Are (All) The Right Stakeholders Involved In Patient Recruitment For Your Clinical Trial?

By Maya Zlatanova, cofounder, FindMeCure

Can patient recruitment for clinical trials be more efficient with more involvement by patient relations and market access directors?

It’s not a secret that recruiting patients for clinical trials is one of the biggest challenges the industry has ever known. There hasn’t been a single clinical research industry event that hasn’t discussed the problem, as well as solutions that can help clinical operations and site management professionals handle patient recruitment and meet their deadlines. While a lot has changed in the last decade, statistics show it is getting harder and harder to find and maintain a sufficient number of eligible patients in clinical trials. This is happening while the number of patients is increasing.

I have been involved in multiple projects to help with patient recruitment, and I know one thing – there is no magic bullet to solve this problem. Perhaps the secret lies, like in many diseases, not in the cure but in the prevention.

This is also the conclusion of more than 30 conversations I had with patient relations and market access directors from 10 of the top pharma companies over the last six months. You might ask why we care about their opinions on patient recruitment. In fact, clinical trials are the responsibility of R&D and clinical operations. We often forget, though, that the final goal of clinical trials is to get new approved products to the market. These are the people who are in charge of aligning the company’s clinical operations with the market requirements and making sure clinical trials are a worthy investment. However, there are three main barriers to their greater involvement in the process:

1. How Clinical Trials Are Planned

No matter how innovative the pharma company is, the process of planning a new clinical trial is pretty much the same. The biggest priority is the science behind the clinical trial. Next come the manufacturing capabilities and distribution channels of the company. This is a high-level overview of how the decision to invest in a new clinical trial is made.

The next important step is feasibility research. Clinical operations directors usually want to know: What is the opportunity in a given country to recruit X number of patients before a certain deadline and what will be the cost/deadlines? The big CROs tend to have exclusive partnerships with sponsors to provide these services on an international level and this is a preparation for a study start-up. Local companies can contribute with more local expertise – regulatory requirements, local key opinion leaders, and site networks. Both types of organizations provide mainly information on sites they’ve been working with, their number of patients, not taking into consideration the number of competitive clinical trials at the very same site and usually not including new sites (usually due to lack of time for research or resistance from the sponsor), and very often estimating a screen-failure rate that is over-optimistic (with the help of the investigators’ judgment). This leaves a huge number of patients without the opportunity to take part in the clinical trial, not to mention the risk of not meeting your deadlines for patient recruitment (which happens to 80 percent of clinical trials in the United States according to the NIH).

When speaking with patient relations or market access directors, they mention that it might be helpful to get the support of international and local patient communities, as well as doctors’ groups, before planning the clinical trial, as this will also answer the following questions:

• Would doctors support the new product?
• What will be the challenges for patients to access the new product?
• Who will be the best advocate for the new product? This includes not only key opinion leaders but also communities, mobile applications, service providers, etc. This is important not only for the distribution of the product down the road but also in the early days, as this will allow identifying early adopters of the new treatment who will be the clinical trial participants.

These questions cannot be answered just by doing site feasibility; it takes deeper market research, combined with patient feasibility, to connect all the dots and create a strategic and successful plan for recruiting patients and managing the clinical trial. These are all answers that these professionals might already have due to the fact that many of them are being asked for the country/region landscape in order to provide local expertise for clinical trials.

2. Little Measurable Support For How Patient Engagement Activities Address The Needs Of Patient Recruitment

All patient relations directors mentioned they are convinced that engagement with patients and patient communities will improve the clinical trial design and performance. As stated above, it will improve their understanding of why people would join or support a clinical trial and the reasons for not doing so. However, when they speak with clinical operations teams, clinical trial experts expect actual numbers and time estimates. Patient engagement has been a trend for the last several years, with only a few companies actually investing time and budget to create something sustainable. Most directors responsible for that don’t always have the numbers to show how engagement with patients speeds up the process of patient recruitment, at least not yet. There are not enough case studies to support this hypothesis. They all mentioned the best way to prove the patient engagement value in clinical trials is to have two similar studies and compare them. The directors would also like to see cross-industry support and be able to share more success stories that can encourage other companies to work in the same direction. Once this is done for several clinical trials, we will know exactly how much improvement can be achieved, and it will be a no-brainer to decide how much to invest in patient engagement.

