The association worked closely with the Taiwan Food and Drug Administration (TFDA) to discuss issues related to Decentralized Clinical Trials (DCT), including meetings "Digitalization Guidelines for Drug Clinical Trials" on March 20, "Guidelines for the Implemention Decentralized Clinical Trials with medical drugs" on May 22, and "Guidelines for Remote Data Collection in Drug Clinical Trials Using Digital Health Technologies" and "Guidelines for the Application of Computerized Systems and Electronic Data in Drug Clinical Trials" on September 27. On June 12, the TFDA announced "Guidelines for Implementing Decentralized Clinical Trials", making Taiwan the first Asian country to publish DCT guidelines!
Continuous dialogue with the Taiwan Food and Drug Administration (TFDA) on "Clinical Research Associate (CRA) Functional Excellence Training Guidelines" and actively participated in the Clinical drug trials practitioners functional excellence enhancement workshop from November 3 to November 4, offering industry views and constructive suggestions, working together to enhance Taiwan's soft power in clinical trials.
Continuing the focus since the 2021 "Clinical Trials Consensus Symposium- Drive for the Future, Together", discussions with the Taiwan Food and Drug Administration (TFDA) from 2022 to 2023 covered the international practices of intention platforms and topics related to "New Drug Clinical Trials and Participant Intention Registration" and "Participant Intention Registration Platform Setup Discussion Meeting" for Taiwan's clinical trial environment, aiming to make clinical trial information more accessible to the public, facilitating their expression of willingness to participate, and searching for suitable clinical trials.
Regarding the current status of domestic clinical trials, the association provided the Taiwan Food and Drug Administration (TFDA) with numerous suggestions to optimize the processes and accelerate the study start-up phase. Additionally, discussions were held with the Department of Health and Welfare's Technology Section, the TFDA, and the Center for Drug Evaluation (CDE) on trial hospital-related issues, offering proactive suggestions to improve the current challenges of clinical trials in Taiwan and enhance international competitiveness.
April 26th., May 10 th., May 24 th., May 31 th., June 7 th., and June 14 th. Based on the enthusiastic response from the lectures held at Taipei Municipal Zhongshan Girls High School (TMZGHS) in 2022, TMZGHS invited the TCRA EDU taskforce conducted a micro-course "FUN Study! The Unknowns of Clinical Trials". Throughout a series of six weeks of lively and interactive sessions, the spirit and essence of clinical trials was promoted, providing high school students with more options for their future and sowing the seeds for future clinical trial talent development.
May 20th. The TCRA launched its Instagram account, TCRA_IG, using different social media platforms to promote clinical trial information with lively and straightforward text and illustrations, making clinical trials more understandable and accessible to different age groups.
August 1st. Clinical trial professionals training- ‘GMP Training & Clinical Supply Workshop’.
September 4th. Discussions were held with the Health and Welfare Ministry's Technology Division, the Taiwan Food and Drug Administration (TFDA), and the Center for Drug Evaluation (CDE) on the topic of "Domestic Clinical Trial Status Discussion Meeting: Issues Related to Trial Hospitals". The meeting focused on in-depth discussions of current difficulties experienced by the industry and proposed suitable solutions. It aimed to accelerate the initiation of clinical trials in Taiwan.
October 2nd. The "Public Area" of the TCRA official website went live. Designed from the perspective of the public, it offers a journey throughout clinical trials, containing links to related clinical trial websites, common questions and video about clinical trials, and so on. This installation ensures the TCRA website is not only for industry professionals but also plays a greater social role, giving the public direct or indirect access to the clinical trial information they need.
October 16th. Clinical trial professionals training- ‘Issue Management Workshop‘.
November 29th. Inspired by the origin of clinical trials: the treatment of scurvy with lemons and oranges, the BTT Taskforce conceptualized and designed mascots representing the TCRA - the Lemon Parrot (Amon) and the Orange Peel Civet (Ding Ding)! The goal is to use mascots to improve event promotion and make events more approachable. This will help strengthen the image and awareness of the TCRA association, as well as enhance the impact of clinical trial outreach efforts.
Continuing the focus from the 2021 "Clinical Trials Consensus Symposium- Drive for the Future, Together", starting from January 27th, the Taiwan Food and Drug Administration (TFDA) began a series of discussions of the feasibility of a new norm in clinical trials—Direct to Patient-IP—. The TCRA participated in several meetings on Decentralized Clinical Trials (DCT) related topics, including expert meetings on "Clinical Trial Computerized Systems and Electronic Data" on September 29, The TCRA cooperated with the TFDA to create guidelines suitable for Taiwan's clinical trials environment.
