Epidemiological Survey on Gastrointestinal and Pulmonary Parasites in Cats Around Toulouse (France).

Various feline parasites are potentially zoonotic thus establishing factors associated with parasitism is of animal and public health interest. The aim of this study was to determine the prevalence of endoparasites in client-owned cats, living in the area of Toulouse, France, over the period 2015 - 2017, and to investigate possible risk factors. A total of 498 faecal samples from cats of the University Animal Hospital of Ecole Nationale Vétérinaire de Toulouse were analysed, 448 from cats presented for consultation and 50 at post-mortem. Analysis was performed using a commercial flotation enrichment method with a hypersaturated sodium chloride solution and Baermann technique. Further examination of the gastrointestinal tract contents was conducted on necropsied cats. Overall, 11.6 % of cats were positive for endoparasites; 50 (11.2 %) consultation cases and 8 (16 %) post-mortem cases, with no significant difference in prevalence between the groups. Amongst infected cats, most were infected by a single species of parasite and 10.3 % (n=6) were infected with two or more. The most common parasite was Toxocara cati with a prevalence of 9.4 % (n=47). Other endoparasites encountered were: Cystoisospora sp 1.0 % (n=5), Aelurostrongylus abstrusus 1.0 % (n=5), Strongyloides sp 0.6 % (n=3), Dipylidium caninum 0.4 % (n=2), Aonchotheca putorii 0.2 % (n=1), Ancylostomatidae 0.2 % (n=1) and Toxascaris leonina 0.2 % (n=1). The examination of the gastronintestinal tract contents of the necropsied cats revealed Mesocestoides sp 0.4 % (n=2) and Tænia (Hydatigera) tæniaeformis sensu lato 0.2 % (n=1) which are seldomly diagnosed by flotation methods. In this study, increasing age and neutered status were statistically associated with reduced odds of infection by endoparasites (helminth and coccidian). Predictors of significantly increased risk included being male, intact, and not receiving regular anthelmintic treatment. The same risk factors were highlighted specifically for Toxocara cati infections, with rural location being an additional risk factor for infection.

Do children and adolescents with type 1 diabetes suffer from a lack of resources in France? Results from a benchmark study in the New Aquitaine region.

BACKGROUND: A benchmark study was conducted in the southwest of France, in the New Aquitaine region, to investigate metabolic outcomes and availability of resources in pediatric diabetes units. We assessed whether the level of care was in accordance with the International Society for Pediatric and Adolescent Diabetes recommendations. METHODS: Demographic and clinical data were collected, as were all HbA1c tests for the 2017 calendar year. Pediatricians specialized in diabetes care were invited to complete an online survey concerning means allocated to the management of type 1 diabetes in their centers. RESULTS: Sixteen centers provided data for 1277 patients and 3873 clinical visits. A total of 1115 children suffering from diabetes for more than 1 year were studied. Median HbA1c was 8% (7.4-8.6) for the whole region. Only 29.2% of children had good metabolic control in accordance with the <7.5% target. We identified slight but significant variation in glycemic control among centers (P=0.029). The use of an insulin pump varied greatly among centers but did not explain HbA1c differences. We did not identify a correlation between medical or paramedical time dedicated to the follow-up of diabetic patients and the mean HbA1c of each center. For 100 diabetic patients, follow-up was provided by 0.42 physicians (0.23-1.50), 0.15 nurses (0-0.56), 0.12 dietitians (0-0.48), and 0.07 psychologists (0-0.30). CONCLUSION: This study demonstrates a lack of human resources allocated to the management of type 1 diabetes in the region that is far below international recommendations. The proportion of children achieving the international glycemic target is low. There is a clear need to improve glycemic control in children, which will only be possible with improved professional practices, encouraged by benchmark studies, and by increasing the size of our multidisciplinary teams.

Lung ultrasonography in patients with COVID-19: comparison with CT.

