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9 Ways to Enhance Enrollment in Neuro Degenerative Clinical Trials

9 Ways to Enhance Enrollment in Neuro Degenerative Clinical Trials
21 February 2019

With approximately 30 percent of patients with diseases like Alzheimer’s and Parkinson’s misdiagnosed, obtaining the proper diagnosis, and then enrolling patients for clinical trials for these and other neuro degenerative diseases can be a challenge. Furthermore, some diseases can exhibit Parkinsonian symptoms even though the problem is not Parkinson’s and, often, Alzheimer’s patients may not exhibit symptoms of the disease until decades after neurons start to die, making this patient group particularly challenging to recruit into studies. Additionally, testing for these diseases can be invasive and expensive, especially when used to pre-screen large numbers of potential patients, with 40 percent or more of potential subjects likely to be excluded as screen-failures.

Some patients may not recognize initial onset of memory loss or may be afraid or embarrassed to talk with their doctors about it. Physicians, with limited time to spend with patients, may not realize cognitive impairment; some studies show that they may be unaware of it in more than 40 percent of patients with these issues. Lastly, some doctors may be reluctant to submit patients to potentially invasive tests and studies.

In 2012 The National Plan to Address Alzheimer’s Disease set out to treat and possibly prevent Alzheimer’s disease by 2025. Achieving these goals would require tens of thousands of patients to participate in clinical trials, in addition to the other thousands of patients also needed for private neuro degenerative clinical trials worldwide. Challenges of enrolling patients for these and other neuro degenerative studies have since been debated at the Alzheimer’s Association International Conference, Clinical Trials on Alzheimer’s Disease, the Advances in Alzheimer Therapy conferences, the EU-US Task Force, the Alzheimer’s Association’s Research Roundtable, and others.

What steps can drug developers take to speed and ensure proper enrollment of patients in neuro degenerative clinical trials? Following are a few suggestions we offer from Synteract:

  • Create a search engine-optimized study website to reach prospective patients searching for information about their illness, as well as to serve as a resource for physicians and others in directing them.
  • Consider advertising in media targeted to patients, caregivers and friends or relatives who may see the information.
  • Leverage social media to create knowledge about studies, enabling posts to be shared by doctors, patients, and others to increase awareness.
  • Make participation easier for patients and caregivers by simplifying protocols and study related requirements – this approach also benefits sites and improves compliance, both at the patient and site level with the protocol. Instead of trying to collect as much data as possible, determine the key information that you are trying to obtain and create protocols around that.
  • Make it clear to patients and their caregivers what the study will entail up front so that they can make informed decisions on participation.
  • Where possible, work with sites experienced in running studies and which have access to patients with neuro degenerative illnesses – if this is not possible, ensure that additional training and support are given to site staff to enable them to perform all of the procedures and assessments with confidence and consistently to the same high standard.
  • Consider swapping out on-site visits with home visits where possible by leveraging home care providers or qualified nurses instead of requiring patients and their caregivers to travel all the time. Taxi, Lyft/Uber services, and/or travel reimbursement can also help, as can the addition of concierge services. Finally, identify flexible ways to schedule appointments, so that they fit in with the schedules of the patients and their caregivers – it may also be possible to employ online or mobile apps that can also be convenient for patients.
  • Leverage relationships with sites and patient advocacy networks that provide education to offer registries of ongoing studies to make families aware of opportunities. Commercial Institutional review board(IRB) groups, and physicians therapeutically aligned to these groups can provide invaluable information in terms of making suggestions regarding the practical implementation of protocols and maximizing   patient eligibility through discussions concerning inclusion/exclusion criteria.
  • Consider the use of non-invasive, cognitive pre-screening tests in study protocols, especially to screen patients. iPads and handheld devices have shown to be useful in this respect, and are also generally language and culturally neutral, so that they can be used for international studies.

These are just a few of the many ways that Synteract helps clients to ensure timely enrollment for neuro degenerative clinical trials. At Synteract, we draw on extensive experience in helping neuro degenerative drug developers recruit for, and navigate, the complex landscapes of these clinical trials.

Contact us today to discover how we can help you.

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