February 21, 2019

Clinical Trial

1. Cutting-edge dose finding designs for phase I clinical trials

We offer innovative and effective Bayesian adaptive designs for dose-finding phase I trials. We lead the fields in method development, such as the modified toxicity probability (mTPI) design (Ji et al., 2010; 2013) and the mTPI-2 design (Guo et al., 2016). We provide the most comprehensive and rapid big-data comparison based on simulation that allows our clients to cross examine different designs in the field. We also provide user-friendly trial monitoring to help clients with ongoing clinical trials using these innovative methods.

2. Subgroup enrichment designs for phase II trials

We specialize in designing subgroup enrichment phase II trials based on SCUBA (Guo et al., 2016), during which precise therapy is realized by allocating subgroups of patients to their desirable treatment arms.

3. Innovative and cost-effective go/no-go decision making in drug development

We partner with our clients on a reliable go/no-go decision for the clinical trial considering the predictive probability of success in the next phase and the cost-effectiveness of the drug. We are capable of performing go/no-go analysis under different definitions of trial success and cost-effectiveness. The analysis is based on Bayesian model, which is natural to go/no-go decision making.

4. Seamless methods for phase I and phase II trials

We provide a coherent, comprehensive and efficient seamless design of phase I and phase II trials that accelerate the drug development while maintaining the safety and medical ethics of the trial. The seamless design is more cost-effective than the traditional design of individual phase I and phase II trials, as the efficacy data can be fully utilized and the trial conduct can be shortened.

5. Immune Oncology trial designs

We lead in the field of immune oncology trial designs and have had extensive experience on a range of issues related to immune oncology therapy. Different from traditional oncology drugs, the immune therapies violate the assumption that efficacy and toxicity are monotonically increasing with dose and hence bring an enormous challenge to the conventional trial designs. Our innovative method is targeting at the biological optimal dose that is the most beneficiary regarding to both toxicity and efficacy.

6. Designs for combinational drugs trials

As developing a new drug is increasingly difficult, drug combination has become popular in pharmaceutical industry. We offer innovative and efficient designs for combinational drugs trials which are tailored according to the clients’ demands. Our methods can rapidly learn the interactive relationship among drugs and the toxicity and efficacy outcomes, and thus speed up the overall trial conduct.

7. Dose insertion during the trial conduct

A trial with poorly elicited dose levels will have a small chance of success. We are capable of providing a coherent method of optimal dose monitoring, which can be an add-on to many existing designs. The method can estimate the optimal dose based on Bayesian modeling of the relationship between the dose and patient outcomes. Once all the elicited dose levels are proved to be far from the optimal dose by the Bayesian model, the method can be utilized to guide the dose insertion if necessary and consequentially increasing the chance of trial success.