Barriers in conducting clinical trials in oncology in the developing world: A cross‑sectional survey of oncologists.

BACKGROUND: Several obstacles impede oncologists from performing clinical trials in the developing world. This study aimed to identify these barriers in order of importance and suggest possible remedial measures. MATERIALS AND METHODS: Design – cross‑sectional survey. Two part questionnaire capturing experience of oncologists in practice and conducting trials (Part 1) and perceived barriers pertaining to investigator (training, time), patient (strict follow‑up protocol), infrastructure (funds) and professional environment (encouragement from seniors) (Part 2) were administered to oncologists in two different settings: (1) Online portal (Survey Monkey) (2) In person during a national conference (Best of American Society of Clinical Oncology). Responses were captured on a Likert scale (1–5). RESULTS: (436/3021) 14.04% responded. A total of 313 (71.8%) had experience in conducting trials, but these were mainly industry‑sponsored or small nonpractice changing studies. Lack of patient follow‑up was the most significant barrier (inter quartile range [IQR] 4–5) followed by inadequate training, time and funds (IQR 2–5) and lack of encouragement (IQR 2–4) in decreasing order of frequency. Lack of adequate training was a barrier across all specialties (113 [71.97%] radiation oncologists, 71 [60.68%] medical oncologists and 73 [71.56%] surgical oncologists). More than half of the respondents without experience in clinical trials worked in academic institutions (50.48%). They perceived time constraint as a barrier more than their counterparts into private practice (175/242 [72.31%] vs. 119/177 [66.47%] respectively). CONCLUSION: Inability to maintain patient follow‑up, lack of protected time and funds, inadequate training were the most significant barriers. Most of these can be addressed.

A prospective study for comparison of hematological parameters in healthy young adult and elderly age group subjects.

Aims & Objectives: This study of hematological parameters is the object of continuing intensive research of hematopoietic system to the functional integrity in aging. (1) Assessment of Hb, total RBC count in healthy young adult as well as in elderly subject.(2) Assessment of Hct & blood indices (MCV, MCH, MCHC) in healthy young adult as well as in elderly subject.(3) Comparing the values of Hb & total RBC count in healthy young adult with the elderly subject.(4) Comparing the values of Hct & blood indices (MCV, MCH, MCHC) in healthy young adult with the elderly subject.(5) To co-relate the results of present study with findings of other studies. Material & Methods: The hematological indices analysed were Hb, HCT, and Total RBC Count, Blood indices like MCV, MCH & MCHC. Hematological values were measured by the different method in laboratory with the use of standard test reagent. Results: In present study, the result shows that a significant decrease in Hb concentration and RBC count are associated with decrease in Hct, MCH, MCHC and little increase in MCV. Conclusion: In present study, the overall assessment shows that a significant decrease in Hb concentration, reticulocyte count and RBC count are associated with decrease in Hct, MCH, MCHC and little increase in MCV. These results show a significant decrease in haematological parameters in old age and fairly accurate reflection of decreased erythropoietic activity of bone marrow.

Deep vein thrombosis associated with osteomyelitis.

Three children developed deep vein thrombosis (DVT) along with osteomyelitis of the femur. Although DVT was recognized early, the diagnosis of associated osteomyelitis was delayed due to overlapping clinical signs and the absence of radiological changes in the initial X-rays.

Deciphering diversity in populations of various linguistic and ethnic affiliations of different geographical regions of India: analysis based on 15 microsatellite markers.

The extent of genetic polymorphism at fifteen autosomal microsatellite markers in 54 ethnically, linguistically and geographically diverse human populations of India was studied to decipher intrapopulation diversity. The parameters used to quantify intrapopulation diversity were average allele diversity, average heterozygosity, allele range (base pairs), and number of alleles. Multilocus genotype frequencies calculated for selected populations were utilized for testing conformity with the assumption of Hardy-Weinberg equilibrium. The exact test values, after Bonferroni correction, showed significant deviation amongst Gowda (vWA, Penta E); Dhangar, Satnami and Gounder (D8S1179); Hmar (FGA); Kuki and Balti (vWA) groups. Relatively low number of alleles and allelic diversity (base-pairs size) had been observed in populations of central India as compared with southern and northern regions of the country. The communities of Indo-Caucasoid ethnic origin and Indo-European linguistic family (Kshatriya of Uttar Pradesh) showed highest allelic diversity, as well as rare alleles, not reported in any other Indian populations. Analysis based on average heterozygosity was also found to be lowest among the populations of central India (0.729) and highest among the populations from north (0.777) and west (0.784) regions of the country, having Indo-Caucasoid ethnic origin and Austro-Asiatic linguistic affiliation. The maximum power of discrimination (85%-89%) had been observed at loci FGA, Penta E, D18S51 and D21S11, suggested high intrapopulation diversity in India. Genetic diversity revealed by STR markers was consistent with the known demographic histories of populations. Thus, the present study clearly demonstrated that the intrapopulation diversity is not only present at the national level, but also within smaller geographical regions of the country. This is the first attempt to understand the extent of diversity within populations of India at such a large scale at genomic level.

Hepatic and renal oxidative stress in acute toxicity of N-nitrosodiethylamine in rats.

Nitrosoamines such as N-nitrosodiethylamine (NDEA) produce oxidative stress due to generation of reactive oxygen species and may alter antioxidant defence system in the tissues. NDEA was administered ip as a single dose to rats in LD50 or in lower amounts and the animals were sacrificed after 0-48 hr of treatment. The results showed that lipid peroxidation in liver increased, however no significant increase in kidney LPO was observed after NDEA administration. Superoxide dismutase (SOD) and glutathione reductase (GSH-R) activity increased in liver, however, catalase (CAT) activity in liver was inhibited in NDEA treated rats. Kidney showed an increase in SOD activity after an initial decrease along with increase in GSH-R activity in NDEA treated rats. However, kidney CAT activity was not significantly altered in NDEA intoxicated rats. Serum transaminases, serum alkaline phosphatase blood urea nitrogen, serum creatinine and scrum proteins were elevated in NDEA treated rats. The results indicate NDEA-induced oxidative stress and alteration in antioxidant enzymes in liver and kidney to neutralise oxidative stress.

Is pseudophakic astigmatism a desirable goal?

PURPOSE: To determine whether pseudophakic astigmatism is a desirable goal, and if so, which one is better: against-the-rule (ATR) or with-the-rule (WTR). METHOD: Eyes were included only if they had an uncorrected vision > or = 6/18 and N/18. Three groups, of 40 patients each were evaluated: group 1, pseudophakes with neutral astigmatism; group 2, with ATR and group 3, with WTR astigmatism Unaided distance and near visual acuity was recorded. Statistical analysis was performed using the chi-square test for independence. RESULTS: Unaided distance vision of > or = 6/7.5 was achieved in 19 eyes (47.5%) of group 1 (neutral), 12 eyes (30%) in group 2 (ATR), and 5 eyes (12.5%) in group 3 (WTR) (p = 0.0133, significant). Unaided near vision of > or = N/9 was achieved in 17 eyes (42.5%) in group 1 (neutral), 34 eyes (85%) in group 2 (ATR), and 10 eyes (25%) in group 3 (WTR) (P < 0.001, significant). Group 1 (neutral) fared the best for unaided distance visual acuity. Group 2 (ATR) was better than in group 3 (WTR) for distant vision. Group 2 (ATR) fared the best for unaided near vision. CONCLUSION: ATR astigmatism could be a desirable goal after cataract extraction in selected populations because the largest proportion of these cases achieved good unaided near vision with acceptable distant vision.