What your team should look like: Clinical trials vendor guide
The goal of any clinical trial should be to provide the best journey for the patient from start to finish. In order to achieve this, a sponsor will collaborate with an array of vendors to handle everything from pre-recruitment to site follow-up. Statistics on outsourcing vary, but largely tell the same story of an upward trend. Big pharma outsources around 40-45% of their activities to contract research organizations (CROs). Small and medium-sized companies outsource more — up to 65-70% of their activities — and emerging biotech startups typically outsource up to 90% of their activities. We take a look at some of the key kinds of services and vendors you should consider adding to your team.
What should your team of clinical trial vendors look like?
The pharmaceutical industry is consistently dealing with evolving regulations, and the COVID-19 pandemic has thrown a new wrench into the picture. Trying to navigate clinical research in the time of a pandemic, combined with increased pressure to reduce the costs of drug development and demand for new therapies has caused a rise in hiring experts for specific tasks to run a trial. Looking for best-in-class vendors for each facet of your trial is key. The list of services and vendors below are some you might find when looking for outsourcing providers:
Direct-to-patient lab services: Third-party vendor laboratories manage pharmacokinetic/pharmacodynamic, serology, stool, and blood analysis data during most clinical trials. They provide different forms of services to their patients, based upon the specific therapeutic area, but the idea is that patients come to screening appointments having already had labs completed. For patients, it’s often much easier to go to a local lab rather than to travel to a site to see if they might be eligible for a study. For sponsors and study teams, it’s important not to waste time screening patients whose lab values would render them ineligible. Working with a direct-to-patient vendor — or their recruitment company partners — to safely provide participants with diagnostic services can accelerate enrollment in your trial and also make your trial more accessible to interested patients. One example: mobile phlebotomy services are growing rapidly, especially due to the COVID-19 pandemic.
Travel vendor: Patients often need to travel for studies, which is one of the biggest burdens on clinical trial participation. That’s why you should consider a travel vendor for your clinical trial. Whether it is to get participants down the street or across the state, reliable travel can be difficult if the patient cannot transport themselves. This is especially key for conditions that impair mobility, such as multiple sclerosis. A travel vendor can ensure the patient attends all study appointments by providing services like ground transportation or medical-assisted transportation. Beyond convenience, a frequent study visit schedule can also result in high costs for transportation, which can add to patient burden. Travel services alleviate these worries, providing benefits not only to patients and care partners, but also to sites and sponsors. Some clinical trial recruitment companies work directly with travel vendors, so be sure to ask about their relationships as you line up your vendor team.
Site and patient follow-up teams: Even if a patient is interested in taking part in clinical research, there are still plenty of opportunities to lose contact in the course of their journey from learning about your trial to randomizing. Patients may miss an email or phone call, or be unable to attend a site visit for additional screening. Outsourcing patient follow-up to healthcare call centers ensures that your patients remain engaged. In addition to traditional call center services, tools like automated follow-ups through digital advertising, emails, calls, and text messages give patients multiple opportunities to stay engaged with the trial. Call center vendors and follow-up services are pivotal for keeping your trial on track. Once again, your recruitment company may offer these services, so be sure you understand their capabilities before hiring a separate vendor.
Recruitment companies: Clinical trial patient recruitment companies use a range of methods, from digital advertising to community partnerships, to find the right patients for your trial. At the core of it, patient recruitment companies conduct patient research, develop robust outreach materials, launch campaigns, analyze metrics, optimize based on success rates, and report on these initiatives. Antidote, for example, works with more than 250 health nonprofits and patient advocates to connect sponsors and research sites with informed, engaged patients interested in clinical trial participation. Other Antidote offerings include lab-validated referrals, targeted digital outreach plans, and a host of other services for trial sponsors.
A clinical trial recruitment company can serve as your study quarterback, facilitating many different services for your trial, from recruitment and patient follow-up services to setting up travel vendors and direct-to-patient lab options. Interested in connecting with a clinical trial recruitment company? These 15 questions can start the conversation and help you connect with the recruitment company that works best for your trial’s needs.