Delivering for patients and sites in 2025

As I look at 2025, and try to see what will happen in the world of clinical trials, it is important to see the progress we have made. As many of you are aware, I have been speaking about the importance of treating the patients in trials as the heroes they are and recognising the importance of the contribution they make for the greater good in improving the human condition.

In 2024, we have definitely made progress in terms of putting the patient at the centre of our thinking about clinical trials. More and more pharma companies have Chief Patient Officers and patient advocacy liaisons. But that is not enough. I would like to think that we have a great opportunity to improve upon what we have done, but I think it is going to take a slightly different approach.

I have also learned that predicting the future is more of a sideline activity, meaning observing what companies are doing, instead of being in the game and actually influencing what could happen. I want to look more at what is needed and how that can happen, rather than what I think will happen if we just watch. I believe that, as a technology company, we can, along with others, encourage the necessary change and direction.

Consistent, emerging messages

In the many discussions I have had with sites, patients, CROs, pharma, and biotech companies and more, consistent messages have emerged.

First, protocols are more complex and are targeting smaller populations. This puts a huge emphasis on recruitment, screening, consenting, and retention. Each patient is more valuable than ever.

Second, the adoption of more and more technology is making the sites’ jobs exponentially more difficult. Not only do they need to adhere to the complexity of the protocol, but they also need to be versed in provisioning technology to the patients and using technology themselves. Most sites are not set up to provide the level of support to accomplish that.

In order to effectively move forward, I see 2025 as an important year. As I look at the challenges, I think that the relationship between the site and the patient is the most important relationship in a clinical trial, and it is our job as technology providers to give both the patients and the sites tools to bolster that relationship.

The relationship between site and patient

Sites are primarily responsible for recruitment, consenting, and enrolling patients to get the trials started. I think 2025 will see a wider adoption of consent management solutions, whether that is eConsent or managing all the paper. Since the trials are getting more complex, the patient understanding what they are signing up for is more important and the consent process is front and centre to that. It is also the consenting process that tends to set the tone for the patient journey throughout the trial.

Next is the screening process, which is becoming more complex for many trials. Establishing a baseline to see if patients qualify for a study is key. Much of that selection is based on exams, co-morbidities, previous treatments, and current medications, but there is a growing area where the screening is done through patient-reported data. For example, sleep studies or pain studies need to establish a baseline over time to see if the person qualifies. That is often done now by providing the patient with technology in the form of ePRO, which would either run on their own device or a provisioned device and would be used during the screening phase. This must be easy for the sites to manage, and the sites will need to see the patient’s data frequently to know if they qualify.

Once the patient is enrolled, the challenge becomes making the patient comfortable with the trial and setting up a schedule of visits, as well as questionnaires that need to be filled out if ePRO is involved. That process needs to be easy for both the sites and the patients, in providing technology as well as planning the activities of the trial.

Setting up the patient’s schedule, deciding what activities are done in the clinic versus what activities can be done from home, arranging the transportation to the clinic, and making sure the patient has adequate technology in their home to conduct virtual visits is key. The site also needs to continue to engage with the patient on an ongoing basis. This is the vital component in establishing and bolstering the relationship between site and patient. The patient needs a way to stay engaged in the trial, and the site needs to act on any patient in danger of dropping out.

I believe that, in 2025, we will see more patient engagement technology adopted, even where ePRO is not required. This would enable the patient to let the site know how the trial is affecting their life, and it would enable the patient to get information about the trial, what is next, and what is required for them to do.

In conclusion, I see 2025 as a year in which the patient will still be centre-stage. But, in order for that to happen effectively, the site is going to need tools to allow them to engage well with the patient, so as to keep them a willing, active, and compliant participant in clinical trials.