{"id":3605,"date":"2024-02-27T16:15:22","date_gmt":"2024-02-27T16:15:22","guid":{"rendered":"https:\/\/www.almacgroup.com\/clinical-technologies\/?p=3605"},"modified":"2024-06-05T11:17:38","modified_gmt":"2024-06-05T10:17:38","slug":"clinical-trial-participation-children-rare-diseases","status":"publish","type":"post","link":"https:\/\/www.almacgroup.com\/clinical-technologies\/blogs\/clinical-trial-participation-children-rare-diseases\/","title":{"rendered":"Easing the Burden of Clinical Trial Participation for Children with Rare Diseases"},"content":{"rendered":"\n

By Devina Lahaie<\/strong><\/p>\n\n\n\n

Business Development Manager<\/strong><\/p>\n\n\n\n

\u201cThe days are long but the years are short.\u201d1<\/sub> To me, this quote perfectly encapsulates the experience of being a parent with busy mornings getting your little one out the door to school and long nights when they can\u2019t sleep with a stuffy nose. Those days were very long but looking back at photos and memories, the years went by in a flash. Parenting can be a fulfilling full-time job, however, if you\u2019re the parent or caregiver to a child with extensive medical needs or a rare disease, the demands can be around the clock.<\/p>\n\n\n\n

Having a rare disease can significantly lower the quality and length of life. With limited treatments available, parents and caregivers look to clinical trials to alleviate the effects of the disease. Participating in a clinical trial can get you access to free healthcare, compensation for your time, being the first to benefit from new medicines or therapies and most importantly, the opportunity to prolong life for those with terminal illnesses. Yet there can be hurdles to getting into and staying engaged with a clinical trial.<\/p>\n\n\n\n

So, what\u2019s in the way? A predominant rate limiting factor to participating in a trial is access to sites. The most often cited barrier to participation was “when a potential participant has no car, transportation can be difficult to access or is too costly.”2<\/sub> Only a subset of hospitals and physicians’ offices also participate in clinical trials, limiting the number of accessible site locations, hence potential participants may need to travel long distances \u2013 extending their time away from home or work. The need to transport medical supplies, a wheelchair, or other bulky medical supplies further compounds the difficulty of getting to the site.<\/p>\n\n\n\n

Another factor to consider is a visit to the doctor\u2019s office can be generally unpleasant for a child. At every visit to the doctor, my daughter asks if she has to get a shot. Just the thought of the needle causes her heart to race, and I have to bribe her with some treat or a toy to put on a brave face and halt the tears (it never works). This is both anxiety-inducing for her and frustrating for me.<\/p>\n\n\n\n

There are tools available now to help young patients and their caregivers make fewer trips to the doctor\u2019s office, while still participating in a clinical trial. Technology vendors that support clinical trials are meeting this need with decentralised clinical trial (DCT) services that enable subjects to participate in trials virtually from their homes:<\/p>\n\n\n\n

Direct-to-Patient Medication Shipments<\/strong><\/p>\n\n\n\n

Almac Clinical Technologies along with Almac Clinical Services offers direct-to-patient shipments of clinical trial medications in studies where the IMP can be shipped. These are clinical trial medications that are not frozen, the patient lives in the same state as the site or depot shipper, and the medicine can be self-administered at home by the patient or their parent\/caregiver. \u00a0Almac also integrates with other clinical data vendors that offer remote eConsent services which helps to automate enrollment into a trial, enabling patients to complete additional scheduled site visits from their home.<\/p>\n\n\n\n

eConsent<\/strong><\/p>\n\n\n\n

In order to participate in a clinical trial, patients need to be educated about the risks of being involved and consent, or assent in the case of a minor, to participation by signing an Informed Consent Form (ICF). This process usually happens in person at a clinical site, however, trials that offer eConsent can collect signatures electronically making the process remote and eliminating a site visit for the patient.<\/p>\n\n\n\n

Telehealth Site Visits<\/strong><\/p>\n\n\n\n

At the onset of the COVID-19 Pandemic, lockdowns delayed or completely stopped progress on many clinical trials mid-study with active patients. In response to this, clinical trial sites adopted the use of currently available tools like Zoom and other remote conference and video calling services to continue to monitor subjects. Commercial telehealth tools for clinical trials are still limited but available. Sponsors should look for vendors whose Telehealth offering is both Part 11 and HIPAA compliant.<\/p>\n\n\n\n

Electronic Patient Reported Outcomes (ePRO)<\/strong><\/p>\n\n\n\n

Electronic tools for collecting outcomes information from patients have improved vastly since its inception. Many vendors offer a bring-your-own-device model enabling patients to use a cell phone or tablet that they are familiar with and already have in their possession. ePRO tools aid study participants’ ability to stay engaged with a trial by providing alerts when it\u2019s time to make entries and collecting data in real-time from subjects where recall is most accurate. <\/p>\n\n\n\n

Giving young patients and their parents access to remote tools for trial participation reduces the amount of time they must commit to travel and time at the site. This is time that can be much better spent on bonding or other restorative family activities that are beneficial to the child and parents. We encourage our pharma and biotech partners to engage with technology vendors that have developed DCT technologies and services for the mutual benefit of our ongoing research, giving patients more time back in their day. For more information in support of caregivers of a loved one with a rare disease, please check out: The National Organization for Rare Disorders | NORD (rarediseases.org)<\/a> and the Caregiver Action Network<\/a>.<\/p>\n\n\n\n

    \n
  1. \u201cThe Happiness Project\u201d by Gretchen Rubin.<\/li>\n\n\n\n
  2. NIH: Review of the Literature: Primary Barriers and Facilitators to Participation in Clinical Research (nih.gov)<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

    By Devina Lahaie Business Development Manager \u201cThe days are long but the years are short.\u201d1 To me, this quote perfectly encapsulates the experience of being a parent with busy mornings getting your little one out the door to school and long nights when they can\u2019t sleep with a stuffy nose. Those days were very long […]<\/p>\n","protected":false},"author":824,"featured_media":3607,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"event_business_unit":[],"class_list":["post-3605","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"acf":[],"yoast_head":"\nEasing the Burden of Clinical Trial Participation for Children with Rare Diseases - Clinical Technologies<\/title>\n<meta name=\"description\" content=\"With limited treatments available, parents and caregivers look to clinical trials to alleviate the effects of the disease\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.almacgroup.com\/clinical-technologies\/blogs\/clinical-trial-participation-children-rare-diseases\/\" 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