AIM: To determine whether findings from lung ultrasound and chest high-resolution computed tomography (HRCT) correlate when evaluating COVID-19 pulmonary involvement. MATERIALS AND METHODS: The present prospective single-centre study included consecutive symptomatic patients with reverse transcription polymerase chain reaction (RT-PCR)-proven COVID-19 who were not in the intensive care unit. All patients were assessed using HRCT and ultrasound of the lungs by distinct operators blinded to each other's findings. The number of areas (0-12) with B-lines and/or consolidations was evaluated using ultrasound and compared to the percentage and classification (absent or limited, <10%; moderate, 10-25%; extensive, 25-50%; severe, 50-75%; critical, >75%) of lung involvement on chest HRCT. RESULTS: Data were analysed for 21 patients with COVID-19 (median [range] age 65 [37-90] years, 76% male) and excellent correlation was found between the ultrasound score for B-lines and the classification (p<0.01) and percentage of lung involvement on chest HRCT (r=0.935, p<0.001). In addition, the ultrasound score correlated positively with supplemental oxygen therapy (r=0.45, p=0.041) and negatively with minimal oxygen saturation at ambient air (r=-0.652, p<0.01). CONCLUSION: The present study suggests that among COVID-19 patients, lung ultrasound and HRCT findings agree in quantifying lung involvement and oxygen parameters. In the context of the COVID-19 pandemic, lung ultrasound could be a relevant alternative to chest HRCT.

Stomoxys calcitrans, mechanical vector of virulent Besnoitia besnoiti from chronically infected cattle to susceptible rabbit.

Cattle besnoitiosis caused by Besnoitia besnoiti (Eucoccidiorida: Sarcocystidae) is a re-emerging disease in Europe. Its mechanical transmission by biting flies has not been investigated since the 1960s. The aim of this study was to re-examine the ability of Stomoxys calcitrans (Diptera: Muscidae) to transmit virulent B. besnoiti bradyzoites from chronically infected cows to susceptible rabbits. Three batches of 300 stable flies were allowed to take an interrupted bloodmeal on chronically infected cows, followed by an immediate bloodmeal on three rabbits (Group B). A control group of rabbits and a group exposed to the bites of non-infected S. calcitrans were included in the study. Blood quantitative polymerase chain reaction (qPCR) analyses, and clinical, serological and haematological surveys were performed in the three groups over 152 days until the rabbits were killed. Quantitative PCR analyses and histological examinations were performed in 24 tissue samples per rabbit. Only one rabbit in Group B exhibited clinical signs of the acute phase of besnoitiosis (hyperthermia, weight loss, regenerative anaemia and transient positive qPCR in blood) and was seroconverted. Parasite DNA was detected in four tissue samples from this rabbit, but no cysts were observed on histological examination. These findings indicate that S. calcitrans may act as a mechanical vector of B. besnoiti more efficiently than was previously considered.

The enantioselective addition of 1-fluoro-1-nitro(phenylsulfonyl)methane to isatin-derived ketimines.

An asymmetric organocatalytic addition of fluorinated phenylsulfonylnitromethane to isatin-derived ketimines was developed. The reaction was efficiently catalyzed by a chiral tertiary amine, cinchonine. This methodology provides a new type of optically active compound with two adjacent quaternary carbon stereocenters in good yield (up to 96%), with moderate diastereoselectivity (up to 5.7 : 1 dr) and excellent enantioselectivity (up to 98/96% ee).

A real-time PCR approach to identify anthelmintic-resistant nematodes in sheep farms.

Resistance to fenbendazole, ivermectin, and moxidectin was explored by a fecal egg count reduction test in four meat sheep flocks in southwestern France where anthelmintic resistance was suspected. The FECR test results of the present study confirmed the presence of benzimidazole resistance in three out of the four farms and the presence of ivermectin resistance in one flock. In addition, a suspicion of moxidectin resistance was shown in this latter farm. Both conventional morphological and molecular identifications were performed on larval cultures before and after the treatment in the studied farms. A high positive correlation was found between the number of larvae counted under binocular microscope and the number of larvae estimated by the qPCR analysis (R 2 = 0.88) and a high Cohen's Kappa value (0.91) in the detection of strongylid larvae in larval cultures. According to qPCR results, Trichostrongylus species demonstrated high levels of BZ resistance and Teladorsagia circumcincta was involved in the IVM resistance in one farm. The molecular procedures used in this study have the potential to be beneficial for anthelmintic resistance surveillance in sheep industry.

Does bovine besnoitiosis affect the sexual function of chronically infected bulls?

