With the clinical trial approval process in Brazil becoming more efficient, patient recruitment and retention is becoming more critical. As approval processes are streamlined, the question that arises is one of how sponsors can deal with these changes. In recent times, the ethics and regulatory approval process for clinical trials has gone through an overhaul in Brazil. The long and endless approval timelines is decreasing, according to a 2016 annual report by Brazil’s regulatory authority.
Interestingly, the report showed an increase of 13 percent in overall approvals contributing to the country’s enhanced competitiveness on the global stage. The increase in approvals is due in large part to a new rule implemented in 2015. It established two 90- and 180-day deadlines for approvals of non-biological and biological molecules, respectively.
And while this has been major plus for clinical research in Brazil, the major challenge for sponsors and study sites is to achieve and maintain high rates for patient recruitment and retention. Although this is not solely a key performance indicator, it is critical and can compromise the results and integrity of a study.
Therefore, recruiting the right patients at the right time is crucial for providing an accurate database for science and regulatory purposes. To reach this goal, many factors have to be taken into account, namely, not just the patients but also the site staff.
Identifying Patients Using a Data-Driven Approach
Clinical trials are complex and require flexible and motivated people to manage a multitude of tasks. With continual advances being made in technology, electronic tools and gadgets are now being used for the report, upload and transfer of data. This means sponsors are adopting data-driven strategies to set specific requirements for feasibility purposes. As a result, companies are able to identify and recruit patients quicker than ever.
This innovative way of working requires people with project management experience who can run multiple studies. Adopting a data-driven approach could prove a turning point for sites as it will enable them to streamline processes and become more efficient at finding participants. This approach is highly recommended not only at new sites, but for sites with high recruitment rates.
The Challenge after a Successful Recruitment Phase – Retention
Once enrolled, keeping the patients active throughout the study, ensuring they complete all scheduled visits and procedures as planned, can prove as challenging as recruitment itself. While the reasons for patient dropouts can vary and are often due to uncontrollable circumstances, in a lot instances, dropouts can be predicted and thus prevented. But in order to do that, sponsors must determine why patients drop out.
Multiple on-site visits in a short period of time can lead to low patient adherence. This mainly affects studies in which the patient does not have a life-threatening condition, such as mild asthma, certain cardiovascular conditions and mild arthritis. Furthermore, the patient’s employer can oftentimes present a barrier for participants who have frequent medical appointments or clinical trial visits.
To mitigate these circumstances, a summary of the benefits for remaining compliant throughout the course of the trial would further encourage greater patient adherence. Although the informed consent form most likely lists these benefits already, having site staff engage with participants to emphasize the advantages would be a better way to address the matter of non-compliance.
Understanding the Patient’s Needs
Ultimately, high dropout rates can be owed in large part to the patient misunderstanding expectations, schedule conflicts, and personal or family-related matters. Considering the daily activities of various clinical trial projects, the patient’s needs might not be fully understood on the part of the sponsor. Therefore, a strong internal communication plan developed by the sponsor for site staff could be key for a successful retention strategy.
A clear strategic communication plan with taking into account the demands of each study should be set in advance. It will help to anticipate obstacles before they crop up, allowing the site to take action proactively or be prepared once they arise. Drawing on some of the failures of past studies is also a good way to address issues and apply actions either in ongoing or upcoming studies.
Once the strategy is rolled out, sponsors and/or CROs should have close and frequent discussions with site staff addressing actions any issues that may occur. It shouldn’t be underestimated what impact a recruitment and retention strategy that factors the needs of patients can have on a clinical trial.
A Continuous and Relentless Pressure for Improvements
Lately in Latin America, there has been a relentless pressure for process improvements in the conduct of clinical trials. The current push among stakeholders improve patient participation rates is by leveraging new and emerging technologies. Despite the access to technology across the world, industry has not yet fully maximized its capabilities, at least not in Latin America.
The potential for leveraging such technologies seems to know no bounds, and the challenge for trial sponsors is to find a way to incorporate them into clinical trials to improve and enhance the patient’s overall experience.
A successful approach for this scenario requires a clear understanding of the patient’s needs, and as such there needs to be alignment between industry and clinical staff if the clinical trial in question is to be a success.
ANVISA – http://portal.anvisa.gov.br/english