EP4 Conducting research
January 30, 2021
We cannot deny that, for many people, lives post-COVID-19 have changed significantly. Since the beginning of 2020, the public health sectors and a number of clinical research projects have also been affected by the COVID-19 outbreak amongst the research patients.
In this article, Oranee Tangphao, MD., who has been directly involved in many clinical studies in the global platform, offers her perspectives on how the COVID-19 pandemic is impacting current and future research.
Patients with underlying or chronic diseases are naturally subject to severe conditions or higher mortality rate. This is affecting ongoing studies as well as those that are just starting, and not just in Thailand but all over the world. The magnitude of the impact depends on how well each government handles the issue. Many countries have revised their clinical research approaches to better cope with the current situation. Both researchers and participating subjects need a new way to collaborate to minimize the impacts on their projects.
Developing knowledge workers is particularly crucial for the development of medical and research sectors in Thailand. The COVID-19 pandemic will unveil the true potential of each agency or country to adapt, develop, and manage crisis. Having patients partaking in the research is an important factor that will enable research advancement in Thailand and lead to future innovations.
Dr. Oranee explains the process of how an interested patient can participate in research projects in Thailand by following this checklist:
1. Eligible participants are those who have been diagnosed with a certain disease or condition which currently have no treatment but are being researched or undergoing a clinical trial.
2. The patient and their family are encouraged to look for more information to evaluate any potential risks associated with joining the program. If their physician cannot recommend any research project suitable for the patient, the patient can access a database to search for any relevant projects which are accepting participants with a particular disease.
3. The patient contacts the research team and inquires for more information. Once the patient understands and agrees to the terms and conditions, they sign the project participation agreement.
4. Once accepted into the program, the participant will receive a thorough health checkup and be monitored by the research team. Any data collected, which includes patient interview, health checkup results, and laboratory test results, will be stored and shared through the software called “ePRO” or Patient Report Outcome. The research team can then review the data from multiple sources to ensure thoroughness and transparency, while allowing the patient to respond promptly and accurately.
5. Once the research is completed, the patient can request copies of their personal data collected throughout the course of the study. The researchers can also feed their research findings directly into the database. Should the patient wish to continue their treatment with another physician, the patient’s data will be safely stored in the database and shared with the physician.
6. The research results will then be published with the conclusion of whether or not the treatment methodology used in the research is effective. Not all methods have proven to be successful but some findings may lead to forming another hypothesis and useful for future research.
Data Collection System
Research teams can store and share digital data using the Electronic Data Capturing System on the Cloud, so the team can collaborate on a project without having to be in the same physical location. This means that knowledge workers in Thailand will no longer need to station in a single location but will be able to access and share their information from anywhere as long as they have reliable internet connection.
At present, the patient’s data cannot be traced back to the patient, to protect their privacy. Such data check and management require a team of people with a range of knowledge and skills. This is an opportunity for young people who are interested in public health, computer science, database management, programming, data output design, and data audit fields to become part of the workforce. With this type of integrative data management system, Thailand would be able to advance considerably in healthcare services and clinical research.
Now we can see how we could turn this crisis into an opportunity to innovate and lead our country and humanity towards never-ending improvement.
Dr. Oranee Tangphao is an expert in clinical drug development. She holds an MD degree from the Faculty of Medicine, Chulalongkorn University, and trained in Internal Medicine. A recipient of the Anandamahidol Foundation scholarship for advanced education abroad, she received her Master’s degree from McMaster University, Canada. Dr. Oranee is Board Certified in Clinical Pharmacology (American Board of Clinical Pharmacology) through her training at Stanford University, where her main focus was on pharmaceutical product development. She is a former Assistant Professor at the Department of Pharmacology, Faculty of Medicine, Chulalongkorn University, and a clinical researcher at Stanford University. Over the last 20 years, Dr. Oranee has achieved multiple successes in her career in drug development and has taken on broader responsibilities. She currently holds the position of Chief Medical Officer at a startup in the US, and serves as a consultant for several public and private organizations in Thailand and the US. She is frequently invited to speak on developments in clinical medicines in both countries.
The “New Normal” of Clinical Studies
It’s not only our way of life that needs to change, it’s also the way we conduct research
The public health sector must continuously adapt. In the case of COVID-19, it is a balance between developing new research and supporting existing preventative systems. How should researchers and participating patients prepare and adapt to the “New Normal”? Dr. Oranee offers her advice on how to improve our research process to ensure smooth sailing through the pandemic.
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