Effective site management

Christene Leiper of Onorach explains how identifying key challenges and improving site management can save time and reduce costs.

Any clinical trial is only as good as its weakest component, and addressing this makes for a stronger, more robust project. Poor site selection and poor site management can be costly in terms of resource and time allocation, and also the clinical trial budget. Any efficiencies that lead to quicker completion of studies will provide an opportunity to bring a drug to market quicker, or at the very least make a decision on the suitability of a drug for market easier and reduce trial costs. Recognizing this, pharmaceutical companies are partnering with innovative CROs to manage site selection and management. 

For any study to succeed, it is essential to choose the right investigator. A principal investigator (PI) should have a formidable knowledge in the therapeutic area of the trials and also strong knowledge of how clinical trials are conducted to FDA requirements. It is critical that the PI's resumé is adequate for the trial undertaken. However, there is more to selecting a PI than just these criteria. A PI must be the right one for your trial. They need to be able to have the right resources available and must be ready when you want to start the trial.

Some PIs are so much in demand that a clinical trial start date is delayed. It then becomes a trade-off: do you wait for the investigator or choose someone who is less in demand?

For day-to-day running of a trial, sub-investigators play a major role, but it is the PI who is the responsible leader of the team. Once again, the challenge is to select the right site and look at the whole team, not just the PI.

Subject recruitment is also crucial. There needs to be a proper search of patient records to justify selecting a site. In the past, sites have been selected that have said they have sufficient numbers for a study, when in reality the subjects have not matched the criteria needed for inclusion. Where the subject population has been minimal and the evaluable number not reached, this has led to poor results and in some instances a failed study.

While any one site might be performing well in a clinical trial, others may be falling behind in areas such as patient enrollment or data collection, or there may be other issues that prevent an individual site from performing well. It is in your interest to identify the issues quickly, before they become a significant block to trial results. A good project management team can help here and ensure your trial stays on track.

Clinical trial management by a CRO that understands the importance of good site selection can assist in the navigation of the clinical trial project, taking the burden off investigators so that they can focus on the patient, and ensuring that the study is conducted at the highest standards of quality, ethics and performance. This support ensures collection of the robust, high-quality study data necessary for regulatory and product approval submissions.

By making the right choices in site selection and management, pharma companies can reduce risk, reduce cost and reduce the time taken to complete a clinical trial.

Key site management tips

• Identify, qualify and select the right sites
• Negotiate good site contracts and budgets
• Get supporting sites in local or central IRB/IEC submissions right
• Design/produce training materials to ICH-GCP standards
• Conduct site training on key aspects and on ICH-GCP requirements for the trial
• Establish toll-free help lines with 24/7 access
• Track/document project communications for Trial Master File compliance
• Provide site with regular study updates

Professor Christene Leiper has over 25 years of experience in clinical research. She is President of Onorach Ltd., a CRO located in Scotland with a global focus. The company philosophy is to engage with clients as a clinical trial partner and they have experience in site selection and management. Prof. Leiper can be contacted at christene.leiper@onorach.com.