At Longboat, we are dedicated to generating better study outcomes by providing site staff with the information they need, when they need it - Guided Compliance™. As the pioneers in the development of assisted protocols, our unique skill set allows us to create innovative and transformational technologies that are integral in bringing novel medicines to patients and their families sooner.
Our Philosophy: One Platform, One Team
All key stakeholders – clinical operations, monitors, site staff, and patients – access the same integrated and consistent support platform. Depending on the user’s role in the study, the interface, and support provided, adjusts to meet their specific needs.
Apart from the simplification and enhanced coordination that stems from this integrated approach, it also engenders a greater “sense of team” across these key groups.
1. Patient Recruitment
In most clinical trials, the patient recruitment phase has a huge impact on the overall timelines for delivery. For the sites themselves, the whole process from setting up ads to screening patients can be overwhelming, particularly if outreach efforts aren’t bringing in the right patients.
As the sponsor, there are ways you can support your sites through the recruitment phase.
Clear Compelling Information
Although protocols are official regulatory documents, they’re not always the best or easiest thing for sites to use on a day-to-day basis. It’s like trying to read an entire novel, when all you really need are the cliff notes. There is a real need for a clear and easy-to-understand list of instructions for each patient visit and each procedure.
This means stripping the protocol information to its essential pieces. Only the most vital information to do the job properly needs to be on hand. A site team that truly understands and engages with your study is far more likely to engage patients to join your trial. It’s an easy way to boost both your site team’s motivation and your recruitment numbers at the same time.
Find out about more ways to better support sites so they become your best recruiters.
Mapping Out Your Recruitment Plan
The importance of site selection, accurate and realistic recruitment rates, and proactive analysis of planned versus actual metrics on accelerating the recruitment phase is well proven. For busy sites, there are a few effective ways to streamline recruitment to speed up the process, while bringing in qualified patients.
Steps like mapping out a recruitment campaign plan, choosing ad targets carefully, and considering partnering with a recruitment company can help. It’s also important for sponsors and CROs to encourage an open dialogue with sites about various recruitment challenges, as this can pinpoint issues with selection criteria that can be remedied quickly, thereby avoiding potential delays to the trial.
Recruitment planning tips like these can help your sites to lighten workloads without sacrificing the patient experience or slowing down the recruitment process.
Read more about how sites can save time on clinical trial recruitment.
2. Patient Screening
Feasibility - the evaluation of whether a particular trial can recruit enough of the right patients so that the study completes on time and within budget - is arguably the most critical part of the clinical trial process. Performing an effective evaluation will significantly reduce a sponsor’s risk in their research and development efforts.
Traditionally, sponsors and CROs have relied on investigators to inform them that the desired specific patent population is available. Yet, it has been estimated that almost half of all sites (48%) do not deliver their anticipated number of patients, and study timelines are typically almost doubled to meet desired enrollment levels.
Platforms that enable investigators to more accurately assess eligible patients not only make for more informed patient recruitment strategies, but can aid sites in alerting you to recruitment issues in a timely manner.
Data is the single biggest tool available to those charged with study planning. Some crucial pieces of information, however, are often not made available to the sponsor. For example:
- Why are patients who are evaluated by the site not progressing to screening?
- What are the reasons for ineligibility?
- Is the patient (or their family) not comfortable with clinical trials?
- Is there some particular aspect of the study that makes it unattractive?
- Where are the patients coming from?
- Site’s own database
- Referral from another site
- Patient recruitment website
Although sites are usually provided with the tools considered necessary to provide this information, the reality is that site staff struggle to find time to carry out this process. Sites will not do anything they do not “have” to do.
The tools we provide during the recruitment phase must match the reality of working at clinical sites and facilitate collection of this critical data.
Longboat has developed a Pre-Screen Navigator that allows sites to pre-screen patients ‘on-the-go’, using their phones, tablets, laptops, or desktop computers. This removes any uncertainty over recruitment activity and also provides the requisite insights for sponsors when making important decisions about their studies and programs.
