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.
Many weak strategies are being tried to tackle this problem.
- 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:.
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