scholarly journals Study Protocol Version Study Population Description

2020 ◽  
Author(s):  
Keyword(s):  
Study Protocol ◽  
Study Population ◽  
Population Description

An analysis of deficiencies identified during investigational new drug (IND) application reviews by the Division of Drug Oncology Products (DDOP) of the US FDA

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6052-6052
Author(s):  
B. S. Mann ◽  
R. Kane ◽  
M. Brave ◽  
Q. Ryan ◽  
M. Hazarika ◽  
...  
Keyword(s):  
Clinical Study ◽  
Study Protocol ◽  
Drug Dose ◽  
Stopping Criteria ◽  
Study Results ◽  
The Us ◽  
Clinical Hold ◽  
Dose Study ◽  
Study Population ◽  
Us Fda

6052 Background: Regulations require IND application review by the FDA prior to initiation of the clinical study. Deficiencies identified in the study protocol require communication between the FDA reviewers and the Sponsor for resolution. If the deficiencies are not adequately resolved, clinical hold and subsequent delay in the start of the clinical study results. To identify and analyze the commonly encountered IND application deficiencies, data from recent reviews were collected. Methods: Eight clinical reviewers analyzed the deficiencies that had been identified in 268 IND applications reviewed in the DDOP FDA from January 2003 to June 2005. All of the study protocol deficiencies leading to a clinical hold, or requiring resolution prior to study initiation were categorized as deficiencies pertaining to: patient eligibility; starting drug dose; study conduct (toxicity management, dose adjustment, stopping criteria); statistical or endpoints; non-clinical; and other issues. Results: 268 IND applications reviewed over a 30-month period by eight medical officers were analyzed. One hundred and twelve (42%) of the applications had no deficiencies; however, 156 (58%) had one (31%) or multiple (69%) deficiencies. Deficiencies pertained to study conduct/scheme (65%), dose (48%), patient eligibility (46%), others (31%), statistics or endpoints (15%), and non-clinical (4%) issues. In 141 (90%) of the deficient applications the deficiencies were adequately addressed by FDA reviewer-Sponsor communication and the trials could start as scheduled. Fifteen (10%) deficient trials were placed on clinical hold. Fourteen (93%) of these trials had multiple deficiencies that pertained to patient eligibility in 12 (80%), starting drug dose in 12 (80%), study conduct in 11 (73%), other in 7 (47%), and non-clinical and statistical issues in 2 (13%) each. Conclusions: Deficiencies were identified in 58% of the reviewed IND applications: 90% of these were resolved by FDA-Sponsor communication. Only 10% of deficient studies were placed on clinical hold; all except one had multiple deficiencies. The most common deficiencies leading to clinical hold pertained to eligibility of study population and proposed starting drug dose. No significant financial relationships to disclose.

VEdeTTE, a Longitudinal Study on Effectiveness of Treatments for Heroin Addiction in Italy: Study Protocol and Characteristics of Study Population

2006 ◽  
Vol 41 (14) ◽  
pp. 1861-1879 ◽  
Author(s):  
Anna Maria Bargagli ◽  
Fabrizio Faggiano ◽  
Laura Amato ◽  
Giuseppe Salamina ◽  
Marina Davoli ◽  
...  
Keyword(s):  
Longitudinal Study ◽  
Study Protocol ◽  
Heroin Addiction ◽  
Study Population

scholarly journals 2015 Behavioral clinical trials: Considerations for design and conduct using the new NIH study protocol template

2018 ◽  
Vol 2 (S1) ◽  
pp. 52-52
Author(s):  
Susan L. Murphy ◽  
Nancy Yovetich ◽  
Melissa Riddle
Keyword(s):  
Clinical Trials ◽  
Study Protocol ◽  
Research Community ◽  
Trial Protocol ◽  
Phase 2 ◽  
Conducting Phase ◽  
Study Population ◽  
Behavioral Trials ◽  
Supporting Materials

OBJECTIVES/SPECIFIC AIMS: (1) To discuss key differences of behavioral clinical trials from trials involving drugs, devices, and biologics and (2) to discuss NIH efforts to provide a study protocol template for use by investigators conducting behavioral clinical trials. METHODS/STUDY POPULATION: A working group was convened by NIH to refine the commonly used protocol template required for investigators conducting Phase 2 or 3 NIH-funded clinical trials. The committee met by phone regularly for 4 months to review, discuss, and refine each section of the template as needed to include aspects relevant to behavioral trials. RESULTS/ANTICIPATED RESULTS: The behavioral trial protocol template draft has been created and is being further modified by feedback from the research community. DISCUSSION/SIGNIFICANCE OF IMPACT: Use of the NIH behavioral trial protocol template is expected to enhance the quality of any behavioral study, because the template and supporting materials were developed with the unique aspects of behavioral research in mind.

scholarly journals The Effectiveness of Single-Dose Azithromycin Versus its Combination With Moxifloxacin Based on the Treatment of Chlamydial Cervicitis: A Study Protocol for a Randomized Clinical Trial

2018 ◽  
Vol 7 (4) ◽  
pp. 442-450
Author(s):  
Farnaz Mohammadzadeh ◽  
Mahrokh Dolatian ◽  
Masoumeh Jorjani ◽  
Maryam Afrakhteh ◽  
Hamid Alavi Majd ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Single Dose ◽  
Randomized Clinical Trial ◽  
Study Protocol ◽  
Diagnostic Value ◽  
Diagnostic Methods ◽  
Transmitted Infection ◽  
Sexually Transmitted ◽  
Study Population ◽  
Proven Case

