Tuesday, October 11, 2016

Whitepaper: Is patient centricity truly at the core of clinical trials?

The complexity of clinical research trials, their exorbitant cost, and poor patient recruitment has reached a critical junction where novel methods of data design and recruitment are essential.  Fortunately, the offspring of technology and the internet has provided options that promote patient recruitment and retention, cut costs and avoid much of the paperwork and angst involved in clinical trials.

The ubiquitous smartphone can be used in a variety of ways. It is a way for researchers to remind patients to take their medications, be available for appointments, and give encouragement and transmit news. Innovative giants like Google and Apple have developed novel wearable devices and app development software so that the patient’s status can be monitored continuously and remotely.  Patients are not inconvenienced by having to travel to the research site which allows researchers access to the elderly, infirm, and rural patients. In addition, study nurses can go to the patients for follow up.
The development of novel trial designs is becoming available. Some trial designs such as biochemical classification examine very narrow and genetically identified individuals, whereas others such as the pragmatic trial design are appropriate for trials involving patient needs, attitudes, concerns, and ideas. Clinical Trial Data Management systems can provide immediate information regarding recruitment, management, project management, complete necessary regulatory paperwork and aid in the analysis of data.

Approaches that harness the internet and social media can be used for enrolling subjects in trials that have limiting inclusion or extensive exclusion criteria. The availability of crowd-sourcing, involvement of support groups, and physician specialists will go a long way in making sure a study recruits sufficient patients to complete the trial. 

Recruiting minority groups will be improved with increased sensitivity to the needs of patients from different cultures, ethnic groups, and low socioeconomic groups. Involvement in the community and providing patients with support such as daycare, meals, and transportation are key to enrolling these underrepresented groups. 

Clinical trials are more frequently conducted in developing countries to save money, but there are unresolved issues of informed consent, ethical treatment of subjects, oversight and risk/benefit ratios.  Unfortunately, there are many examples of these type of abuses that have resulted in a near moratorium on research trials in India. Patients are protected by the Declaration of Helsinki, but there is inadequate oversight of these standards and questions abound about who should be responsible for oversight. 

Data transparency is needed to recover confidence in the research trial process and results.  There are too many examples of drug trials that were never registered, where medications were approved but were later found to ineffective or dangerous and negative studies that have been withheld from publication.  Patients and other medical groups continue to push to make all data available, but large sponsors are concerned about how the data will be misused by competitors and the possible loss of patentable devices or processes.  The FDA has put into place laws that require registration of all past, current, and future clinical trials and the sponsors will also need to provide a synopsis of the trial study results. There are stiff penalties for noncompliance.

This whitepaper looks at the many ways in which clinical research can be made more patient-friendly to enhance recruitment and retention, including wearable technology, social media, novel trial designs, data management, support groups and sensitivity to minorities.

Join the conversation on patient centricity at the Partnerships in Clinical Trials Europe conference in Vienna on 16-17 November 2016. Over 1000 industry leaders will be there and you can join them for less with 10% off ticket prices by entering the code CQ3011BLOG at the checkout (T&Cs apply).

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