Clinical trials offer concrete mechanisms for people living with pain to contribute to the landscape of pain research — they’re probably the most significant ways patients can play a job in creating hope for future pain relief.
But what exactly are clinical trials, how will you become involved, and what do you must know before you start?
Clinical trials are investigations of specific treatments or protocols for a specific health condition or symptom. Volunteers with the health condition receive the treatment and report uncomfortable side effects and outcomes as an element of the method to approve the brand new treatment and make it available to everyone. Some participants may receive a current standard-of-care medication as an alternative, or a placebo (a therapeutic with no treatment value) in order that the studied treatment’s effects will be compared.
Trials happen after the introductory steps of basic, preclinical, and translational research. They’re the ultimate step that should be taken before a latest therapeutic is approved and made available in the marketplace — they usually wouldn’t be possible without patient participation.
Participating in clinical trials gives individuals living with pain no-cost access to investigational therapeutics when the present options in the marketplace aren’t working for them, and it often offers them potential alternatives to more invasive treatments.
“You might receive really excellent medical care as a participant in a clinical trial, and the studied drug for gratis. Those are things which are valued highly by potential participants,” says Michelle Ouellette, associate director, site & patient experience with Syneos Health, a biopharmaceutical solutions organization that works to speed up product success. Syneos Health’s advocacy team seeks to raise the voices and desires of patients throughout clinical development.
Forms of Clinical Trials
Technology advancements and a greater deal with patient needs have led to a recent evolution in how clinical trials are offered.
Whereas most trials previously were offered in a conventional format, with a centralized location and in-person screenings and visits, decentralized trials now offer fully or mostly distant formats. Individuals participating in decentralized trials can often participate completely from home. Screenings and follow-up visits could also be conducted via video conferencing, and a nurse may visit the patient’s home to manage the treatment, or treatments could also be sent by mail.
Hybrid clinical trials are a mixture of the 2 — although there could also be a centralized location and in-person screenings, follow-up visits could also be distant.
“This permits more people to be an element of clinical trials,” says Wealthy Towne, PharmD, RPh, a senior clinical informatics manager for Antidote, a clinical trial patient recruitment and patient engagement company working to bridge the gap between potential treatments and the individuals who need them. “I believe that’s something that’s often missed when designing these protocols while you don’t include a hybrid or decentralized option. The human impact is usually not considered much.”
Decentralized and hybrid trials make pain research more accessible to a wide range of patients — including those whose pain makes it difficult or inconceivable to commit to the demands of a trial when it involves in-person visits, or those that are financially or logistically unable to travel to an in-person trial, even with the travel and price reimbursements which are typically offered during trials.
“There’s more flexibility for the patient,” says Keri McDonough, MA, vp of medical and scientific strategy for Syneos Health and head of the Syneos Health Patient Voice Consortium. “You’ll have to travel to get to a trial, hire a babysitter, or take off work. A decentralized trial minimizes that.”
Veeraindar Goli, MD, MBA, DLFAPA, vp, Medical and Scientific Management, Clinical Solutions with Syneos Health and an emeritus professor with the Duke School of Medicine, adds that giving patients with chronic pain the chance to take part in a trial remotely allows for more nuanced results. As an example, just the means of attending to an appointment and having to attend to see the trial investigator may mean that a patient is already in a pain flare before the trial process even starts, whereas participating from the comfort of home reduces that burden and allows for greater participation.
“Whenever you’re studying chronic pain and have patients who’ve flare-ups of pain which are unexpected or unanticipated, it could be a challenge to succeed in the situation to get the care, or to follow up on clinical trials,” Goli shares. “A few of those limitations are eliminated with a decentralized or hybrid trial.”
There are two major categories of clinical trials. Observational trials track symptoms and outcomes without incorporating a treatment, to evaluate a necessity or gather vital data about pain. Interventional trials involve administering a latest therapeutic being tested, similar to a medicine or device, and assessing its effectiveness and uncomfortable side effects to find out if it needs to be offered in the marketplace.
“It’s really vital that folks understand the extent of protection baked right into a clinical trial,” Towne says. “Only drugs that pass initial measures of safety can be found for trials, and if the FDA gets a touch of something not going right, or a serious side effect, they’ll stop the trial.”
What to Know About Participating
Clinicaltrials.gov and Antidote.me each offer options for looking for available clinical trials. Your medical providers may learn about local trial options as well, and patient advocacy organizations often have details about trials.
There are a selection of inquiries to ask and aspects to think about when considering participation in a clinical trial. For more information, take a look at the U.S. Pain Foundation’s Clinical Trials 101 resource.
“There are some risks or downsides involved, between potential uncomfortable side effects and the undeniable fact that not everybody gets the treatment [and some get a placebo instead],” shares Goli. “The patient is contributing their time and energy with some hope of being on the energetic drug — and in the event that they’re not on the energetic drug, the hope is that they’re not less than providing data so this drug will be available for them to make use of [down the road]. Often, despite the potential risks, it’s still a service to society and a service to the community on the whole for the patient to participate.”