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ORIGINAL ARTICLE
Year : 2021  |  Volume : 4  |  Issue : 4  |  Page : 642-646

Post hoc analysis of the screening log of phase III investigator-initiated randomized clinical trial comparing palliative oral metronomic versus intravenous chemotherapy in head-and-neck cancer


1 Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Kharghar, Navi Mumbai, India
2 Department of Medical Oncology, Tata Memorial Hospital, Mumbai, Maharashtra, India

Correspondence Address:
Vanita Noronha
Room No. 1109, HBB, 11th Floor, Tata Memorial Hospital, Mumbai, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/crst.crst_157_21

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Background: Large number of screen failures in trials often result in delayed drug approvals, an increase in the financial burden for conducting research, and limit the applicability of the study results to patients in the clinic. Objectives: This post hoc analysis was aimed at assessing the reasons for screen failures in a phase III, investigator-initiated clinical trial conducted in India. Materials and Methods: The study was conducted at the Tata Memorial Center, a tertiary cancer center in Mumbai, India. We maintained a log of all potential study candidates who underwent screening in our outpatient department between May 2016 and January 2020. This included the name of the study subject, hospital registration number, age, and sex. We also recorded the screening date and outcome of the screening process (whether enrolled in the study and if not, the reason for it) along with the number of patients who were finally randomized in the study. We evaluated factors that may have impacted screen failure including age, sex, and performance status (PS). Results: A total of 594 patients were screened. Of these, 422 were enrolled and 172 failed screening. Out of the 172 patients who were not enrolled, 105 (61%) did not meet the eligibility criteria and 67 (39%) refused to participate due to various reasons. The reasons for non-enrollment in the trial included the lack of a place to stay in Mumbai (35, 20.3%), patient wanted only a particular therapy (16, 9.3%), age over 70 years (15, 8.7%), poor PS (4, 2.3%), deranged organ function (13, 7.6%), active tuberculosis (2, 1.2%), primary tumor in the nasopharynx/thyroid/salivary gland/unknown primary (31, 18%), positivity for viral markers of infection (12, 7%), platinum-refractory disease (23, 13.4%), unwillingness to participate in research (15, 8.7%), patient not willing as they were not accompanied by a relative=1(0.06%) and other reasons (5, 2.9%). Age over 60 years (P = 0.001), and poor PS (P < 0.001) significantly increased the screen failure rate. Conclusion: The most common cause for screen failures is the nonfulfillment of the eligibility criteria, followed by patient-related reasons such as unavailability of a place to stay at the trial location. Broadening the eligibility criteria to better reflect the patients most commonly seen in the clinic will function both to decrease the rate of screen failures and increase the applicability of the study results.


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