The Importance of Institutional Agreements in Clinical Trials

Institutional Agreements in Clinical Trials: Their Importance

Clinical trials are crucial for the advancement of medical science, the development of new treatments, and the improvement of patient quality of life. However, these processes require not only scientific knowledge but also a complex operational infrastructure. Institutional agreements in clinical trials are one of the cornerstones of this infrastructure and are essential for the success of any research.

Importance of Institutional Agreements

Defining Roles and Responsibilities: Institutional agreements clearly define the roles and responsibilities between the research parties. The specific duties of the sponsor, investigator, and research center are detailed in these agreements. This helps to eliminate uncertainties in the project and ensures alignment between the parties.

Ethical and Legal Compliance: Ensuring that clinical trials are conducted in accordance with ethical guidelines and legal regulations is guaranteed through institutional agreements. Specifically, compliance with Good Clinical Practice (ICH-GCP) guidelines, and standards set by authorities like the FDA and EMA, requires proper management of institutional agreements.

Financial Transparency and Control: Institutional agreements detail the financial aspects of the research, ensuring budget planning and the control of expenses. This transparency fosters trust between the parties and ensures the smooth execution of the financial process.

Protocol Changes and Compliance: Changes that arise during the research process can be effectively managed through institutional agreements. This allows any changes to the research protocol or budget to be incorporated into the agreement with the approval of all parties.

Closure and Final Reporting: At the end of the research, institutional agreements ensure that the project closure is carried out properly and that final reporting is completed. This step plays a critical role in ensuring the accuracy and completeness of data that will be used in future audits.

Preparation Times for Clinical Trial Centers

The timely and effective completion of institutional agreements is a critical factor in the initiation of research at the center. The faster a study center is prepared, the sooner the first patient can be enrolled. Completion times for institutional agreements vary significantly across different countries.

For instance, a study shows that in Germany, it can take an average of 197 days to complete institutional agreements, whereas in France, the process is completed in just 24-76 days.

Many European countries have accelerated the process of institutional agreements by creating national template contracts, speeding up the process by 30-60%. This not only saves time but also reduces costs, making the research process more efficient. In contrast, countries like Germany still experience a lengthier process compared to other European nations.

Public Hospitals Process: In Turkey, for clinical trials conducted in public hospitals, appropriate contracts must first be prepared under the revolving fund regulations. In this process, obtaining ethics committee approvals, completing TİTCK applications, and preparing the documents required by the Ministry of Health are mandatory. Once contracts are signed, the studies are carried out without interrupting the core services of public hospitals. Additionally, 85% of the revolving fund income is allocated to the research team, while 15% is directed to the institution’s budget.

The Situation in Turkey:

In Turkey, institutional agreements are generally completed within 30-80 days, providing a competitive advantage compared to most European countries. Shorter center preparation times are crucial for faster initiation of clinical trials and earlier data collection.

The following graph illustrates the completion times of institutional agreements in different countries. These data clearly highlight how Turkey stands out in comparison to other countries.

Source: VFA Survey Among Its Members, 2021

Omega Pay’s Contribution to Institutional Agreements

Omega Pay is an expert partner in the preparation, management, and implementation of institutional agreements. Supporting you at every stage of your projects, Omega Pay provides assistance with document preparation and approval processes, as well as all operational details.

Omega Pay offers services compliant with international standards such as ICH-GCP, FDA, and EMA, ensuring that your projects are completed in line with ethical and legal requirements. Additionally, Omega Pay guarantees alignment between all parties by managing necessary revisions for protocol changes or budget adjustments.

In the complex world of clinical trials, institutional agreements are the key to success. Omega Pay effectively utilizes this key, helping you successfully conclude your projects.