Seeking More Effective Clinical Drug Trial Recruitment
As recently reported on WSJ.com, it is estimated that 1.7 million patients participate in 80,000 drug-company sponsored trials globally each year. Researchers are finding it more difficult to attract and retain the requested number of patients in order to complete studies on time and within budget. There are significant challenges to clinical drug trial recruitment, including:
- Lengthy and confusing consent forms. Drug giant Eli Lilly and Company is one of those companies trying to cut in half the document, which can run 20-25 pages.
- Study subjects are often deterred by the knowledge that they may not receive an actual treatment, but a placebo.
- Some patients are not willing to commit to the obligations imposed by a trial, including keeping a diary and submitting to regular medical testing.
- In the case of Alzheimer’s and other debilitating illnesses, the caregiver also has to agree to abide by the terms of the study.
According to a study published in Clinical Trials earlier this year, more than $300,000 is spent on recruitment for an average Phase 3 trial. It is this phase of the clinical trial which studies a compound’s safety and effectiveness in large groups of patients, the results of which are often used by regulators in the drug approval process. Recruitment represents approximately 3% of the total investment in a new drug. Some of the current ways to recruit the required number of participants include:
- Searching laboratory test records to identify people with certain conditions, diseases or diagnoses
- Monitoring online forums and social media groups of those looking for information and support
- Doctors asking their own patients specifically to participate
- Television, radio and internet ads recruiting efforts
As the process has gotten more arduous, it has motivated drug companies with promising medications to test new, creative methods for clinical drug trial recruitment.
- Axovant Sciences, developer of dementia drugs, partnered with ride service Lyft Inc. to transport patients to the study location and back home. Realizing that their group of prospective participants may have challenges travelling on their own, this “shuttle service” allows volunteers to join the study when otherwise they could not.
- Parexel International (a research organization that contracts with drug companies to run clinical trials) reviewed over 3 million mentions Alzheimer’s in online forums over the course of 6 months to analyze what patients were looking for. Determining that they needed to appeal to the caregiver’s desire to help a loved one, they ran website ads that were successful in recruiting 900 new participants.
- Eli Lilly has directly enlisted the help of patients to review and assess the design of their pancreatic cancer drug clinical trials, hoping to make clinical drug trial recruitment more patient friendly.
These and other companies have determined that by making the studies easier for participants, that both recruitment times and costs may be reduced; resulting in a quicker path to market for promising new medications.