National Center for Biotechnology Information , U. Front Oncol. Published online Dec Prepublished online Nov Geoffrey S. Followill 3. David S. Author information Article notes Copyright and License information Disclaimer.
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This article has been cited by other articles in PMC. Abstract Cooperative groups, of which the Radiation Therapy Oncology Group is one example, conduct national clinical trials that often involve the use of radiation therapy.
Keywords: quality assurance, health care, clinical trials as topic, anthropomorphic phantoms, credentialing, radiation therapy. Introduction In recent years the approach to treating cancer patients with radiation therapy has evolved considerably. In the case of trials involving radiation oncology there are two general approaches: When the radiation therapy is not part of the trial question, e. Open in a separate window.
Credentialing for Radiation Therapy Clinical Trials A clinical trial may incorporate a credentialing program in an effort to minimize the number of protocol violations and improve the overall quality of the trial Trial-specific credentialing Pre-trial credentialing may require centers to demonstrate that they are able to achieve a high level of treatment accuracy which may be an important element in dose escalation studies 35 or studies involving tight treatment margins or hypofractionated schedule Credentialing for such clinical trials generally involves an evaluation of most if not all of the following aspects: Attestation to use of the particular advanced technology to treat patients previously: institutions must demonstrate that they are familiar with the technique and have used it to treat at least some minimum number of patients.
External Dosimetry Audits Remote audits of treatment machine output At least five organizations conduct regular independent audits of treatment machine output calibration with mailed dosimeters. Results of remote audits of machine calibration The RPC has described results from a large series of annual calibration audits 8 , Figure 1. Table 2 Some of the discrepancies detected during RPC dosimetry review visits to institutions in — Reviews of QA programs Recommendations for performing routine QA in radiation therapy departments are presently in flux.
Observations from reviews of patient records Quality assurance offices often participate in the QA review of the treatment records of patients treated on protocols managed by cooperative study groups. Results of anthropomorphic phantom reviews Several QA offices have reported the results of independent audits with an anthropomorphic phantom.
Incorporating New and Complex Technologies into Clinical Trials Clinical trials that are open to recruitment over a protracted period typically struggle to keep pace with new technology as it is implemented in the clinic. Conclusion Clinical trials can be a powerful tool for demonstrating the effectiveness of a clinical intervention or treatment. Conflict of Interest Statement The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
References 1. Challenges in credentialing institutions and participants in advanced technology multi-institutional clinical trials. Design and implementation of an anthropomorphic quality assurance phantom for intensity-modulated radiation therapy for the Radiation Therapy Oncology Group.
Credentialing results from IMRT irradiations of an anthropomorphic head and neck phantom. Med Phys 40 2 Dose specification and quality assurance of Radiation Therapy Oncology Group protocol ; a cooperative group study of iridium breast implants as sole therapy.
Haworth A, Ibbott G. Medical physics for clinical trials. In: Van Dyke J, editor. Olch AJ, editor. Report No. Ibbott GS. QA in radiation therapy: the RPC perspective. J Phys :1— Stratified randomization for clinical trials. J Clin Epidemiol 52 1 — Kaplan RS.
How can we improve clinical trials? Nat Clin Pract Oncol 4 4 — Quality assurance of dosimetry and the impact on sample size in randomized clinical trials.
Radiother Oncol 86 2 — Intensity-modulated radiation therapy dose prescription, recording, and delivery: patterns of variability among institutions and treatment planning systems. J Natl Cancer Inst 5 — Willins J, Kachnic L. Clinically relevant standards for intensity-modulated radiation therapy dose prescription. Radiographics 29 4 — Clinical impact of dosimetry quality assurance programmes assessed by radiobiological modelling of data from the thermoluminescent dosimetry study of the European Organization for Research and Treatment of Cancer.
Eur J Cancer 36 5 — Critical impact of radiotherapy protocol compliance and quality in the treatment of advanced head and neck cancer: results from TROG J Clin Oncol 28 18 — An overview. Strahlenther Onkol 4 — The Australian Clinical Dosimetry Service: a commentary on the first 18 months.
Australas Phys Eng Sci Med 35 4 — Impact of a dosimetry review program on radiotherapy in group trials. Quality assurance of radiotherapy in clinical trials.
Radiotherapy protocol deviations and clinical outcomes: a meta-analysis of cooperative group clinical trials. J Natl Cancer Inst 6 — Does quality of radiation therapy predict outcomes of multicenter cooperative group trials? A literature review. Tirapazamine, cisplatin, and radiation versus cisplatin and radiation for advanced squamous cell carcinoma of the head and neck TROG Purdy JA.
Quality assurance issues in conducting multi-institutional advanced technology clinical trials. Statistical process control for radiotherapy quality assurance. Med Phys 32 9 — RPC Credentialing for participation in clinical trials. Front Oncol 2 Br J Radiol 82 — Radiother Oncol 73 2 — Radiother Oncol 90 3 — Successful implementation of image-guided radiation therapy quality assurance in the Trans Tasman Radiation Oncology Group Dosimetric intercomparison for two Australasian clinical trials using an anthropomorphic phantom.
Credentialing of institutions for IMRT in clinical trials. High energy photon standard dosimetry data: a quality assurance tool. Med Phys 39 Med Phys 34 6 — Independent evaluations of IMRT through the use of an anthropomorphic phantom. Task Group report: quality assurance of medical accelerators.
Med Phys 36 9 — Med Phys 21 4 — Mailable TLD system for photon and electron therapy beams. Uncertainty analysis of absorbed dose calculations from thermoluminescence dosimeters. Med Phys 19 6 — Optically stimulated luminescence OSL dosimeters can be used for remote dosimetry services. Med Phys 35 Med Phys 38 A thermoluminescent dosimetry postal dose inter-comparison of radiation therapy centres in Malaysia.