The TCRA had proactive discussions regarding the enhancement of the Clinical Research Associate (CRA) professional excellence with the Taiwan Food and Drug Administration (TFDA), sharing practices from Europe, America, and other Asian countries. Collaboratively, with the Taiwan Association for Institutional Review Boards (TAIRB) and the International Research-Based Pharmaceutical Manufacturers Association (IRPMA), a CRA professional excellence enhancement plan was drafted for TFDA’s consideration.
January 12th. Established Branding TCRA Taskforce (BTT) aiming to involve the association more actively in international and domestic clinical trial matters, enhancing its influence and social responsibility to promote Taiwan's competitiveness and globalization in clinical trials.
May 20th. The TCRA launched its Facebook account, TCRA.FB, to bring clinical trials closer to the general public through accessible article and illustrations, making it easier for the general public to understand information related to clinical trials.
August 24th. In cooperation with the Taiwan Association for Institutional Review Boards (TAIRB), the “Good Submission Workshop” was held to clearly define the responsibilities of relevant personnels and discuss common issues. By understanding both parties; positions and challenges, better recommendations were made to improve the quality of IRB submission and optimize the submission process, and implementing an optimization plan together.
October 13th.-14th. Clinical trial professionals training- ‘Monitoring Hands-on Workshop’.
October 26th. Co-hosted with Taipei Municipal Zhongshan Girls High School for the first high school campus talk, continued to promote clinical trials knowledge to the senior high school students.
November 25th. Implemented electronic election. Completed the 8th Board of Directors and Supervisors election via electronic voting.
October 27th. Campus talk (Clinical Trials Master Your Career) at Fu Jen Catholic University.
October 19th. Hosted ‘Clinical Trials Consensus Symposium- Drive for the Future, Together’. The meeting took 6 months to prepare, had 14 pre-meetings with the representatives across government, hospitals and institutions, and formed a working group with members from three host associations. Representatives from various sectors participated on the day of the meeting, 30 joined in person and 60 joined online. Consensus on the three topics (Excellence in IRB review; New Normal- through the pandemic and beyond; Patient Access) was reached successfully. An advice proposal is available for the participating sectors as reference for advocacy and implementation moving forward.
October 7th.-8th. Clinical trial professionals training- ‘Monitoring Hands-on Workshop’.
June 10th. Drove for approval from Central Epidemic Command Center to prioritize COVID-19 vaccination for front line clinical trial professionals, while coordinate with institutions to expedite vaccine administration. This is to ensure accurate clinical trial conduct according to the protocols, and to protect subject safety and well-being.
Special thanks to assistance from the government, as well as to Shuang Ho Hospital Clinical Trials Center (CTC), Hualien Tzu Chi Hospital CTC, Taipei Veterans General Hospital, National Taiwan University Hospital and National Cheng Kung University Hospital for creating COVID-19 vaccination name list for front line clinical trial professionals.
May 19th. Successfully enrolled in the participant list of a joint conference between the Taiwan Food and Drug Administration Pharmaceutical Sector and the Pharmaceutical associations. Communicated with pertinent government sectors proactively to work towards a better clinical trial environment in Taiwan.
December 23rd. Visited Yueh-Ping Liu, Director of Ministry of Health and Welfare, to discuss topics including ’not limit clinical trials subsequent submission reviews to the original group of reviewers’, ‘execution of ICH E6R2 GCP in practice ‘, ‘Suggestions and Principles for the Implementation of Drug Clinical Trials during the Prevention of Severe Pneumonia with Novel Pathogens (COVID-19)’, ‘increase opportunities for subjects to participate in clinical trials’. The Director recommended scheduling a consensus meeting in the coming year in order to achieve agreement among various parties and aid in future implementation.
This visit created the opportunity for the ‘Clinical Trials- Drive for the Future, Together’ meeting in 2021, co-hosted by TCRA, Taiwan Association of IRBs (TAIRB) and International Research-Based Pharmaceutical Manufacturers Association (IRPMA), where the government, the medical professional and the pharmaceutical industry were also invited to take part in.
November 23rd. Established ‘TCRA Director, Supervisor and working group member guideline’ and create On-boarding Training, in order to define role and responsibilities, to enable clear communication and efficient operation.
