7.1.1 To approximate the landscape of ADCs in clinical trials and generate a robust dataset for our report, we developed a proprietary data analytics tool that leverages public records found within the Aggregate Analysis of Clinical Trials (AACT) open source database hosted by the Clinical Trials Transformation Initiative.[120] Alongside this development, an ADC-specific search query was designed in order to better understand the state of clinical trials while curating a dataset with the same accuracy and fidelity as one generated via the use of the ClinicalTrials.gov website. We began by conducting a keyword search for “antibody drug conjugate” and “antibody–drug conjugate.” We then incorporated a heuristic-based sorting pipeline to remove erroneous trials such as conjugated vaccines and monoclonal antibodies. We then text mined and reduced the interventions of each trial in our results to confirm the identity as an ADC. Finally, we searched our dataset with known ADCs to validate the completeness of our dataset.
7.1.2 We identified a total of 1,613 interventional trials as of June 13, 2024, the first of which was initiated in 1990. One immediately striking finding is that the vast majority of interventions were not listed as a biological in the FDA database (Figure 23). According to the FDA, a biological therapy is one isolated from a natural source or produced by biotechnology: “In contrast to most drugs that are chemically synthesized and their structure is known, most biologics are complex mixtures that are not easily identified or characterized.”[121] While the antibody portion of an ADC certainly fits the criteria, it is unclear why they are most commonly classified as a drug. A quick search for “antibody” demonstrates that many unconjugated monoclonal antibodies (mAbs) are also listed as a drug. Additionally, this trend fits with the results for unconjugated bispecific antibodies (bsAbs) that we reported in our report. In the end, it is up to the user of the database to understand what information they are getting when they assess classifications of interventions.
Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.