Bovine besnoitiosis is a reemerging disease in Europe. The clinically Besnoitia besnoiti infection in bulls is characterized by fever, nasal discharge, and orchitis in the acute phase and by scleroderma in the chronic phase. However, in many bulls, B besnoiti infection remains at a subclinical stage. Bull infertility is an economically relevant consequence of besnoitiosis infection. It is not clear, however, if semen quality returns to normal levels when infected animals have clinically recovered. The aim of this study was to examine the relationship between chronic besnoitiosis and bull sexual function in a region of eastern France, where the disease is reemerging, by comparing semen quality and genital lesions in 11 uninfected, 17 subclinically infected, and 12 clinically infected bulls. The presence of anti-B besnoiti antibodies was detected by Western blot test. Semen was collected by electroejaculation. Bulls clinically infected with B besnoiti showed significantly more genital tract alterations than uninfected or subclinically infected bulls. No relationship was evidenced between besnoitiosis infectious status and semen quality, whereas a significant relationship was noted between genital lesions and semen score. This means that in the absence of moderate to severe genital lesions, chronic bovine besnoitiosis is unlikely to alter semen quality. However, as the presence of infected animals could lead to spread of the disease, culling or separation of clinically infected bulls from the remaining healthy animals is strongly recommended.

Efficacy of a new combination of fipronil and permethrin (Effitix®) against Phlebotomus perniciosus in dogs.

Two controlled clinical trials were carried out to assess the anti-feeding and adulticidal effects of a spot-on combining fipronil and permethrin (Effitix(®), Virbac, Carros, France) against Phlebotomus perniciosus in dogs. The first study (Exp. A) was a dose-determination study in which 3 doses of permethrin (30 mg/kg, 60 mg/kg and 120 mg/kg) were compared. The second study (Exp. B) was an efficacy study using commercial dose of permethrin contained in Effitix(®) (the minimum dose of permethrin applied to dogs was 60 mg/kg). Twenty four and twelve Beagle dogs with equal sensitivity to sandflies were included in Exp. A and in Exp. B, respectively. Dogs were challenged with female sandflies (50 per dogs in Exp. A and 80 in Exp. B) for 60±5 min on Days - 7, 1, 7, 14, 21 and 28 (Day 0 being treatment day). Counts and engorgement determination of dead and alive sandflies were performed after each exposure to treated and untreated dogs. Dead sandflies were also counted 24 h after exposure. In Exp. A, the repellency induced by an administration of 30 mg/kg of permethrin to dogs was above 91% for the first two weeks and then dropped to 82.2, 83.1 and 81.1% on Days 14, 21 and 28, respectively. For dogs receiving 60 mg/kg of permethrin, the repellency was a bit higher with 95.8, 97.6, 92.1, 91.4, and 86.8%, for Days 1, 7, 14, 21 and 28, respectively. The repellency induced by 120 mg/kg of permethrin was significantly higher than that induced by 60 mg/kg of permethrin on Day 14 only. In Exp. B the anti-feeding effect of the spot-on formulation was 94.1, 97.8, 96.3, 90.8 and 87% on Days 1, 7, 14, 21 and 28, respectively. The mortality effect was 98.9, 99.1, 99.8, 97.0 and 89.7% on Days 1, 7, 14, 21 and 28, respectively. At each challenge point, the mortality and anti-feeding effects on sandflies were significantly different between control and treatment group (p<0.05). The results indicate that a monthly administration of this new combination of permethrin and fipronil could be used as an effective sandfly control strategy in dogs and therefore recommended for use in an integrated leishmaniosis prevention program.

No detection of Besnoitia besnoiti DNA in the semen of chronically infected bulls.

Bovine besnoitiosis is a chronic and debilitating disease observed in many European countries that may cause important economic losses in cattle. The recent widespread of the parasite in Europe had led the European Food Safety Authority to declare bovine besnoitiosis as a re-emerging disease in Europe. Many aspects of the epidemiology of bovine besnoitiosis such as the main routes of transmission are still unclear and need to be further studied. Among the different hypotheses, a sexual transmission has not yet been investigated. Therefore, the aim of this study was to evaluate the presence of Besnoitia besnoiti DNA in the semen of naturally infected bulls by using a highly sensitive method (real-time qPCR). Both pre-sperm and sperm fractions of 40 bulls, including seronegative (n = 11), seropositive subclinically (n = 17), and seropositive clinically (n = 12) infected animals, were collected by electroejaculation and analyzed by real-time qPCR. No B. besnoiti DNA was detected in 27 pre-sperm and 28 sperm fractions of the 40 examined bulls, suggesting that the transmission of B. besnoiti infection by the semen of chronically infected bulls is very unlikely.

Evaluation of spinosad for the oral treatment and control of flea infestations on cats in Europe.

