One of the words that have been buzzing around clinical trials over the past few years is ‘patient centricity.’ As the rat race continues for pharmaceutical, biotech and medical device companies to be the first one with a new cure, medicine or technology on the shelves, it can be easy to lose sight of the real reason clinical research started in the first place – the patients.
There has been a fair bit of controversy over whether real ‘Patient Centricity’ can be delivered if there is not a universal definition of the phrase. However, there are many approaches that can be implemented throughout a clinical trial that can improve the patient’s experience, ultimately enhancing the trial. Including patient preferences into a trial can also have a positive overall outcome in the respect that patients feel more invested in the trial – if patients are more invested they are more likely to adhere to the trial plan.
A lot of trials miss opportunities throughout the entire process where patients can be included – two of the most obvious areas are at the beginning and the end. There are numerous ways to include patients prior to when the study begins. There has been a rise in the number in patient advocacy groups – in Europe especially; consulting these groups before writing the protocol can help to shape your trial early on.
Educating patients on your product can be advantageous to your trial in many ways. EUPATI (European Patients’ Academy on Therapeutic Innovation) provides scientifically reliable, objective, comprehensive information to patients on medicines research and development. Groups such as EUPATI can help patients connect with your trial. If more patients understand the drug, there is much more likelihood of their participation.
Additionally, it’s worth educating non research physicians on how to refer patients to a clinical trial. There is an untapped pool of patients that are perhaps willing to get involved in trials, however, they are unaware there are relevant trials taking place.
There is an increasing amount of innovation through technology whereby patients are able to report, measure and keep track of their medical status from home. Hereismydata is an example of just that – patients are able to connect all their health data into one ‘dashboard’ that they are able to control and can gain insights to help them manage their own health. There are technologies similar to these that can be incorporated into your trial, which enables the patient to have more control over their medical treatment. Similarly with the innovation in smartphones and the connectivity of devices these days there is a lot of potential to include these into your trials.
Considering patients post trial is also very important. At Arena International’s Outsourcing in Clinical Trials New England conference in 2015, the programme featured a patient panel discussion. All of the patients noted the lack of feedback once the trial was complete – they were not given any reasoning for the trial not being continued or if it had worked. There are numerous simple things companies can put in place to show their gratitude – quite simply send a thank you note, send the study results in a patient friendly language, notifying the participant if/when the product comes to market and giving the patients easy access to the treatment they helped to develop.
Some of these are very simple actions that can be incorporated to have an overall positive effect on your trial and a positive effect on the patients participating. If time is invested into the patients, patients will invest time into your trial. As patients are the focal point of clinical trials it is worth considering what you can do differently.