Drug makers are seeking a record amount of orphan drug designations from the Food and Drug Administration to help patients with diseases that affect a small percentage of the population. At the same time, there is intense competition for clinical trial sites, especially in the fields of oncology, neuroscience, and rare disease.
But all that work to bring new treatments to market hasn’t changed the amount of time it takes to get a clinical trial up and running, according to a study I conducted with my colleagues at the Tufts Center for the Study of Drug Development that was recently published in Therapeutic Innovation & Regulatory Science.
For almost a decade, it’s taken nearly eight months on average to get from site identification to study startup completion, when all sites are initiated and ready to enroll patients. Our global study included more than 400 pharmaceutical and biotech companies as well as contract research organizations, or CROs, which are companies that conduct clinical trials for sponsor organizations. Many clinical trials are outsourced to CROs by pharma and biotech companies.
The startup process is an important part of the clinical trial, but can be dogged by a whole host of delays. These delays can have a huge impact on the cost of a study and ultimately the cost to develop a drug.
Factors that may impact a trial include:
- Changes to the design of a study and the number of lab tests, blood work, and other procedures that a study volunteer has to undergo
- Inability to recruit study volunteers and enroll them in a study
- Restrictive inclusion and exclusion criteria which would exclude those that want to participate in a trial
- Contract and budget negotiations with investigative sites
More global trials are being conducted, which brings the challenges of country selection and initiation, regulatory compliance, and standardizing informed consent language to ensure the protection of patients participating in the trial.
Given the number of sites that are part of a large, multi-center trial, it is costly for companies to initiate a site, estimated at $20,000-$30,000, and then maintain it, which could cost $1,500 per month. Our study also found that on average nearly 11 percent of sites are not activated in a multi-center trial, further increasing costs.
There are a number of solutions that can shorten startup times. CROs, our study found, had faster startup times than pharma or biotech companies because of their investment in technology, such as clinical trial data management systems and commercially available databases and market intelligence on investigators and sites. As sponsors rely more on CROs to conduct clinical trials and manage site activity, CROs are continually looking to implement efficiencies.
Companies could pool and share data on investigative sites within and across organizations. Very often large pharmaceutical companies are siloed and may not be aware of information available within their own organizations. Some large CROs already share investigator and site information. Our study found that startup times were faster for repeat trial sites compared with new ones, or those that an organization has not previously worked with, and companies should give more consideration to these locations. These new sites may be in therapeutic areas where an organization has not conducted trials before and may require more time to gather information and knowledge about these sites.
TransCelerate BioPharma has been one example of an organization with a mission to promote industry collaboration. The nonprofit, currently partnering with 19 leading biopharma company members, has worked on ways to improve clinical trials, such as a shared investigator platform. This platform is a cross-industry solution designed to reduce administrative burdens among sites and sponsors and centralize and streamline study startup processes. TransCelerate has several other initiatives that focus on preclinical and clinical development as well as patient safety.
Given that the industry is seeing more drugs in the pipeline with orphan designations and that there has been an increase in drug approvals for rare disease, the need becomes even greater to make clinical trials more efficient. Companies must address the challenges and implement solutions to get drugs to market faster and offer treatments to patients who desperately need them.
Mary Jo Lamberti, Ph.D., is a senior research fellow at the Tufts Center for the Study of Drug Development, which receives some of its funding from the pharmaceutical and biotechnology industries.
Nice piece! I have long lost count of the number of times I’ve seen massive inefficiency in trials when we are involved as the clinical translations vendor. Not only on larger global studies but just as often on domestic-based studies requiring Spanish translations of patient recruitment materials, ICFs, protocols and other needs. The “silo habit” of CROs, IRBs and sponsors does indeed clog the communications pipeline which of course directly clogs actual drug-to-market results.
The solution to this problem is for Sponsors and CROs to limit the use of large institutional sites who consistently take 6-8 months to execute a Clinical Trial Agreement and/or obtain IRB approval. Sharing of information is useful, but info already known regarding site start-up expectations is typically either accepted or ignored by industry. In essence, we are consenting to this issue by not limiting the cause.
Not all CRO’s operate the same. Often times i find that subject matter experts are lacking. when you do run into someone who knows how to navigate through the academia bureaucracy, it can be magical. these people are few and far between, but when you do bump into them they make activating studies a breeze.