Five Key Points for Planning an Alzheimer’s Clinical Trial

The following is a review of Marcus Evans Webinar on Alzheimer’s disease and Clinical Trial Planning, which ran on the 18th May 2016. The video was produced in partnership with Clariness and features their Senior Director of US Operations, Karen Rosenzweig.

The Background

Alzheimer’s disease is a huge, and rapidly growing, cause for concern. According to Karen (pictured left), 50 million people are currently living with dementia, with that figure set to reach 74 million in twenty years and around 130 million by 2050. There have been roughly 10 million new cases of dementia this year alone.

When set against the backdrop of these staggeringly vast numbers, the case for clinical trials into the disease could not be any more obvious. There are however myriad challenges that one must face in order to plan such a trial. In this review, we will list five of the key points from Karen’s talk — not only providing an insight into the difficulties of planning a trial, but also offering solutions to help ensure that your trial has every chance of success.

  1. Know your patient population

Inclusion and exclusion criteria are integral to proper clinical trial practice. However, if your exclusion criteria are too restrictive you risk reducing this population to the point of making the trial impossible to carry out. For instance, exclusion criteria which leave out those with concomitant diseases alongside Alzheimer’s reduce the population heavily, thereby putting the trial in jeopardy. While the number of Alzheimer’s cases is rising on a massive scale, there is still a finite number of patients and an extensive range of trials running alongside yours.

“Ensure your patient population exists” is the advice that Karen gives when talking about trial requirements. Surveys of potential participants can be helpful during this process, she says.

Also important are the ethics of the trial, especially considering the vulnerability of the patient. Sometimes, especially in the later stages of the disease, the patient will be unable to consent to the trial themselves. In such a case, an advocate or surrogate consent is required; this may or may not be acceptable, dependent on the region in which the trial is being carried out. This brings us on to our second key point…

2. Consider the implications and complications of a global trial

When looking at this international approach, even the most exacting of trials must account for heterogeneity. The broad nature of the trial means that discrepancies can only be minimized, not eradicated.

Karen has extensive research material covering the width and breadth of the world, from which she is able to offer some general strategies.

Obviously, there are several logistical concerns; how to reach the patient becomes a pressing challenge dependent on the remoteness of the area. To gain further insight into this dilemma, a study was carried out asking patients and caregivers how far they were willing to travel for a trial. Forming the two ends of the spectrum highlighted by Karen, patients and caregivers in Poland and Argentina were the most willing to travel over 60 minutes while those in the U.S.A and Australia were the least willing.

Certain countries may render a trial inadmissible, or at least require certain changes in order to adhere to their regulatory laws. This could arise with issues as broad as methods of funding, to details as specific as the use of certain biological markers during the trial.

3. Select Your Trial Site Carefully

Even if you've narrowed down your trial to a country, worries about location remain.

When selecting your site a number of factors will be at play: experience and certification of the clinic, the proximity of imaging facilities, low turnover of patient-facing staff and an established relationship with nursing homes are all highlighted by Karen as being the most important.

4. Maintain a Patient-Friendly Trial Design

If patients are going to be willing to attend your trial, and if they’re going to be engaged enough to stay, then they need to be catered to. Karen says that there are a number of ways this can be achieved, some simpler than others.

Communication is vital with the patient and caregiver, not only to understand their needs but also so they know what’s going on in the trial. By having an upfront attitude, sharing information about any procedures face-to-face, you are able to issue any doubts the patient may have. A tour of the facilities, Karen adds, could also help to this end.

Further support can be given regarding the burden of regular trials. Studies carried out amongst patients and caregivers identified that offering payment for the trials or reimbursing travel costs significantly increasing the likelihood of trial attendance. Making waiting rooms more comfortable, adding WiFi for those caregivers who need to finish work and favouring shorter, more frequent visits all help to remove stress from the process.

5. Use the Internet

Over 65s constitute the fastest-growing internet user base, dependent on region. The idea that you can’t reach seniors over the internet is largely outdated, with Karen mentioning the tremendous success that Clariness has achieved with online advertisements for trials.

Advertising isn’t the only thing the internet can be used for however, with other aspects of the trial benefitting from the web.

Retention can be aided online, with many patients opting for electronic materials to form the bulk of reminders and follow-up from the clinic.

Furthermore, when explaining procedures — an area where many may want access to additional information — it can often be beneficial to provide links to websites with such details. Karen adds that these sites should be readable, with an option to zoom in easily, and mobile-friendly.

Conclusion

Planning a clinical trial is always a challenge — a challenge which, as Karen attests, is only exacerbated by the complications of Alzheimer’s disease. However, by maintaining a patient and caregiver-oriented focus, by considering regional impact and by utilizing technology, your trial has every chance of being a success.

Download the webinar and its accompanying slides here:

Or read the summary here:


Connor O’Malley,
Intern

Marcus Evans
101 Finsbury Pavement,
London, EC2A 1RS

webinars@marcusevansuk.com