How Clinical Trial Site Support can Ensure Success in Multicenter Trials

What are trial support services in clinical trials?

Clinical trial site support services, also known as clinical trial support services or investigator services, refers to comprehensive services aimed at supporting clinical sites in successfully executing a clinical trial. These services are usually provided or organized by the trial sponsor, and focus on providing necessary resources, guidance, and/or assistance to ensure that the trial processes run smoothly, efficiently, and in compliance with regulatory requirements. In its delivery, clinical trial site support could take various forms:

• Staff training
• Development or overview of standard operating procedures (SOPs)
• Operational assistance in trial-related tasks
• Support for data management tools or other electronic systems used as part of the trial protocol
• Regulatory compliance oversight

Why provide clinical trial support services for sites?

Most clinical site partners who get involved in conducting clinical trials are institutions that are already engaged in other activities, such as medical clinics or university research centers. The professional staff of the research centers include medical professionals and skilled researchers, who are sufficiently capable of running a trial site in terms of knowledge and abilities. The problem is that many institutions working in either the medical field or in research are already notoriously busy, with staff working under heavy workloads, strict deadlines, and tight budgets.

This situation explains why it may be in sponsors’ best interests to provide site support services during a trial. Essentially, providing clinical trial support services represents a gesture to sites that you are there to support them through the trial. However, it also works as a way to ensure the site is dedicating proper time and resources to the clinical trial, reminding them that it is an important task amidst their other duties.

Particularly for sites that are inexperienced (either in general or in the specific therapeutic area/design of the trial at hand), without the appropriate support or attention, a variety of issues could arise while conducting a clinical trial, such as:

• Lack of resources or supply shortages
• Problems with infrastructure and equipment involved in the trial
• Patient recruitment setbacks and shortcomings
• Problems with patient retention due to lack of attention, limited engagement strategies, or logistical constraints
• Delays in study timelines
• Administrative burdens
• Regulatory non-compliance issues
• Compromised data quality
• Protocol deviations or errors resulting from insufficient training of study staff, or from inadequate monitoring/oversight

Offering effective clinical trial site support ensures each site has a strong foundation for conducting the study in line with protocol, regulations, timelines, and budget, further supporting the generation of reliable data. Depending on the needs of the site, site support can be directed toward optimizing participant recruitment, ensuring data integrity and adherence to protocol, upholding ethical conduct and patient safety, or lessening the burden placed on site staff overall by maximizing the efficiency of trial-related operations.

5 specific services provided in clinical trial site support

Clinical trial site support could include a range of specific services to ensure smooth operations and optimized data quality at individual clinical trial sites. Depending on the complexity and specific details of the trial, site support can be provided with different foci. For example, if a trial involves custom software solutions or novel operational considerations, then directed site support is likely to be provided in that regard to ensure sites are appropriately equipped to carry out the trial. In general, site support could be geared toward assistance with patient recruitment and retention, general operational assistance, help with data collection and management, support with regulatory compliance, or staff training and the development of standard operating procedures (SOPs) for tasks related to the unique trial at hand. By ensuring that each site has access to adequate resources, assistance, and guidance, clinical site support services can contribute to overall efficiency and effectiveness in multicenter clinical trials.

1. Operational assistance

Operational assistance can encompass nearly anything related to the day-to-day tasks involved in conducting the clinical trial. Sites may be obligated to follow practices, protocols, or routines that are unfamiliar, and since each trial is unique, operational assistance could take many forms. It could even be provided on a site-by-site basis, where the sponsor or a support team is available for a given amount of time to help with whatever aspects the site needs help with. Operational tasks can include activities like scheduling patient visits, recording patient data as per protocol and CRFs, managing study supplies, reporting to the sponsor, etc.

2. Data management support

Clinical trial results can inform decisions on drug approvals and inform patient care guidelines and healthcare policy. With such important implications, it’s essential that clinical trial data be reliable and accurate. While most research centers and medical facilities will have experience handling data, the nature of clinical trial data management is somewhat different. Of particular (unique) relevance to clinical trials are data privacy and confidentiality considerations, such as HIPAA in the US or the GDPR in the EU, dealing with blinded data, and the use of integrated data systems as imposed by the sponsor. Depending on the data collection method(s) used, the site may need particular training on tools or software systems employed, data collection and reporting procedures, data security, etc.

3. Regulatory support

Clinical site support teams can assist individual sites with institutional review board (IRB) submissions and approvals by helping sites prepare essential trial documents in accordance with relevant regulations. Clinical trial documentation can differ significantly from the type of documentation that research sites or medical facilities may be used to, so for inexperienced sites, receiving assistance in this area can be of great help. Sponsors can also provide oversight and assistance to ensure ongoing compliance with protocols and regulatory requirements set forth by local/national authorities or international guidelines such as Good Clinical Practice (GCP).

4. Patient recruitment and retention

Patient recruitment and retention play a critical role in the success of clinical trials, and recruitment is a common source of delays. This is thus another area wherein the sponsor can provide assistance. While some sites might have well-established patient databases or networks and efficient recruitment practices, others may need more assistance from the sponsor (although this factor is almost always considered during site selection). Site support services could help sites identify and leverage community groups or patient advocacy groups to raise awareness about the trial and reach potential participants, or could launch centralized recruitment advertising campaigns on digital platforms that direct patients to the nearest site.

At Power, we offer an advanced patient-friendly platform for matching patients with clinical trials. The platform, www.withpower.com, can be leveraged by sponsors and sites alike to streamline and accelerate recruitment efforts by providing access to a database of patients from a wide demographic breadth who have previously responded to pre-screening questions designed by the trial sponsor.

Once patients are enrolled, site support services can also help sites develop and follow patient engagement strategies to reduce attrition and improve patient adherence. This could involve ensuring sites are well-versed in compassionate and personalized communication, are performing regular follow-ups, and are generally optimizing the first-hand experience of patients who might be going through difficult times. Dedicating time and effort to patient retention can also help maintain the integrity of the study by minimizing dropout rates that could introduce potential bias into collected data.

5. SOP development and staff training

Standard operating procedures (SOPs) play a crucial role in ensuring that sites understand exactly what is required of them, as per the trial protocol. SOPs can be thought of as step-by-step instructions for the daily tasks required in order for the trial to be executed in line with protocol, regulations, and timelines. If any staff member is unsure about how to proceed with anything trial-related, for example in collecting a specific type of patient data or reporting to the sponsor, they should be able to consult a clear and detailed SOP.

Site support teams could help sites develop comprehensive SOPs tailored to the requirements of each specific trial. For sites with SOPs already in place, site support services might review SOP documentation or verify that they are being followed. Moreover, site support teams might be tasked with conducting staff training, either on understanding and following these SOPs, or on other aspects of trial-specific operations in general, such as operating specific medical devices or reporting data according to certain constraints.

Conclusion

Clinical trial site support services play a vital role in supporting clinical research efforts, ensuring that sites have the proper resources, guidance, and/or assistance to conduct the trial smoothly. Site support services can be comprehensive or directed toward specific aspects/goals, such as ensuring adherence to ethical and legal standards or verifying that good practices are implemented in data collection and analysis. While experienced sites may not need clinical trial support services, many sites are often perpetually multitasking and can benefit, in some way or another, from dedicated trial support services from the sponsor or a clinical trial site support team.