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Advent of decentralised clinical trials spurs need for robust rules like USFDA’s Cancer Clinical Trial Eligibility Criteria

Advent of decentralised clinical trials spurs need for robust rules like USFDA’s Cancer Clinical Trial Eligibility Criteria


Posted on May 20, 2024 Updated on May 19, 2024

As India sees the emergence of decentralised clinical trials driven by digital health technologies remote patient monitoring, Electronic Health Records andpatient data capture, it also sees robust rules like the US FDA’s Cancer Clinical Trial Eligibility Criteria as an advantage. Decentralised clinical trials allow patientsto participate in clinical trial in the comfort of patients’ homes, reducing the need for frequent visits to a clinical site.

The number of Indians diagnosed withcancer is estimated to be 29.8 million in 2025, from 2.7 million in 2020, globally too over 35 million new cancer cases are predicted in 2050, from the 20 million cases in 2022. In this scenario, Indian clinical trial sector sees much relevance in decentralised human studies and the USFDA draft guidance oncancer clinical trial eligibilitycriteria: performance status guidance, IRBs (institutional review boards), and clinical investigators to select the intended patient population and reduce potential risks to trial participants.

The guidance provides recommendations regarding eligibility criteria for clinical trials of investigational drugs to include patients with a wider range of performance status (PS). Because there is variability in investigational drugs and trial objectives, eligibility criteria should be developed taking into consideration the mechanism of action of the drug and targeted disease or patient population, said the global regulatory authority.

Unnecessarily restrictive eligibility criteria may limit patients’ access to clinical trials. Broadening cancer trial eligibility criteria can improve the trial results and provide a more detailed characterization of the investigational drug’s benefit-risk profile across the patient population.

A yardstick recommended is the performance status (PS), which is a measure of how well a patient is able to perform ordinary tasks and carry out activities of daily living. In fact, this is one of the most common eligibility criteria in oncology trials. Many trials are limited to good performance status and exclude lower-functioning patients, said USFDA.

Studies have demonstrated that, of patients ineligible for a clinical trial, exclusion was related to low PS across disease type, investigational therapy, and therapy line. As a result, the efficacy and safety outcomes experienced by participants with high performance status may not adequately predict the outcomes for patients with low performance status. The latter could report higher rates of adverse events. This may influence patients’ ability to complete the intended course of treatment. In such cases, FDA recommends that sponsors consider discussing with the appropriate review division a primary efficacy analysis that is restricted to the participant.

USFDA has noted that patients with lower performance status should be included in clinical trials in a way that contributes to a greater understanding of the efficacy and safety profile of the investigational drug while maintaining patient safety.

From an India stand point, the country is a hub for several global oncology drug studies and here USFDA guidance makes big sense, said a section of clinical research companies.

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