In my last article about Feasibility, data sources are defined so that you can recognise the best ones and choose which ones to use.
To summarise, no matter what data sources you use they should be:
Accurate
Meaningful
All-encompassing
If you want to learn more about this, you can read my previous article:
Today we will dive in the MOST USED data sources by feasibility experts.
National Clinical Trial registers:
The best one is clinicaltrials.gov for two main reasons. First, almost all research is conducted in the USA and gets approved through the FDA. And if a clinical trial is under the FDA it should be on their public clinical trial registry, a.k.a clinical trials.gov.
The main challenge is that the registry relies on the sponsors and their collaborators to submit all documentation on time and written in the most accurate manner. For example, it is a big issue that conditions, sites, investigators and everything else are written in a free format, which means that search results might not be full.
Other comprehensive clinical trial registers are EUDRACT, the British Clinical Trial Register, Australian New Zealand Clinical Trial Register. Yet, all of them have just a fraction of the data ct.gov has and also contain fewer details on the trials themselves.
Epidemiological databases:
Epidemiological data like prevalence and incidence rate is super important and maybe the only reliable source answering the question: Where are the patients? The second best are EMR providers. The EMR providers are a lot more accurate as they tell you in which exact hospitals patients are and give you a more detailed profile of the patients.
One thing everyone should consider though is that EMRs are quite limited in terms of which hospitals/countries have them. At the moment the only country that has quality EMR (and when I say quality I mean for the current standard but very far from perfect) is the USA. There are also some Eastern EU countries like Latvia and Estonia that have put a lot of effort into having a unified system for EMRs.
A lot of the EMR providers are also working towards creating them even in countries and hospitals that lack such software by providing their technology for free and then using anonymised data for their services.
The future looks bright with EMRs but we are not there yet. Meanwhile, there are websites and patient registries providing prevalence data on a lot of the indications out there, which is a good starting point.
Publications:
PubMed.gov and ResearchGate are the go-to-places if you want to learn about previous research done and get more details. You can spend hours and even days reading about each indication published by Key Opinion Leaders and experts in the space. This can give you various types of information from previous research results, to prevalence data to best investigators and sites.
Patient Associations:
Understanding the burden of the disease is often challenging if you haven’t personally faced reality. It’s the number one priority of patient associations to know every single step of the patient journey and work towards policies to make it easier for the patient.
This is why feasibility experts try to connect with these communities and get their help in understanding in what way their future clinical trial would fit the patient pathway and what would the patients’ expectations be. The main challenge here (and the reason most clinical trials never get this perspective) is that it is really time-consuming to find and get in contact with the right organisation.
Some feasibility experts have to assess a clinical trial protocol in a matter of no more than 10 days which means that it is next to impossible to get the patient associations’ input too. Another obstacle is the fact that advocates and patient experts are mainly working towards policies and patient education and support. Therefore they are not necessarily experts in providing feedback to clinical trial experts. They also need guidance on how to best contribute to research.
A step forward is the founding of organisations like EUPATI – The European Patients’ Academy. EUPATI is dedicated to educating both patient organisations and patient engagement professionals on how they can best collaborate and find each other more easily.
As a part of their strategic roadmap, they have started working on a Matchmaking Platform bringing advocates and industry together and helping them work more consistently and productively. I am really excited that FindMeCure Foundation is not only supporting them but also the main technology partner.
Local clinical research professionals / consultants / KOLs
CRAs (Local Site Managers) and consultants are not a database or a platform. Yet, they are a very powerful source of information. The majority of feasibility experts rely on their local colleagues or friends with experience to help them assess the local landscape. The challenge here is the same as with patient associations – time.
As all the information sharing happens through emails and phone calls involving multiple people on the chain, this usually requires much more time. This type of data can sometimes be misleading as it represents not a statistical number, but rather personal know-how and opinion.
My experience shows that once you have a protocol in front of you, there are multiple questions you start asking yourself that require data and know-how. The data sources that I have reviewed in this post are just a starting point and how you use them depends on your previous experience in the indication or just performing feasibility studies.
More and more of the clinical trials nowadays include very specific or rare conditions. This is where you need not just data but also the mechanism and flexibility to work with this data – something my team and I are really dedicated to.
