A Case Study: Phase III Clinical Trial Impacts Survival of a Biotech Company
As the clinical trials industry continues to grow and evolve, the role of contract research organisations (CROs) in managing clinical trials becomes increasingly important. CROs can provide valuable support to biotech companies by managing various aspects of clinical trials, including study design, patient recruitment and data analysis.
A case study in collaboration with a German biotech company demonstrated the importance of a specific analysis of requirements and objectives when working with service providers. Effective management of a clinical trial can have serious consequences for a small biotech company. In this case study, a biotech company partnered with a large service provider to conduct a phase III clinical trial for a promising oncology therapy. The biotech company expected the trial to be successful in generating financing for future research and development work and, more importantly, to obtain regulatory approval for this drug.
However, the partnership between the company and the contracted service provider unfortunately resulted in several serious errors that ultimately resulted in the breakdown of the study, the company’s objectives and also the continuation of the company’s business.
In cooperation with independent consultants and experts, in SWAT function, the biotech company wanted to bring the study back into its internal administration in order to rescue what remained to be restored. To Date, the biotech had very carefully and with great effort and expense coordinated a workshop lasting several days, in which they discussed details of the further procedure and what they needed for this very demanding task.
In the course of the process of return the project to in-house administration , it turned out that the communication between the company and the contracted service provider already showed considerable and multi-layered deficits. As a result, only incomplete information was available regarding sponsor oversight, or contractually agreed work requirements were generally not performed. In an extensive procedure, missing documents, work processes and data from the last 2 years had to be retrospectively revised, compared and processed.
There was also a lot of uncertainty among the study sites, involved vendors and stakeholders. Study sites and vendors were not managed effectively and it was not ensured that the study protocol was adhered to. As a result, the study data were not considered to be of sufficient quality to demonstrate the efficacy of the drug. Many of the data were not valid or were not adequately verified. A substantial backlog of data became evident. With a great effort and the support of the study sites, all data had to be retrospectively assessed, transferred to the database, verified again and evaluated.
The biotech company was not sufficiently informed about the status of the study until this date, which led to misunderstandings and delays in decisions and effective work processes. This had a significant impact on compliance processes, the regression of the study and the retrospective processing of the study data.
As a result of these errors, the Phase III trial failed and the biotechnology company was no longer able to secure the funding it needed to continue its research and development efforts. In the end, the focus was on saving data and properly closing the trial. The overall situation was a fatal hit to the company, which was finally forced to reduce its staff, downsize its operations and ultimately be liquidated.
This case study demonstrated the importance of carefully selecting external service providers. As a start-up or growing company, it is important to ensure that their CRO partners have demonstrated success and expertise in the therapeutic area and are able to effectively manage all aspects of a clinical trial. In this specific case (which is not the only case in the past 10 years), it turned out that significant additional costs were planned for insufficient resources. The biotech company was no longer able to oversee the study status. An unbalanced dependence of the biotech company on the service commitment of the CRO occurred. This was an insidious process and resulted in the complete breakdown of the study targets. Finally, the financial resources ran out and the CRO was no longer able to provide specific results of work activities.
Biotech companies with specialised, exploratory clinical trial requirements need to actively track trial progress and ensure that their service partners are meeting their specific expectations and milestones as expected. Effective communication can be essential for the success of the clinical trial.
REAgency+ is happy to advise you on the strategic planning and implementation of clinical trials, also in a CRO context as a second-tier partner or independent consultancy.
