Industry problems with clinical trials

As the science behind drug development has continued to advance, the methods of managing study participants in increasingly competitive markets have remained fairly stagnant.

The global pharmaceutical industry is under enormous financial pressure to cut timelines, accelerate outcomes and increase efficiencies with their drug development initiatives, and companies are looking for new and better solutions. According to Kirkpatrick, one of the greatest challenges in the field of clinical trials is participant engagement.

One of the significant reasons adherence rates are thought to be low is because, typically, the clinical trial protocols require the study participant to perform and document daily self-care activities. Getting individuals with a health condition to perform daily self-care is an on-going challenge in health care, and clinical trials are no exception.

Key Facts:

  • 80% of clinical trials fail to finish on time
    „…Due to drop-out rates and non-adherence, nearly 80% of all clinical studies fail to finish on time, and 20% of those are delayed for six months or more.“ (Kirkpatrick 2002)
  • Adherence in studies on chronic conditions is 78% or less
    „…The average rates of adherence in clinical trials can be remarkably high, owing to the attention study patients receive and to selection of the patients, yet even clinical trials report average adherence rates of only 43 to 78 percent among patients receiving treatment for chronic conditions.“ (Osterberg 2005)
  • Non-adherence leads to misinterpretation of study results
    „…We must be aware that unrecognized nonadherence masquerades as drug resistance. The only way to tell apart those patients who do not respond to their medications from others who do not adhere to their clinical regimens is to monitor adherence.“ (Milgrom 2012)

Many weak strategies are being tried to tackle this problem.

They include

  • creatively packaging medications to improve adherence
  • leveraging smart phones to maintain ongoing patient contact
  • over-recruiting to compensate for non-adherence and drop-outs

To name a few. Unfortunately these strategies, at best, touch the surface of the underlying issues, and at worst, compound the problem. Recruiting more study participants and treating them as though they are all the same, simply creates more disenchanted study participants.

Non-adherence is a big issue leading to:.

  • A lack of study power, that is, the ability to detect an effect if it exists

  • An increase in the sample size and study duration needed to finalize the clinical trial

  • Increased costs, loss of product revenue, and decreased confidence in investigators

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References

Kirkpatrick F et al.
Rev Up Patient Recruitment
Pharmaceutical Executive 2002; 4: 60–66

Milgrom H, Curran-Everett D
Unrecognized nonadherence masquerades as drug resistance
Curr Opin Allergy Clin Immunol 2012; 12: 219-220

Osterberg L, Blaschke T
Adherence to medication
N Engl J Med 2005; 353: 487-497