The success or failure of a clinical trial hinges on many factors, but one of the most critical is patient recruitment. According to research, more than half of regulated clinical trials fail to meet planned patient enrollment targets, putting study data quality and development timelines at risk. Inefficient trial recruitment efforts can add almost 11 months of delays for late-stage trials, driving up operational costs and delaying time to market.
The rush to develop a vaccine against COVID-19 infections brought clinical trials into the public eye. In July 2020, the New England Journal of Medicine reported that if every study registered on clinicaltrials.gov at mid-June met its target enrollment, less than 4% of patients diagnosed with COVID-19 would be enrolled in a randomized, controlled trial. “In the face of a new disease in dire need of proven treatments, every patient not offered enrollment in a well-designed, well-conducted study represents a missed opportunity to advance scientific knowledge, develop therapeutic strategies, and ultimately improve care for everyone who will come next.”
Knowing that robust patient recruitment contributes to the development of better drugs and better options for patients, how can pharmaceutical organizations improve patient recruitment in clinical trials? And how can technology make the recruitment process even easier?
What is patient recruitment in clinical trials?
Patient recruitment includes a variety of activities that identify and enroll appropriate patients in clinical trials. Recruitment and enrollment are time-consuming – so much so that these activities are often the cause of missed trial deadlines.
According to the National Center for Biotechnology Information:
“Insufficient or untimely patient recruitment into [randomized clinical trials] has serious consequences. The length of the trial may need to be extended, leading to increased resource use and costs. Lengthy trials delay the availability of potentially beneficial treatments to the public. The integrity and validity of the study also rely on adequate sample size. If the sample size is not achieved, there is an increased chance of committing a type II error (e.g., you are more likely to find no difference between treatments when one actually exists). The trial may have to be abandoned, and the results may not be publishable.”
Improving patient recruitment is one way that pharmaceutical companies can avoid such costly delays and accelerate the time to market for new drugs. For safety reasons, the drug development process includes clinical trials that take place over four phases, each with a different purpose:
- Phase I trials include 20 to 80 healthy volunteers (or, in the case of cancer clinical trials, people who have the type of cancer the drug is designed to treat) to test the drug’s safety and side effects and determine the proper dosage
- Phase II trials include 100 to 300 people who have the disease or condition the drug is designed to treat, to test the medication’s efficacy
- Phase III trials, known as pivotal studies, are done with a large group of people (300 to 3,000) for further safety and efficacy testing
- Phase IV trials are conducted once the drug obtains FDA approval, and typically includes several thousand volunteers from diverse populations who have the condition or disease
Executed perfectly, this process can still take several years to complete. For that reason, and due to the broad array of activities that make up patient recruitment, pharmaceutical organizations, biotech companies, contract research organizations, and other entities often engage recruitment services from other companies. These activities may include things like study feasibility, population research to ensure diversity in clinical trials, site selection and assessment, and production of trial recruitment materials. Some recruitment companies might also offer media support services and media management to ensure word of study reaches appropriate audiences. Recruitment support can also include the creation of a study website, patient referral follow-up efforts, and community and physician outreach to expand study awareness.
How can pharmaceutical companies minimize recruitment issues?
NCBI recommends that patient recruitment issues should always be considered ahead of time and that different strategies should be developed to head off current challenges in clinical trial patient recruitment and enrollment. The organization recommends these key considerations for more timely trial execution:
#1: Study protocol phase
- Achieve an adequate sample size
- Know the patient population and the likely sources of eligible patients
- Simplify the study protocol
#2: Study conduct phase
- Re-evaluate the inclusion and exclusion criteria if recruitment is low
- Identify sites with consistently low recruitment and address the site-specific problems. Add new investigators and sites if necessary
- Set recruitment quotas and provide incentives to maintain investigator interest
- Spend adequate time with patients and answer any questions they have about the study
#3: Study follow-up period
- Exclude patients who are unlikely to comply with the required follow-up
- Schedule follow-up visits to coincide with routine visits to the office or clinic and facilitate patients’ preferences
- Make every effort to locate lost patients
How does virtual engagement impact patient recruitment in clinical trials?
Pharma companies have long relied on social media platforms, websites, and other digital means to raise awareness and encourage patient recruitment in clinical studies. When the COVID-19 pandemic brought many trials to a temporary standstill due to lockdown measures and travel restrictions, clinical teams adapted quickly to conduct virtual clinical trials where possible. As companies move beyond the crisis stages of the pandemic, they’ll continue using digital tools to make patient recruitment, trial participation, and ongoing monitoring more patient-centered.
This is for good reason: In one study comparing trials with significant patient-centered elements to traditional trials, researchers found that 87% of the patient-centered trials had positive results, much higher than 68% for the traditional trials. And companies that take more patient-centric approaches to trial design and execution have moved the needle on reducing average patient enrollment time and shortening the timeline from first patient dose to product launch.
The ability to take part in a clinical study via a virtual engagement platform from the comfort of home – or at least without frequent clinic visits that could put a burden on patient schedules, finances, and health – stands to increase patient engagement in clinical trials and lower the risk of participants dropping out and jeopardizing the results of the study. Digital tools may also be the answer for pharmaceutical organizations wondering how to increase enrollment in clinical trials from the outset if participation is viewed as more convenient and less time-consuming.