The U.S. Food and Drug Administration (FDA) held a Clinical Investigator Training Course or the CITC last month (12/7-8/2021). This course has been conducted for over ten years. It usually takes place in person, but the COVID-19 pandemic has first pushed the FDA to postpone it and later to provide it virtually due to on-going concerns with public health. (1) The course was delivered online in a novel way, which shows how FDA is adapting to the new situations that present challenges and obstacles for investigators and regulatory bodies.
The 2021 course was mainly focused on topics like COVID-19 (medical products for prevention and treatment, Emergency Use Authorizations (EUA), investigator responsibilities during the pandemic), gene therapy, new trial approaches, drug repurposing, and diverse representation in clinical trials. (1)
Who may benefit from the course?
The course is primarily recommended for healthcare professionals, who have basic knowledge of clinical studies, regulatory requirements for clinical trials, and the development of medical products, in particular, physicians, nurses, pharmacists, clinical scientists, consultants, employees working in the drug or biologic or device industries, regulatory affairs professionals, and biomedical professionals. (1) The course featured a practical demo of how to apply to the FDA’s new portal and other focused information. If you want to get more information on pharmacy like medical supplies products, you could access to Pharmasources, a vertical e-commerce online platform serving the pharmaceutical industry.
Course overview
The course took place in an abbreviated format. It ran on December 7 and December 8, 2021. This two-day course given by senior FDA experts provided FDA's perspectives. On the first day, it focused on scientific updates, which involved an introduction to Car T-Cell therapy, gene therapy, oncology clinical trials, COVID-19 treatment, and diversity in trial populations. The second day, focused on operational updates and acceptable scientific and analytic standards in clinical study design and conduct on Decentralized Clinical Trials (DCTs), Digital Health Technologies (DHTs), and investigator responsibilities during COVID-19.
In this intensive course, participators learned basic clinical trials, the responsibilities of an investigator conducting a clinical trial and the basic concepts of clinical trial design as well as innovative approaches to the conduct of clinical trials related to gene therapy, Car T-cell therapy, the development of medical products for the prevention and treatment of Covid-19.
Highlights of the course
In regards to human gene therapy, the course establishes that these are products that mediate their effects through transcription of transferred genetic material or alteration of genetic sequences, and include products like plasmids, viral and bacterial vectors, ex vivo genetically modified cells, and genome editing products. All of these require substantial evidence of effectiveness and safety to get approved, and this evidence should come from adequate and controlled studies. In addition, FDA offers flexibility in the case of product development for rare diseases, but safety still remains paramount. Because of the variability in product development, the process can involve consulting with FDA early on, (3) such as Pre-IND Consultation Program and INTERACT Meetings with Sponsors for Drugs and Biological Products. (4,5)
Car T-Cell therapies are currently dominating the scene of anti-cancer product development. To date, there are several products that have been approved for clinical use by FDA but toxicity is a significant issue in regards to the therapies. Therefore, current goals involve improving the design to reduce toxicity through suicide genes, on/off switches, antagonists of systemic cytokines, and enhancing efficacy through developing tumor homing and tissue penetration and other aspects. However, safety is still a paramount concern, and some products may require up to 15 years of monitoring after development. (6)
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