Australas Phys Eng Sci Med 27 1 — Feasibility study of glass dosimeter postal dosimetry audit of high-energy radiotherapy photon beams. Feasibility study of radiophotoluminescent glass rod dosimeter postal dose intercomparison for high energy photon beam. Appl Radiat Isot 67 2 — Izewska J, Andreo P. Radiother Oncol 54 1 — J Appl Clin Med Phys 6 4 — Vienna: International Atomic Energy Agency; The approval process for the use of proton therapy in NCI sponsored clinical trials.
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Phys Med Biol 47 16 — Radiother Oncol 80 1 — Clin Oncol R Coll Radiol 20 8 — Monitoring and audit play a key role in assuring quality throughout the trial. Quality assurance refers to systemic and independent audit of all activities and documents related to a clinical trial.
This is performed by quality assurance personnel who are not involved in the research to determine whether the trial was conducted and that the collection, analysis and reporting of data were in accordance with the protocol, standard operating procedures SOPs and Good Clinical Practices GCP.
In short, this process assesses the efficiency of quality control processes carried out by the sponsors. The trial specific quality assurance audits include audits of the trial protocol, case report form CRF , trial sites, trial database, graphs, tables and statistics and trial report. One important aspect of quality assurance in clinical trials is good clinical practice GCP which can be defined as a set of ethical and scientific quality guidelines that must be observed globally for planning, conducting, recording and reporting clinical trials which involve the participation of human subjects.
The quality plan defines how the quality control and quality assurance processes are abided by throughout the clinical trial and describes various quality related tasks in the study.
It documents quality practices, resources and activities that are specific to a project. For more information please go through the links below:. Email Not published. The Guidelines specify the procedures investigators should develop and implement to prevent , to detect , and to correct data quality and integrity problems.
They are presented in three formats:. This document contains the Guidelines and Bibliography. It can be used for multi-center study clinical research projects. There are some generic activities that help to ensure quality in a clinical research environment.
These include the following:. The general purpose of a research project is to collect data that enables the investigators to test the study hypothesis and achieve the study objectives. The data collection and data management processes are as important in achieving the study objectives as having a scientifically sound study design and protocol. To assist in preventing problems with data quality, investigators must incorporate standard research methodology into their studies.
It is essential that study investigators and clinical centers follow and adhere to an approved, common protocol to assure that data collected can be aggregated for analysis and interpretation. Key components of a protocol are the same for single and - or multi-center clinical studies.
The protocol provides a statement of the problem, study objectives, research questions and hypotheses. Training study staff at clinical centers helps to ensure that the protocol is applied in a standardized way across sites and participants by all study staff. Formal training sessions for investigators, site coordinators, and other staff as necessary, are held to review the study goals and procedures, study forms, and often include a certification process.
Accepted research methods and guidance on clinical trials help to ensure that the data required addresses that the study questions are collected and recorded in the same way across sites, investigators, and participants.
These methods and approaches are outlined and briefly described below. The clinical study project team is responsible for developing study materials; recruiting, screening, enrolling, and following study participants; collecting study data, ensuring data quality, and analyzing and presenting study results.
A project organization chart identifies each staff member's responsibilities and communication lines within the center and across sites in multi-center studies. Multi-center studies may involve a clinical coordinating center and data coordinating center, central laboratories and reading centers, drug distribution centers, and numerous clinical sites.
Written job descriptions that describe responsibilities and backup staff are important for staff members within the clinical sites and coordinating centers.
The Manual of Procedures MOP is the document that transforms the protocol into an operational research project. It details the study organization, the definitions of data elements to be collected, visit procedures, data management, data flow, case report forms CRFs , safety monitoring, and quality control procedures. It documents the study flow so that the screening, initial evaluation, enrollment, baseline evaluations, randomization, treatment and follow-up of all study participants are conducted in a structured and standardized manner.
It details how the data are observed, collected, and recorded. The MOP should include sufficient detail so that it could be used as a training manual for new study staff. Before a study begins recruitment, a study flow should be developed that details each contact with study participants or potential study participants, time period, and data that must be collected. Other useful mechanisms to prevent issues with data quality include participant files and a study administrative file or the study binder.
The participant files may contain the participant's informed consent form, source documents, such as copies of the medical record because these are often difficult to retrieve in a hospital setting , laboratory results, MRI scans, and other data related to the study, telephone notes, videos, and instruments or tests completed by the participant.
The study binder contains all protocol documents and amendments, investigator brochures, staff C. Investigators must not have any intellectual or scientific conflict of interest with the conduct of the study.
Further, each local institution has policies and procedures in place that all investigators must comply with, and which govern any potential conflicts of interest. Procedures should be in place to help investigators and other key personnel comply with all requirements. Written procedures document how the study treatment, if relevant, is to be stored, prepared, dispensed, and returned.
Procedures must also describe instructions for completing drug accountability and administration records. An actual pharmacy may or may not be directly involved in a study at the clinic level since the investigational agent may be delivered directly to the clinic site in pre-labeled sealed packages. Written procedures document how laboratory samples, MRIs, and other study participant samples, documents, or materials are to be collected, labeled, handled, shipped to the coordinating center, and tracked so that study data are not lost.
As stated in the new Health Insurance Portability and Accountability Act HIPAA guidelines, personal identifiers such as name, geographic location, social security number, and fifteen other specific individual identifiers should not be used. Thus when transmitting participant materials it is important to specify how the material is to be identified e.
A common issue that can impact the study timeline and study results is participant recruitment. A comprehensive recruitment plan helps to ensure that a study will enroll the target number of participants in a timely manner.
Study staff must define the characteristics and needs of the target population.
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