Patient centricity is arguably the concept du jour for those working in clinical trials. Talk with almost anyone in the industry and they will be discussing, deliberating and determining how best to make their trial patient centric. As a concept this seems almost obvious – why wouldn’t the patient perspective be at the center of all planning and protocol in a clinical trial?
However, as ever with any new buzzword circulating the industry, things are not necessarily as simple as they first appear. Firstly, there is still much debate within the pharmaceutical industry regarding the true meaning of patient centricity and its role within a trial. From patient reported outcomes to patient engagement there is still not a solid definition for what is meant by patient centricity. And here, perhaps, lies half the problem. How can you design a patient centric study without really understanding what this means?
Why is this Particularly Important for Oncology?
This is a challenge which is facing the pharmaceutical industry as a whole, but none are feeling it more than those working in oncology. With the greatest challenge facing oncology being patient recruitment, an obvious solution to this would be a patient centric trial. With oncology being such a diverse field in itself the challenges here are quite diverse, and yet all come down to engaging enough patients to present tangible data. While for some drugs the competition for patients can prove a big challenge, with the struggle simply being not getting lost in the crowd. For others the cancer is so rare that actually finding a big enough pool of patients is the first hurdle. Further, with a typical oncology clinical trial lasting years, patient engagement is crucial. Some companies are working to overcome these complex challenges by ensuring that their trial protocol takes in to account the patients needs wherever possible but, as we know, this is rather easier in conception than in practice.
How can we Incorporate Patient Engagement into our Trials?
In spite of this array of challenges, there is plenty which oncology companies can, and are, doing. A novel idea by Eli Lilly is the 2014 launch of an innovative clinical trial app, alongside their website http://www.lillyoncologypipeline.com/, which will help build the relationship between physician and patient. The aim here is to offer those working in oncology an accessible tool for finding details about clinical trials all over the world – and not only those which Eli Lilly sponsor. On top of industry initiatives such as these; there are also fast growing numbers of Patient Advocacy groups cropping up which are helping bring the patient perspective to oncology trials and in turn improving engagement in these long-term trials.
And while all this is proving key to overcoming some of the major challenges which have been facing the industry for some time, there is still more which can be done. A major area for improvement in designing trials which are truly patient centric is the stage at which the patients are engaged. It is obviously a huge step forward to consider the patient perspective at the initial stages before recruitment and execution of the study. But even better than this, would surely be engaging the patient from the beginning, ensuring their voices are truly heard and their needs fully met as early as the protocol development stage. This would surely help to minimise the timelines and aid in retention.
Another area of focus for many companies is incorporating social media into their recruitment and engagement strategies. With users of social media opening up to include all age groups, this avenue is a key resource for effective patient engagement. With plenty of cancer support groups moving online; it has never been easier to interact with your patients. This is a resource which can be utilised at all stages of your study, from pre-study to post-participation, and provides you with direct access and communication. It is important to note, that this is not only a route of interaction between the trial sponsor and the patient, but also a forum for discussion between patients where feedback on your trial can be given in an open platform.
Impact of Patient Engagement on Trials
A major concern for any new approach is understandably the costs associated with such changes to processes. How can you ensure a return on investment? A patient centric approach can mean you avoid potential study design challenges and amendments midway through the trial. When you are able to incorporate patient centricity into your study you are effectively optimizing the timelines and budgets for enrolment, compliance, reliable data and feedback, patient retention and trust. Measuring the return on investment with the use of adverts, websites and links is incredibly simple as all traffic is trackable so you can really see how much of an impact these are making.
Where can we go from here?
The benefits of patient centric approach are clear to both the sponsor company and the patient, though the road to a truly patient centric trial will not be quick or easy. So where can we go from here? The industry needs to now work together to ensure that patients are placed at the front of mind from the CEO to the CRA.