Reasons for patient′s withdrawal from clinical trials of rheumatoid arthritis in India

Dabhade, Sangeeta; Pandit, Padmakar; Tiwari, Smita; Pandit, D; Chopra, Arvind

doi:10.4103/2319-2585.152144

Cited by 4 publications

(4 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Participant withdrawal affect the success of a study and hence any effectiveness of it. 23,24 The trends in haemoglobin recovery for both the supervised and the unsupervised arms were similar, so were the patterns of fever resolution for both the supervised and unsupervised arms consistent with findings from previous studies. [17][18][19] Limitations It should be noted that the sample size may have not been sufficiently powered in the study small difference.…”

Section: Discussionsupporting

confidence: 82%

Dihydroartemisinin-piperaquine for the routine treatment of uncomplicated malaria in Northern Ghana

et al. 2020

View full text Add to dashboard Cite

Background: Dihydroartemisinin-piperaquine is a first line treatment for uncomplicated malaria in Ghana. A facility-based study was undertaken to examine the effectiveness of the treatment in the routine health care system.Methods: The study was undertaken at the Navrongo demographic surveillance area. Patients presenting with acute febrile illness were enrolled after informed consented and confirmation by microscopy. Patients were randomized into supervised group who received treatment under direct observation and unsupervised group which had only the first treatment given under supervision. Treatment was according to bodyweight and 42 days follow-up was undertaken.Results: A total of 194 patients were enrolled; 54.1% were females and 51% had supervised treatment. The median age and weight were 6.7 years and 20.0 kg respectively. Mean baseline temperature, haemoglobin concentration and parasite density were, 37.6 oC, 11.1 g/dl and 11,098 parasites per microliter of blood respectively. Study completion rate was 93.3%, day 42 polymerase chain reaction-unadjusted adequate clinical and parasitological responses rate (ACPR) was 93.4% by evaluable and 87.1 % by intention-to-treat (ITT). The day 42 ACPR by evaluable was 92.3% in the supervised arm compared to 94.4% in the unsupervised arm. The day 42 ACPR by ITT was 85.7% in the supervised and 88.5% in the unsupervised arms. The fever resolution and haemoglobin concentration changes for the two arms were similar.Conclusions: The results show that dihydroartemisinin-piperaquine is effective and good first-line antimalarial in the routine health delivery system.

show abstract

Section: Discussionsupporting

confidence: 82%

Dihydroartemisinin-piperaquine for the routine treatment of uncomplicated malaria in Northern Ghana

et al. 2020

View full text Add to dashboard Cite

show abstract

“…Adherence rates in RA varies from 30-80% and they fall with the longer duration of treatment. 15,16 Patients in this study had a short duration of treatment and this may have lead to higher adherence rates.…”

Section: Discussionmentioning

confidence: 99%

Oral Methotrexate in split dose weekly versus oral or parenteral Methotrexate once weekly in Rheumatoid Arthritis: a short‐term study

et al. 2016

View full text Add to dashboard Cite

show abstract

“…A total of 27.5% of centers experience patients withdrawing consent, which is exceedingly high and has not been reported earlier from India. [11] We can only assume that the COVID-19 pandemic was the reason, even if that has not been disclosed formally. These data were generated when the global burden of COVID-19positive cases was just under 600,000.…”

Section: Discussionmentioning

confidence: 99%

Clinical Trials Facing “Serious Adverse Events” during the Ongoing COVID-19 Pandemic

Parikh

Mehta

Mvt³

et al. 2020

Indian Journal of Medical and Paediatric Oncology

View full text Add to dashboard Cite

Aims and Objectives: The ongoing COVID-19 pandemic is having a profound impact on the current clinical trials. We wanted to document the extent of the disruption amongst Indian clinical trial sites. Materials and Methods: We conducted an online survey among oncologists in India with active trials to document their experience with challenges and novel solutions. Results: A total of 60 oncologists replied of which 40 had ongoing trials with open recruitment. Majority of them had stopped screening (55%) and recruitment (62.5%). Almost half of the sites did not have adequate infrastructure (47.5%). Almost all the sites had enrolled patients worried about the impact of COVID-19 on their health outcome (up to 87.5%). The majority of sites had problems with adherence to study schedule of events (87.5%) and administration of study medication (42.5%). A total of 55% of the sites had provided the option of virtual visits. Both investigators (75%) and sponsors/contract research organizations (67.5%) had reached out to each other to maintain study integrity. More than half the centers had difficulty related to adverse events and serious adverse events (documentation and reporting; up to 75%). Discussion: Regulatory authorities in several countries have announced guidelines on the conduct of clinical trials during the COVID-19 pandemic. Whether the disruption lasts for a short or long time, its impact on clinical trials is going to be irreparable.

show abstract

Reasons for patient′s withdrawal from clinical trials of rheumatoid arthritis in India

Cited by 4 publications

References 0 publications

Dihydroartemisinin-piperaquine for the routine treatment of uncomplicated malaria in Northern Ghana

Dihydroartemisinin-piperaquine for the routine treatment of uncomplicated malaria in Northern Ghana

Oral Methotrexate in split dose weekly versus oral or parenteral Methotrexate once weekly in Rheumatoid Arthritis: a short‐term study

Clinical Trials Facing “Serious Adverse Events” during the Ongoing COVID-19 Pandemic

Contact Info

Product

Resources

About