3. Informed Consent for Patients
How many times have you quickly ticked the checkbox to say you’ve read some T&Cs, knowing that, at best, you may only have skim-read the first page? We have become conditioned in recent years to ignore the implications of providing our consent and to skirt past the tedious detail.
Informed consent for patients is no different. It’s one of the most challenging and complex legal and ethical aspects of a clinical trial, and serves two essential purposes:
- To provide information about the trial protocol to potential participants so they can make an informed decision on whether or not to take part
- To form a legal agreement between the trial sponsor and the patient
But this legal element means that informed consent forms are typically lengthy and highly technical documents. Add to this the evolving regulatory guidance around electronic informed consent forms, and how can you be sure that informed consent has truly been achieved for your trial?
Achieving Patient-Centric Informed Consent
To achieve truly informed consent, four criteria have been identified:
- Information disclosure
Read more about how to meet the four criteria of truly informed consent for patients.
One of the criteria is comprehension, which we know is a significant challenge when it comes to engaging patients with long and detailed scientific protocols documents. In a survey of nearly 300 cancer trial participants, around 90% said they were satisfied with the consent process and most patients considered themselves well informed. But, when questioned, a large proportion couldn’t recognize many of the terms used throughout the protocol.
To truly achieve patient-centric informed consent, materials not only need to be simplified, but must also be adaptable to the different patients who walk into the clinic. This requires innovation in terms of how information is delivered, along with the harnessing of digital, interactive, and audio-visual platforms that fully explain what clinical trials are, and the role of participants in them.
4. Patient Centricity
Patients are at the heart of everything we do in clinical development. Therefore, it is important to thank patients and ensure they are fully aware of the impact of their study involvement.
Ultimately, this will improve positive public awareness surrounding the importance of clinical research, as well as increased participation into the future.
But how can we be truly patient-centric, if we don't understand what is important to patients on trials?
We were fortunate enough in 2016 to be part of a discussion on how to better communicate with patients on trials. It was clear there is still much work to do; but certain key steps included the need to move to using the term participants rather than subjects, and then ensuring that participants are thanked. The importance of collaboration and the theme of ‘teams’ in driving retention and compliance in studies was also highlighted.
Take a look at some of the patient-centric novel approaches for communicating trial results that emerged from the workshop.
As a company focused on creating useful and usable technology solutions to patients on clinical trials, we wanted to drill into the detail of the patient trial experience. We hosted focus groups to seek out and respond to real-life patient needs and, through these, we’ve gained a number of critical insights.
Creating a Patient-Centric Trial Experience
The first is the seven things that patients told us about taking part in clinical trials, ranging from their experience of recruitment and accessing the trial in the first instance, to finding out the results of the study at the end. First and foremost throughout this process was the need to be included as part of a team and kept in regular dialogue with the study managers.
From this, we were able to generate a wish list for clinical trial patients, which included more comprehensive and practical support, reminders of upcoming visits, and an online source of ongoing information about the trial.
Check out the wish list for clinical trial patients.
Other factors important to patients stretch beyond the actual interactions with study teams while they’re attending their clinic visit: it’s the distance they need to travel, not being able to eat for several hours before their appointment, and queuing for blood tests. That’s why it’s so important to stand in the shoes of a clinical trial participant when planning the practicalities of delivering a trial protocol. Read our guest blog, a day in the life of a clinical trial patient, to get a sense of their reality.
Consider the Caregivers
It’s not just patients that need to be considered in clinical development, but caregivers too. Heralded as the invisible army, caregivers play a crucial role in making trial treatment a success. Caregivers often act as the proxy for many patients in navigating the complex world of clinical trials, and need to be considered in the process. So, what do we know about the caregiver’s role and typical experience in a clinical trial, and how can we best support them?
Three Key Ingredients for Patient Centricity
Throughout all of our conversations and focus groups with patients, the three requests we heard:
- Keep me informed
- Help me to belong
- Give me a great experience
Ultimately, these are the three key ingredients that can help ensure your clinical trials are more patient-centric, and they work for site teams too.
5. Patient Engagement
For an industry that is typically slow to adopt change (think paper to electronic data capture), the pace at which pharma companies are building patient engagement into their core practices is rapid. So, what needs to be in place for truly effective patient engagement?
