With close oversight by independent ethics committees or Institutional Review Boards, clinical trials provide biopharmaceutical companies and the U.S. Food and Drug Administration (FDA) with the scientific information needed to weigh the benefits and risks of a new medication and decide whether it is safe and effective for patients.
The trial process is long and complex, and America’s biopharmaceutical companies are leveraging the latest scientific and technical advances such as the use of innovative trial designs and biomarkers to streamline the process and create efficiencies. These efficiencies have the potential to speed the development of lifesaving treatments that benefit patients. Researchers are also working to ensure the patient’s voice is incorporated into the clinical research process, so that studies evaluate outcomes that are important to both patients and their caregivers.
Patients are partners in the development of new innovative medicines. Therefore, including the patient voice in the drug development process is crucial. It is often difficult to find volunteers for clinical trials due to specific enrollment requirements that are based on the nature of the condition being studied and the patient group that is expected to benefit from the new medicine. Likewise, many people are not aware of the opportunities they might have to participate in a trial. Thus, it can take months, or even years, to recruit and enroll volunteers to participate in clinical trials, and recruitment is a particular challenge for trials focused on rare diseases and pediatric indications. ClinicalTrials.gov is an important online resource for patients and providers to find trials that may be appropriate for participation.
Innovative biopharmaceutical companies are working with stakeholders across the clinical trial ecosystem to increase awareness and encourage greater participation and appropriate representativeness in clinical trials. Inclusion of individuals of varied races, ethnicities, ages and sex in clinical trials can help to improve the completeness and quality of demographic subgroup data reporting and analysis, and make such data more available, meaningful and transparent for health care providers and patients. This is vital, given that certain demographic subgroups of patient populations can respond differently to therapies.