The Northern Hemisphere flu season is fast approaching, bringing with it a multitude of challenges for respiratory clinical trials. The exact dates of the flu season in the Northern Hemisphere vary every year, but it is usually from October to May, with peaks of activity between December and May (CDC). This seasonal aspect of flu requires clinical trial sites to have planned their recruitment activities in advance and be ready to recruit as soon as local cases start to increase. Any problems that occur during preparations could cause delays with starting recruitment and potentially result in missed recruitment targets. A 2023 study by the Tufts Center for the Study of Drug Development found that the cost of a single day of delay is worth approximately $500,000 in lost drug sales and $40,000 in direct daily clinical trial costs (appliedclinicaltrialsonline.com). Failing to meet recruitment targets before the end of the flu season could have significant consequences for patients and their families, and majorly increased costs for sponsors.

In this blog, we will explore key patient-focused patient recruitment aspects that should be considered when preparing to recruit for respiratory clinical trials and maximizing activities when conducting your clinical trials, and how Innovative Trials’ experience can be leveraged to get the best out of your clinical trial sites! 

Patient Awareness

The arrival of winter prompts many of us to spend more time indoors, which allows for rapid transmission of flu, and also other viral infections such as the common cold, respiratory syncytial virus (RSV) and Covid-19. These diseases can often present with similar symptoms and it can be hard for patients to confirm which illness they have. It is crucial that patients are aware that your trial is being conducted, what symptoms to look out for, and that your trial is a viable option for treatment or vaccination. For treatment studies, awareness should be high by the beginning of the season. Whereas for vaccine studies, sites should be prepared before the season to catch participants before they would receive their usual annual flu vaccine. Each region, country, and site have their unique nuances that will need to be considered by sites when recruiting patients, including language, religion, cultural, geographical, socioeconomic, and diversity & inclusion factors. Our in-country Clinical Enrolment Managers (CEMs) regularly identify that sites are considering some of these factors, but not all, so are not making the most out of their local patient population. This will affect the number of patients being identified and ultimately how many and how quickly patients are enrolled onto a clinical trial. Therefore, it is essential that sites understand their local population to reach as many potential patients as possible as well as making the study accessible to all.

There are currently 194 flu, 72 RSV and 1,072 Covid-19 clinical trials listed on clinicaltrials.gov that are active, recruiting or due to recruit, so successfully differentiating your trials from others can significantly improve the number of patients choosing your trials above others.

This starts with producing fit-for-purpose patient-facing recruitment materials. They should be catchy, clear and relevant to the local trial site audience, with imagery and languages reflecting local demographics. Our Branding & Materials Development team has extensive experience in developing trial branding, fit-for-purpose recruitment & retention materials, translations into multiple languages, and printing & shipping to trial sites in over 70 countries. Next is utilizing and presenting these materials. Many sites will only put study brochures in their waiting room and maybe a poster on the wall at their site, but much more can be done to raise study awareness in the local area. Based on our 1:1 site support experience, our in-country CEMs have noticed great success in discussing their local patient population and their recruitment material strategy with each site, providing suggestions and coaching to maximize the impact of these strategies and reach as wide an audience as possible. 

Community Outreach has also shown a great impact on flu studies. This involved CEMs physically visiting target locations and target businesses local to the trial site to distribute recruitment materials, provide information on how to contact the site team as well as discuss your trial and relevant eligibility criteria with members of the public. This is a very effective strategy for contagious infections as they are likely to affect a wide population, so you want as many people aware of your trial as possible. CEMs work with sites to fully understand the target population, identify appropriate locations to visit and agree on the best time to conduct the outreach. Correct timing of outreach is critical to raise awareness when it is most relevant for the patient population i.e. start of flu season. 

Referral Networks

When attempting to identify eligible patients for a clinical trial, it is important for sites to understand where they are in a patient’s treatment pathway. Sites can be at a range of stages from initial diagnosis, early treatment, ongoing management of the indication, or sites may be across multiple stages. With this knowledge, sites can discern which other internal departments or external healthcare professionals (HCPs) may see patients with the relevant indication and at which stage of the illness this is. The majority of protocols have strict timelines around diagnosis so it is vital to target HCPs who see patients at the correct time point in their treatment journey. Many sites have existing internal or external referral networks, but these are commonly underutilized and sites can miss out on many patients due to these relationships breaking down. Based on our experience, in-country patient recruitment support who speak the local language proves to be extremely effective in boosting patient recruitment in many ways: discussing the above topics with the sites, determining a patient’s HCP touch points in their local area, exploring each site’s current referral network and the activities related to these networks, providing advice on how best to keep partners engaged, and referring patients themselves. A good referral network is key to widening a patient pool for any clinical trial, but this is doubly important for fast-moving and widespread illnesses like the flu. To maximize this, our CEMs will also research a site’s local area to identify additional HCP referral opportunities, sharing these with the sites, and providing advice on how best to contact and initiate a referring relationship. CEMs can also conduct this introduction themselves to gauge each HCP’s willingness to refer patients, the process to refer patients, and to share site information.

To further boost referral network expansion at sites, CEMs can conduct in-person HCP Outreach on behalf of sites. This involves CEMs visiting HCPs and relevant specialists in the local area to study sites to introduce the study, discuss key eligibility criteria, distribute recruitment materials and share information on how to refer patients. Target locations may include General Practitioners, other departments, local health clinics, or pharmacies.

Recently, we successfully supported one of our clients in a flu study, working with 108 sites across 11 countries in APAC, EMEA, and LATAM. The most common patient-focused challenges encountered by sites were the lack of active flu cases, the prevalence of other respiratory illnesses (Covid-19), and certain exclusion criteria such as prohibited medication or vaccine usage. The lack of active flu cases was a major recruitment barrier due to patients being identified and contacted too late by the site, but also due to a lack of patient knowledge and trial awareness within the target patient population. Innovative Trials deployed an in-country 1:1 patient recruitment support for our client’s sites in order to mitigate these recruitment barriers and boost patient recruitment. Our clients successfully increased patient randomization rates by +297%, screening rates by +252%, and the number of performing sites by +16%, compared to sites that were not supported by Innovative Trials.

Summary

Increased patient awareness and expanding referral networks are two positive strategies that can mitigate commonly seen patient-focused recruitment barriers. However, over the course of clinical trial recruitment phases, other challenges that have a negative impact on patient recruitment may arise. Innovative Trials’ CEMs can bring a wealth of knowledge and experience to develop site-specific recruitment plans that minimize the impact of these barriers and maximize patient recruitment activities at sites, all done in-country and in local language for the site. 

Our next blog will focus on site-focus challenges that are commonly experienced when recruiting for seasonal clinical trials and what you can do to support these sites, reducing recruitment burden and ensuring recruitment targets are met on time.

As flu season is approaching, we are offering a free 30-minute strategy call with our CEO Kate Shaw to ensure your influenza studies stand out from the competition: https://itrials-bd.youcanbook.me/ 

 

 

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