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Patients are the most important stakeholder in the whole clinical trials process. For people outside the industry, this may seem like an obvious statement – so they would likely be surprised how little involvement there has traditionally been for patients in the trial design process.

It’s undeniably the case that, without patients – trial participants – there would be no clinical trials. And consequently no drug development or pharmaceuticals industry.

So it’s good to see a move in recent years towards true patient-centricity in the design and operation of clinical trials – rather than simply paying lip service in a ‘checkbox exercise’.

Patients are volunteers in the process and should really be regarded as a trial’s most valuable asset. They are – after all – giving up their time, and putting their physiology on the line, in order to help develop better treatments and healthcare outcomes for us all.

Patient recruitment solutions providers – or vendors – are brought in to increase the number of participants engaged with a trial. They usually focus on the elements of finding and engaging with potential trial volunteers, then implementing some form of pre-screening process, before handing those people over to the research site for full screening and consenting.

One of the main methods that solutions providers use for recruiting patients is through advertising – both digital, such as through social media, and traditional, such as through newspapers and radio.

As well as this, the firms may utilize additional outreach strategies – for example, to healthcare professionals, community organizations, and patient groups.

Research sites have traditionally been skeptical of central advertising campaigns from patient recruitment firms that may be forced on them by the sponsor or CRO. But the good solutions providers are always a valuable addition to any trial.

Research sites are the front line of the clinical trials industry. Despite the large amount of discussion around Decentralized Trials – DCTs – especially since the advent of the Covid pandemic, the overwhelming majority of trials are still conducted at research sites.

These can be large institutions, such as hospitals, or smaller sites – which primary care physicians may also work from.

The sites carry out the necessary procedures as outlined in the trial protocol – for example blood tests, physical examinations, recording of trial data etc. – as well as serving as the primary point of contact for the trial participants and other stakeholders.

A key element of a trial that a research site will be responsible for is to go through the Informed Consent process with patients. They will also ensure the trial is conducted in compliance with the stipulations for Good Clinical Practice.

CROs – Contract Research Organizations – are brought in by the trial sponsor to administer and manage the trial. Their core role is usually project management and overseeing the day to day operations of the trial. They may also have some input to trial and protocol design, and may advise on the various regulations in place in the regions where the trial is being operated.

CROs are often tasked with recruiting and retaining patients. This will likely involve them going back to research sites they’ve already worked with who they believe may have relevant patients that would qualify for the trial. And sometimes they bring in a solutions provider to augment these activities. In particular, the smaller, boutique CROs are increasingly likely to collaborate with solutions providers rather than present themselves as a one-stop shop in the way the larger organizations often do.

Sponsors are the fundamental drivers of clinical research. My own experience with them is primarily dealing with commercial drug development organizations, such as pharma and biotech companies, or medical device developers.

Outside of these, some trials are sponsored by government agencies – such as the NHS in the UK – hospitals or academic institutions, charities, patient groups, even sometimes physicians who set up what’s known as Investigator-Initiated Trials.

Sponsors are especially interested in having an effective and efficient patient recruitment process in place. If the trial can’t recruit enough patients, and have them stay on the trial to completion, the sponsor can’t submit their treatment for approval and ultimately start generating revenue from it.

The level of funding required for a trial can make it a very expensive operation to be involved with, so sponsors are always keen to get the maximum return from their investment.

There are various stakeholders involved in the operation of a clinical trial. The trial will ordinarily be initiated and funded by a sponsor – in the commercial sector this is usually a pharmaceutical, biotech, or medical device company – who is ultimately responsible for the trial.

Most trials will utilize the services of a Contract Research Organization – a CRO – to set up and oversee the research on behalf of the sponsor.

Even in the era of Decentralized Trials – DCTs – the vast majority of trials are conducted at research sites.

Many trials will also utilize the services of a patient recruitment solutions provider – in order to attract people to take part.

And then there’s the key stakeholder – without whom the whole industry wouldn’t even exist – the trial participant. Commonly referred to as the patient.

In the next few videos I’ll look at each of these stakeholders in turn.

I went to Wimbledon for the tennis recently, and I was struck by a system they have in operation for allowing people to queue for returned tickets, in order to get as many people in to watch the matches as possible.

It got me thinking that having an effective wait list system in place for trials would seem like a good idea. Now, of course, the biggest problem is recruiting enough patients in the first place. But in situations where there are a large number of potential trial participants, I’d say it could make sense to continue with the recruitment process – at a reduced level – even after the required number of patients have been recruited.

This can help you with replacements for the inevitable drop-outs from the trial, plus potentially provide a database of willing participants for future trials in the same area.