745 Clin. Invest. (Lond.) (2015) 5(9), 745–753 ISSN 2041-6792 Clinical Trial Perspective part of 10.4155/cli.15.41 © 2015 Future Science Ltd e Our objective was to provide broad perspective on causes and consequences of clinical trial delays and suggest process-oriented and technology-enabled pragmatic solutions to minimize trial delays, in particular context of doing trials in India. The main challenges for successful completion of clinical trials stem from regulatory and ethics review, investigator selection, site initiations, participant recruitment and retention, monitoring and data management issues. Careful planning, sorting out ownership issues in the initial steps and a partnership based on shared issues among all the stakeholders will help reduce the trial delays. Such a shared vision will enable adherence to regulatory requirements, enhance the quality of trial conduct and ultimately enable improved access to new treatments and its benefits to the Indian population. Keywords: clinical trial delays • ethics and regulatory issues • participant recruitment and  retention • technological solutions Clinical trials are an essential component of the drug discovery and development pro- cess [1] . On average, a drug spends over 10 years going through different phases of clini- cal trials and regulatory processes to get a marketing authorization (license) [2] . The success of clinical trials is contingent upon timely completion of several sequential pro- cesses: ethics and regulatory review, inves- tigator site selection, site initiations, partici- pant recruitment and follow-up, monitoring and data management, to name a few [3] . Poor management of any of these tasks can affect the performance and outcome of the trial and cause delays, a common problem resulting in increased cost and sometimes premature termination of research [4,5] . Trial delays impose economic and ethical implica- tions: by increasing trial costs for the spon- sor, which may translate into increased cost of drug when approved, and delayed access to better treatments for the society [5–7] . While there is no single remedy for the complex issue of trial delays, in this review we outline the most common causes of trial delays, the consequences and suggest pragmatic solu- tions to alleviate trial delays, in particular context of doing clinical trials in India. Causes, consequences & potential solutions of trial delays Ethics & regulatory review Ethics and regulatory review, while serv- ing an important function to safeguard trial participants, and ensuring scientific credibility of research study, is generally regarded as a cumbersome and time-con- suming process. The ethical and regulatory review in India is still paper based and the whole process takes about a year for mul- ticenter trials. In the recent past, concerns raised by the NGOs regarding unethical practices in clinical trials in India prompted the Supreme Court to intervene and call for an overhaul of the regulatory environ- ment [8,9] . As a consequence, drug trial reg- ulations were amended and new processes to review clinical trial applications and to monitor trial conduct were put in place [10] . The objective was to establish a robust sys- Solving clinical trial delays: innovative solutions Kavita Singh * , M Abdul Salam 1 , Raji Devarajan 2 & Dorairaj Prabhakaran 2 1 The George Institute for Global Health,  Unit No. 301, Second Floor, ANR Center,  Road No.1, Banjara Hills, Hyderabad -  500 034 Telangana, India 2 Centre for Chronic Condition & Injuries,  Public Health Foundation of India, 4th  Floor, Plot No. 47, Sector 44, Institutional  Area, Gurgaon - 122 002, Haryana 3 Department of Endocrinology &  Metabolism, All India Institute of Medical  Sciences, Ansari Nagar, New Delhi -  110029, India *Author for correspondence:  Tel.: +91 9899 69 11 50 kavita@ccdcindia.org