Globally, clinical research is the foundation for developing and testing new drugs and vaccines. Because of the high disease burden in India, a well-established clinical research setup is imperative to improve health outcomes.
Currently, only a handful of institutions actively involved in clinical research in India have access to tools and technologies that help to navigate the country’s complex and ever-evolving regulatory, ethical, and legal frameworks. In addition, the present processes are very time-consuming and paper-driven.
Helping clinical researchers save time and effort
To strengthen clinical research through better use of technology, PATH and FERCI (Forum for Ethics Review Committees in India) developed the CReATE software suite. The suite consists of five cloud-based solutions and is part of the Clinical Development Training Program, which is funded by the Bill & Melinda Gates Foundation.
The CReATE software suite was developed to address concerns regarding setting up and running clinical research faced by researchers and institutional ethics committees in India. One concern is inappropriate translations—there is no standard dictionary to translate complex medical research terminology into Indian languages. Another is the absence of any exhaustive glossary for commonly used medical terms. Both can lead to difficulty in preparing easy-to-understand informed consent documents. Another area of concern is inadequate research proposals because a researcher is unsure whether their protocol and informed consent document is ethically sound or not. In addition, the culture of paper-based submissions to ethics committees leads to issues with accurate tracking of the status of submissions and managing the high paper burden due to multiple prints of the bulky documents. Finally, the frequently changing regulations make it difficult for researchers to remain updated on changes in processes and regulations.
CReATE software suite: cloud-based software solutions
To address such concerns, the CReATE software suite includes the following five solutions:
- Interpreter is a searchable electronic database that contains commonly used terms in clinical research, which are translated into vernacular Indian languages for inclusion in informed consent documents. The database helps reduce errors during translations.
- Simplifier is a searchable electronic database of an exhaustive glossary with easy-to-understand definitions of commonly used terms in clinical research for inclusion in informed consent documents.
- CheckEthix is a software solution to assess the ethical soundness of study protocols and informed consent documents. It serves as a screening tool to potentially decrease the workload of ethics committees, and it helps researchers to self-score protocols for ethical soundness before submission.
- e-EC is an online document management system for efficient and paperless functioning of ethics committees. It provides a platform for investigators and ethics committee members to submit studies, conduct ethics reviews, communicate, and view online tracking in real time.
- Regulert is a software solution to monitor updates from different regulatory agencies involved in clinical research. This software helps researchers keep abreast of the latest global developments in the area of ethics in clinical research.
A robust process was followed to develop, test, and validate all five software tools. Following development, each tool was validated by experts through extensive testing. A third-party information technology firm also tested the solutions for data security and stability by identifying vulnerabilities and providing suggestions to address them.
The CReATE software suite is currently free of cost and can be accessed from anywhere in the world through a web-based interface.
Recently, Dr. Soumya Swaminathan, deputy director at the World Health Organization (then director general of the Indian Council of Medical Research with the government of India), released the CReATE software suite at an international conference in New Delhi, attended by about 400 participants from 19 countries.
As a result of the launch, there is significant interest from the clinical research community in adapting and using the tools in their respective countries. I expect in the near future there will be increased usage of some of these cloud-based solutions by researchers globally.
Several new initiatives are being taken up to improve the usability, intuitiveness, and overall user experience for seamless implementation of these solutions. For example, new regional languages are being included in the Interpreter tool, the glossary is being increased in Simplifier, more study designs are being added to Checkethix, and training and education materials are in development.
The CReATE software suite has come at a time when the Indian government is prioritizing the highest ethical and scientific standards in clinical research with the long-term vision of improving health and reducing India’s disease burden. The next step would be to increase the adoption of these software solutions by researchers and ethics committees so that they can help clinical researchers and thereby play a small role in fast-tracking the development of critical drugs and vaccines that can have global public health impact. Find out more about each solution in the CReATE software suite.
- Varun Sharma is the team leader of the PATH’s clinical development training project in India.