How to Ensure a Clinical Research Success

Clinical research – and especially the development of medicinal products through clinical trials – is heavily regulated. These regulations are primarily in place to safeguard the safety and privacy of participants, ensure data quality, and establish result reliability. However, when it comes to the qualifications of research teams, national and international guidelines often provide requirements that may lack specificity. For example, the ICH-GCP guideline only indicates that clinical trials should be designed and conducted by qualified individuals (ICH E6 R3, section 5.1) “Individuals involved in a trial should be qualified by education, training and experience to perform their respective task(s).”

Effective training is the cornerstone of success in clinical research. It plays a pivotal role in several critical areas:

-?????? Compliance and Regulatory Adherence: Proper training ensures that site and study teams are aware of and comply with regulatory requirements, including GCP guidelines.

-?????? Data Integrity: Trained personnel are more likely to collect, record, and manage data accurately, reducing errors and potential data discrepancies.

-?????? Patient Safety: Competent site staff contribute to patient safety by correctly administering investigational drugs or treatments and following safety protocols.

Despite the clear importance of training, there are challenges to achieving harmonisation in training programs across different organisations. While broad training areas may appear similar, the actual content provided can vary significantly. Additionally, while knowledge domains are often effectively addressed through classroom and online teaching programs, the development of essential skills, especially soft and interpersonal skills, can be lacking.

Regardless of your role—site staff, sponsor, or service provider in the clinical research landscape—training holds equal importance.

Ensuring Your Organization is on the Right Track:

Here are a few key considerations to ensure that your organisation is building a strong foundation for clinical research success:

?1.??? Proper onboarding training:

Onboarding begins before the employee’s first day, and it can go a long way to making staff feel welcome and supported. The goal is to accustom staff to their new environment, set goals and expectations for their role, and prepare them to be successful at your organisation.

This crucial step in the employee experience helps new team members familiarise themselves with your organisation and their team plus understand the systems, processes, and skills that will help them succeed.

I have onboarded close to a hundred clinical research specialists, and I recommend following the 3 Cs structure - Culture, Compliance, and Check-Ins.

• Culture: Communicate the shared vision, values, and behaviours that define your organisation so new staff can gain a sense of belonging. Set clear expectations during onboarding so the employee understands their role, responsibilities, and performance expectations.
• Compliance: Ensure the new employee has completed all mandatory training for their role. This is especially important as noncompliance can result in regulatory/audit observations. Consider assigning soft and interpersonal skills training as applicable to the role.
• Check-in: Provide ongoing support to help new employees address concerns or challenges that arise after their initial onboarding. Having regular communication channels or feedback can help new hires feel supported and valued. Building connections with colleagues and leaders is essential for creating a sense of community.

2.??? Developing Competency Assessments

One of the main barriers to the conduct of clinical research is the lack of qualified, well-trained personnel. To ensure that basic concepts and skills related to the conduct of clinical research are taught, many organisations are adopting competency-based models of education. Competence in clinical research means possessing the required knowledge, skills, abilities, and behaviours (competencies) needed to perform specific, defined research tasks.

Here are a few tips for developing competency assessment:

• Define Competency: It includes knowledge and the practical skills required to perform tasks effectively.
• Assessment Methods: There are various methods for assessing competency. Whichever you decide to implement, consider ongoing assessments rather than one-time evaluations.
• Identify Gaps: Competency assessments can help identify personnel gaps in knowledge or skills. Addressing these gaps leads to improved performance.

3.??? Ongoing Learning

Quality in clinical research starts with well-trained and competent individuals. Encourage a culture of continuous learning and improvement. Ongoing training and competency assessments foster a proactive approach to addressing challenges and adapting to changes in the industry. Don’t forget to encourage cross-functional training and collaboration. When team members understand each other’s roles and responsibilities, they can work more cohesively and address issues more effectively. Developing channels for connections between staff, leadership, and other stakeholders is important. This can include anything from who to go to for day-to-day questions to finding a mentor.

?In conclusion

·????? A competent team can execute tasks more efficiently, reducing delays in study timelines.

·????? Your competent team can enhance patient recruitment and retention through effective communication and patient-centred approaches.

·????? Well-trained personnel contribute to reliable data collection and management, which is crucial for study outcomes and regulatory submissions.

Investing in training and fostering a culture of continuous learning is not just a choice; it's a commitment to the future of clinical research excellence. Share your best practices and resources to help us collectively elevate the standards of our industry.