Necessary Condition ◽  
Control Group ◽  
Placebo Control ◽  
Experimental Drug

SummaryThe use of a placebo control group in the evaluation of a new product is today considered by most as a necessary condition of experimental drug research. Placebo response is an essential consideration in all clinical trials. If not properly controlled, incorrect and dangerous conclusion may be inferred for a product efficacy and safety profile. However, the inclusion of a placebo group in clinical trials in neuropsychiatric research raises several ethical and scientific questions. Whereas in certain indications, such as suicidal patients and severe and psychotic depression, the use of a placebo is generally not accepted, it is difficult to assess drug efficacy. This article discusses the concept of placebo in clinical trials, the occurrence of adverse events after placebo treatment and the high response rate of placebo in neuropsychiatric clinical research. The experimental methodology to adequately control all the factors involved is also analysed and discussed.

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