A key part of the progress seen already has been overcoming existing perceptions on both the pharma and patient sides. This can then be the start of a trusted relationship in which both sides understand what is important to each other and understand what is feasible within the constraints of clinical research.
Read more about why building trust is the first step towards patient engagement.
In addition to trust, patients we’ve spoken to tell us there are three key things that would help them to feel more engaged:
- Feeling well informed
- Being part of a team
- Seamless and smooth site visits
To understand what this really means for patients, check out our blog on factors influencing site and patient engagement.
Feeling Well Informed
Top of the engagement criteria for patients is to feel well informed, and to ensure this happens you need a robust engagement strategy. This strategy should take into account the unique needs of your patient population, which can cover a diverse range of age, ethnicities, and health literacy levels. It should also consider their preferences when it comes to communication, their information-seeking behaviors, and what messages are most likely to resonate. This sounds like a lot of work, but, in reality, it simply means establishing a dialogue with your target patient group early on during planning. Then, you can be sure that the information you send to your patients is relevant and fit for their needs.
Being Part of a Team
Research has shown that there are highly significant benefits to even just “feeling” part of a team. And although it might seem daunting on a large, international, multicenter trial to evoke a sense of team, it does not take great effort or change to create this feeling of unity. There is enormous latent “team” energy within a clinical trial team that could be harnessed to power patient engagement.
Learn how to capture that energy: Want Patient Engagement, Think Team.
Seamless and Smooth Site Visits
To ensure that site visits are smooth and seamless for patients, you need to first understand what factors influence the experience of patients when they visit the clinic. But, it’s just as important to understand what factors affect the site team also, as it is ultimately the patient’s interaction with those site staff that will make the most impact during their visit.
Read more about how patient and site team experience impacts study managers.
A good trial experience relies on sponsors and CROs focusing on what really matters to both sites and patients, and looking for solutions to make things easier. This might mean focusing on training your site team thoroughly so that they are well prepared ahead of site visits.
Our blog on how to cure protocol deviation and increase clinical compliance delves into this.
It’s also about ensuring that it’s easy for both patients and site staff to find trial documents in one centralized location, and that everyone understands what is expected of them ahead of the clinic visit.
Engagement Can Improve Patient Compliance
Ultimately, patient engagement has a profound impact on the success of a clinical trial. It will be measured by the study’s success in recruiting and retaining patients, but it is also an important factor in maximizing the chances of compliance.
Read more about how patient engagement can improve patient compliance.
Patients often leave the investigator site without a full understanding of the instructions they have been given. The patient's interaction with site staff on the clinical trial is often just sporadic or at irregular visits, which can mean they simply forget many of the study requirements while going about their day-to-day life.
Promoting a sense of team between site staff and patients, facilitating more regular communication, and emphasizing the idea that the patient is the star player whose input and feedback are critical to the success of the study, may lead to better compliance.
Find out more about the measures that can support patient compliance.
Another aspect is to provide tools that support the patient in fulfilling the requirements of the protocol, without them having to rely on committing all the details to memory.
Being part of a clinical trial needs to be burden-free. At Longboat, we think that providing patients with the key information about their study when they need it, in the format they use most, is a good start to improving patient-centricity. Our patient portal is a one-stop-shop where participants and their carers can find out about their trial and their progress through each visit, as well as access meaningful information about their condition and their treatment.
Read more about it in our blog Where Patient Centricity Meets Protocol Compliance.
6. Patient Monitoring
Risk identification and mitigation is the most important step in any clinical trial, and central to recently updated good clinical practice guidelines (ICH E6 R2). If you have a true understanding of where the main risks for your study lie, you can develop a comprehensive monitoring plan based on the key risk indicators and performance metrics that you identify upfront.
Find out more about different types of risk-based monitoring.
One of the key risks on any trial is participant drop-out. To optimize the chances of seeing a robust effect in a trial, you need to give your study plenty of statistical power by ensuring that you recruit and retain enough participants. Monitoring and using data in clinical decision-making can help to retain more patients, ensuring the robustness of your trial.
