Conducting clinical trials in Greece offers significant opportunities, but it also comes with various challenges. Despite Greece’s potential to attract international clinical trials, several difficulties affect their execution. Here are the main challenges faced by clinical trials in Greece.
Bureaucracy and Regulatory Framework
Approval Delays: The processes for obtaining approvals from ethics committees and regulatory authorities can be slow. Delays in the approval of clinical trials can hinder the timely initiation of studies.
Complex Regulatory Requirements: Compliance with the regulatory framework in Greece, which includes the National Organization for Medicines (EOF) and local ethics committees, can be complicated and time-consuming. Different hospitals may have varying procedures, adding to the complexity.
Funding and Infrastructure
Limited Funding: Greece has limited financial resources allocated to research and clinical trials. This can result in fewer opportunities for clinical research and may limit the ability of sites to participate in larger, multinational studies.
Inadequate Infrastructure: Some research centers may lack the infrastructure needed for advanced clinical trials, such as specialized equipment, modern facilities, or trained personnel.
Patient Recruitment
Recruitment Challenges: Recruiting patients for clinical trials in Greece can be difficult, especially in studies requiring specific patient populations or rare diseases. There may be low awareness of clinical trials among the general public, and patients may be hesitant to participate.
Geographical Barriers: Greece’s geographical landscape, with many islands and remote areas, can make it difficult for patients to access trial centers. This can limit the pool of potential participants and create logistical challenges.
Limited Experience in Multinational Trials
Lack of Experience in Global Trials: Compared to other European countries, Greece has less experience in hosting large, multinational clinical trials. This can lead to challenges in meeting the strict timelines and regulatory standards required by international sponsors.
Language Barriers: While many Greek healthcare professionals speak English, language barriers can still be an issue, especially when dealing with international protocols, data submission, and communication with global sponsors.
Human Resources and Training
Limited Availability of Trained Personnel: There is a shortage of clinical research professionals with extensive experience in clinical trial management and regulatory affairs. This includes Clinical Research Associates (CRAs), clinical trial coordinators, and data managers.
Staff Turnover: High turnover rates in the healthcare sector can affect the continuity and quality of clinical trial operations, leading to delays and disruptions in study conduct.
Public Perception and Awareness
Low Awareness of Clinical Trials: There is often limited public awareness about the benefits and purpose of clinical trials. This lack of awareness can contribute to patient hesitation or reluctance to participate.
Concerns about Safety: Patients may have concerns about the safety and ethics of participating in clinical trials, especially if they involve experimental treatments or investigational drugs.
Administrative Challenges at Hospital Level
Delays in Contract Negotiations: Negotiating contracts between hospitals, sponsors, and CROs can take longer than anticipated, causing delays in trial initiation.
Bureaucratic Hurdles in Public Hospitals: Clinical trials conducted in public hospitals face additional administrative challenges, such as obtaining necessary approvals from various departments and managing workload pressures on hospital staff.
Impact of Economic Conditions
Economic Constraints: Greece’s economic situation can impact the availability of resources for clinical trials, including hospital infrastructure and human resources. Budget cuts in healthcare can limit the capacity of sites to participate in clinical research.
Investment Hesitancy: Sponsors and CROs may hesitate to invest in Greece due to economic uncertainty, affecting the country’s ability to attract large-scale clinical studies.