Ten years of clinical trial registration in a resource‐limited setting: Experience of the Sri Lanka clinical trials registry

Ranawaka, Udaya K.; Abrew, Ashwini de; Wimalachandra, Manujasri; Samaranayake, NR; Goonaratna, Colvin

doi:10.1111/jebm.12284

Cited by 9 publications

(11 citation statements)

References 16 publications

(45 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Also, the financial support from the industry can influence publication bias, trial data, and authorship . Otherwise, Ranakawa et al describe that most RCTs registered in Sri Lanka Clinical Trials Registry were funded by researchers …”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Twenty‐two years’ experience registering trials in a low‐middle income country: The Peruvian Clinical Trial Registry

Alarcón-Ruiz

Roque‐Roque

Heredia

et al. 2019

J Evidence Based Medicine

View full text Add to dashboard Cite

Aim This study analyzes the quantitative and qualitative evolution of the Peruvian Clinical Trial Registry during the last 22 years. Methods Following a cross‐sectional design, we reviewed all clinical trials registered at the Peruvian Clinical Trial Registry during 1995‐2017. We downloaded and extracted all registries on 31 March 2018. We summarized qualitative variables and quantitative variables. Also, we performed trends analysis of the records by year, clinical phase, institutional review board, and children's participation. Results The Peruvian Clinical Trial Registry recorded 1748 clinical trials during 1995‐2017. Considering World Health Organization 20‐standard descriptors as the standard, the registry suitably recorded four of them in 1995 and 19 since 2013. There was a meaningful change in the trend of the registries, showing a significant upward registry trend until 2008 and a significant downward registry trend since then. This trend could be influenced by new regulation in clinical trials registry. Several trials had incomplete entries for different studied variables. Most of the clinical trials (82%) included male and female participants, and only 14% included children. Oncological disorders were the diseases most frequently investigated (20%). Most of clinical trials were registered by pharmaceutical companies. A few institutional review boards evaluated most of the clinical trials. Conclusion The registration of clinical trials in Peru has improved quantitatively and qualitatively since it started, but its quantitative grow stopped in 2008. Since then, the number of registries has declined steadily. There is an influence of pharmaceutical companies in clinical trial registration.

show abstract

Section: Discussionmentioning

confidence: 99%

“…Trials Registry were funded by researchers. 27 Additionally, the influence of pharmaceutical industry could affect the diseases that most study. Most RCTs registered in REPEC were from oncology, infectology, rheumatology, pneumology, and endocrinology specialty.…”

Section: Ranakawa Et Al Describe That Most Rcts Registered In Sri Lanmentioning

confidence: 99%

Twenty‐two years’ experience registering trials in a low‐middle income country: The Peruvian Clinical Trial Registry

Alarcón-Ruiz

Roque‐Roque

Heredia

et al. 2019

J Evidence Based Medicine

View full text Add to dashboard Cite

show abstract

“…The SLCTR was established in 2006 and is a Primary Registry of the WHO–ICTRP Registry Network . It has completed ten years of existence as the national clinical trials registry in Sri Lanka . Over the years, it has taken several steps to inform the Sri Lankan scientific and clinical community on the need for clinical trial registration and the availability of the SLCTR as a national platform to facilitate this.…”

Section: Discussionmentioning

confidence: 99%

Awareness of clinical trial registration among healthcare professionals: An observational study

