5 Challenges in Clinical Trials Management and a novel approach to overcome them

August 1, 2021
by RxE2

New drugs and treatments have to undergo a slew of studies and tests to help patients who need cures for their conditions. Clinical trials lay the foundation of efficacy and safety for new therapies and drugs. However, the process could be herculean for trial coordinators and pharmaceutical companies that dedicate a great deal of time, money, and other resources to develop and market a new drug. The average clinical trial cost per drug is $700 million and a typical trial takes 6 – 7 years to complete (the entire drug development cycle usually takes 10 – 12 years), and bring the new therapy or drug to market. Two other key numbers to note are that 80% of clinical trials fail to finish in time and only 10% of drugs are ultimately approved by the FDA and actually make to it to market.

The main challenges in clinical trials and the reasons they fail

Effective assessment of each phase of the trial lays the foundation for a new drug or treatment. Each of the known clinical trial phases faces its own challenges, be they regulatory, logistic, or financial. The most daunting challenges, however, and the main contributing factors to clinical trial failure, are probably the following 5, usually encountered in the more advanced, patient-facing, stages of the trial.

We could probably classify the challenges by three main types: Recruitment, Engagement/Adherence and Operations. Within each of these main types of challenges there are multiple larger or smaller obstacles any trial site coordinator or CRO manager knows well.

Patient recruitment

Recruiting patients is the heart and soul of any clinical study. After all, without the engagement of patients, there is no trial. However, people show hesitancy in joining clinical trials. Researchers have observed that even educated younger people tend to stay clear of trials for various reasons ranging from fear to inconvenience and everything in between.

Moreover, finding and recruiting volunteers in diversified age and ethnic groups is a whole other challenge. A new drug has to work well for people of all ages, genders, and ethnicities, and in all climates, cultural conditions. However, recruiting people in different regions with different demographics turns out to be extremely difficult and time-consuming for drug testers. It poses multiple regulatory and logistical challenges as different countries (and sometimes even different regions within the same country) often have vastly different regulations, and people who live in more remote or rural areas are less likely to be able to access information on trials, not to mention actually get to the trial site.

Overall, the access of trial sites (hospitals, clinics) and CROs to diversified patients is limited at best. The bottom line is that 50% of clinical trials simply fail to recruit enough patients to even get started.

Patient engagement and retention

Assuming the recruitment was a success and the trial launches with enough patients, the next order of business is to keep the patients engaged in the trial and retain them.

85% of clinical trials fail to retain enough patients for the duration of the trial. But what does that mean? Simply put, it means patients opt for leaving the trial and are dropping out mid-way. The official data is around 30% dropout rate. This is a major problem as it could stop a trial in its tracks and literally close the lid on a new drug.

The other side of this coin is engagement. Keeping patients engaged is crucial not only for retention and minimizing dropouts, but more so for adherence. Trials are run by strict protocols and rigid standards, but unless they take place in a closely monitored environment (e.g hospitalized patients), the patients are usually going about their daily lives with only periodic check-ins and check-ups at the trial site. But what happens in between? How can the trial coordinators know that the patients are indeed adhering to the protocol? How can they know if the patients are okay or if they  have some mild adverse reactions they forget about and fail to report by the time they reach their periodic check-in meeting? How can they assess whether or not the protocol even works with the quirks of daily life? Once again, data shows nearly 40% of patients fail to adhere to the trial protocol.

Operations

The operational aspect of a clinical trial includes many nuts and bolts. One of these is the actual trial drug dispensing. In most situations, the patients receive the trial drugs either directly at the site (when they check in for monitoring), in which case they’ll get the amount that serves them until the next check-in, per their protocol, or delivered to their home, especially in times of a global pandemic and “stay at home” orders.

Depending on the trial, its design usually tests not only the safety and efficacy of a drug by comparing to placebo but also the effects of different doses and different protocols (the times of the day a drug is taken, delivery mechanisms, etc.).

