Clinical study planning: the need to engage with patients sooner

Research suggests that most clinical studies fail to meet recruitment targets by the deadline originally specified. Even once studies have successfully recruited patients, some people choose to stop taking part. So, it seems clinical study sponsors still haven’t mastered how to run a successful study in this regard. Why is this still the case if the first randomised controlled trial was in 1946? Perhaps the industry needs to take a step back and consider who are really at the heart of clinical studies: patients.

It’s highly likely that clinical studies are deterring patients based on decisions made in the early stages, such as during planning and design.

COUCH Health has previously discussed the importance of understanding the patient journey here. This can help us to optimise the patient experience and make it more likely that patients will both join and remain in a clinical study. We need to think about the very beginning of each patient’s journey. Their life before the diagnosis, experiencing symptoms, the diagnosis itself and reaching a point where they can consider joining a clinical study. All with the end goal of maximising the quality of clinical research and benefitting other people in the future.

Clinical study design

If we don’t involve patients from the very beginning of study development, how can we expect the study to be relevant to them? And if it’s not relevant, patients won’t be engaged, motivated or able to join a clinical study. If they do enrol, maybe they will end up dropping out. From inclusion and exclusion criteria to the number of assessments and appointments, patients need to be at the core of the decision-making process.

Inclusion and exclusion criteria need to be aligned with safety and ethics, and reflect the questions that researchers are looking to answer. But it is possible that the criteria for some studies are too strict; organisations are unknowingly making it even more difficult for a patient to join a study by not considering the characteristics of that patient population. If a patient and those close to them are reading information about a study, it seems obvious that they will be put off if they have to travel to the study clinic on a regular basis. Reducing the number of appointments to the fewest possible (while still being able to meet endpoints) will make patients more likely to want to join and continue taking part in a study.

Patient reported outcomes (PROs) have gained increased attention over the years; studies can raise their credibility by publishing PRO results. Most importantly, patients would often prefer to be asked about PROs than studied for physiological or pharmacological changes. PROs are more meaningful to some patients and can reflect how they truly feel about living with their condition. Poor or altered quality of life is a huge impact of many conditions and some people are more concerned by this than physiological effects.

Recruitment

It’s time for organisations running clinical studies to revolutionise their strategies. To maximise patient engagement, we need to stay up to date with technology and get creative. Continuing to think about the patient journey – patients are now at a point where they could join a study. Why would they want to sign up? How do they like to receive information? By making sure we know the answers to questions like these, we can increase the likelihood of successful recruitment. We need to make sure patients and their support network have enough information to fully understand the study and whether they really want to take part.

Informed consent

Informed consent forms are often lengthy, technical and complex. How can people be expected to truly engage with materials when their perspective is not considered? Can materials written and/or designed by those working in the pharmaceutical or healthcare industry be the most effective if patients have not been involved? It is paramount that clinical studies involve patients and the general public when preparing any written materials. It is not just about making a document easy to read (avoiding complex scientific terms and jargon). It is about showing understanding of what people truly want and need and what might motivate them to join a clinical study. What can you do for them?

The industry needs to do more

Engaging with patients earlier in clinical study planning should lead to clinical studies being more successful. Most importantly, it is gateway for organisations running studies to truly become patient centric.

If you want to know more about the different ways you can improve clinical study enrolment through patient centricity, download our white paper here.