Clinical trials are structured to ensure safety and efficacy during four phases that test the treatment on human subjects. Because these phases each follow a strict protocol and depend on adequate patient enrollment and engagement. It takes about ten years for a new treatment to progress from initial discovery to launch.
Studies are somewhat lengthy by nature, due in part to the importance of quality assurance in clinical trials. However, there are many other factors that influence the timeline of clinical trials, including common clinical trial enrollment challenges like economic concerns, ineffective recruitment strategies, or poor patient retention rates.
Let’s discuss typical clinical trial timelines and some potential solutions, including broader adoption of decentralized trials and technological tools that aid in better clinical trial design.
How long do clinical trials take?
Clinical trials alone take six to seven years to complete on average. But before this can happen, scientists research new developments in the discovery phase, which can take from three to six years. Once a potential treatment reaches the clinical trial stage, the typical timeline of a trial progresses as follows:
These trials enroll 20 to 100 healthy volunteers or people with the medical condition being studied and last several months. This phase 1 clinical trial measures safety by testing for any adverse side effects of the new treatment, but not necessarily how effective the drug or device is.
About 70% of potential new drugs progress to phase 2, which continues to measure safety along with looking at how effective the treatment is and carefully investigating the side effects. Phase 2 trials usually recruit up to several hundred patients with the medical condition the drug was designed to treat to take part in the clinical study, and this phase can last anywhere from several months to two years.
Phase 3 and FDA approval
Only about 33% of drugs make it to this phase, which tests the potential treatment in the largest number of people – up to thousands of volunteers. The phase 3 trial can last from one to four years. After a phase 3 trial, drug companies can submit a New Drug Application (NDA) or a biologics license application (BLA) for the new treatment to the US Food and Drug Administration (FDA). The FDA reviews the results from all previous stages of the trial to make a determination of whether or not it will approve the drug and allow the pharmaceutical company to start marketing it to the public.
Often called post-approval clinical research and monitoring, this phase is when the pharmaceutical or medical device company may continue to monitor patients using the treatment to learn more about its possible longer-term effects and compare it against other already-approved products. Because it may take time for long-term side effects to appear, this phase is still very important.
How did COVID-19 affect clinical trials?
Prior to the pandemic, pharmaceutical firms relied mostly on in-person investigator meetings and patient visits, working through scheduling challenges and years-long development cycles to reach commercialization endpoints for their new drugs and therapies. But lockdown measures and travel restrictions left most of those activities off the table, and about 80% of non-COVID trials stopped or were interrupted by the crisis. Fragile timelines were at risk of getting even further off track.
In many cases, trials were prevented from enrolling new patients. Those with patients already receiving treatment pivoted from in-clinic visits and drug distribution to telehealth and courier drop-offs. The FDA issued guidance on protecting patient safety, leaving it to trial sponsor/s to “determine that the protection of a trial participant’s safety, welfare, and rights is best served by continuing a study participant in the trial as per the protocol or by discontinuing administration or use of the investigational product or even participation in the trial.”
From the early days of lockdowns through to a post-vaccine world still dealing with the emergence of variants and accompanying uncertainty, clinical teams found new ways to conduct their work, even after it became possible to see more patients in person. “COVID-19 taught us that there’s a lot more flexibility in the clinical trials system than we realized,” said Meg Mooney, associate director of the Cancer Therapy Evaluation Program at the US National Cancer Institute in Bethesda, Maryland.
How does virtual engagement shorten trial timelines?
One aspect of this newfound flexibility came in the opportunity to shift some trial activities to asynchronous virtual engagement. Platforms like Within3 gave investigators, researchers, and even patients to engage with each other over a period of days or weeks by logging in to over-time discussion platforms. No longer restricted by one-time video meetings or waylaid by last-minute no-shows, stakeholders could continue important work while still tending to in-clinic and at-home commitments.
Clinical teams began to adapt – and then champion – virtual engagement. They learned to rethink meeting structure, evolving from large-format live meetings to asynchronous sessions with on-demand webcast elements. By doing more virtual work and sitting through fewer virtual meetings, clinical teams began to see that virtual engagement wasn’t just a crisis-induced stopgap.
To move forward with a more virtual-first approach, Within3 recommends the following:
- Good change management. Any new process or tech needs buy-in, and communicating the value of a new approach is critical.
- A learning mindset. Change can have benefits, and it would be a missed opportunity not to rethink outdated or ineffective processes.
- Open-mindedness. Help your team and your leadership understand the benefits of increased agility and a more patient-centered approach to clinical trial development and execution.
Within3 works with the world’s top pharmaceutical and medical device companies to help them transform their approach to engagement and insight-gathering. Learn how to get started – download our white paper.