For a more in-depth look at how to retain patients to maintain the statistical power of your study, check out this blog-post.
Monitoring Recruitment and Retention Risks
So, how do you ensure that your site teams are effectively monitoring risks related to patient recruitment and retention? Make sure the technology platform you select supports intelligent monitoring with real-time visualization, and red-flags trial-level issues like recruitment delays or protocol deviations. Early oversight of risk empowers you to quickly identify problems and roll out prompt and efficient interventions.
When adopting a risk-based monitoring (RBM) approach, it’s also essential to consider how you will train your study teams, monitors, principal investigators, and coordinators to use it. This includes ensuring that they are compliant with communications, and that when there are updates to documents and processes, you have an audit trail to ensure that everyone is up to speed.
Take a look at the eight essentials for clinical trial training platforms.
7. Leveraging Clinical Technology for Patient Recruiting, Experience, and Engagement
Running a clinical trial is a complicated business. Each clinical trial protocol is unique, with its own intricacies; each visit is different with its own set of procedures. Increased protocol complexity leads to the increased chance of protocol non-compliance, while increased workload leads to the increased chance that sites will not recruit.
Thankfully, we have technology at our fingertips that can help. An integrated clinical trial platform can support every aspect of running a trial, providing a 21 CFR Part 11 compliant record of training and communication.
Learn about running a 21 CFR part 11 compliant clinical trial.
One of the biggest benefits a clinical trial platform can bring to your study is the ability to store all trial documentation in a single repository. The need is clear: more complex trials drawing from larger patient populations, and with many more stakeholders involved, require a more systematic and sophisticated approach to study management.
One of the main benefits in having all documentation in one place is that it provides up-to-date versions of trial information, on-demand, to patients – making it simple to check the ‘keep me informed’ criterion off the wish list.
What makes a great integrated clinical trial platform? Find out in Creating the Change – The Importance of Integration in Clinical Technologies.
Getting Trials Up and Running Sooner
Technology can help make your trial more efficient in other ways too. Although lagging behind other industries when it comes to the business philosophy of ‘lean’, clinical development is catching up.
Leaner trials hold the promise of not just saving money, but also speeding up development – good news for sponsors and patients alike. The great news is that the technology already exists to make these happen!
How to use technology to design leaner clinical trials shows you how!
Being Part of the Team
A simple way to create a feeling of inclusion for patients (and site staff) is to inspire them with the story of the research they are helping to make possible; and today’s technology can bring the complex world of clinical research to life in animated form as never before.
At Longboat, our highly specialized pharmacology, 3D animation, and medical teams work together to create captivating, bespoke animations, highlighting the important details of the disease and investigational drug being trialed, in terms of its mechanism of action on the body.
Ensuring Real-World Representation in Trials
Although the over-65s are the fastest-growing proportion of the population worldwide, we lack significant information on the safety and efficacy of treatments for older patients.
A key misconception we frequently hear about at Longboat is that older patients consider the increasing use of technology in trials a barrier to participation and will not engage with digital technologies. Mounting evidence, however, demonstrates that this is simply not the case. In fact, as older adults become more digitally savvy, technology could hold the key to better engagement of this demographic.
Ensuring Technology is User-Friendly
As everyone who has ever had a bad experience with a website, application, or device knows too well, technology only offers a good solution if it makes life easier and does not create an additional burden.
In a world where patients, site staff, and study team members are engaging with new clinical trial technologies to support them in conducting clinical trial activities, it is critical that the technology does not frustrate the key trial stakeholders and result in delays, confusion, or non-usage.
Check out our top ten key user interface design considerations for clinical trial technologies.
Future Clinical ‘Smart’ Technologies
Gains in computing power are spurring new paradigms within clinical research, such as in silico clinical trials (ISCTs), blockchain-based trials, AI for patient recruitment, and digital pills. Some organizations are running trials without actual patients and drugs, instead using ISCTs to help them analyze diverse datasets and explore alternative study designs.
We take a closer look at the “mysteries” of blockchain and AI in this blog-post: Clinical Studies with Smart Technology.