The traditional purposes of controlled clinical trials have been to prove effectiveness of new drugs on scientific evidence basis:
- Determine optimal dosage
- State undesired side effects
- Seek for drug authority approvals
Patients, pharmaceutical companies and health professionals are demanding new approaches to:
- Measure and improve lifestyle habits
- Understand the effect of comorbidity conditions
- Discover long term drug interactions
- Age-related dosage adjustment
- Systems medicine based variability
During the
DIA Clinical Forum 2015 conference, Dr. Jim Roldan, Linkcare's CEO, made a presentation on the potential of Lifestyle Interventions, Patient Reported Outcomes and Observational Trials to address the current challenges on clinical research.
New challenges clinical trials need to address
Personalised medicine requirements also increase the difficulties to find the right case candidates. Phenotype variation, omics diversity and lifestyle implications are becoming an increased source of interest and concern.
Long term monitoring of drug effects and environmental interaction with disease are also important topics requiring new trial approaches.
Some recent episodes, such as the recent ones related Ebola treatment has shown the ethic limitations of controlled trials to face extremely adverse prognosis situations.
A number of recently published studies have shown the important role of lifestyle behaviors such as dietary habits, drug abuse, daily activity, sleep disorders and social behavior to play a much important role on health and disease personal record.
Theories imported from psychology such as the "perceived behavioral control theory” and “theory of planned behavior” are changing the way we understand lifestyle interventions.
Such behaviors not only influence treatment adherence but has a paramount impact on treatment effectiveness and disease progression.
The role of patient reported outcomes (PRO)
As chronic disease prevalence has increased due to life expectancy increase, new end points have been identified to be added to the traditional ones based on laboratory and functional findings, exacerbation records and survival rates.
Today, the patients perception of his own quality of life has become a central focus, as life quality and self perceived happiness become sometimes more relevant for patients than purely objective clinical data.
The availability of smart phones and the lower cost of telecommunication infrastructures have become enabling technologies making patient self report simple and inexpensive
Raising interest of observational trials
All the above is having a tremendous impact in many aspects of clinical trial design and goals.
The possibility of following up a controlled set on patients world wide during a long period of time as part of their daily care is making possible to design observational trials that allow long term longitudinal data to be collected an analyzed.
The establishment of a strong networks of researchers and practitioners around health-profile-oriented panels will allow unprecedented treatment benchmarking.
A new wave of treatment efficacy improvements is expected to outcome in the next years.
The era of clinical shared knowledge
A wider range of therapeutic options available, a much better understanding of personal and disease profile implications and an accelerated growth of the knowledge generated by big data sources and exponential research put translational medicine under reform.
New health care professional profiles specifically trained for case management require a different set of skills and will use new tools for their daily care to address the increased demand of care, derived from population ageing.
Despite they will lack of the expertise that only many years of practice can provide, new forms of knowledge exchange and clinical decision support services facilitate the access to knowledge.
More info:
Conference presentation
The development of the Linkcare precision trials platform has been supported by the Spanish Ministry of Economy and Competitiveness under the project IDENSSA (INNPACTO program grant number IPT-2011-1333-900000)