In some cases, the trial also checks the specific safety and efficacy of a new drug on patients who already take other drugs.

This makes the action of dispensing the trial drug to patients not only important but also high-precision.

The trial site coordinators must know and be able to monitor exactly how, when, and how much drug a trial participant receives, how and when they take it (and also IF they take it), and what it does to them. All this needs to be logged, tracked, and analyzed.

Dispensing the drugs once every few weeks at the trial site or delivering to their patient’s home with a standard delivery service simply doesn’t cut it.

Site-less/remote clinical trials

Traditionally, clinical trials are site-centric. This means there is a site (for every region/territory), usually within a hospital or research facility, where the patients need to go to enroll in the trial and then do their check-ins. In many cases, this means they have to travel once every few weeks to the site, which could be located far from where they live. Depending on their condition and the tests they need to undergo, they may also not be able to drive themselves and will require someone else to take them and bring them back, resulting in inconveniencing more people (family or friends) or additional costs (using public transport or driver services).

The Covid-19 pandemic hit the accelerator hard on digital health and telemedicine solutions that aim to reverse the trend from site-centric clinical trials to home-centric, by  bringing the trial into the patient’s home. The notion of decentralized trials (also known as “siteless” or “remote” trials) simply means that the trial has a “site” in each of the trial participants’ homes.

However, this creates a plethora of new operational challenges. First, it alienates the patients even more. In most trials the participants are not healthy people. They are people already burdened with life-threatening or chronic conditions who find it hard to navigate daily life as it is. At least by coming to the trial site once every so often they would meet a friendly face, maybe meet fellow patients (depending on the trial design) and feel important and cared for. Now, they stay home and everything is delivered by messenger with the trial coordinators chatting to them on the phone, on video calls, or on an app. Second, it is even harder for the trial coordinator to ensure adherence and monitor it. Using telehealth tools creates multiple regulatory issues as well as technological challenges, such as matching the patient’s digital literacy level or the infrastructure not supporting the digital platforms.

Timeline & Cost

This challenge is the sum of all previous challenges put together. We already noted clinical trials take six to seven  years to complete and cost an average of $700 million per drug. Much of that long duration and the cost are spent recruiting, retaining and monitoring patients. The industry needs to find ways to cut these costs and timelines to make trials more efficient and cost-effective. After all, we’re all in this to help more patients and improve their outcomes.  

Overcoming clinical trial challenges – a novel approach

Overcoming the challenges we listed and taking clinical trials into a future where they are shorter, more accessible to diverse patients, cost less, and bring more drugs to the market faster than before, is a matter of strategy.

So far the industry has been focused on new tools and technology but that is all tactics. The gap is in seeing the bigger picture and finding a good way to build a bridge between the extreme traditional site-centric trial design to the extreme hype of home-centric trial design.

The way to do this is undoubtedly with the aid of cutting-edge technologies as the industry already understands, but there’s a secret sauce that’s missing and it is not necessarily bits and bytes.

We believe that leveraging powerful technology and putting it in the hands of the right people, makes a huge difference.

Community pharmacists – the bridge between clinical trials and patients, is built across the community

We believe that community pharmacies are the game-changer in clinical trials. Independent community pharmacies are already established across the US with dozens of thousands of pharmacies and experts.

By engaging pharmacists and involving them in clinical trials we can create a powerful network that overcomes each of the above-mentioned challenges:

• They already have access to patients anywhere

• They are able to recruit diversified patients

• They are already positioned to provide additional and enhanced health services to their community

• They are trusted by their patients

• They know their community and patients well and are able to therefore monitor them better

By adapting the cutting-edge technology to the daily operation of pharmacists, training them and providing them with the right tools, we can create a win-win situation in which patients are less burdened and enjoy a better trial experience (easier recruitment and better engagement).  At the same time sponsors and CROs get better patient diversity, reduced trial costs, and gain faster time to market for new drugs. The community pharmacists facilitate all this using the best technology has to offer and play a crucial role in the future of drug development.

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