White Paper SPCD

Download the white paper “The Sequential Parallel Comparison Design for Reducing Placebo Response”

Introduction

In the past several decades, it is recognized that increasing spending of clinical research does not reflect an increase of the success rate of drug development. Moreover, the pharmaceutical industry has realized that the classical structured clinical trials do not offer enough flexibility to make use of continuously emerging knowledge that is generated as trial progresses.

One of the innovations strongly recommended by the authorities is the use of adaptive designs in clinical trials and the potential use of Bayesian approach in clinical research. Although planning such trials comes at the cost of additional operational complexity, adaptive designs offer the benefit of flexibility to update trial design and objectives as data accrue.

In this white paper, we will explore a two-stage adaptive design called the “Sequential Parallel Comparison Design” (SPCD) for enrichment of placebo non-responders.

Background

The placebo response has progressively increased over time in clinical trials for psychiatric disorders. High placebo response reduces the ability of trials to detect the treatment effect, resulting larger rates of failed and negative trials. The sequentially parallel comparison design (SPCD) invented in 2003 at Massachusetts General Hospital by Dr Fava and Dr Schoenfeld (Fava et al., 2003) is an effective approach for reducing both the high placebo response and the required sample size. Due to the two-stage design, the inference procedure of the SPCD is not straightforward. The aim of this white paper is to walkthrough the computation of a P value, a confidence interval and an estimate of the overall treatment effect at the termination of the two-stage trial.

Download the white paper







    Information privacy policy

    Consent pursuant to art. 6 Regulation (EU) 2016/679
    Upon reading the Information Notice outlined above:

    a) The undersigned shall give specific consent to the processing of personal data for marketing purposes (namely direct sale, sending of advertising material, market research and commercial communication). This consent is provided for marketing carried out by using both traditional systems (such as paper mail, phone call with operator) and automated systems of call or communication without operator, email, telefax, short text messages, MMS, or other automated means of communication. The data subject’s right to oppose the processing of their personal data for the purpose of direct marketing through automated contact methods also covers the traditional ones, with the possibility of exercising this right also partially. The data subject may express their consent to receiving communications for the abovementioned purposes exclusively through traditional methods of contact. The data subject’s refusal to give consent will result in the company’s failure to process their data for marketing purposes.

    b) The undersigned shall give specific consent to the processing of their personal data for profiling activities.

    c) The undersigned shall give specific consent to the processing of their personal data for communicating data to third parties for marketing purposes.


     

    Would you like to learn more? Watch the recording of our webinar “Innovations in Clinical Trial Design: Patient Enrichment Approach for Placebo Non-responders and Responders”.