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Considerations for Clinical Trials Involving Microneedle Devices
Published in Boris Stoeber, Raja K Sivamani, Howard I. Maibach, Microneedling in Clinical Practice, 2020
The submission for medical devices includes an IRB-approved clinical protocol and informed consent, reports of nonclinical safety testing (e.g., biocompatibility), manufacturing process controls (e.g., bioburden control), device design controls, and risk management. Studies investigating use of microneedles as devices (no active therapeutic agent) may qualify as nonsignificant risk studies (NSR) by submission of rationale to an IRB. If the IRB approves NSR status, submission of the IDE to FDA is not required, and documentation of abbreviated IDE controls is maintained by the Sponsor.
Matched Data
Published in Peter Cummings, Analysis of Incidence Rates, 2019
In a crossover study of two (or more) treatments, each subject receives both treatments and their outcomes under the two treatments are compared (Hills and Armitage 1979, Senn 2002, Jones and Kenward 2003, Mills et al. 2009). If treatment order is randomized, this is a type of randomized controlled trial. The design controls for confounding by any factor which is invariant within a person; genetic make-up, for example. A factor that changes over time, from the first treatment to the second, can be a potential confounder, although randomizing the order of the treatments may control for some of these factors. In these studies there is often concern about carryover bias (Cummings 2010), worry that the effect of the first treatment may persist long enough to influence the results of the second treatment. This is a matched design trial, in which each person given a treatment is matched to themselves when not given the treatment (or a different treatment) at another time.
United States Medical Device Regulatory Framework
Published in Jack Wong, Raymond K. Y. Tong, Handbook of Medical Device Regulatory Affairs in Asia, 2018
An IDE allows an investigational device to be used in a clinical study in order to collect safety and/or performance data, typically in support of a marketing application. The studies must be conducted under the principles of medical device Good Clinical Practices (GCP). The GCP refer to the regulations and requirements that must be complied with while conducting a clinical study. These regulations apply to the manufacturers, sponsors, clinical investigators, institutional review boards, and the medical device. The primary regulations address the following important areas: Investigational Device Exemption (21CFR 812); Protection of Human Subjects (i.e., informed consent) (21CFR 50); Institutional Review Boards or IRB (21CFR 56); Clinical Investigators' Financial Disclosure (21CFR 54); Good Laboratory Practice or GLP for Nonclinical Laboratory Studies (21 CFR 58); and Design Controls of the Quality System Regulation (21CFR 820).
Peer-led, transformative learning approaches increase classroom engagement in care self-management classes during inpatient rehabilitation of individuals with spinal cord injury
Published in The Journal of Spinal Cord Medicine, 2019
Julie Gassaway, Michael L. Jones, W. Mark Sweatman, Tamara Young
Study Design. We used a multiple-baseline design, wherein the revised classes were introduced across three subject areas in step-wise fashion over successive weeks.22, 23 Commonly used in single-subject research, characteristics of this design include repeated baseline measurements and staggered introduction of the intervention across at least three behaviors (of a single participant), settings, or individuals. The multiple-baseline design can also be applied to groups of individuals or settings (such as classes) assuming the groups are independent, that is change in one group following introduction of an intervention does not carry over to other groups.24 The design controls for the effect of extraneous events (history) by showing that changes occur after and only after introduction of the intervention to each group.25 Data analysis of the design involves examining – visually and statistically – changes in the slope or level of the repeated measures taken before and after introduction of the intervention across each group. In this case, the classes for three subject areas – skin care, bladder management, and special concerns – were treated as groups. Over a 15-week period, the conventional classes for each of these subject areas were replaced with revised, peer-led classes. The order in which the revised classes were introduced across subject areas was determined randomly.
Current trends in PLGA based long-acting injectable products: The industry perspective
Published in Expert Opinion on Drug Delivery, 2022
Omkara Swami Muddineti, Abdelwahab Omri
Further, an important area of development of PLGA based LAI is focusing research on drug–device combination products such as syringes, auto-injectors, dual-chamber pens. This technology helps in reducing the complexity of dose preparation and administration and finally increases self-administration for patients. But, device design, performance testing, design controls, and human factors evaluations need specialized skills, and massive investment in manufacturing is required for tooling, filling, and assembly of the combination products. Consequently, generic competitors must pursue partnerships with design firms, suppliers, or contract manufacturers to successfully establish the field.
Biosynthetic alternatives for corneal transplant surgery
Published in Expert Review of Ophthalmology, 2020
May Griffith, Bijay Kumar Poudel, Kamal Malhotra, Naoufal Akla, Miguel González-Andrades, David Courtman, Victor Hu, Emilio I. Alarcon
Production of implants for clinical trials is heavily dependent upon the implant classification, whether it is a medical device, a biologic, or a medicinal product. This is briefly discussed in Section 6.2, and standards that need to be followed are in Section 6.3. A key component in device manufacturing is the early establishment of design controls and maintenance of these records throughout the development process. It is appreciated that even during the early clinical feasibility trials where the device may be modified to accommodate user preferences or clinical needs, nevertheless, appropriate verification and validation must be performed and documented during this process.