TrialReach

Clinical Trials: Top 5 Reasons Why It’s So Hard To Find Participants

Clinical trials are not a rare thing. They are the way to market for all new treatments and medical devices. Thousands of studies are carried out every year around the world, involving billions of pounds of investment and thousands of jobs. Most critically, the lives and well-being of all of us depend on them.

Yet, the majority of clinical trials face enormous difficulties to enrol the patients required, with the consequences ranging from minor delays to the closing down of entire companies.

Clinical trials are intrinsically a delicate matter that require a careful, meticulous approach to selecting participants.

However, we believe that other factors are contributing to making the process unnecessarily difficult and complex. Below are our top 5 reasons why trials fail to recruit patients:

# 5 –Competing trials

Intuitively, competition is a good thing: it encourages individuals and organisations to work harder, faster and better. Competition happens in clinical trials too, with companies and researchers working on similar treatments at the same time at the same locations.

Competing trials can be good for patients. There will be more research treatment options, and hopefully a better product will come out as a result. But when the patient population is small, and the number of preferred clinics is even smaller (not all clinics are equal – we’ll leave that for another post), the competition for those individuals can be fierce.

When two or more studies are in direct competition, there will inevitably be a lot of time and resources wasted that could have been applied to other valuable projects. And the real downside is that the winner is not necessarily the best treatment.

# 4 –Doctor-to-doctor referrals

A typical study involves only a small number of consultants/investigators per country to conduct the trial. They rely on their own list of patients, plus on those being referred to them from other clinics in the area. The problem is that too few doctors actually refer their patients to other doctors/investigators, which creates an immediate shortage in recruitment that is only overcome with time.

There are many reasons for the low number of doctor-to-doctor referrals, from not having a robust communication system between doctors to concerns about losing patients to a neighbouring clinic, and this is true for both private and public practices worldwide (some notable exceptions do occur).

More transparency, electronic health records, and a system that incentivized referrals would all be useful measures to encourage physicians to refer more patients and simplify the search for patients.

# 3 – Lack of information

It’s extremely hard for patients to find reliable information about clinical studies -on or offline- and it’s even harder to make any use of the little information there is.

Patients traditionally learned about medical research from their physicians but the Internet is changing the rules of this game as well. Millions of us are turning to search engines, health portals, forums and patient communities to find out what else is out there. However, except for very few notable exceptions (TrialReach being one of them!), the actual content available is not suitable for lay readers.

We find it incredible that this sort of information is not mandatory for every trial in the world, especially considering that it is the patient who must decide to take part in a study. And we also believe that this lack of adequate information strongly contributes to generating fear and distrust about medical research, giving clinical trials an undeserved bad reputation amongst the majority of the population.

#2 – Clinical data: Ideal vs. Real

Clinical trials require conditions to be as controlled as possible to deliver meaningful results. But ‘as possible’ is a relative concept, and sometimes the requirements that patients must meet in order to participate in a study can be too strict.

From a scientific point of view, it would be ideal to conduct a study on individuals with a long list of very precise characteristics, but in real life, it may be that there just aren’t enough people who would fit that narrow bill.

The trade-off between purity of the data vs. wider eligibility poses a permanent challenge but there may be ways to narrow the gap without significantly compromising the quality of the results. More transparency and distribution of existing data would be hugely beneficial in determining to what extent these patients really are like needles in a haystack.

#1 – No patient-recruitment plan

When designing a trial, companies traditionally rely on researchers’ estimations and historical data from similar trials to prepare enrolment forecasts. But in reality, the circumstances around each trial vary too much to bank on past experiences. And still, the results would only be forecasts, without details about the tactics and means demanded to achieve it.

Surprisingly,  a really tiny fraction of studies include a methodical set of measures prepared in advance  to determine how the patients will be found, who will be responsible for it, and how much time and money will be required.

If the saying is true and failing to plan is like planning to fail, this could be reason #1 to explain why so many clinical trials fail to meet their enrolment deadlines.