November 17th. Campus talk (Clinical Trials Master Your Career) at National Tsing Hua University.
November 3rd. Public health education at Shuang Ho Hospital.
October 21st. Updated official website, implemented electronic process such as meeting admission and electronic financial process. This upgrade to the website enhanced its convenience of use and efficiency, and it's at the same time, energy saving, carbon reduction, earth loving.
September 3rd.-4th. Clinical trial professionals training- ‘Monitoring Hands-on Workshop’.
August 7th. Resumed periodic conversation with Taiwan Association of IRBs (TAIRB), discuss current clinical trial environment issues with TAIRB on a continuous basis, around every 3 months.
Added Growth & Learn Session to the Directors and Supervisors meetings, for the Directors and Supervisors to not only work together but grow together as well.
August 2nd. Public health education at Taipei Veterans General Hospital.
June 25th. Clinical trial professionals training- ‘Issue Management Workshop’.
June 5th. Campus talk (Clinical Trials Master Your Career) at National Yang-Ming University.
May 29th. Campus talk (Clinical Trials Master Your Career) at National Taiwan University.
November 9th. Clinical trial professionals training- ‘Issue Management Workshop’.
September 7th. Public health education at Hualien Tzu Chi Hospital.
August 16th. Clinical trial professionals training- ‘GMP Training & Clinical Supply Workshop’.
Proactively drove the initiative of standardizing IRB submission forms and supporting documents, and an absolute paperless submission process.
Supported the Ministry of Health and Welfare and the Taiwan Food and Drug Administration to include the following items at the Medical Affairs and Pharmaceutical Affairs joint meeting on August 15th:
1. Include IRB review efficiency as part of hospital accreditation for Medical Centers.
2. Plan to invite relevant Medical Centers to comment on Multiregional Clinical Trial (MRCT) review process.
3. Introduce a template for IRB submission form and include it in the IRB checkup agenda.
4. Set up electronic system for submission in order to increase clinical trial submission review efficiency and advance Taiwan’s overall competitiveness internationally.
September 21st. Public health education at Taipei Municipal Wanfang Hospital.
August 17th. Clinical trial professionals training- ‘GMP Training & Clinical Supply Workshop’.
July 26th. Public health education at China Medical University Hospital.
April 26th. Public health education at Taipei Veterans General Hospital.
December 12th. Public health education at Kaohsiung Medical University Chung-Ho Memorial Hospital.
June 15th. Public health education at Chang Gung Medical Hospital, Linkou.
June 14th. Clinical trial professionals training- ‘GMP Training & Clinical Supply Workshop’.
April 13th. Public health education at National Cheng Kung University Hospital.
March 31st. Publish TCRA new logo. This aided in branding the association on its advocacy moving forward.
October 14th. Public health education at National Taiwan University Hospital.
Built ‘EMR System Survey Form’. This was to aid in understanding and recording electronic chart systems at each institution, in turn this would save manpower and time for both the institution and the pharmaceutical company.
October 9th. ‘ Electronic Medical Record for Clinical Trial Workshop ’
June 6th. Clinical trial professionals training- ‘GMP Training & Clinical Supply Workshop’.
Established ‘Taskforce’: Divides the work and work in teams to better focus and advocate for clinical trial related matters. Hopes to enhance our abilities in clinical trial conduct through the participation and collaboration from each member companies. As well as maintain positive interaction and communication with organizations such as relevant competent authorities, institutions and other associations.
August 10th. Hosted ‘EMR Workshop’. Special thanks to Ministry of Health and Welfare, Taiwan Food and Drug Administration, National Taiwan University Hospital, Chang Gung Memorial Hospital, Chung Shan Medical University Hospital, Chi Mei Hospital, Yonglin HealthCare Foundation in joining this event to drive the usage of electronic medical record.
November 4th. Launched TCRA official website www.tcra-org.tw
July 31st. Established Taiwan Clinical Research Association, TCRA.
Goal is to advance clinical research environment and new drug development in Taiwan, to enhance clinical trial quality and standards, and to align with the world. This was the first nonprofit organization comprised of a full range of companies with different interests that conduct clinical trials.
October 13th. Established Medical Affairs Association, MAA, predecessor of TCRA.
Goal was to enhance clinical trial quality and standards by academic interactions and experience sharing, to represent member companies to communicate and resolve clinical trial conduct issues with collaborating organizations, to look out for member company rights and assist in growth among members.