Comparisons between US and UK Regulatory Environments for Conducting Phase I Clinical Research

2016 ◽  
Author(s):  
Peter Scholes
Keyword(s):  
Clinical Research ◽  
Phase I ◽  
Conducting Phase

Methods for Using Ecological Momentary Assessment to Assess Weight-related Behaviors in the Home Environment of Children from Low-Income, Racially/Ethnically Diverse and Immigrant Households (Preprint)

2021 ◽  
Author(s):  
Amanda Trofholz ◽  
Allan Tate ◽  
Mark Janowiec ◽  
Angela Fertig ◽  
Katie Loth ◽  
...  
Keyword(s):  
Native American ◽  
Phase I ◽  
Home Environment ◽  
Low Income ◽  
Ecological Momentary Assessment ◽  
Ethnically Diverse ◽  
Conducting Phase ◽  
The Family ◽  
Ecological Momentary ◽  
Momentary Assessment

BACKGROUND Ecological momentary assessment (EMA) is an innovative tool to capture in-the-moment health behaviors as people go about their regular lives. EMA is an ideal tool to measure weight-related behaviors, such as parent feeding practices, stress, and dietary intake, as these occur on a daily basis and vary across time and context. A recent systematic review recommended standardized reporting of EMA design for studies that address weight-related behaviors. OBJECTIVE This manuscript describes in detail the EMA design of the Family Matters study. METHODS Family Matters is an incremental, two-phased, mixed-methods study conducted with a racially/ethnically diverse and immigrant/refugee sample from largely low-income households designed to examine the risk and protective factors for childhood obesity in the home environment. The Family Matters study intentionally recruited White, Black, Hmong, Latino, Native American, and Somali parents with young children. Parents in Phase I of the study completed eight days of EMA on their smart phones, which included 1) signal-contingent surveys (e.g., asking about the parent’s stress at the time of the survey); 2) event-contingent surveys (e.g., descriptions of the meal the child ate); 3) end-of-day surveys (e.g., overall assessment of the child’s day).cribes in detail the EMA design of the Family Matters study. RESULTS A detailed description of EMA strategies, protocols, and methods used in Phase I of the Family Matters study is provided. Compliance with EMA surveys and participant time spent completing EMA surveys is presented, stratified by race/ethnicity. Additionally, lessons learned while conducting Phase I EMA are shared to document how EMA methods were improved and expanded upon for Phase II. CONCLUSIONS Results from this study provide an important next step in identifying best practices for EMA use in assessing weight-related behaviors in the home environment.

Ethical issues in phase I oncology research: a comparison of investigators and institutional review board chairpersons.

1992 ◽  
Vol 10 (11) ◽  
pp. 1810-1816 ◽  
Author(s):  
E Kodish ◽  
C Stocking ◽  
M J Ratain ◽  
A Kohrman ◽  
M Siegler
Keyword(s):  
Phase I ◽  
Ethical Issues ◽  
Institutional Review Board ◽  
Phase I Trials ◽  
Conducting Phase ◽  
Institutional Practice ◽  
Oncology Research ◽  
Institutional Review ◽  
Differences Of Opinion ◽  
Board Chairpersons

PURPOSE Phase I research trials assess the safety of agents never before administered to humans. In the field of oncology, this practice raises several important ethical questions. We examined the ethics of these trials by surveying phase I oncology investigators and institutional review board (IRB) chairpersons at major cancer research centers around the country. METHODS Questionnaires were mailed to 78 investigators and 47 chairpersons to obtain their views on the ethical propriety of conducting phase I oncology research, and on institutional practice regarding these trials. The response rate was 68% in each group. RESULTS The majority of each group reported that phase I oncology trials face no more scrutiny or resistance in their institution's IRB process than other research protocols. Nevertheless, IRB chairpersons were more likely than investigators to favor special procedural safeguards to protect subjects in phase I oncology trials. Nearly all respondents agreed that although actual medical benefit was very uncommon, most patients entered for a chance at a therapeutic effect. Investigators were more likely than chairpersons to report that patients obtained psychologic benefit from participation in phase I trials. CONCLUSION Although individual IRB chairpersons and oncology investigators may have important differences of opinion concerning the ethics of phase I trials, these disagreements do not represent a widespread area of ethical conflict in clinical research.

Phase I studies: a test bench for Italian clinical research

2019 ◽  
Vol 106 (4) ◽  
pp. 295-300
Author(s):  
Celeste Cagnazzo ◽  
Oriana Nanni ◽  
Francesca Arizio ◽  
Veronica Franchina ◽  
Rosita Cenna ◽  
...  
Keyword(s):  
Clinical Research ◽  
Phase I ◽  
Asymmetric Distribution ◽  
Phase I Studies ◽  
Clinical Phase ◽  
Trial Quality ◽  
Clinical Research Coordinator ◽  
Nonprofit Studies ◽  
Research Coordinator ◽  
Medical Directors