METHODS: An ectoparasiticide containing spinosad was evaluated as an oral formulation for cats. Two European laboratory studies and a European multicentre field efficacy and safety study assessed the use of a chewable tablet formulation of spinosad at a dose range of 50-75 mg/kg for treatment and control of flea infestations on cats. RESULTS: The studies with experimentally infested cats consistently demonstrated persistent activity against Ctenocephalides felis with >98 per cent efficacy at four weeks post-treatment. In the field study with naturally infested client-owned cats from 18 clinics across Germany and Italy, two monthly doses of spinosad were administered; selamectin was the comparator product. Safety was evaluated in 226 cats, each receiving at least one dose of spinosad or selamectin; both products were well tolerated. 113 spinosad-treated cats and 71 selamectin-treated cats showed >97 per cent reductions in geometric mean flea counts within 14 days post-treatment and at 60 days post-treatment efficacy was >98 per cent in both groups. Analysis of success rates showed 96 per cent in spinosad-treated cats compared with 90.9 per cent in selamectin-treated cats at day 60. The spinosad tablets were successfully administered to over 98 percent of cats. These studies indicate that this formulation of spinosad is safe and efficacious for treatment and prevention of flea infestations in cats.

Efficacy of dinotefuran, permethrin and pyriproxyfen combination spot-on on dogs against Phlebotomus perniciosus and Ctenocephalides canis.

This study was conducted to evaluate the efficacy of a new topical ectoparasiticidal spot-on containing 4.95% dinotefuran (w/w), 36.08% permethrin (w/w) and 0.44% pyriproxyfen (w/w) (Vectra 3D, Ceva, Libourne, France) against Portuguese strain of Phlebotomus perniciosus and a French strain of Ctenocephalides canis in dogs. Twelve beagle dogs were exposed for 1 h to 100 P. perniciosus on day 6 for allocation in two groups. One group was treated on day 0, and the other group was the control group. The dogs were exposed for 1 h to 100 P. perniciosus on days 1, 7, 14, 21 and 28. After each sandfly challenge, the same dogs were infested with 100 C. canis. Counts of living fleas were determined 48 h after infestation on days 4, 3, 9, 16, 23 and 30. For sandflies, the anti-feeding effect was 96.9, 99.7, 98.7, 83.5 and 87.0 % on days 1, 7, 14, 21 and 28, respectively. The mortality effect was 97.8, 99.8, 73.7, 27.5 and 39.6% on days 1, 7, 14, 21 and 28, respectively. At each challenge point, the mortality and anti-feeding effects on sandflies were significantly different between the control and treatment groups (p < 0.05). The adulticidal effect on C. canis remained above 99% throughout the study period. The results indicate that a combination with dinotefuran, permethrin and pyriproxyfen may be used as an effective part of an overall flea and sandfly control strategy in dogs for monthly use.

Development of a protocol testing the ability of Stomoxys calcitrans (Linnaeus, 1758) (Diptera: Muscidae) to transmit Besnoitia besnoiti (Henry, 1913) (Apicomplexa: Sarcocystidae).

Cattle besnoitiosis due to the cyst-forming coccidian parasite Besnoitia besnoiti has recently been reported in expansion in Europe since the end of the twentieth century. The B. besnoiti life cycle and many epidemiological traits are still poorly known. Hematophagous flies, including the worldwide-distributed Stomoxys calcitrans, could be mechanical vectors in the contamination of mouthparts after the puncture of cutaneous cysts or ingestion of infected blood. In this study, a protocol is presented to assess more deeply the role of S. calcitrans, reared in laboratory conditions, in parasite transmission. A preliminary trial showed that stable flies could transmit tachyzoites from bovine artificially parasite-enriched blood to B. besnoiti-free blood using glass feeders. Evidence of transmission was provided by the detection of parasite DNA with Ct values ranging between 32 and 37 in the blood recipient. In a second time, a B. besnoiti-infected heifer harboring many cysts in its dermis was used as a donor of B. besnoiti. An interruption of the blood meal taken by 300 stable flies from this heifer was performed. Immediately after the blood meal was interrupted, they were transferred to a glass feeder containing B. besnoiti-free blood from a non-infected heifer. Quantitative PCR and modified direct fluorescence antibody test (dFAT) were used to detect B. besnoiti DNA and entire parasites, respectively, in the blood recipient, the mouthparts, and the gut contents of S. calcitrans at two time intervals: 1 and 24 h after the interrupted blood meal. Parasite DNA was detected at both time intervals (1 and 24 h) in all samples (blood recipient, mouthparts, and gut contents of stable flies) while entire parasites by dFAT were only found in the abdominal compartment 1 h after the interrupted blood meal. Then, S. calcitrans were able to carry B. besnoiti from chronically infected cattle to an artificial recipient in the conditions of the protocol.

