India is poised to become the largest hub of Clinical Research in the world. Many natural & international pharmaceutical companies are already conducting or planning to initiate Clinical Research in India. This means that the next time you go to see your doctor you may be asked to participate in a Clinical Research project.

In its simplest description, it can be considered as research in humans. A more comprehensive but also complicated definition is given by the Association of American Medical Colleges Task Force on Clinical Research as

‘…….a component of medical and health research intended to produce knowledge essential for understanding human disease, preventing and treating illness, and promoting health. Clinical Research embraces a continuum of studies involving interaction with patients, diagnostic clinical materials or data or populations in any of these categories: disease mechanisms; translational research; clinical knowledge; detection; diagnosis and natural history of disease; therapeutic interventions including clinical trials; prevention and health promotion; behavioral research; health services research; epidemiology and community – based and managed care-based research.’

The concept of clinical research is not very clear to the physicians (we have known several experienced and reputed physicians who are excellent at treating patients but poor at planning or conducting research, and that include ourselves, at least in the beginning of our careers), leave alone the general population.

While the physician or the scientist actually carries out the research, it is the patients and healthy volunteers hailing from the lay populace that constitute the other arm of clinical research. Therefore, in our opinion, it is of utmost importance that correct information about clinical research reaches the participating population.

This book aims to provide you with the necessary information that you should possess before you agree to participate in Clinical Research. This book is also an attempt to allay your anxieties and answer most of your queries about participation in Clinical Research so that you become an active participant and not merely a passive observer at the mercy of your doctor.

We have also included a chapter on the process of informed consent. When a researcher asks for your consent to participate in a study, you, by signing the consent form (after understanding what is written there), give permission to the investigator (researcher) to be included in the research study. The book will also help you to find out how and by whom are your rights as research participants ensured. You will also read about ethics committees that function in many institutions in order to safeguard your interests as a research participant.

Finally, one chapter is devoted to the topic of interpreting the research-related news that you come across in lay press. Undue expectations from the results of a published research study or unfounded fears regarding side-effects of drugs are the two extremes to which our lay press devotes considerable space. This book will allow you to objectively analyze such published material and will lead you to ask pertinent questions seeking more information from your physicians before jumping to any conclusions.

We added two chapters as an afterthought. Two events in the recent past, one of the change of patent laws governing drug and the other of surge of advertisements of claims of miraculous cure by complimentary and alternative medicines prompted us to include these two chapters. We feel the first of these two holds its relevance as the change in patent law predicts an increase in research in drug development. The chapter on complimentary and alternative medicine discusses the need, status of research in the field and the issues associated with research in these systems of medicine.

The language of the book has been deliberately kept simple and some of the medical jargon (that you are likely to encounter if you decide to participate in a study) has been explained in layperson’s language. If some sections appear difficult to comprehend, our suggestion will be that you do not pay too much attention and move further. Most of the times, the picture will become clear as you go on reading. Some repetition that you will come across is intentional to emphasize certain key points.

Since everyone falls ill at one time or the other, this book is intended for all of you.

The authors have more than 50 years of collective experience in Clinical Research. All of them are currently working in the Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh, India, which is a premier Institute of the nation. They have more than three hundred publications in national as well as international journals of repute.

Their advice is frequently sought by regulatory authorities, pharmaceutical companies, medical journals  and doctors in matters relating to planning conduct and publication of Clinical Research. They are governed by a passion to make Indian citizens fully versed with the nuances of Clinical Research so that a single patient is exploited.

However, the authors also believe that the benefits of Clinical Research must reach the Indian patients but the patients must also be able to take their own decisions based on their newly acquired knowledge about risks and benefits of Clinical Research.

Many of the incidents referred to in the book have been taken from the personal experiences of the authors. A large part of the book is based on the actual questions asked by the patients.

If there are any doubts or if you require any clarifications you can contact the authors at clinical_research_pgi@yahoo.com.