A successful clinical trial depends on effectively enrolling and retaining participants. As the study progresses from Phase 1 to Phase 3 the number of participants required increases. Research shows that 9 out of 10 trials would not meet enrollment goals in a stipulated time which results in delays in finding a new and better medication.
The following are the key challenges that impact patient enrollment and retention.
- Lack of awareness
Firstly, most of the people are unaware that clinical trials are an option for cure. According to a Subjectwell survey of clinical awareness
- 50% of all respondents were not aware of clinical trials.
- 4% have participated in a trial.
- 96% have never participated in a trial.
Participants prefer communication and motivation about trials from their immediate care physicians. The physicians are unaware of research possibilities and might hesitate to refer elderly patients to studies. The approval to participate in a trial depends on the advice of the doctor and trust in his practice.
- Complex protocol
The complexity in trials is another key factor that is responsible for low enrollment rates.
Studies show that only 10 to 27% of patients with Alzheimer’s are eligible for trials. In a study of Alzheimer’s 205 patients with the disease were selected from the database initially. The following were not included based on the specific inclusion and exclusion criteria.
- 57% had abnormalities with MRI
- 37% were on unauthorized medication
- 37% lack of study informant
- 24%presence of non-authorized disease
- Long manual procedures
Patients are burdened with questionnaires which are lengthy, and they eventually lose interest. Once enrolled they undergo test procedures in many health centers at various intervals based on the study requirements. Patients are unwilling to undergo few procedures like brain imaging and quit due to this.
- Treatment risks
Patients are promised of getting better treatment by participating in trials than the existing one. At the same time, they are at risk of receiving a placebo or adverse effects during the trial.
In a study of Adverse effects of antidepressants, one of the drug Amitriptyline (25 mg/day) was compared with placebo and the following results were observed.
- 52% faced adverse effects in Amitriptyline group
- 27% under the Placebo group
- 3% withdrew from the study
The frequent adverse effects reported were drowsiness, constipation and dry mouth.
Patient enrollment and retention will remain the biggest hurdle in Clinical trials and to overcome this site should educate patients & support them throughout the trial process. Building awareness about safe clinical practices and relating to successfully completed trials will encourage patients to participate. Our next series of blogs will focus on the probable solutions and research findings related to patient recruitment and retention.
By Mythri Raghunandan