Background: The Agenzia Italiana del Farmaco (AIFA) Determination 809/2015 sets all the requirements that clinical units and laboratories must meet in order to conduct phase I studies. Requirements include buildings, equipment, personnel, emergency management, as well as quality requirements defined in a set of standard operating procedures. Methods: In September 2018, the Italian Association of Medical Oncology working group, Clinical Research Coordinator, created an anonymous survey addressed to 51 medical directors of oncologic/hematologic clinical phase I units and all medical directors of generic and transversal units located in Italy and listed at the AIFA website. Results: Questionnaires from 24 institutions were collected, 9 previously inspected by competent authorities. All surveyed structures are certified to conduct profit studies and 1 is authorized to include healthy volunteers; 15 units implemented a Clinical Trial Quality Team in order to conduct nonprofit studies. At the time of data collection, a total of 398 proposals for phase I trials have been received, more than 50% coming from 3 institutes. A total of 144 phase I studies were active, with a median of 2.5 (Q1–Q3=0–6) studies for each center and asymmetric distribution of proposals. Conclusion: The considerable number of proposals received from the interviewed centers indicates that Italy plays an important role in the international pharmaceutical scene, despite bureaucratic procedures that threaten exclusion from decision-making. The AIFA Determination will be an important opportunity to acquire a competitive working approach.

North American Clinical Trials Network for the Treatment of Spinal Cord Injury: goals and progress

2012 ◽  
Vol 17 (Suppl1) ◽  
pp. 6-10 ◽  
Author(s):  
Robert G. Grossman ◽  
Elizabeth G. Toups ◽  
Ralph F. Frankowski ◽  
Keith D. Burau ◽  
Susan Howley
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Clinical Trials ◽  
Phase I ◽  
Data Management ◽  
North American ◽  
Conducting Phase ◽  
The North ◽  
Number Of Patients ◽  
Cord Injury

The North American Clinical Trials Network (NACTN) for the Treatment of Spinal Cord Injury is a consortium of 10 neurosurgery departments, a data management center, and a pharmacological center. The NACTN was established with the goal of bringing recent molecular and cell-based discoveries in neuroprotection and regeneration from the laboratory into clinical trials that optimize meaningful data outcomes and maximum safety to patients. The requirements of planning and executing clinical trials in spinal cord injury (SCI) and the steps that the NACTN has taken to address these requirements are discussed and illustrated in articles in this issue of the Journal of Neurosurgery: Spine. The progress that the NACTN has made in meeting these goals can be summarized as organizing a network of hospitals capable of enrolling a sufficient number of patients for conducting Phase I and II trials; creating a Data Management Center and a database of the natural history of recovery after SCI (at the time of this writing 485 patients were enrolled in the database); creating a database of the incidence and severity of complications that occur during acute and subacute treatment after SCI; developing a Pharmacological Center capable of performing pharmacokinetic and pharmacodynamic studies of therapeutic drugs; completing enrollment of 36 patients in NACTN's first clinical trial, a Phase I study of riluzole, a neuroprotective drug; and performing pharmacokinetic and pharmacodynamic studies of riluzole in acute SCI.

Continuity of Physician Participation in Phase I Clinical Research

1994 ◽  
Vol 28 (4) ◽  
pp. 1133-1138
Author(s):  
Philip M. Brown ◽  
Joseph M. Scavone ◽  
Richard Ferraro
Keyword(s):  
Clinical Research ◽  
Phase I ◽  
Physician Participation

scholarly journals Qualitative study investigating the underlying motivations of healthy participants in phase I clinical trials

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e024224 ◽  
Author(s):  
Kerry J Manton ◽  
Cassandra S Gauld ◽  
Katherine M White ◽  
Paul M Griffin ◽  
Suzanne L Elliott
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Phase I ◽  
Time Frame ◽  
Phase I Clinical Trial ◽  
Trial Participation ◽  
Phase I Clinical Trials ◽  
Conducting Phase ◽  
Patient Health ◽  
Healthy Participants

ObjectivesIf patients are to reap the benefits of continued drug development, an understanding of why healthy participants take part in phase I clinical trials is imperative. The current study aimed to explore the nature of these underlying motivations which may, in turn, improve the overall participant experience and assist in the development of more effective recruitment and retention strategies.DesignThis study used a qualitative design based on the theory of planned behaviour. Specifically, it explored healthy participants’ underlying behavioural, control and normative beliefs which influence their participation in phase I clinical trials.SettingThis study took place at a company that specialises in conducting phase I and phase II clinical trials in the Australian state of Queensland.ParticipantsParticipants (n=31) were either currently undergoing a phase I clinical trial or had previously taken part in a phase I clinical trial.ResultsResults showed that the motivations were varied and not solely centred on financial gains. Reported advantages of participation included altruism, while inconvenience was most often reported as a disadvantage. Friends were reported as those most likely to approve, while one’s mother was reported as most likely to disapprove. Having a suitable time frame/flexible scheduling and feeling comfortable taking part in the trial were both the most commonly reported facilitators, while inflexible scheduling/time commitment was the most commonly reported barrier.ConclusionsPractical implications included the need for organisations involved in clinical trials to be mindful of inflexible scheduling and exploring the possibility of making educational materials available to family members who may be concerned about the risks associated with participation. Overall, it is anticipated that the results of this study will improve the understanding of factors that influence phase I clinical trial participation which may, ultimately, help develop new therapeutics to improve patient health.

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