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From Patient-Centric to Patient-Driven Trials

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Patients have increasingly more influence in clinical trials. There is a growing impetus within the clinical research industry to understand patients’ needs and engage them throughout the clinical development process, as well as giving them the freedom to choose what’s right for them.

As patients become increasingly aware of the available options for improving their quality of life, we must listen to and understand their evolving needs and concerns. Only then can all stakeholders work together effectively to meet those needs.

Our VP Patient Engagement, Valeria Nicoli-Carr delivered the following presentation at the virtual Pharma & Patient Europe 2020 conference on 15-16th September 2020. 

In her presentation, Vale discusses:

  • How the clinical trial paradigm has evolved, and how it is shifting
  • The role of the “informed patient” in clinical trials today
  • How we can work together to better address patients’ needs
  • What role each clinical trial stakeholder will play in the future

Watch the full presentation here:

Read the presentation transcript:

Clinical trials have been fundamental in fostering the development of new treatments in medicine, and they are continually changing. Many changes have been shaped by historical events.

In 1747, a trial conducted by a Scottish doctor, James Lind, was regarded as the very first clinical trial to ever take place. Dr. Lind was on a ship, and during the voyage it was noted that many of the sailors were getting ill with scurvy. He decided to treat some of the sailors with citrus fruit to see if this had an impact on their physical health. He discovered that the sailors eating the citrus fruits were recovering much faster than the sailors not having any of the fruit. This simple experiment is still regarded today as the first clinical trial, and it’s interesting to see how clinical trials have evolved from that point to today.

In 1947 the Nuremberg Code was created. This was important because it made voluntary consent mandatory for those taking part in clinical research. This was a very important development because consent had not been mandatory up to that point.

Another important event took place in 1948 – the iconic trial of the streptomycin for pulmonary tuberculosis, considered to be the first modern randomised controlled trial. This marked the dawn of a new era in clinical research. The Declaration of Helsinki followed in 1964, which meant that for the first time, all the ethical principles of clinical trials were codified.

In 1976, the Tuskegee Syphilis studies took place, in turn leading to the Belmont Report which focused on increased protection for human research subjects and defined informed consent in different research settings. Finally, the current COVID-19 pandemic will surely be one of the key events that has shaped, and is still shaping, the clinical trial design process.

Often, we talk about the “new norm” that has been brought about by the COVID-19 pandemic. As a company we look after thousands of patients involved in hundreds of studies, and recently we have seen a massive spike in the use of telemedicine. This is the ability to send drugs and medicinal products to patients’ homes.

We are seeing many more studies happening at home, and with the help of research nurses and new technology, patients are able to continue being part of a trial, even if they’re not able to attend a hospital or testing site. With a lot of consent being gathered remotely, it is helping patients to still be part of a trial without having to physically go into the hospital. 

A lot of our studies are now moving towards a fully digital experience, and if somebody had told us six months ago that we would be at this point now, we wouldn’t have believed that! But we’ve seen a massive transformation in the way that clinical trials are conducted, and how patients are responding positively. They still want to be part of the trial, they still want to be part of the research, and they’re willing to explore different options that six months ago were not available to them, or were perhaps too difficult to be implemented.

The same has been seen at the sites – which are very open to remote monitoring – with the use of new technologies ensuring patients are safe in their home environment and they can continue to be part of the trial.

At the very beginning of the pandemic we saw a massive halt in non-COVID related trials, with around 80% of trials being stopped or interrupted. But we were still able to make sure patients could carry on with the research in a different sort of setting, either at home or with the use of telemedicine which allowed the trials to happen in a decentralised way.

More recently, we have seen a spike in COVID-19 trials, with nearly 3,000 clinical trials related to COVID-19 being registered with ClinicalTrials.gov since December 2019.

