Partnering with the right vendors such as DCTs and CROs is key
The massive growth of DCTs during COVID-19 has increased activity in the space, with top CROs recently leveraging M&A deals and strategic partnerships to develop DCT solutions. By 2024, survey respondents estimate that 22% of all DCTs will be exclusively run by a pharma or biotech company sponsoring the trial, 35% exclusively CRO-run, and 44% will involve both parties.
When selecting vendors, the average CRO respondent slightly prefers working with new vendors, while large sponsors (revenue >$10b) prefer working with existing vendors and small sponsors (revenue <$1b) do not express a preference. Both sponsor and CRO respondents have a strong preference for vendors with end-to-end capabilities, defined as providing all the solutions necessary to perform clinical, safety and regulatory activities with a unified IT system to keep the data in sync. Vendor market leaders were determined by percent experience using or planning to use by sponsors or CROs.
The top challenge for pharma sponsors is the ability to integrate DCT data within existing ecosystems. Other challenges include optimizing study execution in patients’ homes, obtaining clearer regulatory guidance, data protection and privacy, and the availability of solutions that facilitate compliance with regulatory guidelines. For CROs, the top three challenges are the optimization of study execution in patient homes, clearer regulatory guidance and the ability to integrate DCT data within existing ecosystems (Figure 3).
Primary interviews indicate that this is due to the complexity of more moving parts in a decentralized model, where there are multiple patient homes with personnel such as sponsor investigators, medical professionals and regulators.
Of the top challenges, clearer regulatory guidance is seen as the largest catalyst to accelerate global adoption of DCTs (38% picked as the top choice; next highest choice was 19%). Increased clarity is needed in areas such as benefit/risk assessment, protocol amendments, documentation, data/IT systems, data privacy and communication cadence. Guidance from regulators on these matters will ease uncertainties and facilitate much greater adoption of DCTs.