According to Dr. Dorothy L. Smith, President and CEO of McLean-based Consumer Health Information Corporation (CHIC), "Research shows that many patients are overestimating their adherence and not providing the study investigators with honest self-reports. The study design may be flawless, but if the patient does not understand the medication instructions and is not motivated to take the study medications as prescribed, the results of the clinical trial might be flawed." She asked: "Could this be part of the reason for the unexpectedly high adverse drug reactions and deaths that have made recent headlines and resulted in numerous post-marketing dilemmas?"
The main reason that patients over-report their usage is because they do not want to disappoint their doctors. Failure to report the patient's adherence has a huge impact on study results. Data on the efficacy of the study could be misinterpreted or the dose required to provide a desired effect overestimated.
Smith urged the pharmaceutical industry and clinical pharmacists to take the time to ensure that patients understand all information they need when participating in a clinical trial, by developing consent documents written in plain language, explaining how to take the study medications and use any device correctly, and the need to be honest with the study investigators regarding any problems they are having taking the medication.
Patients in clinical trials need to understand how important their study results are to the general population who will be taking the medication in the future.
Reported in Medical News Today
Clinical Trials Stats
- A growing trend of constant trial delays can cost a company up to $8 million each day their product is not on the market.
- More than 35% of patients do not understand the informed consent documents because they are not written in plain language.
- It is estimated that up to 30% of patients in clinical trials dump study drugs.
- Only 6 percent of clinical trials are completed on time, and 72 percent of trials run over schedule by more than one month.
- Recent NIH data indicates that just 4% of the U.S. population has participated in clinical trials
- Within 3 years, up to 65% of FDA-regulated clinical trials will be conducted outside of the U.S.
- In clinical trials just a 20% decrease in patient adherence requires a 50% increase in sample size to maintain equivalent power.
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Med Adherence Stats
- Better adherence to antihypertensive treatment alone could prevent 89,000 premature deaths in the United States annually.
- People who are prescribed self-administered medications typically take less than half the prescribed doses.
- People ages 45-54 years old are most likely to be non-compliant with their doctor’s advice
- Medication non-adherence is responsible for up to 33% to 69% of medication-related hospital admissions.
- The New England Healthcare Institute estimates that $290 billion in healthcare costs could be avoided if medication adherence were improved.
- Of the 3 billion medication prescriptions issued each year in the US, 12% are never picked up by the patient and 40% are not taken correctly
- UnitedHealthcare also looked at whether breast-cancer patients were compliant with their medication. It found that 38% weren't filling prescriptions for their aromatase inhibitors, drugs that stop the estrogen production that can feed certain cancers.
- 49% of consumers who look online for pharmaceutical information are interested in email or text reminders for prescriptions/refills
- A one month pilot proved that by using SMS-based appointment reminders, Kaiser was able to save $150 per appointment, their no-show cost, which equated to a total cost savings of over $275,000 at a single clinic.
- A study of California healthcare noted that 24.5% of blacks reported putting off filling a prescription, compared with 14.9% of whites, 10.8% of Hispanics and 6.1% of Asian-Americans.
- Among patients with diabetes, those with lower levels of adherence have nearly twice the total annual healthcare costs of those with high levels of adherence ($16,498 versus $8,886).
- Chronic diseases are estimated to constitute 75% of overall healthcare costs.
- In one survey, of those who don't take pills they're supposed to, 79 percent said they simply forgot.
- Adherence-related spending by brands runs 8-15% of overall marketing spending.
- 29% of Americans stop taking their medicine before it runs out.
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