Getting new treatments to patients is a long and costly endeavor. Most drugs take upward of eight years and billions of dollars to receive regulatory approval. One of the biggest problems sponsor companies face when trying to launch a Phase 3 trial is finding enough patients to take part in the study.
Everyone seems to be aware of the problem, but few have been able to offer a solution. The number of clinical trials is increasing, but it seems the number of patients available to participate in them is not. Research has found that 80 percent of trials are delayed due to recruitment issues, and many others will never get off the ground. The problem will only get worse as the number of trials continues to increase.
The underlying problems are well known to everyone in the industry. Many patients are not aware that clinical trials exist. Those patients who actually are aware of trials often have no idea where to find information on them or how to determine if they qualify for one. Physicians know their patients better than anyone, but most of them do not discuss trial options with them. Most physicians have also never served as an investigator on a trial, and those that do rarely return for a second one.
We Need Better Tools
I first learned about TrialReach (now called Antidote) back in August 2016. I interviewed Derek Rapp, president and CEO of JDRF, a global organization dedicated to funding research into type 1 diabetes. Rapp lamented the patient recruitment problem and how the industry simply did not have the right tools available to assist with recruitment. Something was needed to help patients find and enroll in trials, without the assistance of their physicians.
Rapp noted physicians are not aware of trials, are not trained on making referrals, and do not have the resources to participate in one. Others are actually fearful of losing patients that are referred to a trial. ClinicalTrials.gov, a government database containing details on current trials, can be difficult for patients to navigate and understand. But if patients are not aware of trials and physicians are not referring them, how do we solve the recruitment problem?
This is where Antidote came into play. JDRF partnered with the technology provider to create Clinical Trials Connection, a tool patients could use to locate a clinical trial. By accessing the Clinical Trials Connection website and answering a few questions, patients are presented with a list of clinical trials for which they qualify. There are no ads. The graphics are simple and easy to understand. For patients, the process is simple and intuitive.
Shortly after launch, JDRF had well over 100 individuals per day accessing the site. On its best day, more than 4,000 patients performed a search for a trial. For patients and the JDRF, there is also no cost to use the tool.
A Simple Idea For Recruitment
The idea behind Antidote was quite simple. When you use Expedia or other travel sites to book a hotel room or flight, if nothing is an exact match for your search criteria, you are never left with zero options. The site will come back with other hotels or flights that closely match your search criteria. You can then peruse those options to see if one matches your needs. With almost 20,000 trials recruiting patients in the U.S. alone, something similar was needed for patients to easily locate a clinical trial.
Antidote is attempting to do for trials what Orbitz, Trivago, and Expedia did for travel. To be eligible for a trial, patients have to meet specified inclusion/exclusion criteria. While information like age and sex were entered into databases as structured data, some inclusion and exclusion criteria was entered in a free text field. That means it could not be read by machines.
Antidote used clinical experts to standardize the free text fields into structured data that is friendly to search engines. The language was then used to identify and categorize trials. Although the initial focus was on diabetes and Alzheimer’s, Antidote has now grown to 14,000 trials covering 726 conditions. By simply entering your age, sex, location, ailment, and distance you’re willing to travel, Antidote can provide you with a list of available trials. Antidote also has 231 partnerships in place with patient organizations including JDRF, the National Kidney Foundation, MDA, and the Lung Cancer Alliance.
We Have Come A Long Way
Antidote has come a long way since JDRF first launched Clinical Trials Connection. Sydney Yovic, assistant VP of research operations and mission at JDRF, Notes that 87 percent of diabetes patients using the site will make it through to the study results (a listing of eligible trials). That means patients are completing the surveys and finding matching trials, and most report having a pleasant experience doing so.
“The Clinical Trials Connection matching tool is a great asset for JDRF and our community," says Yovic. “The tool continues to be used by approximately 130 individuals every day. We have performed demonstrations of the tool for people with diabetes and caregivers at JDRF Summits held around the country, and the feedback we receive is overwhelmingly positive. Users note they heard good things about the tool and found it easy to use and navigate. I have also spoken to clinicians who report engaging in discussions with patients who have used the tool.”
While information is not available on how many patients have actually enrolled in diabetes trials using the tool, Yovic is encouraged by the continued use of it almost two years after the initial launch. There also seem to be more discussions taking place about trials. She notes the team at Antidote is always making upgrades and improvements. Antidote has also created videos that explain to patients why clinical trial participation is important in bringing new treatments to market.
One new tool recently added to the product is Antidote Bridge. The tool is free to clinical sites and allows researchers to provide trial details that patients desire when making clinical trial decisions. These details can include information on the procedures used, required overnight stays, placebo use, and financial compensation. Including that information takes just a few minutes and can improve patient engagement.
“I think this type of technology can really help make people with type 1 diabetes aware of trials go a long way towards solving the recruitment issues that exist in pharma,” adds Yovic. “It can also alleviate a lot of misconceptions about trials. There is still a lot of work that needs to be done, but technologies like this are helping to engage patients and move the industry in the right direction.”