ABSTRACT
While high risk of failure is an inherent part of developing innovative therapies, it can be reduced by adherence to evidence-based rigorous research practices. Supported through the European Union's Innovative Medicines Initiative, the EQIPD consortium has developed a novel preclinical research quality system that can be applied in both public and private sectors and is free for anyone to use. The EQIPD Quality System was designed to be suited to boost innovation by ensuring the generation of robust and reliable preclinical data while being lean, effective and not becoming a burden that could negatively impact the freedom to explore scientific questions. EQIPD defines research quality as the extent to which research data are fit for their intended use. Fitness, in this context, is defined by the stakeholders, who are the scientists directly involved in the research, but also their funders, sponsors, publishers, research tool manufacturers, and collaboration partners such as peers in a multi-site research project. The essence of the EQIPD Quality System is the set of 18 core requirements that can be addressed flexibly, according to user-specific needs and following a user-defined trajectory. The EQIPD Quality System proposes guidance on expectations for quality-related measures, defines criteria for adequate processes (i.e. performance standards) and provides examples of how such measures can be developed and implemented. However, it does not prescribe any pre-determined solutions. EQIPD has also developed tools (for optional use) to support users in implementing the system and assessment services for those research units that successfully implement the quality system and seek formal accreditation. Building upon the feedback from users and continuous improvement, a sustainable EQIPD Quality System will ultimately serve the entire community of scientists conducting non-regulated preclinical research, by helping them generate reliable data that are fit for their intended use.
Subject(s)
Biomedical Research/standards , Drug Evaluation, Preclinical/standards , Research Design/standards , Cooperative Behavior , Data Accuracy , Diffusion of Innovation , Europe , Humans , Interdisciplinary Communication , Quality Control , Quality Improvement , Stakeholder ParticipationABSTRACT
Gerbils subjected to global ischemia or sham-ischemia received electro-acupuncture (EA) or sham EA at points 26 Du (Renzhong) and 8 Du (Junsuo). All animals were then tested for motor activity in an open field, and for spontaneous alternation in a T maze. Results show that EA alone did not affect any behavioral parameter. Ischemia alone increased motor activity without significantly interfering with spontaneous alternation. EA in ischemic gerbils potentiated the increase of motor activity and elicited a decrease in spontaneous alternation. Thus, our data show an interaction between global ischemia and EA applied at specific acupoints which, however, consists of a potentiation rather than an alleviation of the behavioral alterations consecutive to the ischemic insult.
Subject(s)
Electroacupuncture , Ischemic Attack, Transient/physiopathology , Ischemic Attack, Transient/therapy , Maze Learning , Motor Activity , Spatial Behavior , Analysis of Variance , Animals , Disease Models, Animal , Gerbillinae , MaleABSTRACT
Latent inhibition (LI) consists of decreased associative strength between an elemental stimulus (CS: tone) paired with an unconditioned stimulus (US: footshock) following non-reinforced pre-exposure to the tone. In view of the differences shown by C57BL/6 (C57) and DBA/2 (DBA) mice in processing elemental vs. configural stimuli, the present experiments were designed (1) to assess whether these differences were likely to interfere with the capability of each strain to show LI, and (2) to verify the extent to which lesions of the nucleus accumbens, which have been reported to enhance attention towards contextual stimuli under certain conditions, might interfere with the development of LI. C57 and DBA mice with Nacc or sham lesions were given two periods (4 or 7 days) of pre-exposure to a CS (tone) then subjected to two CS-US pairings given on a single day. On the day after, freezing to the tone was examined in each group. Results show that, following the shorter period of pre-exposure, LI developed in sham-lesioned DBA but did not in sham-lesioned C57. Nacc lesions, however, were found (1) to block LI in DBA but (2) to promote LI in C57. After the longer period of pre-exposure LI was observed in both strain and lesion conditions. In general, these results confirm that strain differences in processing the tone as a single elemental cue (DBA) or, alternatively, as a part of a contextual configural stimulus (C57) can interfere with the development of LI. In addition, they indicate that Nacc lesions, that are susceptible to increase attention to the background, might modify the salience of the tone and produce opposite effect on LI according to the strain specialisation to show elemental or configural responding.