Regulatory affairs in clinical trials

2022 ◽  
pp. 241-261
Author(s):  
Mohammad Ahmed Khan ◽  
Sadat Shafi ◽  
Syed Sufian Ahmad ◽  
Faraha Ahmed
Keyword(s):  
Clinical Trials ◽  
Regulatory Affairs

A timing and process flow analysis of opening clinical trials within an oncology cooperative group setting: The case of the CALGB

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6015-6015
Author(s):  
D. M. Dilts ◽  
A. B. Sandler ◽  
M. Baker ◽  
S. Cheng ◽  
S. McGuire ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase Iii ◽  
Group Setting ◽  
Calendar Time ◽  
Time Step ◽  
Center Staff ◽  
Regulatory Affairs ◽  
Decision Points ◽  
Phase Iii Study ◽  
Phase Iii Studies

6015 Background: Cooperative oncology groups are major sponsors of Phase III clinical trials, yet the number of steps and times required to setup and open such a trial have yet to be studied. This study assesses these items in the Cancer and Leukemia Group B (CALGB) for all Phase III studies opened in a 3 year period. Methods: Step 1: headquarters and statistical center staff were interviewed to discover the detailed steps required for a study to transit from initial concept submission by a potential study chair to final activation of the study. The formal procedures manuals were also reviewed. All study records and draft protocol documents were inspected to verify and identify additional setup steps. Finally, data was collected through direct contact with study chairs and disease committee chairs. Step 2: timing data for each of the major functions or processes were collected. All times are from initial initiation of the function to the final completion of the task. Times represent calendar time. Step 3: creation of stream-lined process flows, currently underway. Members from the CALGB and the Vanderbilt Center for Management Research in Healthcare (cmrhc.org) will spend 2 days creating a process to significantly reduce the time and the number of steps to opening a trial. Results: A total of 13 Phase III studies were activated during the 3 years study period. 372 processes are required to open a Phase III at CALGB, which include 314 work steps, 43 major decision points. Interesting, most of the decision points (63%) are external to CALGB. There are 23 processing loops that require repeating processes. The process map, which lists all processes, is a chart 243.5” × 41 in 8 pt font (or about the length of a 20 passenger bus). Median calendar days to activate a Phase III study at CALGB is 767 days (min = 488, max = 1,441). The three functions requiring the greatest median days are protocol development (477), forms development (434), and regulatory affairs (350). Conclusion: It can require years to open a Phase III study at a major cooperative oncology group. Using process redesign techniques, we expect to be able to significantly streamline the process. Support provided by the NCI. No significant financial relationships to disclose.

P63 Registers of clinical trials in the regulatory affairs process

1997 ◽  
Vol 18 (3) ◽  
pp. S148-S149
Author(s):  
W.N. Strang ◽  
J.P. Boissel
Keyword(s):  
Clinical Trials ◽  
Regulatory Affairs

scholarly journals An investigation into the factors affecting investigator-initiated trial start-up in Ireland

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Lauren Leddy ◽  
Prasanth Sukumar ◽  
Lydia O’Sullivan ◽  
Fionnuala Keane ◽  
Declan Devane ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Structured Interviews ◽  
Factors Affecting ◽  
Staff Members ◽  
Regulatory Affairs ◽  
Protocol Development ◽  
Start Up ◽  
Ethical Approval ◽  
Two Stages ◽  
Site Identification

Abstract Background In common with many countries, Ireland has seen an increasing trend in the number of clinical trials conducted over the past few years. Yet, as elsewhere, trialists in Ireland face several problems and barriers in the starting-up of clinical trials. These barriers impede trial activity significantly, with consequent impacts on patient care. It is critical to understand these issues, to develop approaches to facilitate trial start up. This study identifies the challenges in conducting clinical trials in Ireland and specifically the contractual, ethical, logistical, and regulatory barriers that hinder the start-up of investigator-led trials in Ireland. Methods Data for this study were collected in two stages. In the first stage, a survey was conducted among trialists in Ireland. A total of 44 trialists responded to the survey, and information was collected about their experience in conducting clinical trials, the scale and nature of their most recently completed trial, and the details of specific barriers they encountered during the starting-up of the trial. In the second stage, nine semi-structured interviews were conducted with the awardees of 2018 Irish Health Research Board’s Definitive Intervention Feasibility Award. These interviews facilitated a deeper exploration of issues and problems in conducting clinical trials in Ireland. Results This study identified several issues and bottlenecks in starting-up clinical trials in Ireland with contracts and ethical approval cited as the major issues. The data shows that site identification and activation was also problematic in some cases. Several respondents reported difficulties in accessing dedicated time for protocol development and believe that support in this area can be greatly beneficial. It was reported that availability of skilled staff members like statisticians and data managers was as an issue, especially for small trials. Conclusion This study found that several factors impact trial initiation and progression in Ireland. Delays associated with obtaining contract and ethics approval are perceived as major barriers. Specialist supports in areas such as ethics and regulatory affairs and availability of specialised staff members in areas such as statistics and data management are key actions to enable enhanced clinical trial activity in Ireland.

Clinical Research and Regulatory Affairs

2021 ◽  
pp. 160-184
Author(s):  
Maria Teresa Herdeiro ◽  
Nélia Gouveia ◽  
Fátima Roque
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Medical Devices ◽  
Clinical Studies ◽  
Market Access ◽  
Systems Of Care ◽  
Therapeutic Interventions ◽  
Knowledge And Skills ◽  
Regulatory Affairs ◽  
Before And After

Clinical research is a large umbrella, and it mainly includes the implementation of clinical studies/trials. This field is crucial to assess the value of new developments in healthcare, be it new therapeutic interventions, medical devices, or systems of care. In order to protect human rights, the implementation of clinical trials is complex and extremely costly. In this context, medicines and medical devices are strongly regulated products before and after the market authorization. So during their training, pharmacists must develop skills in the area of regulatory affairs, design and methodology of clinical trials, and other clinical studies, as well as in the management of clinical projects to be prepared for the challenges of the clinical research and market access processes. With that purpose, knowledge and skills for clinical research should be developed in association with regulatory affairs.

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