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Real patient voices

The #Human behind every number project


Question (Q): What does ‘patient-centricity’ mean to you as the CEO of a contract research organisation?

Mike Jagielski (MJ): Patient-centricity is a very broad term and is one that is often used by the life science industry. For many, patient-centricity in general terms means recognising patients as active collaborators in studies and trying to engage them with different tools and solutions to improve their clinical trial experience. However, what we try to provide for patients often may not resemble their true needs. For example, it is difficult for me to imagine that offering a mobile app to a 70-year-old oncology patient with a simple background to support his treatment in a clinical trial would be of any real use

To find out what patients really need, we decided to go one step further and engage directly with those who have been or who still are participating in clinical trials, to learn about their experiences. This is how the project #HumanBehindEveryNumber was born. The idea behind this initiative was simple yet innovative: to listen to real patients’ voices and perspectives and to learn about patients’ motivations, concerns and convictions when participating in a clinical study.

We have contacted patients in many countries and what we have learned during this project was amazing. We have collected and collated real patient accounts, witnessed their different emotions and learned about their clinical trial journeys. It has been a truly incredible experience.

Q: What was innovative about your approach and your views about patients who participate in clinical trials?

MJ: The whole project has been dedicated to understanding patient requirements. Therefore, we approached the patients directly and established close contact with them to listen to real accounts of their clinical trial experiences. Also, the methodology we applied was important.

KCR has teamed up with a service design firm, The Story, to apply a service design methodology in this project. It means that a clinical trial has been viewed as a service and a patient as a client. Applying this methodology enabled us to fully map the patient’s journey when participating in a clinical trial and understand the emotions associated with each stage.

The project team organised interviews and workshops with patients to understand how they feel when making a decision which will affect their life and health: whether to participate in a clinical trial - how they feel when being treated with a new drug, the questions they have, the answers they need and the information they’re given.

The entire process has shown how clinical trials are seen from a patient’s perspective. The project team has recognised six stages that patients experience:

  1. awareness of clinical trials in general
  2. verbal explanations about their specifics
  3. document verification
  4. deciding whether to join
  5. taking the first steps in  the clinical trial and
  6. monitoring the process.

Each stage is associated with different emotions, recognised as optimistic, neutral and reserved. Mapping these emotions is crucial to support patients when they experience the clinical trial journey.

Q: Why was it so important to talk to patients from different countries?

MJ: The project was run across different countries to enable us to interview patients with different nationalities, backgrounds, ages and indications. We wanted to consider different healthcare systems, cultural contexts and different people’s attitudes towards doctors and researchers.

Every meeting was well prepared and led by a researcher and facilitator in the local language. We visited Ukraine, Poland, Bulgaria, Germany and the US and met patients to hear their stories. We also listened to researchers, academic representatives and thought leaders. Gathering these views empowered the project team to build a comprehensive picture about the clinical trial journey from the patient’s perspective.

Q: Who is this project dedicated to and who do you think will benefit from the work you have done?

MJ: Our aim is to share the results of the #HumanBehindEveryNumber project with the whole industry and at the same time initiate a discussion about what patient-centricity really means and how it might influence the future of clinical trials.

In our opinion, gathering and understanding patients’ direct experiences as they go on the clinical trial journey will help the industry to better design clinical trials in the future. The project #HumanBehindEveryNumber helps to identify which stages of the clinical trials are more demanding for patients, what might affect a patient’s decision to participate in or continue the study, what can be improved or approached differently. The results from all the information collected will translate into a better trial design, more efficienct use of time and successful market entry of a new treatment.

For patients, the project has educational benefits by providing them with first-hand experience of what clinical trials really are. The video platform with unique content from the projects - interviews with patients - gives other people’s views, shows their experience and shares their emotions. Real stories from real patients offer them an opportunity to learn more about the clinical trial process and help them make their own decisions.

Q: What was a direct result of your research?  

MJ: The main question we want to answer with this project is: what does patient-centricity really mean? What does it mean for the industry? What does it mean for patients?

Q: What conclusions can you share with the industry?

MJ: After conducting the direct dialogue with patients and mapping the patients’ journeys and emotions, the first conclusion was that patient-centricity means diversity. Therefore, true patient-centric solutions require a high degree of customisation.

Some factors to be considered for a successful design of patient-centric solutions are region, country specifics, educational background, age and therapeutic area. All these factors can help to address patients’ concerns about clinical trials and help to make patients feel more comfortable. It is very important to be aware of these concerns as they are closely connected to the recruitment and drop-out rates of clinical trials participants.

Q: Why did you name the project #HumanBehind

MJ: The #HumanBehindEveryNumber comes from the KCR tagline: We see a human being behind every number. We all know that clinical trials are based on collecting data that is crucial for the testing and evaluating the potential of medical solutions. However, we must remember that behind all this data there is a human being with a story, emotions and disease journey. Therefore, a true patient-centric approach is to put the patient in the spotlight and map the clinical trial journey from her or his perspective.

Our #HumanBehindEveryNumber project is ongoing and we would welcome partners and cooperators who would like to share further research with us so we can learn more about patients in clinical trials.

Article by
Mike Jagielski

is CEO of KCR, a contract research organisation

19th January 2018

Article by
Mike Jagielski

is CEO of KCR, a contract research organisation

19th January 2018

From: Regulatory



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