Everyone involved in the planning and running of clinical trials has heard of country and site feasibility. Selecting the right countries and partnering with the right hospitals and investigators can impact your trial profoundly – it can be the difference between smooth recruitment and a failed study.
Country and site feasibility is especially important for Pharma: not only are you trying to balance market access with the best recruiting countries but you are also always on the lookout for new sites with specialized experience and, hopefully, less competition.
There is one key ingredient, however, that is just now being talked about in the industry. Getting this right can unlock or unblock your country and even site selection, make you stand out from the competition and get your drug to the market – where a bigger pool of patients can benefit from it – sooner. This key ingredient is Patient Feasibility.
What is Patient Feasibility?
Patient diversity, patient inclusion, patient centricity – none of that is possible without doing proper Patient Feasibility from the get-go. From the moment you start planning a new study, Patient Feasibility should be your first stop and biggest priority.
But what is Patient Feasibility? In essence, Patient Feasibility is the deep understanding you gain about your target patients by carefully assessing their:
- Standard of Care country by country;
- Unique pathway from first symptoms to treatment;
- Untapped needs and biggest frustrations;
- Demographic profile and cultural background;
- Disease-specific burden and lifestyle limitations.
These insights will not only help you objectively evaluate your trial protocol before you make amendments but also provide guidance when selecting your countries. Having provided data for the planning of over 6,000 trials, at TrialHub we are aware that multiple considerations factor in country selection: capacity and previous experience, regulations and market access strategy, to name a few. Yet, your target patients’ demographic profile and access to care can hinder recruitment in the most experienced of countries.
Knowing upfront who your target patients are, where they are located and what they need can help you prepare for challenges or identify potential opportunities.
Patient Feasibility vs Patient Recruitment
After a trial has been designed – and in many cases, after some recruitment challenges have been encountered – sponsors often enlist the help of Patient Recruitment companies. How do we know this? Because before we created TrialHub and started providing Pharma and CROs with all of the data needed for feasibility (yes, including Patient Feasibility), we were helping them do Patient Recruitment.
Here are some of the barriers to patient participation we discovered that proper Patient Feasibility could’ve prevented from the start:
- Patients with difficulty swallowing were asked to swallow big pills;
- Patients with limited mobility and extreme muscle fatigue were asked to travel for hours to and from the trial sites;
- Patients who were aging and needed every extra hour they could get with their children and grandchildren were expected to spend hours in hospitals multiple times a week – more than they otherwise would on Standard of Care;
- Patients reluctant to trust technology were introduced to the “convenience” of eConsent and eDiaries.
We have many more examples! In these and many other cases Patient Recruitment was like a band-aid on a bullet hole. Those patients didn’t need to see more advertisement – they needed to be understood and provided with the actual conveniences that would make trial participation more accessible.
Patient Feasibility is the process of taking all of these factors into consideration before your trial goes awry. Patient Recruitment is the process of making a well-designed trial widely known to the patients who can benefit from it. Think of it this way: when you have a great product-market fit, marketing said product becomes that much more efficient. When you don’t – all the marketing in the world means nothing.
Where can Pharma get the data needed to run Patient Feasibility?
This is the million dollar question, isn’t it? When it comes to the US landscape, a lot of this data can come from Electronic Health Records (EHRs), patient advocacy groups and KOLs. Sponsors, however, typically do not only run their trials in the US.
For the rest of the world, Standard of Care can be extracted from medical guidelines. Those are often lengthy documents in foreign languages that take hours to digest, if not days. This data can then be supplemented with the insights of local patient advocates and PIs. Another route, of course, is to contact local colleagues and hope they’re not swamped with other priorities.
Many Pharma companies keep record of studies they’ve done in certain patient populations – surveys and interviews to help them gauge patient needs and attitudes. Yet these are often, as is the case with medical guidelines, lengthy, indigestible documents that in many cases collect dust once the studies have been conducted.
It’s no wonder Patient Feasibility often takes second place to country and site selection. But we are determined to change that. Patients deserve trials designed around their needs and Pharma companies deserve to operate with the full scope of data available.
This is why we created TrialHub – a data intelligence platform developed by the gurus behind the British and Australian clinical trial registries. Out technology experts employ NLP, ML and AI algorithms on top of data verified by medical experts in-house and worldwide. This is how we ensure we’re different from those other misleading feasibility tools.
Now on top of our Standard of Care module, we are introducing the capability to query sources like PubMed and medical guidelines to discover the full picture of your target patients’ pathway.
Pharma companies who trust us love this next option. Thanks to our AI-powered chat, now you can securely upload your own proprietary data – we’re talking all of the patient surveys you’ve generated over the years – query it and get answers in seconds. Yep, we hate that you and your team have to spend hours searching for a needle in a haystack as much as you do.
If you believe in the need for Patient Feasibility as much as we do – reach out to our team and see the kind of data you can have at your fingertips. It’s time to design truly patient-centric trials.