Feeding and breeding aspects of Stomoxys calcitrans (Diptera: Muscidae) under laboratory conditions.

Bionomic aspects of Stomoxys calcitrans (Linnaeus, 1758) (Diptera: Muscidae) were studied under laboratory conditions. For this reason, laboratory-rearing techniques were optimized at the National Veterinary School of Toulouse. The colony was maintained at 25±2°C, 50±10% RH under a 12-hour light cycle and observed daily. The size of each adult cage is 30x30x30 cm and designed to house about 500-1,000 flies. The average cycle from egg to adult was 19.2±1.7 days. The mean longevity of imagos was 9.3±5.8 days and not significantly different between sexes. Stable flies were split into two groups; the first was fed with blood, honey and water, and the second was fed only with honey and water. The mean weight of a blood meal was 11.1±3.8 mg with no significant differences between males and females. The mean longevity of non-blood fed flies was found to be significantly higher (10.4±3.9 days) than those fed with blood. The maximum lifespan was shorter for non-blood fed males (17 days) and females (18 days) than for those fed with blood (females: 24 days, males: 23 days). Under these laboratory conditions, S. calcitrans rearing was successfully established. In the end, the number of expected generations of S. calcitrans and the net reproduction rate were estimated to be 11.8 generations/year and 16.2 living females per female respectively.

Efficacy of permethrin, dinotefuran and pyriproxyfen on adult fleas, flea eggs collection, and flea egg development following transplantation of mature female fleas (Ctenocephalides felis felis) from cats to dogs.

A novel spot-on formulation combining permethrin, pyriproxifen and dinotefuran (Vectra 3D™ spot-on solution for dogs) was evaluated in adult Beagle dogs in a study to determine adulticidal efficacy, egg laying inhibition and viability of Ctenocephalides felis felis eggs (development and emergence of fleas from the collected eggs). Prior to treatment sixteen dogs were checked for their ability to keep fleas 24 hours after infestation and were allocated to treatment groups: 8 dogs served as untreated controls, and 8 dogs were treated once with the tested formulation. The spot on was administered respecting the laboratory recommendations at a dosage of 65-126 mg/kg of permethrin; 8.9-17.4 mg/kg of dinotefuran and 0.8-1.5mg/kg of pyriproxyfen. Each dog was infested with 100 adult cat fleas ready to lay eggs after 72 hours spent feeding on cats. Dogs were infested 24 hours after treatment and then weekly during 63 days. Eggs were collected and counted 24 hours after each infestation and dogs were combed 48 hours after each infestation. Fleas were counted and removed. Collected eggs were placed in incubator to study their development in larvae and into newly emerged adults. A single treatment provided 99.7% adulticidal efficacy on fleas within 48 hours after treatment and controlled re-infestations for up to 30 days (efficacy >96.20%, p<0.05). The egg laying inhibition was over 92.3% for up to 29 days (p<0.05). The adult emergence inhibition remained 100% during 8 weeks after treatment and was 99.8% nine weeks after treatment (p<0.001).

PhRMA survey of pharmacogenomic and pharmacodynamic evaluations: what next?

Interindividual variation in pharmacodynamic (PD) response to drugs is an ongoing area of research for drugs in clinical development, pre- and postapproval. To characterize how pharmacogenomic (PG ) variations can serves a predictor of differences in PD outcomes, the pharmaceutical industry has incorporated PG /PD analysis into clinical drug development. The Pharmaceutical Research and Manufacturers of America (PhRMA ) and the Industry Pharmacogenomics Working Group (I-PWG) conducted a survey of 16 pharmaceutical companies to ascertain to what extent PG/PD research is being incorporated into drug development. The survey results showed that, while the industry has made some attempt to incorporate PG/PD studies into drug development, application has been inconsistent. Nevertheless, several valid PG/PD markers have since emerged in drug labels. The I-PWG considers PG/PD research an important approach to improving success rates in drug development. This article reports the results of the survey and proposes steps toward increasing the use of PG/PD research by the industry.

Defining the concept of 'tick repellency' in veterinary medicine.

