doc and patient

Since James Lind conducted the first ever clinical trial aboard the HMS Salisbury in Britain’s Royal Navy fleet in 1747, clinical trials have been the linchpin to the entire drug development process, which is why we celebrate International Clinical Trials Day every May. On this day, we honor James Lind, and all of the researchers who followed in his footsteps to bring countless innovative treatments to patients.

Though this is also a day to reflect on how we can continue to improve our clinical trial process. The strategies we follow today for running trials are too long and expensive to meet the needs of patients, regulators, or the biopharmaceutical companies running them. And it is time make a change. We as an industry must implement strategies to modernize clinical trials through innovations that can deliver better medicines faster and at less cost to patients who need them. When companies invest billions of dollars to test new cures in clinical trials, everyone in the trial delivery system, including government entities, have an obligation to introduce efficiencies and reduce redundancies.

Better, faster, cheaper

The biopharmaceutical and biopharmaceutical services industries, along with the FDA and other key stakeholders, have already made great strides in improving the clinical trial process. We are working more closely together than we ever have before to enhance the way we design and execute clinical trials so that we can root out wasted time and cost while delivering greater value — and we have seen many successes. Nonetheless, much more must be accomplished.

If we want to improve the future of clinical trial research, we have to invest more time and effort into cross-industry collaborations to generate best practices across the drug development lifecycle that will improve the overall time, cost and value for everyone involved.

An area that I believe holds great promise in delivering these results is improving the way we collect, access and disseminate data. Through the expedition of data sharing, improving clinicaltrials.gov, and creating linkages between Electronic Health Records (EHR) and clinical research databases, we can facilitate more rapid and accurate identification of patient recruits, which is one of the most time consuming and high-risk steps in the trial. Harnessing newer design approaches and improving data accessibility will ensure that we find the right candidates for these trials more quickly while improving our overall focus on the patients.

We also need to look for opportunities to eliminate redundancies in the trial process so we can increase quality, efficiency and timeliness. I believe the greatest opportunity for improvement is in the start-up phase, where it can take up to 18 months and enormous staff time just to get to the point where a study is open for patient enrollment. The recently released revised draft of the “21st Century Cures Act” takes important steps in encouraging patient safety and timely start-up by removing some of the barriers to use of single Internal Review Boards (IRBs) in multi-center trials, which in our experience can cut the time to start an individual investigative site from several months to 45 days.

Establishing alternative development pathways to speed the introduction of new therapies is another innovative strategy that can help us address unmet medical needs for patients with serious or life-threatening conditions. In these alternative pathways, new entities meet safety and efficacy endpoints (including clinically and biologically meaningful, non-mortality surrogates) in smaller, well-defined populations and are then granted limited market approval for that specific sub-population. Quintiles’ research suggests that some patients are willing to use therapies developed under an accelerated pathway if it offers potential to improve their health, making this a viable solution for patients eager for treatment alternatives. All of the necessary pieces are in place to embrace alternative pathways for drug evaluation and approval and I am excited to see this innovative option move forward.

These are just a few solutions that can potentially generate ongoing improvements in the way we perform clinical trials. The key to achieving any of them is continued collaboration across stakeholder groups, and a willingness to question long held beliefs about how clinical trials are performed. The more we question our system the more opportunities we will identify to deliver improvement.