Dynamic boundaries and system-solving

Dynamic boundaries and system-solving. As our project reaches cruise altitude, one of our priorities is to understand the boundaries of the clinical trials process within the larger drug development system in the U.S. and globally.

We had a number of interactions with experts, advisors and representatives from different interest groups that addressed specific areas of the process that will be central to our research. Those conversations gave us a broad view of clinical trials, one we could have never obtained from a single source or stakeholder group.

The lesson from this extraordinary multi-stakeholder perspective is that the boundaries of the clinical trials process are dynamic, changing slowly as the drug development ecosystem does.

As ongoing advances in biotechnology empower smaller organizations and interest groups to pursue their goals using new models, we realize that the traditional way in which big industry, academia and public agencies conduct clinical trials today is being questioned.
These are three examples of new models disrupting clinical trials that have caught our attention:

Open source drug discovery. A few companies and consortia support the notion of increasing productivity and decreasing duplication by means of open source molecules. They question the validity of competition-based drug discovery, with its high cost and cost-prohibitive duplicity rate.

Crowdsourcing. Taking lead from a trend that is now well established in society and has proven successful in other arenas, some see the future of clinical trials in crowdsourcing. This approach increases the participation of patients in the full process of clinical trials design. Crowdsourcing promises cheaper and faster clinical trials with more advantages for patients.

New technologies in automated production. A successful example is how mRNA science has proven effective in bringing new medicines to patients. A few companies are positioned to disrupt clinical trials by using highly automated production to increase the speed and accuracy in which they conduct clinical research. To support their approach, they have garnered the interest and investments of a number of big industry leaders.

We wish that conventional problem-solving methods might suffice to help us set boundaries for our project. But we are not problem-solving: we are system-solving. We deal with dynamic boundaries and evolving patterns to fulfill our goal of reinventing a more efficient system.

We envision a simplified system that produces better drugs, at a cheaper cost to patients, and at a higher pace than the current one; a system that incentivizes stakeholder integration and believes that win-all should be the new gold standard in clinical trials; a system that is truly global and thrives on international collaboration and shared goals; a system designed to maximize the benefits for patients by being flexible enough to diversify the ways in which new drugs may be developed by better using all the resources at our disposal.

Enrique Martinez