So, we are definitely seeing a massive shift in the way that clinical trials are conducted and we are very busy because of that. We are seeing a different kind of experience from a patient perspective, from a site perspective and from a pharmaceutical perspective. In a way, the COVID-19 pandemic has allowed a massive acceleration of technology, and a massive step forward in terms of how clinical trials are being conducted. Not only are clinical trials now conducted in a different way, and the design is now different, but we are also seeing different sorts of patients taking part in trials. 

We have talked a lot about patient-centred trials and about patients being better informed, and it’s clear that the development of a patient-centred approach to medicine is gradually allowing more patients to be involved in their own medical decisions. Patients in general are more informed about their conditions and about what is available to them to help improve their quality of life.

We can clearly see that doctor and patient relationships are changing. We can also say that this change is not happening at the same rate in clinical trial research where the research is still performed ‘on’ patients and not ‘with’ patients, where patients continue to be regarded as a source of data and not as the true protagonist of the process. But what we are now seeing is a gradual shift towards patients being more informed, and patients being regarded as investors or clients to pharma companies. They are considered as key stakeholders of the process. This together with the expansion of information technology is really accelerating the evolution of clinical trials.

Not only are we seeing a massive change in terms of how clinical trials are actually conducted, but also a change in how patients are responding. When patients are better informed and more aware of their options, pharma companies really start to consider patients as a real investor and make sure that the patients are involved at every stage of the clinical trial process. With this approach, we can better address patients’ needs. We are setting priorities with patients and we are seeing more patient groups involved in study leadership and design.

On a general level, we can say that clinical trials are more available to a wider population. Access to clinical trials is being improved, with groups focusing on patient education allowing patients to understand clinical trial terminology which bridges the gap between clinical trials and the patients.

Something we are experiencing as a company is that patients are now more involved not only in creating and reviewing the patient-facing documentation, but they are also involved in evaluating their own experience. We’re collecting feedback from patients about their trial experience, and this is a crucial part of what we do, making sure that all of that information is fed back into the study trial.

At the same time, patients are also more aware of the results. They want to know what’s happening with the data, and they want to make sure that the time they are giving up to take part in clinical trials is helpful for other people suffering a similar or the same condition. So it’s important to make sure patients are involved at every stage and are kept informed – not only about the trial itself but also the results in order to help the patient population to improve their condition. 

As we consider the future of clinical trials and how new technologies are shaping the design of new clinical trials, we must also consider the increase in the volume of different data sources. Many companies are now gathering information from different kinds of data sources such as wearable devices or other remote patient monitoring techniques, and this leads to higher complexity in terms of the data collected. This is one of the challenges that many companies are facing right now. When they have a lot of different sources they need to make sure there’s consistency, and that the data is clearly readable and clearly integrated into the clinical trial process. 

What we are seeing on the horizon is an increase in decentralised trials with global access, and trials being fully managed at home or in a remote environment with the use of technology. But also we expect to see studies becoming more global, more diverse, and more inclusive. We hope to see a change that ensures minorities and diverse population groups are not only included in trials but have full access to the research and the results, and that they’re fully integrated into the clinical trial process. 

In summary, this is what we are experiencing now as a company through talking to our clients, our sites and our patients. If you would like to discuss your clinical trial needs further, please feel free to reach out to us or have a look at our website, and we will be very pleased to discuss any kind of needs or queries you would like to address.


Looking for more support with patient engagement and retention services?

Our personalised patient retention services and technologies support patients, their families and carers, and healthcare practitioners at each stage of the clinical journey. 

On average, 18% of randomized patients drop out of a clinical trial, costing three times the amount to replace them as it did to recruit them. It doesn’t have to be that way. 

By putting patients first at every stage, our services are designed to target the reasons patients fail to join or drop out of a clinical trial, improving recruitment and drastically reducing patient drop-out rates.

From small rare disease studies with very specialised patient needs to large-scale trials with simpler patient logistics, our services can be tailored to meet the specific requirements of your patients, with the flexibility to adapt to changes as they occur. 

To discuss your clinical trial requirements and learn more about mdgroup and our patient services, get in touch by emailing info@mdgroup.com