PB2281 BIOSIMILAR TRIALS IN DEVELOPING COUNTRIES: FINAL RESULTS OF AN ACTION PLAN TO DETECT AND ERADICATE BARRIERS TO PATIENT RECRUITMENT

Abstract

Background:The development of biosimilar drugs requires a strong comparability exercise and also a phase 3 head‐to‐head trial to show no differences between reference and biosimilar drugs. Discussion about study design issues and biosimilarity evaluation has been done, but little has been discussed about its impact on clinical trial conduction, in special related to recruitment issues.Aims:To identify barriers in an international biosimilar trial with rituximab in patients with diffuse large B cell lymphoma, propose actions to overcome those issues and analyze the results.Methods:In order to understand the barriers in a biosimilar trial, Libbs Farmacêutica organized a meeting with investigators and clinical research coordinators involved in a biosimilar trial where the recruitment was a gap and proposed an action plan to solve the identified issues.Results:The main barriers to recruitment related to the biosimilar drug were the negative attitude towards biosimilar drugs caused due to misconception or lack of knowledge related to biosimilar drug or its development process among patients and physicians. Some issues not related to the biosimilar were lack of clinical research network, lack of knowledge from patients related to clinical trials, complexity of onco‐hematologic diseases, study complexity and eligibility criteria and low motivation among investigators due to lack of knowledge about biosimilar. The action plan included to reinforce and spread the concept of biosimilar and clinical research included a Brazilian site on biosimilars (www.biossimilaresbrasil.com.br); scientific publications in medical and patient congresses; advertisements in medical and patient journals; visits to the research centers in 15 Brazilian states to report on the study and on biosimilars, as well as visits to pathologists and treatment centers in these states that did not participate in the study to refer patients to the research centers; video to explain clinical research for patients; involvement of the local state health secretary; strategies for early diagnosis of cancer to allow the patient to enter the clinical study; pay PET‐CT that is not available in the public health system in Brazil. Considering one year prior to this action plan, 11 patients were recruited and 4 randomized; after one year (end of the inclusion period) 51 patients were recruited (an increase of 3.6 in the number of patients) and 28 randomized (an increase of 7), allowing Brazil to reach its goal in relation to the patients’ inclusion (Figure).Summary/Conclusion:Modification of physician and patient's attitude toward participation in clinical trials with biosimiliar is the main challenge and can be overcome through continuing education. The development of a national network reference to investigational sites among physicians can act as facilitators through promotion of communication and enhancing integration. The diminished resources in the public health care system has impact on accrual to cancer clinical trials. Multidimensional approaches such as publication plan, screening and enrollment strategies, and awareness activities are the best strategy to raise recruitment in multicenter trials. The development of biosimilar trials is needed in order to the delivery of high quality biosimilar products and to increase drug access.image