Ranawaka

Abrew

Wimalachandra

et al. 2018

J Evidence Based Medicine

Self Cite

View full text Add to dashboard Cite

Aim: Prospective registration in a freely accessible public platform is a key step in the ethical conduct of clinical trials. Little is known of the awareness of clinical trial registration among the scientific community. This study aimed to assess awareness of clinical trial registration among participants attending a medical congress in Sri Lanka.Methods: Knowledge of trial registration was assessed using a self-administered questionnaire, which spanned domains such as involvement in research, and knowledge and perceptions regarding trial registration. A knowledge score was calculated and correlated with demographic variables.Results: Of 251 survey respondents, 53.4% were male, 74.9% were below the age of 40 years, and 56.6% were currently engaged in research. Registration was considered necessary for trial publication by 73.3%, and 70.5% agreed that trials should be registered prospectively. Most achieved a knowledge score of 'Acceptable' (41%) or 'Good' (19.9%). Mid-or advanced career stages, postgraduate training, current involvement in research, and recent research publications/presentations were correlated with higher knowledge scores (P < 0.05). Beneficial effects considered to be associated with trial registration were access to findings of all trials (61.4%), access to negative results (47.8%), preventing trial duplication (69.3%), and preventing multiple publications (70.1%). Increasing research workload (49.8%), additional restrictions on research conduct (52.2%), and the possibility of 'intellectual theft' (56.2%) were seen as potential negative effects. Conclusions:Most participants were aware of the need for prospective registration as a requirement for publication of clinical trials. Concerns were expressed regarding several perceived negative effects of trial registration. K E Y W O R D Sawareness, biomedical research, clinical trials, registries, Sri Lanka

show abstract

“…e SLCTR statistics also showed that out of 210 trials, 164 included male and female participants, whereas 43 trials were conducted on females only and three trials on males only. [10] In the past 10 years, diabetes (including gestation) made up for more than 14% of registered trials and was the most researched therapeutic area. is was followed by pregnancy and its outcomes (12.4%) and infections/ infestations (7.14%).…”

Section: Introductionmentioning

confidence: 99%

“…[10] Over one-third of the registered trials (37.1%) had completed recruitment according to SLCTR statistics over the past 10 years. [10] Most of the principal investigators were affiliated to either a local or foreign university, while 19% were affiliated to a hospital and 6.2% were affiliated to institutions of the Ministry of Health. Only 1.4% of trials were directly affiliated with the pharmaceutical industry.…”

Section: Introductionmentioning

confidence: 99%

Clinical trials landscape in Sri Lanka

Wijesinghe¹,

Dahanayaka²,

Jeevaraja³

et al. 2021

IJMIO

View full text Add to dashboard Cite

Sri Lanka is an ideal destination for the global clinical trial industry due to its favorable national policies, growing economy, and rapid digitalization directly influencing the increasing global market size of clinical trials. Its comprehensive primary health care coverage, educated population, free standard of care, non-communicable disease burden equals to western countries, qualified medical practitioners, and a core of competent and committed clinical researchers combined with its population’s proficiency in English also make this South Asian nation a potentially excellent regional clinical trials destination. Making an environment favorable to research partnership while guaranteeing the safe and ethical conduct of clinical trials has been a repetitive subject for conversation and discussion in the nation. A robust regulatory framework and ethical reviewing process have minimized legal loopholes ensuring the rights, safety, and well-being of trial participants that are protected. The Sri Lanka Clinical Trials Registry is a non-revenue driven registry and it can be considered a key stimulus to the ongoing discussions on clinical trials in Sri Lanka. Moreover, the adoption of new technology in clinical research and the rise of the pharmaceutical industry encourages and creates opportunities for more clinical trials to be conducted in Sri Lanka which, in turn, influences the growth of the industry.

show abstract

Ten years of clinical trial registration in a resource‐limited setting: Experience of the Sri Lanka clinical trials registry

Abstract: There is a steady increase in the number of trials registered at the SLCTR. Complete entries for all the data fields were seen in all trial registrations. The SLCTR has made a positive contribution to the emergence of a healthy clinical research environment in Sri Lanka.

Cited by 9 publications

References 16 publications

Twenty‐two years’ experience registering trials in a low‐middle income country: The Peruvian Clinical Trial Registry

Twenty‐two years’ experience registering trials in a low‐middle income country: The Peruvian Clinical Trial Registry

Awareness of clinical trial registration among healthcare professionals: An observational study

Clinical trials landscape in Sri Lanka

Contact Info

Product

Resources

About