A Workshop on Research Methodology in Lahore

Dr. Sultan Faisal explaining the process of ethical review at the meeting which took place on March 13th.

A one-day Workshop on Research Methodology was held in Lahore, Pakistan, as part of the Shaukat Khanum Memorial Cancer Hospital & Research Centre (SKMCH&RC) Annual Meeting. Entitled "What you always wanted to know, but were afraid to ask", the program covered all aspects of clinical research, the emphasis being on practical advice for doctors-in-training.

Dr. Asim Amin began by addressing the ethical and practical questions involved in the design and implementation of clinical trials in oncology. Starting with the basic tenets of ethical research, he went on to define the objectives of Phase I, II and III trials, the relationship between them, and their limitations. Dr. Aziza Shad then described the roles of the individuals who comprise the Clinical Research Team, those who actually treat patients, and their relationship with the pharmaceutical house (if involved) and the "Contract Research Organization" (if applicable).

Dr. Faisal Sultan introduced the concept of the Institutional Review Board ("Ethics Committee") by referring to the notorious Tuskegee Syphilis study, conducted over a forty-year period starting in 1932. Four hundred, poor, black, American men were not told that they had syphilis and were not treated for it, even though penicillin was available from 1947. They were, however, offered free medical examinations, meals and even free "burial insurance." As a consequence of the study, numerous people died unnecessarily and many of their wives and children were infected. Fortunately, times have changed. The principles of the Declaration of Helsinki, originally adopted in 1964 and subsequently modified, remain the ethical basis of clinical research to this day. Dr. Sultan explained the process of ethical review, emphazising that consent is "a process, not a document."

Dr. Peter Tutschka and Dr. Stephen Spiro described ways of obtaining funds from abroad for clinical research in developing countries. They recognised that this was difficult, since most funding bodies are national, and pharmaceutical houses are not generally keen to support clinical trials in developing countries. Scholarships and fellowships do exist for people wanting to train in a specific technique or laboratory methodology.

Dr. Zeba Aziz spoke about the importance of clinical research in Pakistan, using breast cancer as an example. She emphazised the necessity of assessing the feasibility and efficacy of a protocol in the country concerned, rather than extrapolating from results obtained under often very different circumstances in the West.

Dr. Ute Hamann and Dr. Suresh Advani went on to discuss very successful research projects conducted in Pakistan and India respectively, Dr. Hamann described a study in Lahore in which groups of newborn children from four different social strata were followed from before birth to five years of age. The study identified areas for intervention and has resulted in several community-based trials for improving maternal and child health in Pakistan.

I talked about how to write an abstract, often a difficult task because it has to be concise and yet convey the hypothesis or question being posed; it must also include the methodology, results and, of course, a conclusion. Above all, the abstract must contain data, otherwise it cannot be judged by the reviewers. Dr. Muhammad Jahanzeb gave advice about how to get a manuscript published. He discussed the most frequent causes of rejection by journals and suggested ways in which that these problems might be overcome. Dr. Nausherwan Burki discussed Writing grant Proposal, describing common pitfalls and misconceptions.

It was an enlightening day for everyone.

Ama Rohatiner, Director of Educational Programs, INCTR