Quality of clinical trials depends on data integrity and subject protection. Globalization, outsourcing and increasing complexicity of clinical trials have made the target of achieving global quality challenging. The quality, as judged by regulatory inspections of the investigator sites, sponsors/contract research organizations and Institutional Review Board, has been of concern to the US Food and Drug Administration, as there has been hardly any change in frequency and nature of common deficiencies. To meet the regulatory expectations, the sponsors need to improve quality by developing systems with specific standards for each clinical trial process. The quality systems include: personnel roles and responsibilities, training, policies and procedures, quality assurance and auditing, document management, record retention, and reporting and corrective and preventive action. With an objective to improve quality, the FDA has planned new inspection approaches such as risk-based inspections, surveillance inspections, real-time oversight, and audit of sponsor quality systems. The FDA has partnered with Duke University for Clinical Trials Transformation Initiative, which will conduct research projects on design principles, data quality and quantity including monitoring, study start-up, and adverse event reporting. These recent initiatives will go a long way in improving quality of clinical trials.

Pharmaceutical companies, over a period of time, have attempted to use innovative and modern technologies for quicker and more efficient methods of clinical data capture and analysis. In today's scenario, Electronic Data Capture (EDC) is considered to be the preferred technology that can provide significant benefits over existing manual methods. This article highlights the lacunae of the traditional data capture method and discusses the advantages of using EDC for better data quality, improved performance and productivity, and reduced cost in clinical trial management. It also emphasizes the need for IT infrastructure, training, and 21 CFR Part 11 compliance issues. The authors have also described the challenges to be faced by the investigators and sponsors in implementing EDC. Finally, the article concludes emphasizing the fact that EDC is the future mantra for the clinical trials and all stake holders should face challenges of infrastructure, technology, regulations, and training to make it a success.

Global pandemic of COVID-19 is a serious unmet medical need requiring clinical research into effective therapies. Clinical trials during pandemics of infections face complex challenges of putting scientific and ethical principles into practice. Some of these issues – selection of investigational product and participants, study design, assessment of efficacy and safety, ethics review, informed consent and publication, sample size, and publications – require in-depth consideration in planning and implementation of clinical trials during pandemics.

The International Council for Harmonisation (ICH) E6 – good clinical practice (GCP) (R2) addendum – was released in 2016 to encourage implementation of improved approaches for the management of clinical trials. The changes in different sections include new approaches – quality management system, risk-based monitoring with emphasis on human subject protection, and data integrity. The article discusses challenges in adoption and implementation of the changes in ICH GCP guideline for clinical trial stakeholders.

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