Written By: Melissa Triebell
As of June 21, 2015, ClinicalTrials.gov listed 92,862 studies with locations in all 50 States and in 187 countries. However, while 20% are eligible, the National Cancer Institute (NCI) estimates only 3-5% of the 10.1 million adults with cancer participate in clinical trials and only 2% of primary care providers routinely discuss oncology trials with patients. Clinical trials are lengthy and the most costly portion of the drug development process, usually accounting for 45% to 75% of the $1.2 billion average cost of developing a new medication. Phases 1, 2 and 3 of a clinical trial last on average 6 – 8 years. Drug and medical devices companies are seeking ways to streamline their clinical development plans by conducting fewer but more successful trials, completing trials more quickly and efficiently and accelerating the transition between the clinical trial phases.
Slow patient recruitment is a major rate-limiting step that clinical trialists face, resulting in 48% of the trial sites missing enrollment targets, 80% of the trials running behind schedule and 11% of the investigators never enrolling a patient. Patient enrollment rates plummeted from 75% in 2000 to 59% in 2006. While patient recruitment is genuinely the most difficult and challenging step in running a clinical trial, patient retention is often overlooked. Patient retention is vital throughout the clinical trial lifecycle. Poor retention impacts both the internal and external validity of the research study and incurs increased costs to replace study volunteers. Study participant dropouts rates accounted for approximately 15. 40% of enrolled patients in clinical trials. In addition to higher study-related costs, sponsors can potentially experience sales losses from $600,000 to $8 million per day due to trial delays.
Solution: Clinical 6
The biopharmaceutical industry does not need to be made aware of the patient recruitment and retention issues. They need suggestions on how to improve subject accrual and new strategies to boost enrollment. Top barriers of clinical trial enrollment delays and patient dropouts include:
- Inconsistent planning
- Poor visibility of enrollment trends
- Unaware of adjustments to resolve a problem trial
- Poor awareness and communication between the principal investigator, clinical team and the patient
To reduce the risk of dropout or lost to follow-up, it is important to maintain patient motivation and provide positive reinforcement. A recent study noted that 45% of clinical studies did not use any retention tactics. Educational materials, appreciation of the subject’s time and involvement and efficient communication are three key components of patient retention. With developing platforms, there are innovative techniques emerging in patient recruitment and retention.
Parallel 6 has a patented and proven Clinical 6 platform that provides:
- Direct communication with patients through a mobile handset
- Decreased data delay through real-time patient updates
- Optimized patient distribution through real-time analytics and insights
The Clinical 6 transforms mobile apps into a highly effective, patient- engagement experience. Listening to patients and being concerned to their needs can greatly reduce patient withdrawals. Clinical 6 provides clinicians and patients to communicate at any time. By providing a confidential tool for subjects to provide their experiences can be a valuable means for patients who may not be comfortable vocalizing their concerns in person. Honest patient feedback provides the opportunity to address any issues that may arise, perhaps even from something as simple as a missed dosage or finding the nearest clinical laboratory.
Life is short, science is long, opportunity is elusive, experiment is dangerous, judgment is difficult. It is not enough for the physician to do what is necessary, the patient and the attendants must do their part as well, and circumstances must be favorable. —Hippocratic writings
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