Q: What do you consider to be the key recent developments and expected trends in this area?
A: Life science and biopharma companies are embracing the idea of dedicated clinical trial websites to dispense everything a patient, healthcare provider (HCP) or family member needs to know about a study. These clinical trial landing pages act as the “mothership” for everything needed to understand who’s sponsoring the trial, what is being tested, who is eligible, where the sites are located, and so on.
Designed correctly, these branded sites can be optimized to rank on Google page number 1 results for the keywords around the study, promoted using Google Ads for rapid enrollment while SEO takes hold, and shared across the web with support groups and alliance partners. Customized doctor database campaigns and social media marketing efforts can also point to these clinical trial websites to promote the science, relay the details, encourage diversity through design and drive patient enrollment.
Other technological advances are making recruitment more cost-effective, innovative and evidence based. An increased focus on patient safety and data privacy in the wake of the COVID-19 has certainly been a major transformation.
Technology is being applied to speed up the subject recruitment process and to automate data collection and analysis. The U.S. Food & Drug Administration’s recent release of guidance for the use of Artificial Intelligence (AI) in clinical trials is interesting, and as of January 2023 there are more than 520 cleared AI medical algorithms available in the United States. AI may be able to identify suitable cohorts for clinical trials by analyzing a person’s social media content, although so far, we are still seeing patients who actively use Google search tend to have better clinical trial participation visitor intent compared to “interruption advertising” on social media. Put simply, those actively seeking information regarding clinical trials are signing up to trials more readily that more casual browsers.
There is an increased focus on patient-centricity in trials. This involves designing trials to be more inclusive of diverse patient populations, as well as providing data-driven insights into patients’ experiences in order to inform better decision making. As a result, many regulatory agencies have published guidance on implementing patient-centered designs, such as the FDA’s Patient-Focused Drug Development initiative.
Finally, the increase in clinical trials and digital patient data are seeing data privacy and security become critical factors in clinical trial designs. Improved data systems, processes and greater emphasis to develop more secure clinical trial websites (e.g., not on platforms such as WordPress, which are more susceptible to hacking and malware attacks) are being deployed to ensure that patient data is securely stored and managed in compliance with legal and HIPAA and GDPR regulatory requirements. In addition, many organizations are implementing blockchain technologies to improve the accuracy and security of patient data. It’s certainly an exciting time for the clinical trial recruitment marketing space!
Q: What can be done to make the public clearer about what drives the life sciences industry and how they operate to reduce fear in relation to clinical trials that may also help with retention?
A: A Google search on a disease to find out how to treat it is a natural first step for anyone recently diagnosed. What is the standard of care? Are there alternatives if standard of care is too invasive? etc. Unfortunately, when traditional methods fail, the next search is for a clinical trial. This goes for the subject’s family and friends as well.
Again, providing a dedicated clinical trial website “mothership” for all information relating to the trial, an excellent way to convey detailed information to audiences. Clarity, transparency and building trust are key. In addition to crafting a visitor journey, Trial AMPlify utilizes an accordion FAQ section in almost all study landing pages to help answer quick questions and answers in a consolidated manner. Subjects, HCPs and others can dive deeper using links to additional information and content from there if they like. Everyone needs to be onboard with a person’s decision to participate in a study. Dedicated clinical trial websites make this possible.
Q: What can companies do to involve patients more throughout the whole process, for example should they be transparent about everything including funding?
A: Recruiting a patient for a clinical study is only the first step of the journey with them. It’s important that we hold on to that person to ensure they do not abandon the trial prematurely and guide them through each stage of the process. Patients may leave for a variety of reasons. We examined the eight main reasons why patients leave a study early in a recent blog post: Why Some Patients Abandon Clinical Trials Prematurely.
To combat this and to be more transparent with the patients, we encourage our clients to invest in Subject Enrollment Support Materials. These support materials can take the form of brochures or mailers that are provided to enrolled subjects. Questions and concerns are raised and answered early in the study to help the subject deal with what might be a sometimes long and uncomfortable journey. This is also a great way for sponsors to convey empathy and appreciation.
Timing the dispense of these support materials is also key. We recommend support materials ahead of study treatment, in the middle of treatment and just before the patient crosses the finish line. These branded study materials can offer encouragement along with support groups and phone numbers to make sure folks feel like they’re part of the system, not just a number.
Q: What key things could remove the barriers to enrolment and retention?
A: Incorporating success stories can inspire and encourage participation and sticking with the program. There is nothing better than sharing the personal journey of a patient and their successful outcome. Doing so in a video, online, print or all of the above is very effective. If a study is in phase one, and no stories are yet available, a general ‘clinical trial’ journey narrative might be considered. This shows the patient they are not alone in their fight, and that many others in similar shoes have stepped forward and elected to be part of a trial.
No one can truly know the fear, uncertainty, or doubt (FUD) a subject may have. There could even be a family member who is against participation in any clinical trial who is pushing back on the subject’s participation. Giving patients support, hope and inspiration early on during their investigation-phase is an excellent way to connect and encourage them on their journey.
Q: What are the specific challenges still to be overcome with clinical trials involving children?
A: Clinical trials involving children remain a contentious issue, particularly due to the ethical considerations involved when assessing them as participants. Children are often considered more sensitive to treatment effects, and as such, special sensitivity is needed when designing trials with them. There are several challenges that need to be overcome in order to ensure that the trials are conducted safely and effectively.
Proper dosing based on body mass and metabolic rate of children are different than those of adults. Children are also growing and developing. The effects of the medication or treatment must be monitored as they age to ensure that the dose remains appropriate.
A second challenge in clinical trials involving children is the need for informed consent. As minors, children may not be able to fully understand their rights and risks when it comes to participating in clinical trials, making it difficult for researchers to obtain informed consent from them. In these cases, researchers must involve the parents or guardians in the process to ensure that the trial is conducted ethically. Should children be made aware and at what age?
Clinical trials involving children must also consider the long-term effects of the treatment or medication. Due to the short lifespan of a patient’s childhood, it can be difficult to determine the long-term effects of a particular drug or treatment before they can reach adulthood. Therefore, researchers must take extra care when conducting trials with children, making sure to monitor them throughout the process and conducting long-term follow-up studies in order to ensure that the long-term effects are known and accounted for.
Q: In your opinion should there be a universal or national patient identifier?
A: That’s a tough question to end on! Imagine a world where all of your medical information is centralized, simplifying the process of sharing your medical records and making medical care more efficient, regardless of your location. The flip side to that, of course, is concern over data being hacked and compromised. How many times do we hear in the news that a major corporation or government entity database was compromised? What are the ramifications for a generation of folks who have their health data seized?
A universal or national patient identifier could be a useful tool for improving healthcare if the potential issues and implications of such a system are identified, addressed, and managed properly. Ultimately, all citizens have a right to know and should be aware of the implications of such a system and should make sure that their data is kept secure and private, regardless of the implementation of a universal or national patient identifier system.