Clinical trials are often mentioned as an afterthought when discussing the length of time it takes for drugs to be approved by the FDA. On the contrary, clinical trials are major factors in the development, safety, and marketing of new drugs.
Yet as reported in a recently published BiopharmaDive article, enrolling patients for clinical trials is not only challenging but very costly. About 80% of the delays that occur relating to clinical trials can be attributed to retention and recruitment.
Using figures dating back to 2015, the average cost for new patient recruitment was $6,500, but replacing that patient cost $19,000. Those numbers have increased to 32% for patient recruitment. It is the largest cost factor of a clinical trial.
Over half of the clinical trials are not able to meet the timelines set for patient recruitment. The UK reports a 44% drop in enrollment in clinical trials over the past five years.
Despite the guidance given by sponsors and the FDA to encourage diversity, it is at its lowest in the past ten years. Reports indicate that Black/African Americans as well as Hispanic patients are severely under-represented in U.S. clinical trial sites.
Adding the fact that between 15-40% of patients who have enrolled in trials will leave the trial prior to its completion, retention must be included as a critical and also costly issue.
Putting the Patient First
Patient centricity is now more important than ever. Special attention should be given to patients who have a chronic disease, limited mobility, or complex medical history. The trials should include patient satisfaction and participation and be designed to cover the issues that really matter to patients. Improved retention will follow.
An omnibus spending bill of 2023 requires diversity action plans for clinical trials enrolling ethnic and racial participants. The bill is only one facet of the regulatory guidelines pertaining to diversity in clinical trials that are increasing. Simply stated, clinical trials should reflect the demographics that are expected to utilize the drug.
Bloomberg Law reports that investigators should be encouraged to reach a wide study population at the beginning of a trial. This is certainly preferable to either omitting the strategy entirely or recruiting mid-trial which results in a more costly and lengthy process.
Federal rules have been put in place as of October 6 2022 to allow patients to access their digital health records. This will eliminate a large number of duplicate testing and should reduce trial costs considerably.
Building Patients’ Trust
One of the most popular features of patient-centered clinical trials is to engage patients conveniently online.
Other options include:
- More transparency in the design of a study, its aims, and its outcomes.
- Offering financial support such as transportation assistance.
- Increase patient engagement
- Acting on patient feedback
- Participant involvement in data control
In a 2022 survey of 2000 caregivers and patients, 97% responded that in addition to receiving compensation for participation, they prefer reimbursement for meals and transportation.
Patients have a clear preference for mobile technologies for their online screening, consent, enrollment, and data sharing where automation and technology play the most critical role.