Although widely used, the term repellency needs to be employed with care when applied to ticks and other periodic or permanent ectoparasites. Repellency has classically been used to describe the effects of a substance that causes a flying arthropod to make oriented movements away from its source. However, for crawling arthropods such as ticks, the term commonly subsumes a range of effects that include arthropod irritation and consequent avoiding or leaving the host, failing to attach, to bite, or to feed. The objective of the present article is to highlight the need for clarity, to propose consensus descriptions and methods for the evaluation of various effects on ticks caused by chemical substances.

Evaluation of spinosad for the oral treatment and control of flea infestations on dogs in Europe.

The novel ectoparasiticide spinosad is a naturally occurring mixture of spinosyns A and D formed during a fermentation process. The spinosyns are tetracyclic macrolides with a unique ring system. Their mode of action differs from that of other commercially available insecticides. Laboratory and field trials were conducted to evaluate the use of spinosad in a chewable tablet at a dose range of 45 to 70 mg/kg for the treatment and control of flea infestations on dogs in Europe. Laboratory studies with artificially infested dogs confirmed persistent activity against Ctenocephalides felis of higher than 99 per cent at three weeks post-treatment with values of 96.5 to 97.8 per cent at four weeks. Two multicentric field trials with naturally infected client-owned animals in five European countries used selamectin as comparator. Monthly doses were given during the summer when many homes were heavily infested. Households with spinosad-treated dogs showed cumulative benefits with flea burdens reduced by about 97 per cent at 14 and 30 days and by 99.6 per cent at 60 and 90 days. Corresponding figures for selamectin were significantly lower (P<0.05) at all time points: between 88.5 and 91 per cent at 14 and 30 days, then 97.8 and 98.2 per cent at 60 and 90 days. Thus, the performance of spinosad compared favourably with that of the established reference product.

Current practices for DNA sample collection and storage in the pharmaceutical industry, and potential areas for harmonization: perspective of the I-PWG.

Collection and storage of DNA samples in clinical drug development programs are an important investment for the pharmaceutical industry to allow efficient evaluation of observed variability in drug response. To enable collection and future use of samples, individual companies must define (i) processes to collect specimens worldwide, (ii) whether collection is optional or mandatory, (iii) conditions and duration of sample storage, (iv) whether research data can be returned to subjects, and (v) other logistical aspects. To determine current industry practices for collection and storage of these samples, the Industry Pharmacogenomics Working Group (I-PWG) conducted a survey of the industry (21 respondents) to identify areas of commonality and divergence. On the basis of the survey results, the I-PWG details areas of focus for harmonization of the industry's sample collection practices. A more unified approach would facilitate DNA sample collection, thereby contributing to the advancement of personalized medicine and more efficient development of safe and effective drugs.

Coding of DNA samples and data in the pharmaceutical industry: current practices and future directions--perspective of the I-PWG.

DNA samples collected in clinical trials and stored for future research are valuable to pharmaceutical drug development. Given the perceived higher risk associated with genetic research, industry has implemented complex coding methods for DNA. Following years of experience with these methods and with addressing questions from institutional review boards (IRBs), ethics committees (ECs) and health authorities, the industry has started reexamining the extent of the added value offered by these methods. With the goal of harmonization, the Industry Pharmacogenomics Working Group (I-PWG) conducted a survey to gain an understanding of company practices for DNA coding and to solicit opinions on their effectiveness at protecting privacy. The results of the survey and the limitations of the coding methods are described. The I-PWG recommends dialogue with key stakeholders regarding coding practices such that equal standards are applied to DNA and non-DNA samples. The I-PWG believes that industry standards for privacy protection should provide adequate safeguards for DNA and non-DNA samples/data and suggests a need for more universal standards for samples stored for future research.

Challenges in obtaining adequate genetic sample sets in clinical trials: the perspective of the industry pharmacogenomics working group.

Collection of DNA samples from subjects participating in clinical trials is vital to understanding variability in drug response. The purpose of this study was to assess pharmacogenetic sample-collection practices in the industry and to gather information on issues affecting collection. A survey questionnaire was developed and distributed to 20 pharmaceutical companies; 15 provided responses. Assessments included rate of DNA sample collection, reasons for low collection rates, reasons for rejection by health authorities (HAs) and institutional review boards/ethics committees (IRBs/ECs), and country-specific hurdles to sample collection. The results indicated that, although DNA samples are frequently collected, sample-acquisition rates remain lower than expected. Overall, the companies' experience has been that restrictions on sample usage are not consistently applied by regulatory bodies. This may reflect changing opinions/interpretations of HAs/IRBs/ECs. Collection of DNA samples in industry trials is still a challenge. Harmonization of sample-collection practices may facilitate the process.