3. How Clinical Operations Teams And Market Access And Patient Relation Directors Communicate

Or don’t communicate? This is the case in most companies. These experts shared that they could contribute to the clinical operations “if there was a system to allow them to share feedback and provide suggestions.” In large or even medium pharma companies, like in other big organizations, internal communication is often a real challenge. In some cases, this is normal, but it is very often the case that some of the mistakes made during clinical research can be prevented by using internal market know-how.

Market access directors usually know very well the network of doctors within a specific country. They speak to each other often and attend the same events. They could provide information to identify who will be the first supporters of a clinical trial; what, in their opinion, the challenges will be; and even ideas on how to improve the design. An example is a Phase 3 clinical trial on early breast cancer. The clinical trial team selected more than 55 sites across Europe, but after a year, the sponsor and CRO realized they were having trouble finding enough patients (due to the tight eligibility criteria). Though they tried different strategies after that, it turned out that the only way to get more patients was through their specialists, and the specialists were not happy to refer patients if they were not involved in the trial. So, a referral strategy did not work out well in this case.

Patient relations directors’ job is to be among patient communities. These communities are the first door to understanding patients’ local challenges and potential interest in a new solution (aka clinical trial). They can also describe the burdens patients have in their daily lives, which can contribute to finding the best schedule for the clinical trial. For example, a clinical trial from last year (rare disease), took place in multiple European countries, including Poland. The clinical trial team there had the idea of having remote nurses go to the patients’ homes, decreasing the number of visits the patients made to the site. It turned out that patients were so used to going to the hospitals (at least once a week) due to their condition and so attached to their doctors that they were not happy about the reduced frequency of site visits. As a result, they were not interested in joining the study (they felt they would lose control over their condition). This could have been prevented by members of the local communities who understood the patients’ psychology and knew how much they care about their specialists.

Miscommunication or lack of communication between the different departments of a pharma company can come at a great cost, including not only delays but also actual failures. Some of the industry’s leaders, like Novartis, Merck Group, and Roche, have realized that and are working on a system to bring multiple experts together. Some of the measures they are taking that might be valuable to other organizations include:

• Consolidating data into one general hub and creating multiple platforms to allow experts to access information and analyze it from different perspectives. (Roche, for example, uses this not only for enabling different departments to work better but also to speed up clinical trials by removing the need for placebos in their studies. This makes them not only faster but also more patient-friendly, which also contributes to better patient recruitment.)
• Regular meetings and platforms to allow market access, clinical operations, and patient relations representatives to meet together based on therapeutic area experience.

Conclusion

The challenges that we all have with patient recruitment require some serious measures and restructuring. Sometimes, when we discuss solutions, we forget that it is not only about getting more patients to volunteer for clinical trials, we also need to take into consideration study design, site training, engagement with patient and patient communities, and, as shared above, the involvement of more people who are familiar with the entire journey of doctors and patients. This is not only helpful for clinical trials, it also ensures alignment with the company’s long-term goals and helps achieve greater efficiency. Market access and patient relations directors have KPIs not directly related to clinical research, yet they can benefit from thinking about new products earlier in their development process, which makes the collaboration between them and clinical operations teams mutually beneficial.

About The Author:

Maya Zlatanova is a business development expert with more than 10 years of experience in the clinical research industry. She has done regulations training to some of the biggest pharma companies, as well as to the United Nations and Ministries of Health. She is a cofounder of FindMeCure, a global platform transforming the way people find, understand, and join clinical trials, and is a board member of the Patient Empowerment Initiative Committee at the Alliance for Clinical Research Excellence and Safety (ACRES).