Big pharma has only scratched the surface in terms of utilizing the potential for accelerating R&D though crowdsourcing. The Internet and social media have created a new public health ecosystem that spans across state borders. According to Google, the number of smart phone users globally was 1.75 billion in 2014, and is projected to increase to 2 billion by the end of 2015. Consumers are increasingly using smart phone applications and wearable technology to track their personal health, and are now more willing to share their data with researchers (Click here to read more on: How Wearable Technology Will Change Clinical Trials).
Open source clinical software and electronic data capture solutions are further enabling the crowdsourcing trend to grow. Apple recently announced its ResearchKit open source software framework for researchers where developers would be able to design health and fitness apps that can communicate with each other. This would give researchers fast and easy access to more clinical data than ever before. Other benefits to crowdsourcing clinical research include:
Crowd sourcing offers an innovative approach to reducing the cost of conducting clinical trials. Labor markets such as MTurk, for example, offer many convenient features for accessing a large pool of workers for recruitment. The cost of designing and running a study using this platform is reportedly modest compared to hiring staff directly and custom designing the trial setup. However, it is important to note that the goal here is not to replace traditional expert-driven clinical trials but rather enhance data quality and quantity without increasing cost.
Increasing participation in clinical trials
Crowdsourcing facilitates education about clinical trials and can thus significantly improve participation rates. In the States, only about 3% of cancer patients decide to enroll in cancer clinical trials. Recent research shows than educating the public can dramatically increase the number of volunteers and accelerate trial accrual, which ultimately gets questions answered quicker.
Improving disease understanding
Crowd sourcing allows access to large cohorts and real-time data. The SERMO social media for doctors platform has 382,000 members- all of whom are verified physicians with current credentials. A lot of community doctors don’t have experience with clinical trial protocols but strive to remain active in contributing to advancing research. Crowdsourcing, therefore, provides them with the perfect outlet where they can choose their level of participation and the time they’d like to dedicate, and still develop research ideas with peers from across the globe. Ultimately, this fosters innovation and generates new drugs and treatments that better meet patients’ needs.
Break down barriers
Language or cultural barriers can also pose problems when a diverse population cohort is needed in a clinical study. If the content were made available on an open platform- doctors, caregivers and patients could collaborate which would provide more culturally sensitive solutions to their problems.
For example, during a 2007 medical conference, a group of Italian researchers reported that lithium (used for bipolar disease) had shown to delay amyotrophic lateral sclerosis (ALS) progression. Even before their paper was published officially, ALS patients had already used Google translate to share the paper abstract in English. Soon enough, patients collaborated on a group Google spreadsheet, tracking their own personal data, and comparing it to that of the researchers in Italy. About 160 patients tested lithium on themselves, which prompted PatientsLikeMe to build more tools for data structuring. Some of the patients even posted their personal experience on YouTube.
Accelerate research and development
Crowdsourcing challenges providing a financial incentive to participants attract a fresh pool of perspectives which can bring along new solutions outside the clinical research community. This format for data collection is also beneficial as the problem solvers don’t have access to each other’s algorithms, which allows for a better assessment.
A great example of this is the DREAM-Phil Bowen ALS Prediction Prize4Life challenge. Containing nearly nine thousand patients, PRO-ACT was launched as an open access platform for researchers in December 2012. In the Prize4Life crowdsourcing challenge, solvers were asked to use three months of individual patient level clinical trial information to predict that patient’s disease progression over the subsequent nine months. The challenge resulted in 37 unique algorithms from which two winning entries were selected.
Ultimately, the winning algorithms outperformed a baseline model as well as ALS clinicians using the same data. The organizers estimated that using both winning algorithms in future trial designs could reduce the required number of patients by at least 20%. The challenge also identified several potential predictors of disease progression (including uric acid, creatinine and surprisingly, blood pressure), shedding light on ALS research and development.
Drawbacks to crowdsourcing
Crowdsourcing does come with certain disadvantages. For example, in the cases where clinical trial sponsors don’t use existent crowdsourcing platforms (such as Amazon’s M Turk), they need to create a website for crowd participation, which increases clinical trial cost. Some experts also criticize crowdsourcing initiatives, such as contests, for being unethical and rewarding a few individuals while the work of the majority is exploited for free. The two main clinical crowdsourcing drawbacks, however, are the quality of data and the unregulated nature of this new trend.
In crowd sourced clinical studies, the sheer volume of gathered data can cause clutter and make it hard to dig through the unstructured and noisy information. Another reported complaint is that crowdsourcing labor market platforms such as Amazon’s MTurk can’t weed out spammers or poorly performing workers. On the employee side, there is no guarantee of payment for their work, which is why the federal government is reluctant to approve such research studies. In addition, MTurk studies’ quality control and evaluation are said to be dependent on domain experts, which deems it unsuitable for complex studies with sophisticated algorithms. This is also not a viable option for clinical studies that contain sensitive information and thus rely on confidentiality.
Crowdsourcing is a new, uncharted territory, still unregulated by most governments. However, innovation calls for change and the social trend of sharing personal health and disease information has started to change the traditional circumstances around clinical research and development.
However, a recent customer survey on data ownership shows that 57% of consumers would only share their data on the condition of privacy protection. Over 90% said this is very important to them, and a small percentage were open to sharing their data with the mobile device company that collected it.
The lack of industry standards around crowdsourcing also raises concern about the validity of the collected patient health data. However, experts believe that the mainstream adoption of tech health devices would force the industry to address information governance and impose standards in the near future.
Click here to read the full crowdsourcing paper for free
Future of clinical crowdsourcing
New platforms, products and services leveraging the power of the crowd are constantly emerging on the market. Amateur scientists are looking for crowd funding to start their own clinical studies on platforms such as GoFundMe and IndieGogo. The wide adoption of smart technology and social media are prompting new behavioral boundaries where sharing personal health data is acceptable. Google X is working on a clinical trial wristband that would allow scientists to gather health data from thousands of users.
However, crowdsourcing is still very much a buzzword and many argue that it cannot be fully utilized in clinical research and development until the FDA regulates it. Even if this happens in the near future, experts agree that crowd sourced health research is not meant to replace traditional clinical studies but rather complement and extend them. It will be very interesting to see how it evolves over time as more tools and apps become common.