Providing Ancillary Care in Clinical Research: A Case of Diffuse Large B-Cell Lymphoma during a Malaria Vaccine Trial in Equatorial Guinea

Author:

Manock Stephen R.12,Mtoro Ali3,Urbano Nsue Ndong Vicente4,Olotu Ally35,Chemba Mwajuma3,Sama Roca Antonio E.6,Eburi Esther6,García Guillermo A.7,Cortes Falla Carlos6,Niemczura de Carvalho Julie7,Contreras Jaime8,Saturno Baltasar8,Riocalo Juan de Dios8,Nze Mba José Luis9,Koka Rima10,Lee Seung Tae10,Menon Hari11,Church L. W. Preston1,Ayekaba Mitoha Ondo’o4,Billingsley Peter F.1,Abdulla Salim3,Richie Thomas L.1,Hoffman Stephen L.1

Affiliation:

1. 1Sanaria, Inc., Rockville, Maryland;

2. 2Department of Family Medicine, John Peter Smith Hospital, Fort Worth, Texas;

3. 3Ifakara Health Institute, Bagamoyo, Tanzania;

4. 4Ministry of Health and Social Welfare, Malabo, Equatorial Guinea;

5. 5KEMRI Wellcome Trust Research Programme, Kilifi, Kenya;

6. 6Medical Care Development International, Malabo, Equatorial Guinea;

7. 7Medical Care Development International, Silver Spring, Maryland;

8. 8La Paz Medical Center, Malabo, Equatorial Guinea;

9. 9Policlínico Dr. Loeri Comba, Instituto de Seguridad Social, Malabo, Equatorial Guinea;

10. 10University of Maryland Medical Center, Baltimore, Maryland;

11. 11Cytecare Cancer Hospital, Bengaluru, Karnataka, India

Abstract

ABSTRACTProviding medical care for participants in clinical trials in resource-limited settings can be challenging and costly. Evaluation and treatment of a young man who developed cervical lymphadenopathy during a malaria vaccine trial in Equatorial Guinea required concerted efforts of a multinational, multidisciplinary team. Once a diagnosis of diffuse large B-cell lymphoma was made, the patient was taken to India to receive immunochemotherapy. This case demonstrates how high-quality medical care was provided for a serious illness that occurred during a trial that was conducted in a setting in which positron emission tomography for diagnostic staging, an oncologist for supervision of treatment, and an optimal therapeutic intervention were not available. Clinical researchers should anticipate the occurrence of medical conditions among study subjects, clearly delineate the extent to which health care will be provided, and set aside funds commensurate with those commitments.

Publisher

American Society of Tropical Medicine and Hygiene

Subject

Virology,Infectious Diseases,Parasitology

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