As a CRO’s Director of Operations, it is my job to focus on the management of the studies we conduct and to evaluate whether the processes we undertake deliver maximum value to trial sponsors, while safeguarding quality and never compromising on patient safety.

A significant part of this process relates to the best possible interactions with volunteers and patients. As a starting point, it is essential to identify and remove potential barriers to a person participating in a trial by considering the burdens placed on participants and ensuring the research does not unnecessarily interfere with their day-to-day activities and treatment.

Many CROs (and their outsourced providers) make the mistake of assuming they know what attracts and motivates participants to join a study and, more importantly, keeps them on board, often without speaking to patients at all.

Our team has sought to understand patient preferences in more detail by conducting a series of feasibility studies, involving surveys and on-site meetings with patient populations being considered for studies. These studies are frequently performed to continually improve patient engagement. In our experience, the time taken to listen to their feedback has paid dividends. Richmond Pharmacology regularly shares patients’ experiences on a variety of trials through our website www.trials4us.co.uk. These testimonials help others who are considering participating in future studies, as they can garner a more rounded view of the realities and disburse any misconceptions of volunteering.

What emerges clearly is that a personalised experience is hugely important in keeping patients engaged on clinical trials – some which may run over several years.

What does this mean in practice? As an example, ‘John’ from the Isle of Wight explained that the familiarity developed between the couple of taxi drivers allocated to him and consistency in reception and support staff made his experience that much easier. He explained that while journey times may be considerable, he has never felt it to be a hindrance. John also outlined that the flexibility to have hotel accommodation when required is also beneficial.
Other patients making frequent visits to the ward highlighted the importance of a centre being accommodating about how they can use their free time between doses. Enabling private rooms to be fitted with amenities in line with patients’ requests, such as Netflix, games consoles and reading materials, can help individuals to relax and reduces the likelihood of even long waits being regarded as overly burdensome.

More recently, health and safety protocols have also been important to patients visiting a unit. In a COVID-19 world, some volunteers have remarked that they are confident about not contracting the virus, given the rigorous testing protocols they experience on arrival and throughout their stay within the research facility.

While uniformity in process is essential, a ‘one-size-fits-all’ policy should not be adopted when it comes to patients, as they will all have different mindsets, lifestyles and conditions. It is worth focusing more on how condition types can motivate participants in different ways.

One example would be a patient with a rare life-threatening condition who has the opportunity to participate in a trial that will use a ground-breaking gene editing technology for the first time. Identifying and cultivating a relationship with an appropriate patient, or patients, can take time, even when operating in a global city like London. Under these circumstances patients may be apprehensive that the medicine has never been administered to a human, but the prospect that gene editing could potentially transform their lives is an extremely powerful motivator.

This is a markedly different situation to patients with a common chronic condition – diabetes, for example. In this circumstance, our experience with patients suggests they recognise that a trial may not benefit them directly; however, they are often motivated by a camaraderie and a sense of responsibility to their patient group community, as well as future sufferers of the condition, who may benefit from research undertaken now.

Studies involving patient populations where treatment options exist must be managed differently from those where a patient has no other treatment option. The former as described previously see these trials as an opportunity to ‘give back’; however their engagement is typically less self-serving and thus commitment to completing the study may be less than those without treatment options. As a result, the engagement of these patients with the CRO’s team is as significant, if not more so, than those without treatment options, in order to help that patient through the journey and see the trial through to completion.

Investors and trial sponsors need to be confident that patients are retained in studies as high attrition rates cause delays, disruption and additional expense.

There are ways to be assured about this. For example, CROs who do not outsource their recruitment or engagement with volunteers and patients are more likely to be more successful at patient retention as a relationship is built between patients and the centre recruiting the patients and performing the trial. In practical terms, this means retaining in-house expertise in everything from databases and patient records to communication and logistics.

Furthermore, and as borne out in recent patient experience surveys, single-centre clinical research operations also tend to enhance the patient experience. This is because treatments can be administered in a timelier and more coordinated manner, with the same staff available to guide patients through the whole process and – significantly where processes are fixed and consistent – get to know and address the individuals’ concerns and fears, as well as adapting their treatment accordingly. This process builds meaningful relationships which can, in addition to adaptive and integrated safety protocols, provide a human touch, which is crucial to retaining individuals and providing efficient medicine development.

In short, the process of making society healthier starts by creating long-term relationships with volunteers and patients – before, during and after the study – with ongoing engagement programmes that are specific to their preferences and which keep them well-informed and empowered.

The patient’s name has been changed for anonymity purposes.