ICON partnered with a drug development sponsor to conduct a global programme for Multiple sclerosis (MS) studies in over 2,200 patients. The studies faced many regulatory and patient recruitment challenges which presented a risk of activation and enrollment delays. ICON’s prompt evaluation and proactive solutions, in conjunction with the strong, collaborative partnership with the sponsor helped mitigate delays and reinforce the client’s reputation in the MS research field.

The two main studies required the regulatory approval of 30+ countries as well as the ethics approvals for 375+ sites. During the regulatory approval process, the Ministry of Health and Clinical Events Committees had many questions about the initial submissions, resulting in multiple protocol amendments, changes in the client strategy, and significant delays in site activations. When some countries disagreed with the study design, submissions had to be withdrawn. In addition to regulatory delays, the competitive landscape in Europe and the United States worsened and recruitment rates dropped. Most of the high-performing sites were involved in at least three other competing studies. These challenges combined with inherent hurdles in negotiating contracts across multiple sites in multiple regions all threatened to affect enrollment timelines.

Since delays in activation threatened overall enrollment timelines, ICON and the client initiated a series of regional meetings to foster the public’s enthusiasm and to reinforce the drug’s importance, hoping to increase recruitment rates. ICON and the client held a recruitment strategy meeting for the team when the project was still under 50% of its goal of recruiting 1,100 patients.

ICON’s global Regulatory Affairs group oversaw the entire regulatory submission process to ensure consistency and coordination in filings across all countries. To manage the regulatory agencies’ numerous questions and to ensure we provided consistent answers, ICON and the client developed a database of questions and responses. Once the agencies accepted the responses, the team began submitting them with initial submissions to prevent further delays. For each country, ICON also developed a comprehensive risk management plan that featured clear mitigation and contingency plans by site to minimise further activation delays.

The ICON team reviewed the plans weekly throughout the start-up period. The risk management plan also provided guidance to quickly identifying alternate countries to replace the ones experiencing significant regulatory delays.

Furthermore, as mitigation against delays involved with global contract negotiation, ICON and the client developed contract negotiation guidelines that outlined the contracting/negotiation process, accountability, sign off, and buy-in from each party. The involved legal teams also agreed to amend the signature requirements to speed the process considerably.

ICON also assigned CRAs from validation through close-out to provide sites with primary contacts and create client-dedicated project teams. To enhance recruitment results and overall communication with investigators, we assigned CRAs who had already established relationships with the studies’ sites.

The client’s reputation in the MS research field combined with ICON’s proactive approach to developing solutions helped mitigate delays. Just over three months after the project team meeting, the team reached its recruitment goal. Although the original timelines were not met, the implementation of the risk management plan prevented additional activation delays.