Bioanalytical Complex Assay Development - Mini Podcast Biosimilar Development Capabilities – Watch Now Vaccine Development Capabilities - Brochure Check out our latest Validated PK & ADA Methods List Read about Veeda's partnership with Ahammune Biosciences for first in human studies Watch our Latest Symposium on Immuno-centric Approach to Biosimilar and Vaccine Development Check out our Assay List (Method Library)


Home > Veeda Insights > Approach for Rescue Trials

Approach for Rescue Trials

Conducting a clinical trial is a complex and challenging task and involves robust scientific understanding and logistics planning. Although there are international guidelines for good clinical practices, the standard approach may not work for all clinical trials especially in the case of trials that use orphan drugs, terminally ill patients, epidemiological trials, and so on.

Factors that plague clinical trials

It has been reported that approximately 50% of phase III clinical trials do not achieve their objective or fail to demonstrate the desired results. Some of the major issues that pharmaceutical companies face while conducting large-scale trials are:

Meeting regulatory deadlines: Inadequate or poor patient recruitment, poor execution, or complicated study design are some reasons that contributed to the inability of a company to meet timelines. Approximately, 80% of trials are behind schedule. Analysis shows patient recruitment to be one of the prime reasons for study delay.

Data quality: A flawed study design and complacency in following the patient eligibility criteria required for enrolment also affect the data quality and ethics of a trial. In addition, lack of patient informed consent or breach of confidentiality are other serious unethical practices that affect final data quality.

Infrastructure and resources: While accounting for infrastructure and resources, sponsor companies sometimes underestimate the requirement of trained staff at each step of a trial. A sponsor may need to recruit more number of clinical trial associates, study coordinators as well as other trained personnel depending upon the number of trial sites and targeted cohort size. At times, the importance of site inspection is also overlooked. Site inspections help in evaluating the technical capability of the staff and confirm if the site is well equipped to handle additional responsibilities.

Unexpected challenges: Sponsor companies are sometimes caught unawares by challenges that crop up during execution of a trial. Without a risk management plan (RMP), it is impossible to identify warning signs and can also bring the trial to an abrupt halt.

All the above factors require the sponsor to look for remediation measures and this is where rescue trials come into picture.

Rescue trials

There are different approaches that pharmaceutical companies employ for rescue support. For specific issues, the company may choose to bring on board a third party with expertise in a specific function or completely outsource study management and control to a contract research organization (CRO).

Integrating into an ongoing study requires the on boarding team to have the flexibility as well as the insight to identify problem areas that have led to the failure of the Sponsor’s trial. Therefore, it is necessary for the CRO to have demonstrated expertise in handling a particular therapeutic area or to have the technical knowhow of running rescue studies. This will help in seamless knowledge transition and identification of bottlenecks that have caused the trial to fail.

In case the trial is being transferred from another CRO, there should be a clear communication and handover plan from the outgoing CRO to the on boarding CRO and the Sponsor Company. This communication should include strategic details such as current study status, vendors involved, database migration, documentation and quality control, current risk management plan, to name some of them.

Key takeaway

For a successful rescue study, there should be document compliance and effective documented communication between the sponsor and CRO. Corrective action and preventive action (CAPA) at each stage of the trial is necessary, especially in the case of rescue studies, to meet study milestones and to avoid any further delay in trial execution

The information contained on this article is intended solely to provide general guidance on matters of interest for the personal use of the reader, who accepts full responsibility for its use. Accordingly, the information on this article is provided with the understanding that the author(s) and publisher(s) are not herein engaged in rendering professional advice or services. As such, it should not be used as a substitute for consultation with a competent adviser. Before making any decision or taking any action, the reader should always consult a professional adviser relating to the relevant article posting.

While every attempt has been made to ensure that the information contained on this article has been obtained from reliable sources, Veeda Clinical Research is not responsible for any errors or omissions, or for the results obtained from the use of this information. All information on this article is provided “as is”, with no guarantee of completeness, accuracy, timeliness or of the results obtained from the use of this information, and without warranty of any kind, express or implied, including, but not limited to warranties of performance, merchantability and fitness for a particular purpose. Nothing herein shall to any extent substitute for the independent investigations and the sound technical and business judgment of the reader. In no event will Veeda Clinical Research, or its partners, employees or agents, be liable to the reader or anyone else for any decision made or action taken in reliance on the information on this article or for any consequential, special or similar damages, even if advised of the possibility of such damages. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, mechanical, electronic, photocopying, recording or otherwise without the prior written permission of the publisher.

For information, contact us at:
Veeda Clinical Research Private Limited
Vedant Complex, Beside YMCA Club, S. G. Highway,
Vejalpur, Ahmedabad – 380 051,
Gujarat India.
Phone: +91-79-3001-3000
Fax: +91-79-3001-3010