Objectives: Chlamydia trachomatis is globally reported as a pathogenic infection and is the most common bacterial cause of sexually transmitted infection (STI) in most countries. In addition, chlamydial cervicitis and the adverse complications of the first line treatment, namely, azithromycin failure are highly prevalent. Thus, the present study will be conducted to determine and compare the effects of single-dose azithromycin and its combination with moxifloxacin based on syndromic and etiologic methods in the diagnosis and treatment of chlamydial cervicitis. Materials and Methods: This is a study protocol for a randomized clinical trial which will be performed at the Women’s Clinics and Health Centers in Amol, Iran during 2018. Further, the study will evaluate women with cervicitis complaints, who have a proven case of chlamydial cervicitis through syndromic or etiologic diagnostic methods and meet the inclusion criteria for the study population. Discussion: To the best of our knowledge, this trial will be the first study to explore the effects of single-dose azithromycin in combination with moxifloxacin in the treatment of chlamydial cervicitis. The results of this trial will further reveal the diagnostic value of syndromic and etiologic methods in the diagnosis of chlamydial cervicitis.

scholarly journals Assessing the hospital volume-outcome relationship in surgery: a scoping review

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Mathieu Levaillant ◽  
Romaric Marcilly ◽  
Lucie Levaillant ◽  
Philippe Michel ◽  
Jean-François Hamel-Broza ◽  
...  
Keyword(s):  
Surgical Procedures ◽  
Study Protocol ◽  
Scoping Review ◽  
Hospital Volume ◽  
Oncological Surgery ◽  
Outcome Relationship ◽  
Study Population ◽  
Volume Outcome ◽  
Digestive Tract Surgery ◽  
Type Of Surgery

Abstract Introduction Many recent studies have investigated the hospital volume-outcome relationship in surgery. In some cases, the results have prompted the centralization of surgical activity. However, the methodologies and interpretations differ markedly from one study to another. The objective of the present scoping review was to describe the various features used to assess the volume-outcome relationship: the analyzed datasets, study population, outcome, covariates, confounders, volume modalities, and statistical methods. Methods and analysis The review was conducted according to a study protocol published in BMJ Open in 2020. Two authors (both of whom had helped to design the study protocol) screened publications independently according to the title, the abstract and then the full text. To ensure exhaustivity, all the papers included by each reviewer went through to the next step. Interpretation The 403 included studies covered 90 types of surgery, 61 types of outcome, and 72 covariates or potential confounders. 191 (47.5%) studies focussed on oncological surgery and 37.8% focussed visceral or digestive tract surgery. Overall, 86.6% of the studies found a statistically significant volume-outcome relationship, although the findings differed from one type of surgery to another. Furthermore, the types of outcome and the covariates were highly diverse. The majority of studies were performed in Western countries, and oncological and visceral surgical procedures were over-represented; this might limit the generalizability and comparability of the studies’ results.

Do They Understand? (Part II)

2003 ◽  
Vol 98 (3) ◽  
pp. 609-614 ◽  
Author(s):  
Alan R. Tait ◽  
Terri Voepel-Lewis ◽  
Shobha Malviya
Keyword(s):  
Clinical Research ◽  
Study Protocol ◽  
Research Participant ◽  
Complete Understanding ◽  
Parental Permission ◽  
Core Elements ◽  
Study Population ◽  
Clinical Anesthesia ◽  
Level Of Understanding

Background Participation of children in clinical research requires not only parental permission but also the assent of the child. Although there is no fixed age at which assent should be sought, investigators should obtain assent from children considered able to provide it. This study was designed to determine children's understanding of the elements of disclosure for studies in which they had assented to participate. Methods The study population included 102 children aged 7-18 yr who had given their assent to participate in a clinical anesthesia or surgical study. Children were interviewed using a semistructured format to determine their understanding of eight core elements of disclosure for the study to which they had agreed to participate. Two independent assessors scored the children's levels of understanding of these elements. Results The children's perceived level of understanding of the elements of disclosure was significantly greater than their measured understanding (7.0 +/- 2.4 vs 5.3 +/- 2.7, 0-10 scale; P< 0.0001). Complete understanding of the elements of disclosure for all children ranged from 30.4 to 89.4%. Children aged more than 11 yr had significantly greater understanding compared with younger children, particularly with respect to understanding of the study protocol, the benefits, and the freedom to withdraw. Conclusions Children approached for their assent to participate in a clinical anesthesia or surgery study have limited understanding of the elements of disclosure and their role as a research participant, particularly if they are aged less than 11 yr.

scholarly journals Engaging community stakeholders in research on best practices for clinical genomic sequencing

2020 ◽  
Vol 17 (6) ◽  
pp. 435-444
Author(s):  
Ida Griesemer ◽  
Brooke S Staley ◽  
Alexandra F Lightfoot ◽  
Lizzy Bain ◽  
Derrick Byrd ◽  
...  
Keyword(s):  
Best Practices ◽  
Study Protocol ◽  
Clinical Care ◽  
Genomic Sequencing ◽  
Community Stakeholders ◽  
Genomics Research ◽  
Study Population ◽  
The Impact ◽  
Clinical Genomic ◽  
Unique Study

Aim: Maximizing the utility and equity of genomic sequencing integration in clinical care requires engaging patients, their families, and communities. The NCGENES 2 study explores the impact of engagement between clinicians and caregivers of children with undiagnosed conditions in the context of a diagnostic genomic sequencing study. Methods: A Community Consult Team (CCT) of diverse parents and advocates for children with genetic and/or neurodevelopmental conditions was formed. Results: Early and consistent engagement with the CCT resulted in adaptations to study protocol and materials relevant to this unique study population. Discussion: This study demonstrates valuable contributions of community stakeholders to inform the implementation of translational genomics research for diverse participants.

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