Clinical Research: Challenge is big, Returns are bigger
Health and Healing
‘Pill for every ill’ is an old adage, which is being focused and pursued. It may not be possible to have a disease free world but we can definitely aspire for solutions to relieve misery and make patients life comfortable to a great extent. It has been possible to control several fatal diseases during the past 50 years, but many new ones have been added to the sufferings. Thus, there is a great scope to develop novel drugs for treating new diseases and a big concern about improving the therapeutic approach to common ailments. Ultimately, the aim is to ensure good quality of life to patients undergoing treatment. This can only be achieved with quality drugs having maximum therapeutic benefit with minimum side effect, and are available at low cost to all communities.
Now the question is - What if we suffer from a disease which has no definite treatment or whose treatment is extremely expensive or the available drugs have poor efficacy and safety? Thus arises a need for developing a new medicine which can protect us from such diseases, provide relief and that are pocket-friendly. This is achieved through a specialized discipline called 'Clinical Research' which focuses on innovating, developing and turning new molecules into therapeutic drugs. This process of drug development is unique as it involves testing of new drugs on human subjects before getting entry into the market. Human testing is mandatory since animal studies do not give reliable results because of species and genetic differences.
Why develop New Drugs?
1. We have many diseases for which no treatment is available.
2. Many of the available drugs may not be very efficacious or safe.
3. For reducing the cost of treatment of certain diseases.
4. Development of tolerance and resistance against therapeutic drugs.
5. Vaccine development for prevention of diseases.
6. Cosmetics, medical devices and diagnostic equipments need to be updated or evolved.
7. Treating new diseases with available drugs.
The above reasons will always promote the need for testing the effectiveness and safety of therapeutic and diagnostic agents in human subjects before they getting approved for marketing.
Challenges in Medical Research:
How can we conduct experiments on human beings? Is it ethical to do so? How does law permit this? Do we require the consent of the participating subjects? Does the medical fraternity allow such experiments? Are they scientifically acceptable? All these concerns pose a big challenge to medical science which has been addressed through an internationally accepted approach called 'Clinical Trials'. It refers to systematic assessment of the safety and efficacy of an investigational drug on human subjects under controlled experimental conditions.
Several clinical research academies are chipping in to bridge the gap between the current demand and supply. Here the concern is that the curriculum must be based on industry needs both in terms of technical knowledge as well as soft skills that are essential as a team player. These academies should have established a link with the CROs/hospitals providing them with an opportunity to participate in ongoing studies with their freshly acquired knowledge. A well designed program will prepare the candidates for a global career in clinical research industry with a through understanding of the national and International guidelines on patient safety, ethical issues, Standard operating procedures and regulatory environment in various regions of the world.
Deciphering Global Education
Clinical research being a multidisciplinary science offers a good platform to Life Science, Biotechnology, Pharmacy and Medical graduates to shape up their career in this global industry. Depending upon the orientation and interest, one can enter this field as Investigator, Clinical Research Associate, Monitor, Data Safety Manager, Quality Assurance Executive, Regulatory Manager, Medical Writer, Data Manager, Project Manager, Pharmacovigilance Executive, Business Development Executive and go up the ladder to reach the level of being a Global Head. Every member of the study team has a significant role to play for the success of the trial. Various Ethical guidelines and regulatory agencies not only impart projection to the participating subjects but also help in generating data to draw meaningful conclusions. One successful drug changes the face of medical treatment as well as the society.
No wonder, the Challenge is big, but the returns are bigger.
Contributed By:
Dr. Anoop Agarwal
Principal
Institute of Clinical Research (India)
Delhi
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